@Article{info:doi/10.2196/56798, author="Flaucher, Madeleine and Berzins, Sabrina and Jaeger, M. Katharina and Nissen, Michael and Rolny, Jana and Tri{\ss}ler, Patricia and Eckl, Sebastian and Eskofier, M. Bjoern and Leutheuser, Heike", title="Perception and Evaluation of a Knowledge Transfer Concept in a Digital Health Application for Patients With Heart Failure: Mixed Methods Study", journal="JMIR Hum Factors", year="2025", month="Mar", day="31", volume="12", pages="e56798", keywords="health literacy", keywords="digital Literacy", keywords="user-centered design", keywords="digital health app", keywords="heart failure", keywords="mixed methods study", keywords="user centered deign", keywords="usability", keywords="patient engagement", keywords="mHealth app", keywords="development", abstract="Background: Digital health education can enhance the quality of life of patients with heart failure by providing accessible and tailored information, which is essential for effective self-care and self-management. Objective: This work aims to develop a mobile health knowledge transfer concept for heart failure in a user-centered design process grounded in theoretical frameworks. This approach centers on enhancing the usability, patient engagement, and meaningfulness of mobile health education in the context of heart failure. Methods: A user-centered design process was employed. First, semistructured stakeholder interviews were conducted with patients (n=9) and medical experts (n=5). The results were used to develop a health knowledge transfer concept for a mobile health app for heart failure. This concept was implemented as a digital prototype based on an existing German mobile health app for patients with heart failure. We used this prototype to evaluate our concept with patients with heart failure in a study composed of user testing and semistructured patient interviews (n=7). Results: Stakeholder interviews identified five themes relevant to mobile health education: individualization, content relevance, media diversity, motivation strategies, and trust-building mechanisms. The evaluation of our prototype showed that patients value the adaptation of content to individual interests and prior knowledge. Digital rewards such as badges and push notifications can increase motivation and engagement but should be used with care to avoid overload, irrelevance, and repetition. Conclusions: Our findings emphasize the importance of tailoring mobile health education to the specific needs and preferences of patients with heart failure. At the same time, they also highlight the careful implementation of motivation strategies to promote user engagement effectively. These implications offer guidance for developing more impactful interventions to improve health outcomes for this population. ", doi="10.2196/56798", url="https://humanfactors.jmir.org/2025/1/e56798" } @Article{info:doi/10.2196/63057, author="Ullrich, Greta and B{\"a}uerle, Alexander and Vogt, Hannah and Mahabadi, Abbas Amir and Pald{\'a}n, Katrin and Messiha, Daniel and Jahre, Maria Lisa and Rammos, Christos and Rassaf, Tienush and Lortz, Julia", title="Digital Health Literacy and Attitudes Toward eHealth Technologies Among Patients With Cardiovascular Disease and Their Implications for Secondary Prevention: Survey Study", journal="JMIR Form Res", year="2025", month="Mar", day="19", volume="9", pages="e63057", keywords="cardiovascular diseases", keywords="telemedicine", keywords="eHealth", keywords="patient-centered approach", keywords="digital health literacy", keywords="digital health", keywords="cardiovascular disease", keywords="mortality", keywords="artery disease", keywords="ischemic", keywords="heart disease", keywords="diabetes mellitus", keywords="obesity", keywords="patient education", keywords="eHealth literacy", keywords="mobile phone", abstract="Background: Cardiovascular disease is the major cause of death worldwide, leading to a significant socioeconomic burden. Although secondary prevention is a cornerstone in chronic disease management, adherence to guideline recommendations in this regard often falters, leading to suboptimal outcomes. While eHealth technologies are promising for improving treatment adherence, they also represent a new approach to secondary prevention. However, a common critique is that extensive digitalization may not adequately address the needs of older adults with chronic medical conditions. Objective: This study aims to analyze eHealth literacy, digital use patterns, and general attitudes toward digital technologies in a collective of patients with cardiovascular disease to identify potential obstacles in implementing mobile health technologies in secondary preventive therapy. Methods: This survey-based study was a part of the baseline examination of the PreventiPlaque trial. It involved 240 participants with known coronary artery disease. The assessment evaluated their current understanding of the general use of digital devices. The questionnaire covered aspects such as the duration of daily use, personal attitudes, and the perceived burden associated with digital media. eHealth literacy was assessed within the target population and general demographic data were gathered, focusing on cardiovascular comorbidities and risk factors. Results: The analysis revealed an average age of 61.9 (SD 8.9) years, with 59.9\% (n=144) of the participants being male. Overall, 37.3\% (n=90) of the participants had previous knowledge of digital health interventions, while only 17.8\% (n=41) had used them. Despite the generally low practical application within this study population, there was a high level of confidence in handling digital devices, with 61.9\% (n=149) expressing themselves as either rather confident or very confident. Regarding the levels of eHealth literacy among the participants, 71.2\% (n=170) claimed to be familiar with locating health information on the internet, and 64\% (n=153) of participants felt capable of critically evaluating its quality. These levels of digital confidence were consistent across all age groups. Moreover, internet use rates remained high even among the older participants, with 80\% (n=192) of those participants older than 75 years using the internet for 1-3 hours a day. Conclusions: The study unveiled a notable confidence level among participants regarding the use of digital devices, coupled with a favorable attitude toward digital media evident across all age brackets. Remarkably, internet use rates remained high, even among older participants. The actual utilization of digital health interventions was relatively low, potentially stemming from challenges in locating reliable sources. These findings emphasize the prospect of future eHealth interventions customized to the distinct needs and preferences of patients in cardiovascular disease management. Recognizing the incongruity between confidence in device use and the restricted adoption of digital health tools can guide the development of focused interventions to narrow this divide. Trial Registration: ClinicalTrials.gov NCT05096637; https://clinicaltrials.gov/study/NCT05096637 ", doi="10.2196/63057", url="https://formative.jmir.org/2025/1/e63057" } @Article{info:doi/10.2196/63805, author="Jin, Xiaorong and Zhang, Yimei and Zhou, Min and Mei, Qian and Bai, Yangjuan and Hu, Qiulan and Wei, Wei and Zhang, Xiong and Ma, Fang", title="An Actor-Partner Interdependence Mediation Model for Assessing the Association Between Health Literacy and mHealth Use Intention in Dyads of Patients With Chronic Heart Failure and Their Caregivers: Cross-Sectional Study", journal="JMIR Mhealth Uhealth", year="2025", month="Mar", day="6", volume="13", pages="e63805", keywords="chronic heart failure", keywords="caregivers", keywords="health literacy", keywords="mHealth", keywords="actor-partner interdependence mediation model", keywords="mobile health", abstract="Background: Chronic heart failure (CHF) has become a serious threat to the health of the global population. Self-management is the key to treating CHF, and the emergence of mobile health (mHealth) has provided new ideas for the self-management of CHF. Despite the many potential benefits of mHealth, public utilization of mHealth apps is low, and poor health literacy (HL) is a key barrier to mHealth use. However, the mechanism of the influence is unclear. Objective: The aim of this study is to explore the dyadic associations between HL and mHealth usage intentions in dyads of patients with CHF and their caregivers, and the mediating role of mHealth perceived usefulness and perceived ease of use in these associations. Methods: This study had a cross-sectional research design, with a sample of 312 dyads of patients with CHF who had been hospitalized in the cardiology departments of 2 tertiary care hospitals in China from March to October 2023 and their caregivers. A general information questionnaire, the Chinese version of the Heart Failure-Specific Health Literacy Scale, and the mHealth Intention to Use Scale were used to conduct the survey; the data were analyzed using the actor-partner interdependence mediation model. Results: The results of the actor-partner interdependent mediation analysis of HL, perceived usefulness of mHealth, and mHealth use intention among patients with CHF and their caregivers showed that all of the model's actor effects were valid ($\beta$=.26?0.45; P<.001), the partner effects were partially valid ($\beta$=.08?0.20; P<.05), and the mediation effects were valid ($\beta$=.002?0.242, 95\% CI 0.003?0.321; P<.05). Actor-partner interdependent mediation analyses of HL, perceived ease of use of mHealth, and mHealth use intention among patients with CHF and caregivers showed that the model's actor effect partially held ($\beta$=.17?0.71; P<.01), the partner effect partially held ($\beta$=.15; P<.01), and the mediation effect partially held ($\beta$=.355?0.584, 95\% CI 0.234?0.764; P<.001). Conclusions: Our study proposes that the HL of patients with CHF and their caregivers positively contributes to their own intention to use mHealth, suggesting that the use of mHealth by patients with CHF can be promoted by improving the HL of patients and caregivers. Our findings also suggest that the perceived usefulness of patients with CHF and caregivers affects patients' mHealth use intention, and therefore patients with CHF and their caregivers should be involved throughout the mHealth development process to improve the usability of mHealth for both patients and caregivers. This study emphasizes the key role of patients' perception that mHealth is easy to use in facilitating their use of mHealth. Therefore, it is recommended that the development of mHealth should focus on simplifying operational procedures and providing relevant operational training according to the needs of the patients when necessary. ", doi="10.2196/63805", url="https://mhealth.jmir.org/2025/1/e63805" } @Article{info:doi/10.2196/51502, author="Caruso, Rosario and Conte, Gianluca and Castelvecchio, Serenella and Baroni, Irene and Paglione, Giulia and De Angeli, Giada and Pasek, Malgorzata and Magon, Arianna", title="Assessing Preparedness for Self-Management of Oral Anticoagulation in Adults With the PERSONAE Scale: Protocol for a Development and Validation Study", journal="JMIR Res Protoc", year="2025", month="Feb", day="26", volume="14", pages="e51502", keywords="self-monitoring", keywords="self-management", keywords="oral anticoagulation", keywords="vitamin K antagonists", keywords="preparedness", keywords="validation", abstract="Background: Optimal anticoagulation using vitamin K antagonists prevents strokes associated with atrial fibrillation and heart valve replacements. Preparedness for self-monitoring and self-management could improve outcomes, but this remains a challenge. Objective: This study aimed to outline the methodology for developing and validating the PERSONAE scale, a self-report measure designed to assess the preparedness for self-monitoring and self-management of oral anticoagulation in adult patients. Methods: This study comprises 2 main phases, and it adheres to the ``COnsensus-based Standards for the selection of health Measurement INstruments'' (COSMIN) guidelines for instrument development. The first phase involved the conceptualization of the PERSONAE scale, where a comprehensive literature review and a consensus meeting among experts were conducted to draft the initial items. Face and content validity were then established through an expert panel review. In the second phase (ongoing), a detailed sampling methodology will be used, targeting adult Italian patients on long-term oral anticoagulation. According to a performed simulation-based power analysis, the study aims to recruit a sample size of approximately 500 participants by using a combination of convenience and snowball sampling. Data collection will be facilitated through web-based surveys distributed through social media and patient networks, ensuring a wide and representative sample. Analytical procedures will include Mokken scaling analysis for item selection and confirmatory factor analysis to validate the scale's structure. In addition, internal consistency will be assessed using Molenaar Sijtsma statistics. Results: The scale's content derived from phase 1 (process completed in December 2023) is grounded in a comprehensive literature review and based on the assessments of a panel of 12 health care expert professionals. The PERSONAE scale derived from phase 1 encompasses 20 items reflecting essential behaviors needed to assess the preparedness for self-monitoring and self-management of oral anticoagulation. Each item obtained a content validity ratio higher than 0.67, which is the critical content validity ratio indicating the minimum level of agreement among the experts for an item to be considered essential beyond the level of chance at a significance level of .05 for a 1-tailed test. From January 2024 to May 2024, we conducted the initial round of data collection and use Mokken scaling analysis to select items. A second round of data collection for confirmatory factor analysis was scheduled from June 2024 to September 2024, which will validate the scale's unidimensional structure. We expect to achieve robust psychometric properties, including high internal consistency and validated constructs. Conclusions: The PERSONAE scale will be a valuable tool to assess patients' preparedness for self-monitoring and self-management of oral anticoagulation. The study's insights into technology-assisted learning preferences will inform the design of future educational interventions to enhance preparedness in adult patients. Trial Registration: ClinicalTrials.gov NCT05973240; https://clinicaltrials.gov/study/NCT05973240 International Registered Report Identifier (IRRID): PRR1-10.2196/51502 ", doi="10.2196/51502", url="https://www.researchprotocols.org/2025/1/e51502" } @Article{info:doi/10.2196/60256, author="Lunde, Pernille and Bye, Asta and Grimsmo, Jostein and Pripp, Hugo Are and Ritschel, Vibeke and Jarstad, Even and Nilsson, Blakstad Birgitta", title="Effects of Individualized Follow-Up With an App Postcardiac Rehabilitation: Five-Year Follow-Up of a Randomized Controlled Trial", journal="J Med Internet Res", year="2025", month="Feb", day="13", volume="27", pages="e60256", keywords="mHealth", keywords="cardiac rehabilitation", keywords="mobile phone app", keywords="smartphone", keywords="lifestyle", abstract="Background: Adherence to healthy behaviors initiated or adapted during cardiac rehabilitation (CR) remains a significant challenge, with few patients meeting guideline standards for secondary prevention. The use of mobile health (mHealth) interventions has been proposed as a potential solution to improve adherence to healthy behaviors after CR. In particular, app-based interventions have shown promise due to their ability to provide monitoring and feedback anytime and anywhere. Growing evidence supports the use of apps in post-CR settings to enhance adherence. In 2020, we demonstrated that individualized follow-up via an app increased adherence to healthy behaviors 1 year after CR. However, it remains uncertain whether these effects persist once the follow-up is discontinued. Objective: This study aims to evaluate the long-term effects of individualized follow-up using an app, assessed 4 years after the intervention. Methods: A single-blinded multicenter randomized controlled trial was conducted. Patients were recruited from 2 CR centers in eastern Norway. The intervention group (IG) received individualized follow-up through an app for 1 year, while the control group (CG) received usual care. After the 1-year follow-up, the app-based follow-up was discontinued for the IG, and both groups were encouraged to maintain or improve their healthy behaviors based on their individual risk profiles. The primary outcome was the difference in peak oxygen uptake (VO2peak). The secondary outcomes included exercise performance, body weight, blood pressure, lipid profile, exercise habits, health-related quality of life, health status, cardiac events, and physical activity. Linear mixed models for repeated measurements were used to analyze differences between groups. All tests were 2-sided, and P values ?0.05 were considered statistically significant. Results: At the 5-year follow-up, 101 out of the initial 113 randomized participants were reassessed. Intention-to-treat analyses, using a mixed model for repeated measurements, revealed a statistically significant difference (P=.04) in exercise habits in favor of the IG, with a mean difference of 0.67 (95\% CI 0.04-1.29) exercise sessions per week. Statistically significant differences were also observed in triglycerides (mean difference 0.40, 95\% CI 0.00-0.79 mmol/l, P=.048) and walking (P=.03), but these were in favor of the CG. No differences were found between the groups for other evaluated outcomes. Conclusions: Most of the benefits derived from the app-based follow-up diminished by 4 years after the intervention. Although the IG reported statistically significantly higher levels of exercise, this did not translate into improved VO2peak or exercise performance. Our study highlights the need for follow-up from health care providers to enhance adherence to healthy behaviors in the long term following CR. Trial Registration: ClinicalTrials.gov NCT03174106; https://clinicaltrials.gov/ct2/show/NCT03174106 (original study protocol) and NCT05697120; https://clinicaltrials.gov/ct2/show/NCT05697120 (updated study protocol) ", doi="10.2196/60256", url="https://www.jmir.org/2025/1/e60256" } @Article{info:doi/10.2196/64410, author="Yu, Tianzhuo and Parry, Monica and Yu, Tianyue and Xu, Linqi and Wu, Yuejin and Zeng, Ting and Leng, Xin and Tong, Qian and Li, Feng", title="Effectiveness of Mobile Health--Based Gamification Interventions for Improving Physical Activity in Individuals With Cardiovascular Diseases: Systematic Review and Meta-Analysis of Randomized Controlled Trials", journal="JMIR Serious Games", year="2025", month="Jan", day="24", volume="13", pages="e64410", keywords="cardiovascular diseases", keywords="digital health", keywords="mobile health", keywords="gamification", keywords="exercise", keywords="physical activity", keywords="systematic review", keywords="meta-analysis", abstract="Background: Gamification refers to using game design elements in nongame contexts. Promoting physical activity (PA) through gamification is a novel and promising avenue for improving lifestyles and mitigating the advancement of cardiovascular diseases (CVDs). However, evidence of its effectiveness remains mixed. Objective: This systematic review and meta-analysis aimed to evaluate the efficacy of gamification interventions in promoting PA during short-term and follow-up periods in individuals with CVDs and to explore the most effective game design elements. Methods: A comprehensive search of 7 electronic databases was conducted for randomized controlled trials published in English from January 1, 2010, to February 3, 2024. Eligible studies used mobile health--based gamification interventions to promote PA or reduce sedentary behavior in individuals with CVDs. In total, 2 independent reviewers screened the retrieved records, extracted data, and evaluated the risk of bias using the RoB 2 tool. Discrepancies were resolved by a third reviewer. Meta-analyses were performed using a random-effects model with the Sidik-Jonkman method adjusted by the Knapp-Hartung method. Sensitivity analysis and influence analysis examined the robustness of results, while prediction intervals indicated heterogeneity. A meta-regression using a multimodel inference approach explored the most important game design elements. Statistical analyses were conducted using R (version 4.3.2; R Foundation for Statistical Computing). Results: In total, 6 randomized controlled trials were included. Meta-analysis of 5 studies revealed a small effect of gamification interventions on short-term PA (after sensitivity analysis: Hedges g=0.32, 95\% CI 0.19-0.45, 95\% prediction interval [PI] 0.02-0.62). Meta-analysis of 3 studies found the maintenance effect (measured with follow-up averaging 2.5 months after the end of the intervention) was small (Hedges g=0.20, 95\% CI 0.12-0.29, 95\% PI --0.01 to 0.41). A meta-analysis of 3 studies found participants taking 696.96 more steps per day than the control group (95\% CI 327.80 to 1066.12, 95\% PI --121.39 to 1515.31). ``Feedback'' was the most important game design element, followed by ``Avatar.'' Conclusions: This meta-analysis demonstrates that gamification interventions effectively promote PA in individuals with CVD, with effects persisting beyond the intervention period, indicating they are not merely novel effects caused by the game nature of gamification. The 95\% PI suggests that implementing gamification interventions in similar populations in the future will lead to actual effects in promoting PA in the vast majority of cases. However, the limited number of included studies underscores the urgent need for more high-quality research in this emerging field. Trial Registration: PROSPERO CRD42024518795; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=518795 ", doi="10.2196/64410", url="https://games.jmir.org/2025/1/e64410" } @Article{info:doi/10.2196/50693, author="Ehrler, Frederic and Gschwind, Liliane and Hagberg, Hamdi and Meyer, Philippe and Blondon, Katherine", title="A Medication Management App (Smart-Meds) for Patients After an Acute Coronary Syndrome: Pilot Pre-Post Mixed Methods Study", journal="JMIR Cardio", year="2025", month="Jan", day="23", volume="9", pages="e50693", keywords="medication adherence", keywords="gamified app", keywords="narration", keywords="acute coronary syndrome", keywords="beliefs about medication", keywords="self-reported adherence", keywords="pilot study", keywords="usability evaluation", keywords="storytelling component", abstract="Background: Medication nonadherence remains a significant challenge in the management of chronic conditions, often leading to suboptimal treatment outcomes and increased health care costs. Innovative interventions that address the underlying factors contributing to nonadherence are needed. Gamified mobile apps have shown promise in promoting behavior change and engagement. Objective: This pilot study aimed to evaluate the efficacy and usability of a gamified mobile app that used a narrative storytelling approach to enhance medication adherence among patients following acute coronary syndrome (ACS). The study aimed to assess changes in participants' beliefs about medication and self-reported adherence before and after the intervention. Additionally, user feedback regarding the narrative component of the app was gathered. Methods: Overall, 18 patients who recently experienced ACS were recruited for a 1-month intervention using the gamified app. Participants' beliefs about medication and self-reported adherence were assessed using standardized scales pre- and postintervention. The app's usability was also evaluated through a postintervention questionnaire. Statistical analyses were performed to determine the significance of changes in belief and adherence scores. Results: Although 33\% (6/18) of the participants did not use the intervention more than once, the remaining 12 remained engaged during the 30 days of the study. The results did not indicate a significant improvement in participants' beliefs about medication following the intervention. However, self-reported adherence significantly improved (P<.05) after the intervention with a mean score going from 29.1 (SD 6.9) to 32.4 (SD 5.6), with participants demonstrating a greater self-efficacy to their prescribed medication regimen. However, the results did not indicate a significant improvement in participants' beliefs about medication. With a mean average score of 80.6, the usability evaluation indicates a good usability rating for the gamified app. However, the narrative storytelling component of the app was not favored by the participants, as indicated by their feedback. Conclusions: This pilot study suggests that a gamified mobile app using narration may effectively enhance medication self-efficacy and positively influence patients' beliefs about medication following ACS. However, the narrative component of the app did not receive favorable feedback from participants. Future research should focus on exploring alternative methods to engage participants in the app's narrative elements while maintaining the positive impact on adherence and beliefs about medication observed in this study. ", doi="10.2196/50693", url="https://cardio.jmir.org/2025/1/e50693" } @Article{info:doi/10.2196/55586, author="Kitsiou, Spyros and Gerber, S. Ben and Buchholz, W. Susan and Kansal, M. Mayank and Sun, Jiehuan and Pressler, J. Susan", title="Patient-Centered mHealth Intervention to Improve Self-Care in Patients With Chronic Heart Failure: Phase 1 Randomized Controlled Trial", journal="J Med Internet Res", year="2025", month="Jan", day="15", volume="27", pages="e55586", keywords="mHealth", keywords="app", keywords="digital health", keywords="telehealth", keywords="text messaging", keywords="smartphone", keywords="wearable electronic devices", keywords="heart failure", keywords="self-care", keywords="self-management", keywords="randomized controlled trial", keywords="cardiology", keywords="SMS", abstract="Background: Heart failure (HF) is one of the most common causes of hospital readmission in the United States. These hospitalizations are often driven by insufficient self-care. Commercial mobile health (mHealth) technologies, such as consumer-grade apps and wearable devices, offer opportunities for improving HF self-care, but their efficacy remains largely underexplored. Objective: The objective of this study was to examine the feasibility, acceptability, safety, and preliminary efficacy of a patient-centered mHealth intervention (iCardia4HF) that integrates 3 consumer mHealth apps and devices (Heart Failure Health Storylines, Fitbit, and Withings) with a program of individually tailored SMS text messages to improve HF self-care. Methods: We conducted a phase 1 randomized controlled trial. Eligible patients had stage C HF, were aged ?40 years, and had New York Heart Association (NYHA) class I, II, or III HF. Patients were randomly assigned to either iCardia4HF plus usual care or to usual care only and were observed for 8 weeks. Key feasibility measures were recruitment and retention rates. The primary efficacy outcome was change in HF self-care subscale scores (maintenance, symptom perception, and self-care management) at 8 weeks, assessed with the Self-Care Heart Failure Index (SCHFI; version 7.2). Key secondary outcomes were modifiable behaviors targeted by the intervention (health beliefs, self-efficacy, and HF knowledge), health status, and adherence to daily self-monitoring of 2 core vital signs (body weight and blood pressure). Results: A total of 27 patients were enrolled in the study and randomly assigned to iCardia4HF (n=13, 48\%) or usual care (n=14, 52\%). Of these 27 patients, 11 (41\%) in the intervention group (iCardia4HF) and 14 (52\%) in the usual care group started their assigned care and were included in the full analysis. Patients' mean age was 56 (SD 8.3) years, 44\% (11/25) were female, 92\% (23/25) self-reported race as Black, 76\% (19/25) had NYHA class II or III HF, and 60\% (15/25) had HF with reduced left ventricular ejection fraction. Participant retention, completion of study visits, and adherence to using the mHealth apps and devices for daily self-monitoring were high (>80\%). At 8 weeks, the mean group differences in changes in the SCHFI subscale scores favored the intervention over the control group: maintenance (Cohen d=0.19, 95\% CI --0.65 to 1.02), symptom perception (Cohen d=0.33, 95\% CI --0.51 to 1.17), and self-care management (Cohen d=0.25, 95\% CI --0.55 to 1.04). The greatest improvements in terms of effect size were observed in self-efficacy (Cohen d=0.68) and health beliefs about medication adherence (Cohen d=0.63) and self-monitoring adherence (Cohen d=0.94). There were no adverse events due to the intervention. Conclusions: iCardia4HF was found to be feasible, acceptable, and safe. A larger trial with a longer follow-up duration is warranted to examine its efficacy among patients with HF. Trial Registration: ClinicalTrials.gov NCT03642275; https://clinicaltrials.gov/study/NCT03642275 ", doi="10.2196/55586", url="https://www.jmir.org/2025/1/e55586" } @Article{info:doi/10.2196/63941, author="Simioni, Lisa and Tessitore, Elena and Hagberg, Hamdi and Schneider-Paccot, Aur{\'e}lie and Blondon, Katherine and Gschwind, Liliane and Meyer, Philippe and Ehrler, Frederic", title="Cardiomeds, an mHealth App for Self-Management to Support Swiss Patients With Heart Failure: 2-Stage Mixed Methods Usability Study", journal="JMIR Form Res", year="2025", month="Jan", day="15", volume="9", pages="e63941", keywords="usability", keywords="medication", keywords="mobile health", keywords="mHealth", keywords="Cardiomeds", keywords="mobile app", keywords="patient empowerment", keywords="eHealth", keywords="smartphone", keywords="heart failure", keywords="HF", keywords="chronic disease", keywords="interactive", keywords="self-monitoring", keywords="usability test", keywords="mobile phone", abstract="Background: Mobile health apps have shown promising results in improving self-management of several chronic diseases in patients. We have developed a mobile health app (Cardiomeds) dedicated to patients with heart failure (HF). This app includes an interactive medication list; daily self-monitoring of symptoms, weight, blood pressure, and heart rate; and educational information on HF delivered through various formats. Objective: This study aimed to perform a mixed methods usability study of Cardiomeds. Methods: Smartphone users with HF were recruited from the HF outpatient clinic at the University Hospital of Geneva. The usability test was conducted in 2 stages, with modifications made to the app after the first stage to address major usability issues. Each stage required 10 participants to perform 14 tasks, such as entering vital signs, entering a new medication and time of intake, or finding information about HF. Each task was timed, sessions were recorded, and all data were anonymized. After completing the tasks, patients completed the System Usability Scale 10-item questionnaire and answered 5 open questions about their perceptions of Cardiomeds. Results: Twenty patients with HF, 75\% (15/20) of whom were men, with a mean age of 55 years, were included in this study. The average time to complete all 14 tasks was 18 (SD 5.7) minutes. Manual medication entry was the most time-consuming task, taking an average of 154.40 (SD 68.08) seconds in the first stage, 103.10 (SD 42.76) seconds in the second stage, and 128 (SD 63) seconds overall. The mean overall success rate was 77\% (SD 0.23\%) for the first stage and 94\% (SD 0.07\%) for the second stage. A total of 30\% (3/10) of participants in the first stage completed all tasks without any help compared with 50\% (5/10) of participants during the second stage. The average System Usability Scale score was 80\% (SD 17\%), showing a slight increase from 79\% (SD 16\%) in the first stage to 80\% (SD 28\%) in the second stage, which qualifies the app as ``good'' in terms of usability. Between the 2 stages, part of the app interface was redesigned to address the key issues identified in the first stage. Despite these improvements, problems related to guidance were frequent and comprised 36\% (8/22) of the problems in the first stage and 40\% (6/15) in the second stage. In response to open questions, 85\% (17/20) of the participants responded that they would like to use the app when it became available. Conclusions: The usability test indicated that Cardiomeds is a suitable and user-friendly app for patients with HF. The app will be further tested in a randomized clinical trial (2022-00731) after acute HF hospitalization to assess its impact on patients' knowledge about HF, self-care, and quality of life. ", doi="10.2196/63941", url="https://formative.jmir.org/2025/1/e63941", url="http://www.ncbi.nlm.nih.gov/pubmed/39813081" } @Article{info:doi/10.2196/65981, author="Sakairi, Mizuki and Miyagami, Taiju and Tabata, Hiroki and Yanagisawa, Naotake and Saita, Mizue and Suzuki, Mai and Fujibayashi, Kazutoshi and Fukuda, Hiroshi and Naito, Toshio", title="Efficacy of Unsupervised YouTube Dance Exercise for Patients With Hypertension: Randomized Controlled Trial", journal="JMIR Cardio", year="2025", month="Jan", day="9", volume="9", pages="e65981", keywords="dance", keywords="video", keywords="exercise therapy", keywords="hypertension", keywords="blood pressure therapy", keywords="YouTube", keywords="mHealth", abstract="Background: High blood pressure (BP) is linked to unhealthy lifestyles, and its treatment includes medications and exercise therapy. Many previous studies have evaluated the effects of exercise on BP improvement; however, exercise requires securing a location, time, and staff, which can be challenging in clinical settings. The antihypertensive effects of dance exercise for patients with hypertension have already been verified, and it has been found that adherence and dropout rates are better compared to other forms of exercise. If the burden of providing dance instruction is reduced, dance exercise will become a highly useful intervention for hypertension treatment. Objective: This study aims to investigate the effects of regular exercise therapy using dance videos on the BP of patients with hypertension, with the goal of providing a reference for prescribing exercise therapy that is highly feasible in clinical settings. Methods: This nonblind, double-arm, randomized controlled trial was conducted at Juntendo University, Tokyo, from April to December 2023. A total of 40 patients with hypertension were randomly assigned to either an intervention group (dance) or a control group (self-selected exercise), with each group comprising 20 participants. The intervention group performed daily dance exercises using street dance videos (10 min per video) uploaded to YouTube. The control group was instructed to choose any exercise other than dance and perform it for 10 minutes each day. The activity levels of the participants were monitored using a triaxial accelerometer. BP and body composition were measured on the day of participation and after 2 months. During the intervention period, we did not provide exercise instruction or supervise participants' activities. Results: A total of 34 patients were included in the study (16 in the intervention group and 18 in the control group). The exclusion criteria were the absence of BP data, medication changes, or withdrawal from the study. The mean age was 56 (SD 9.8) years, and 18 (53\%) of the patients were female. The mean BMI was 28.0 (SD 6.3) m/kg2, and systolic blood pressure (SBP) and diastolic blood pressure (DBP) were 139.5 (SD 17.1) mm Hg and 85.8 (SD 9.1) mm Hg, respectively. The basic characteristics did not differ between the two groups. In the multivariate analysis, SBP and DBP improved significantly in the intervention group compared to the control group (mean SBP --12.8, SD 6.1 mm Hg; P=.047; mean DBP --9.7, SD 3.3 mm Hg; P=.006). Conclusions: This study evaluated the effects of dance exercise on patients with hypertension, as previously verified, under the additional condition of using dance videos without direct staff instruction or supervision. The results showed that dance videos were more effective in lowering BP than conventional exercise prescriptions. Trial Registration: University Hospital Medical Information Network UMIN 000051251; https://center6.umin.ac.jp/cgi-open-bin/ctr\_e/ctr\_view.cgi?recptno=R000058446 ", doi="10.2196/65981", url="https://cardio.jmir.org/2025/1/e65981" } @Article{info:doi/10.2196/54524, author="Deka, Pallav and Salahshurian, Erin and Ng, Teresa and Buchholz, W. Susan and Klompstra, Leonie and Alonso, Windy", title="Use of mHealth Technology for Improving Exercise Adherence in Patients With Heart Failure: Systematic Review", journal="J Med Internet Res", year="2025", month="Jan", day="9", volume="27", pages="e54524", keywords="adherence", keywords="activity monitors", keywords="exercise", keywords="heart failure", keywords="mHealth", keywords="mobile health", keywords="smartphone", keywords="videoconferencing", keywords="heart", keywords="mHealth technology", keywords="exercise programs", keywords="age", keywords="sex", keywords="race", keywords="telehealth technology", keywords="software apps", keywords="feasibility", keywords="mobile phone", abstract="Background: The known and established benefits of exercise in patients with heart failure (HF) are often hampered by low exercise adherence. Mobile health (mHealth) technology provides opportunities to overcome barriers to exercise adherence in this population. Objective: This systematic review builds on prior research to (1) describe study characteristics of mHealth interventions for exercise adherence in HF including details of sample demographics, sample sizes, exercise programs, and theoretical frameworks; (2) summarize types of mHealth technology used to improve exercise adherence in patients with HF; (3) highlight how the term ``adherence'' was defined and how it was measured across mHealth studies and adherence achieved; and (4) highlight the effect of age, sex, race, New York Heart Association (NYHA) functional classification, and HF etiology (systolic vs diastolic) on exercise adherence. Methods: We searched for papers in PubMed, MEDLINE, and CINAHL databases and included studies published between January 1, 2015, and June 30, 2022. The risk of bias was analyzed. Results: In total, 8 studies (4 randomized controlled trials and 4 quasi-experimental trials) met our inclusion and exclusion criteria. A moderate to high risk of bias was noted in the studies. All studies included patients with HF in NYHA classification I-III, with sample sizes ranging from 12 to 81 and study durations lasting 4 to 26 weeks. Six studies had an equal distribution of male and female participants whose ages ranged between 53 and 73 years. Videoconferencing was used in 4 studies, while 4 studies used smartphone apps. Three studies using videoconferencing included an intervention that engaged participants in a group setting. A total of 1 study used a yoga program, 1 study used a walking program, 1 study combined jogging with walking, 1 study used a cycle ergometer, 2 studies combined walking with cycle ergometry, and 1 study used a stepper. Two studies incorporated resistance exercises in their program. Exercise programs varied, ranging between 3 and 5 days of exercise per week, with exercise sessions ranging from 30 to 60 minutes. The Borg rating of perceived exertion scale was mostly used to regulate exercise intensity, with 3 studies using heart rate monitoring using a Fitbit. Only 1 study implicitly mentions developing their intervention using a theoretical framework. Adherence was reported to the investigator-developed exercise programs. All studies were mostly feasibility or pilot studies, and the?effect of age, sex, race, and NYHA classification on exercise adherence with the use of mHealth was not reported. Conclusions: The results show some preliminary evidence of the feasibility of using mHealth technology for building exercise adherence in patients with HF; however, theoretically sound and fully powered studies, including studies on minoritized communities, are lacking. In addition, the sustainability of adherence beyond the intervention period is unknown. ", doi="10.2196/54524", url="https://www.jmir.org/2025/1/e54524" } @Article{info:doi/10.2196/54871, author="Ceugniez, Maxime and Devanne, Herv{\'e} and Hermand, Eric", title="Reliability and Accuracy of the Fitbit Charge 4 Photoplethysmography Heart Rate Sensor in Ecological Conditions: Validation Study", journal="JMIR Mhealth Uhealth", year="2025", month="Jan", day="8", volume="13", pages="e54871", keywords="photoplethysmography", keywords="physical activity", keywords="ecological conditions", keywords="accuracy", keywords="reliability", keywords="Fitbit Charge 4", keywords="Fitbit", keywords="exercise", keywords="ecological", keywords="wrist-worn device", keywords="device", keywords="sensor", keywords="wearables", keywords="usefulness", keywords="variability", keywords="sensitivity", keywords="heart rate", keywords="heart rate sensor", abstract="Background: Wrist-worn photoplethysmography (PPG) sensors allow for continuous heart rate (HR) measurement without the inconveniences of wearing a chest belt. Although green light PPG technology reduces HR measurement motion artifacts, only a limited number of studies have investigated the reliability and accuracy of wearables in non--laboratory-controlled conditions with actual specific and various physical activity movements. Objective: The purpose of this study was to (1) assess the reliability and accuracy of the PPG-based HR sensor of the Fitbit Charge 4 (FC4) in ecological conditions and (2) quantify the potential variability caused by the nature of activities. Methods: We collected HR data from participants who performed badminton, tennis, orienteering running, running, cycling, and soccer while simultaneously wearing the FC4 and the Polar H10 chest belt (criterion sensor). Skin tone was assessed with the Fitzpatrick Skin Scale. Once data from the FC4 and criterion data were synchronized, accuracy and reliability analyses were performed, using intraclass correlation coefficients (ICCs), Lin concordance correlation coefficients (CCCs), mean absolute percentage errors (MAPEs), and Bland-Altman tests. A linear univariate model was also used to evaluate the effect of skin tone on bias. All analyses were stratified by activity and pooled activity types (racket sports and running sports). Results: A total of 77.5 hours of HR recordings from 26 participants (age: mean 21.1, SD 5.8 years) were analyzed. The highest reliability was found for running sports, with ICCs and CCCs of 0.90 and 0.99 for running and 0.80 and 0.93 for orienteering running, respectively, whereas the ICCs and CCCs were 0.37 and 0.78, 0.42 and 0.88, 0.65 and 0.97, and 0.49 and 0.81 for badminton, tennis, cycling, and soccer, respectively. We found the highest accuracy for running (bias: 0.1 beats per minute [bpm]; MAPE 1.2\%, SD 4.6\%) and the lowest for badminton (bias: ?16.5 bpm; MAPE 16.2\%, SD 14.4\%) and soccer (bias: ?16.5 bpm; MAPE 17.5\%, SD 20.8\%). Limit of agreement (LOA) width and artifact rate followed the same trend. No effect of skin tone was observed on bias. Conclusions: LOA width, bias, and MAPE results found for racket sports and soccer suggest a high sensitivity to motion artifacts for activities that involve ``sharp'' and random arm movements. In this study, we did not measure arm motion, which limits our results. However, whereas individuals might benefit from using the FC4 for casual training in aerobic sports, we cannot recommend the use of the FC4 for specific purposes requiring high reliability and accuracy, such as research purposes. ", doi="10.2196/54871", url="https://mhealth.jmir.org/2025/1/e54871" } @Article{info:doi/10.2196/60117, author="Malhotra, Chetna and Yee, Alethea and Ramakrishnan, Chandrika and Kaurani, Naraindas Sanam and Chua, Ivy and Lakin, R. Joshua and Sim, David and Balakrishnan, Iswaree and Ling, Jin Vera Goh and Weiliang, Huang and Ling, Fong Lee and Pollak, I. Kathryn", title="Development and Usability of an Advance Care Planning Website (My Voice) to Empower Patients With Heart Failure and Their Caregivers: Mixed Methods Study", journal="JMIR Aging", year="2024", month="Dec", day="18", volume="7", pages="e60117", keywords="advance care planning", keywords="decision aid", keywords="heart", keywords="website", keywords="heart failure", keywords="care plan", keywords="caregiver", keywords="usability", keywords="acceptability", abstract="Background: Web-based advance care planning (ACP) interventions offer a promising solution to improve ACP engagement, but none are specifically designed to meet the needs of patients with heart failure and their caregivers. Objective: We aimed to develop and assess the usability and acceptability of a web-based ACP decision aid called ``My Voice,'' which is tailored for patients with heart failure and their caregivers. Methods: This study's team and advisory board codeveloped the content for both patient and caregiver modules in ``My Voice.'' Using a mixed methods approach, we iteratively tested usability and acceptability, incorporating feedback from patients, caregivers, and health care professionals (HCPs). Results: We interviewed 30 participants (11 patients, 9 caregivers, and 10 HCPs). Participants found the website easy to navigate, with simple and clear content facilitating communication of patients' values and goals. They also appreciated that it allowed them to revisit their care goals periodically. The average System Usability Scale score was 74 (SD 14.8; range: 42.5-95), indicating good usability. Over 80\% (8/11) of patients and 87\% (7/8) of caregivers rated the website's acceptability as good or excellent. Additionally, 70\% (7/10) of HCPs strongly agreed or agreed with 11 of the 15 items testing the website's acceptability. Conclusions: ``My Voice'' shows promise as a tool for patients with heart failure to initiate and revisit ACP conversations with HCPs and caregivers. We will evaluate its efficacy in improving patient and caregiver outcomes in a randomized controlled trial. Trial Registration: ClinicalTrials.gov NCT06090734; https://clinicaltrials.gov/study/NCT06090734 ", doi="10.2196/60117", url="https://aging.jmir.org/2024/1/e60117" } @Article{info:doi/10.2196/63391, author="Spethmann, Sebastian and Hindricks, Gerhard and Koehler, Kerstin and Stoerk, Stefan and Angermann, E. Christiane and B{\"o}hm, Michael and Assmus, Birgit and Winkler, Sebastian and M{\"o}ckel, Martin and Mittermaier, Mirja and Lelgemann, Monika and Reuter, Daniel and Bosch, Ralph and Albrecht, Alexander and von Haehling, Stephan and Helms, M. Thomas and Sack, Stefan and Bekfani, Tarek and Gr{\"o}schel, Wolfgang Jan and Koehler, Magdalena and Melzer, Christoph and Wintrich, Jan and Zippel-Schultz, Bettina and Ertl, Georg and Vogelmeier, Claus and Dagres, Nikolaos and Zernikow, Jasmin and Koehler, Friedrich", title="Telemonitoring for Chronic Heart Failure: Narrative Review of the 20-Year Journey From Concept to Standard Care in Germany", journal="J Med Internet Res", year="2024", month="Dec", day="4", volume="26", pages="e63391", keywords="telemedicine", keywords="e-counseling", keywords="heart decompensation", keywords="Europe", keywords="patient care management", abstract="Background: Chronic heart failure (CHF) is a major cause of morbidity and mortality worldwide, placing a significant burden on health care systems. The concept of telemedicine for CHF was first introduced in the late 1990s, and since 2010, studies have demonstrated its potential to improve patient outcomes and reduce health care costs. Over the following decade, technological advancements and changes in health care policy led to the development of more sophisticated telemedicine solutions for CHF, including remote patient management through invasive or noninvasive telemonitoring devices, mobile apps, and virtual consultations. Years of public funding in Germany have generated evidence that remote patient management improves outcomes for patients with CHF, such as quality of life, and reduces hospital admissions. Based on these data, the Federal Joint Committee (Gemeinsamer Bundesausschuss; G-BA) decided, independently of the current European Society of Cardiology recommendations, to incorporate telemedicine as a standard digital intervention for high-risk patients with reduced left ventricular ejection fraction in Germany in 2020. Objective: This review aims to illustrate the journey from the initial concept through pioneering studies that led to telemedicine's integration into standard care, and to share current experiences that have positioned Germany as a leader in cardiovascular telemedicine. Methods: We review and discuss existing literature and evidence on the development and implementation of telemonitoring for CHF in Germany over the past 20 years. Relevant studies, reports, and guidelines were identified through a comprehensive search of electronic databases, including PubMed, Google Scholar, and specialized journals focused on CHF telemonitoring. Results: Pioneering studies, such as the TIM-HF2 (Telemedical Interventional Management in Heart Failure II) and IN-TIME (Influence of Home Monitoring on Mortality and Morbidity in Heart Failure Patients with Impaired Left Ventricular Function) trials, demonstrated the effectiveness of remote patient management applications for patients with CHF in Germany and their applicability to current practices involving both invasive and noninvasive methods. Collaborations between researchers and technology developers overcame barriers, leading to sustainable improvements in patient care. Ongoing research on artificial intelligence applications for prioritizing and interpreting individual health data will continue to transform digital health care. Conclusions: The establishment of telemedical care for patients with HF across Europe is likely to benefit from experiences in Germany, where significant improvements have been achieved in the care of patients with HF. ", doi="10.2196/63391", url="https://www.jmir.org/2024/1/e63391" } @Article{info:doi/10.2196/52266, author="Matsumura, Koichiro and Nakagomi, Atsushi and Yagi, Eijiro and Yamada, Nobuhiro and Funauchi, Yohei and Kakehi, Kazuyoshi and Yoshida, Ayano and Kawamura, Takayuki and Ueno, Masafumi and Nakazawa, Gaku and Tabuchi, Takahiro", title="Impact of an mHealth App (Kencom) on Patients With Untreated Hypertension Initiating Antihypertensive Medications: Real-World Cohort Study", journal="JMIR Cardio", year="2024", month="Nov", day="26", volume="8", pages="e52266", keywords="untreated hypertension", keywords="mobile health app", keywords="antihypertensive medication", keywords="cardiovascular disease", keywords="mHealth", abstract="Background: To prevent the further development of cardiovascular diseases, it is a growing global priority to detect untreated hypertension in patients and ensure adequate blood pressure control via drug therapy. However, few effective tools that facilitate the initiation of antihypertensive medications among such patients have been identified. Objective: We aimed to determine whether a mobile health (mHealth) app facilitates the initiation of antihypertensive medications among patients with untreated hypertension. Methods: We analyzed a large longitudinal integrated database mainly comprised of data from middle-aged, employed people and their families. The database contained data from health checkups, health insurance claims, and the mHealth app kencom. kencom is used to manage daily life logs (eg, weight, number of steps) and to provide health information tailored to customers. Patients with untreated hypertension were identified using the baseline health checkup data, and follow-up health checkups were conducted to identify the rate of initiation of antihypertensive medications between mHealth app users and nonusers. Antihypertensive medication status was confirmed via a questionnaire administered during the medical checkup as well as a review of the health insurance claims database. We conducted a modified Poisson regression analysis, weighted by inverse probability of treatment weighting, to examine the effect of mHealth app usage on the initiation of antihypertensive medications. Additionally, data from four lifestyle questionnaires from the baseline and follow-up health checkups were collected to evaluate lifestyle modifications that could be attributed to the mHealth app. Results: Data were collected from 50,803 eligible patients (mean age 49, SD 9 years; men n=39,412, 77.6\%; women n=11,391, 22.4\%) with a median follow-up period of 3.0 (IQR 2.3?3.1) years. The rate of initiation of antihypertensive medications was significantly higher in the mHealth app user group than in the nonuser group: 23.4\% (3482/14,879) versus 18.5\% (6646/35,924; P<.001), respectively. The risk ratio of mHealth app usage for initiated antihypertensive medications was 1.28 (95\% CI 1.23?1.33). Among those who did not intend to improve their lifestyle habits such as exercise and diet at baseline, the rate of lifestyle improvement at follow-up was compared between mHealth app users and nonusers, using data from the questionnaires; mHealth app users demonstrated a significantly higher rate of lifestyle changes than nonusers. Conclusions: For patients with untreated hypertension, the use of the mHealth app kencom, which was not dedicated to hypertension treatment, was associated with a higher initiation of antihypertensive medications. ", doi="10.2196/52266", url="https://cardio.jmir.org/2024/1/e52266" } @Article{info:doi/10.2196/54978, author="Zhou, You and Li, Si-Jia and Huang, Ren-Qian and Ma, Hao-Ming and Wang, Ao-Qi and Tang, Xing-Yi and Pei, Run-Yuan and Piao, Mei-Hua", title="Behavior Change Techniques Used in Self-Management Interventions Based on mHealth Apps for Adults With Hypertension: Systematic Review and Meta-Analysis of Randomized Controlled Trials", journal="J Med Internet Res", year="2024", month="Oct", day="22", volume="26", pages="e54978", keywords="hypertension", keywords="mHealth", keywords="app", keywords="behavior change technique", keywords="systematic review", keywords="meta-analysis", keywords="mobile phone", abstract="Background: Hypertension has become an important global public health challenge. Mobile health (mHealth) intervention is a viable strategy to improve outcomes for patients with hypertension. However, evidence on the effect of mHealth app interventions on self-management in patients with hypertension is yet to be updated, and the active ingredients promoting behavior change in interventions remain unclear. Objective: We aimed to evaluate the effect of mHealth app self-management interventions on blood pressure (BP) management and investigate the use of behavior change techniques (BCTs) in mHealth app interventions. Methods: We conducted a literature search in 6 electronic databases from January 2009 to October 2023 for studies reporting the application of mHealth apps in self-management interventions. The Cochrane Risk of Bias (version 2) tool for randomized controlled trials was used to assess the quality of the studies. BCTs were coded according to the Taxonomy of BCTs (version 1). The extracted data were analyzed using RevMan5.4 software (Cochrane Collaboration). Results: We reviewed 20 studies, of which 16 were included in the meta-analysis. In total, 21 different BCTs (mean 8.7, SD 3.8 BCTs) from 12 BCT categories were reported in mHealth app interventions. The most common BCTs were self-monitoring of outcomes of behavior, feedback on outcomes of behavior, instruction on how to perform the behavior, and pharmacological support. The mHealth app interventions resulted in a --5.78 mm Hg (95\% CI --7.97 mm Hg to --3.59 mm Hg; P<.001) reduction in systolic BP and a --3.28 mm Hg (95\% CI --4.39 mm Hg to --2.17 mm Hg; P<.001) reduction in diastolic BP. The effect of interventions on BP reduction was associated with risk factors, such as hypertension, that were addressed by the mHealth app intervention (multiple risk factors vs a single risk factor: --6.50 mm Hg, 95\% CI --9.00 mm Hg to --3.99 mm Hg vs --1.54 mm Hg, 95\% CI --4.15 mm Hg to 1.06 mm Hg; P=.007); the presence of a theoretical foundation (with vs without behavior change theory: --10.06 mm Hg, 95\% CI --16.42 mm Hg to --3.70 mm Hg vs --4.13 mm Hg, 95\% CI --5.50 to --2.75 mm Hg; P=.07); intervention duration (3 vs ?6 months: --8.87 mm Hg, 95\% CI --10.90 mm Hg to --6.83 mm Hg vs --5.76 mm Hg, 95\% CI --8.74 mm Hg to --2.77 mm Hg; P=.09); and the number of BCTs (?11 vs <11 BCTs: --9.68 mm Hg, 95\% CI --13.49 mm Hg to --5.87 mm Hg vs --2.88 mm Hg, 95\% CI --3.90 mm Hg to --1.86 mm Hg; P<.001). Conclusions: The self-management interventions based on mHealth apps were effective strategies for lowering BP in patients with hypertension. The effect of interventions was influenced by factors related to the study's intervention design and BCT. ", doi="10.2196/54978", url="https://www.jmir.org/2024/1/e54978" } @Article{info:doi/10.2196/60719, author="Kashiwakura, Daisaku and Hiyama, Akiko and Muramatsu, Masumi and Hinotsu, Atsuko and Takeda, Michiko and Suzuki, Norio and Akiyama, Sachie and Kurihara, Sayuri and Kida, Keisuke", title="A Self-Administered Eating Behavior Scale for Patients With Heart Failure Living at Home: Protocol for a Mixed Methods Scale Development Study", journal="JMIR Res Protoc", year="2024", month="Oct", day="18", volume="13", pages="e60719", keywords="heart failure", keywords="eating behavior", keywords="self-care", keywords="patient-reported outcome measures", keywords="International Classification of Functioning, Disability, and Health (ICF)", abstract="Background: The prevalence of heart failure (HF) is increasing worldwide, with the associated mortality rates rising consistently. Preventing HF progression requires adherence to restricted sodium intake alongside sufficient and balanced nutritional consumption. For patients at home, preparing nutritionally balanced meals is essential, either self-assisted or with the aid of close individuals. Patients with HF frequently experience decreased exercise tolerance, depression, anxiety, and social isolation, which interfere with eating behaviors, leading to inadequate dietary habits. However, measures focusing on the determinants of eating behavior among patients with HF are currently lacking. Objective: This study aims to develop a self-administered scale to assess the eating behaviors of patients with HF living at home (Self-Administered Eating Behaviors Scale for Heart Failure [SEBS-HF]). Methods: This study encompasses 3 phases. Phase 1 involves identifying factors influencing eating behaviors in patients with HF. First, a literature review will be conducted using PubMed and CINAHL databases. The specified literature will be analyzed qualitatively and inductively. Additionally, verbatim transcripts obtained from semistructured interviews of patients with HF and medical experts will be qualitatively analyzed. Based on the Phase 1 results, a preliminary scale will be constructed. In Phase 2, cognitive interviews will be conducted with patients with HF and experts; the preliminary scale will be used to qualitatively evaluate its content validity. After validation, the scale will be used in Phase 3 to conduct a cross-sectional study involving patients with HF. In Phase 3, data will be collected from clinical records and self-administered questionnaires or scales. After conducting a preliminary survey, the main survey will be conducted. The reliability and validity of the scale will be assessed using statistical methods. Results: The first phase of this study commenced in September 2023, and by May 2, 2024, a total of 7 patients with HF and 6 expert professionals were enrolled as study participants. The draft creation of the scale will be completed in 2024, and the content validity evaluation of the draft scale is expected to be finished by early 2025. The third phase will begin its investigation in mid-2025 and is expected to be completed by late 2025, after which the SEBS-HF will be published. Conclusions: The development and use of this scale will enable a more comprehensive evaluation of the factors influencing eating behaviors in patients with HF. Thus, medical and welfare professionals should provide appropriate support tailored to the specific needs of patients with HF. International Registered Report Identifier (IRRID): DERR1-10.2196/60719 ", doi="10.2196/60719", url="https://www.researchprotocols.org/2024/1/e60719" } @Article{info:doi/10.2196/56162, author="Muehlensiepen, Felix and Bruch, Dunja and Seifert, Frances and Wengemuth, Eileen and Heinze, Martin and Spethmann, Sebastian and May, Susann", title="mHealth Apps for Hypertension Self-Management: Interview Study Among Patient-Users", journal="JMIR Form Res", year="2024", month="Sep", day="27", volume="8", pages="e56162", keywords="hypertension", keywords="mobile health", keywords="mHealth apps", keywords="digital health", keywords="patient perspective", keywords="qualitative study", keywords="cardiology", abstract="Background: Hypertension is a major risk factor for cardiovascular disease, affecting over a billion people worldwide. Mobile health (mHealth) apps have emerged as effective tools for managing hypertension, offering capabilities for monitoring blood pressure, fostering lifestyle changes, and improving treatment adherence. Objective: This study aimed to explore patient-users' perspectives on the hypertension care mHealth app Hypertension.APP, focusing on its accessibility, expected benefits, potential risks, and role in hypertension management in Germany. Methods: A qualitative study was conducted involving semistructured interviews with 20 patient-users of a hypertension care mHealth app, Hypertension.APP. Participants were recruited between January and June 2023 using purposive sampling. Verbatim transcripts were analyzed using qualitative content analysis. Results: Participants primarily discovered the app independently, driven by recent hypertension diagnoses and insufficient information from health care professionals regarding effective self-management strategies for their blood pressure. They valued the app for its continuous monitoring and feedback capabilities, aiding in understanding their condition and making lifestyle adjustments. Risks were perceived as minimal, mainly concerning data privacy and potential overreliance on the app. The app became integral to patient-users' hypertension management by offering consistent information and support. The integration into formal health care was limited, as patient-users felt that health care professionals did not accept the use of the technology or might have even felt intimidated to use it. Conclusions: Among the sample studied, mHealth apps like Hypertension.APP were valued for their continuous monitoring and educational content, aiding in hypertension management. The findings suggest potential benefits of mHealth apps for effective hypertension care among patients who are health- and digitally literate as well as self-effective. There is a critical need for better integration of these apps into routine health care practices, as perceived by the app users. Given the small and specific sample of this qualitative study, further quantitative research with a broader and more varied participant group is necessary to validate these findings. Trial Registration: Deutsches Register Klinischer Studien DRKS00029761; https://tinyurl.com/r33ru22s ", doi="10.2196/56162", url="https://formative.jmir.org/2024/1/e56162" } @Article{info:doi/10.2196/54909, author="Heinert, W. Sara and Guzman-Baez, Kelvin and Aamir, Affan and Penugonda, Ananya and Crabtree, F. Benjamin and Greene, Kathryn and Heckman, J. Carolyn and Levy, Phillip and Strickland, Ohman Pamela and Hudson, V. Shawna", title="Developing a Youth-Led Digital Hypertension Education Intervention for Adults With Hypertension: Qualitative Study on Refinement and Acceptability", journal="JMIR Form Res", year="2024", month="Sep", day="6", volume="8", pages="e54909", keywords="hypertension", keywords="adolescents", keywords="adults", keywords="emergency department", keywords="digital health intervention", keywords="dyad intervention", keywords="intervention development", keywords="qualitative research", keywords="youth", keywords="adolescent", keywords="teen", keywords="teens", keywords="teenager", keywords="teenagers", keywords="adult", keywords="youth-led", keywords="digital health", keywords="health education", keywords="refinement", keywords="acceptability", keywords="USA", keywords="United States", keywords="care navigation", keywords="effectiveness", keywords="formative study", keywords="prototype", keywords="self-guided", keywords="online module", keywords="online modules", keywords="engagement", keywords="blood pressure", keywords="health knowledge", keywords="health promotion", keywords="nutrition education", keywords="support intervention", keywords="support", keywords="supports", abstract="Background: Hypertension affects one-third of adults in the United States and is the leading risk factor for death. Underserved populations are seen disproportionately in the emergency department (ED) and tend to have worse blood pressure (BP) control. For adults, a lack of hypertension knowledge is a common barrier to hypertension control, while social support is a strong facilitator, and providing information that is culturally sensitive and relevant is especially important in this context. The youth experience increased confidence when given the responsibility to provide health education and care navigation to others. As such, we planned a randomized controlled trial (RCT) for the effectiveness of a digital youth-led hypertension education intervention for adult patients in the ED with hypertension, focusing on change in BP and hypertension knowledge. Objective: In preparation for an RCT, we conducted a formative study to determine acceptable and easily comprehensible ways to present hypertension information to adults with hypertension and optimal ways to engage youth to support adults on how to achieve better hypertension control. Methods: After creating an intervention prototype with 6 weekly self-guided hypertension online modules, we recruited 12 youth (adolescents, aged 15-18 years) for 3 focus groups and 10 adult ED patients with hypertension for individual online interviews to garner feedback on the prototype. After completing a brief questionnaire, participants were asked about experiences with hypertension, preferences for a hypertension education intervention, and acceptability, feasibility, obstacles, and solutions for intervention implementation with youth and adults. The moderator described and showed participants the prototyped intervention process and materials and asked for feedback. Questionnaire data were descriptively summarized, and qualitative data were analyzed using the template organizing style of analysis by 3 study team members. Results: Participants showed great interest in the intervention prototype, thought their peers would find it acceptable, and appreciated its involvement of youth. Youth with family members with hypertension reported that their family members need more support for their hypertension. Youth suggested adding more nutrition education activities to the intervention, such as a sodium tracker and examples of high-sodium foods. Adults discussed the need for a hypertension support intervention for themselves and the expected benefits to youth. They mentioned the overwhelming amount of hypertension information available and appreciated the intervention's concise content presentation. They suggested adding more mental health and smoking cessation resources, information about specific hypertension medications, and adding active links for health care information. Conclusions: Based on focus groups and interviews with participants, a youth-led digital hypertension intervention is an acceptable strategy to engage both adults with hypertension and youth. Incorporating participant suggestions into the intervention may improve its clarity, engagement, and impact when used in a subsequent RCT. ", doi="10.2196/54909", url="https://formative.jmir.org/2024/1/e54909", url="http://www.ncbi.nlm.nih.gov/pubmed/39240662" } @Article{info:doi/10.2196/56380, author="Miki, Takahiro and Yamada, Junya and Ishida, Shinpei and Sakui, Daisuke and Kanai, Masashi and Hagiwara, Yuta", title="Exploring the Feasibility and Initial Impact of an mHealth-Based Disease Management Program for Chronic Ischemic Heart Disease: Formative Study", journal="JMIR Form Res", year="2024", month="Aug", day="22", volume="8", pages="e56380", keywords="mobile health", keywords="chronic ischemic heart disease", keywords="disease management program", keywords="mobile phone", keywords="behavior change", abstract="Background: Ischemic heart disease (IHD) is a leading cause of morbidity and mortality worldwide, requiring innovative management strategies. Traditional disease management programs often struggle to maintain patient engagement and ensure long-term adherence to lifestyle modifications and treatment plans. Mobile health (mHealth) technologies have emerged as a promising approach to address these challenges by providing continuous, personalized support and monitoring. However, the reported use and effectiveness of mHealth in the management of chronic diseases, such as IHD, have not been fully explored. Objective: The primary aim of this study was to evaluate the feasibility and initial impact of an mHealth-based disease management program on coronary risk factors, specifically focusing on low-density lipoprotein cholesterol (LDL-C) levels, in individuals with chronic IHD. This formative study assessed changes in LDL-C and other metabolic health indicators over a 6-month period to determine the initial impact of the program on promoting cardiovascular health and lifestyle modification. Methods: This study was conducted using data from 266 individuals enrolled in an mHealth-based disease management program between December 2018 and October 2022. Eligibility was based on a documented history of IHD, with participants undergoing a comprehensive cardiac risk assessment before enrollment. The program included biweekly telephone sessions, health tracking via a smartphone app, and regular progress reports to physicians. The study measured change in LDL-C levels as the primary outcome, with secondary outcomes including body weight, triglyceride levels, and other metabolic health indicators. Statistical analysis used paired 2-tailed t tests and stratified analyses to assess the impact of the program. Results: Participants experienced a significant reduction in LDL-C, with LDL-C levels decreasing from a mean of 98.82 (SD 40.92) mg/dL to 86.62 (SD 39.86) mg/dL (P<.001). The intervention was particularly effective in individuals with high baseline LDL-C levels. Additional improvements were seen in body weight and triglyceride levels, suggesting a broader impact on metabolic health. Program adherence and engagement metrics suggested high participant satisfaction and compliance. Conclusions: The results of this study suggest that the mHealth-based disease management program is feasible and has an initial positive impact on reducing LDL-C levels and improving metabolic health in individuals with chronic IHD. However, the study design does not allow for a definitive conclusion regarding whether mHealth-based disease management programs are more effective than traditional face-to-face care. Future studies are needed to further validate these findings and to examine the comparative effectiveness of these interventions in more detail. ", doi="10.2196/56380", url="https://formative.jmir.org/2024/1/e56380" } @Article{info:doi/10.2196/50066, author="Berglund, Aseel and Klompstra, Leonie and Or{\"a}dd, Helena and Fallstr{\"o}m, Johan and Str{\"o}mberg, Anna and Jaarsma, Tiny and Berglund, Erik", title="The Rationale Behind the Design Decisions in an Augmented Reality Mobile eHealth Exergame to Increase Physical Activity for Inactive Older People With Heart Failure", journal="JMIR Serious Games", year="2024", month="Aug", day="21", volume="12", pages="e50066", keywords="sedentary", keywords="exercise", keywords="exertion", keywords="exergames", keywords="technology", keywords="training", keywords="inactivity", keywords="eHealth application", keywords="heart disease", keywords="physical activity", doi="10.2196/50066", url="https://games.jmir.org/2024/1/e50066" } @Article{info:doi/10.2196/57241, author="Kapoor, Melissa and Holman, Blair and Cohen, Carolyn", title="Contactless and Calibration-Free Blood Pressure and Pulse Rate Monitor for Screening and Monitoring of Hypertension: Cross-Sectional Validation Study", journal="JMIR Cardio", year="2024", month="Aug", day="5", volume="8", pages="e57241", keywords="remote photoplethysmography", keywords="vital signs", keywords="calibration-free blood pressure monitor", keywords="medical device", keywords="hypertension screening", keywords="home blood pressure monitoring", keywords="vital", keywords="vitals", keywords="device", keywords="devices", keywords="hypertension", keywords="hypertensive", keywords="cardiovascular", keywords="cardiology", keywords="heart", keywords="blood pressure", keywords="monitoring", keywords="monitor", keywords="mHealth", keywords="mobile health", keywords="validation", abstract="Background: The key to reducing the immense morbidity and mortality burdens of cardiovascular diseases is to help people keep their blood pressure (BP) at safe levels. This requires that more people with hypertension be identified, diagnosed, and given tools to lower their BP. BP monitors are critical to hypertension diagnosis and management. However, there are characteristics of conventional BP monitors (oscillometric cuff sphygmomanometers) that hinder rapid and effective hypertension diagnosis and management. Calibration-free, software-only BP monitors that operate on ubiquitous mobile devices can enable on-demand BP monitoring, overcoming the hardware barriers of conventional BP monitors. Objective: This study aims to investigate the accuracy of a contactless BP monitor software app for classifying the full range of clinically relevant BPs as hypertensive or nonhypertensive and to evaluate its accuracy for measuring the pulse rate (PR) and BP of people with BPs relevant to stage-1 hypertension. Methods: The software app, known commercially as Lifelight, was investigated following the data collection and data analysis methodology outlined in International Organization for Standardization (ISO) 81060-2:2018/AMD 1:2020 ``Non-invasive Sphygmomanometers---Part 2: Clinical investigation of automated measurement type.'' This validation study was conducted by the independent laboratory Element Materials Technology Boulder (formerly Clinimark). The study generated data from 85 people aged 18-85 years with a wide-ranging distribution of BPs specified in ISO 81060-2:2018/AMD 1:2020. At least 20\% were required to have Fitzpatrick scale skin tones of 5 or 6 (ie, dark skin tones). The accuracy of the app's BP measurements was assessed by comparing its BP measurements with measurements made by dual-observer manual auscultation using the same-arm sequential method specified in ISO 81060-2:2018/AMD 1:2020. The accuracy of the app's PR measurements was assessed by comparing its measurements with concurrent electroencephalography-derived heart rate values. Results: The app measured PR with an accuracy root-mean-square of 1.3 beats per minute and mean absolute error of 1.1 (SD 0.8) beats per minute. The sensitivity and specificity with which it determined that BPs exceeded the in-clinic systolic threshold for hypertension diagnosis were 70.1\% and 71.7\%, respectively. These rates are consistent with those reported for conventional BP monitors in a literature review by The National Institute for Health and Care Excellence. The app's mean error for measuring BP in the range of normotension and stage-1 hypertension (ie, 65/85, 76\% of participants) was 6.5 (SD 12.9) mm Hg for systolic BP and 0.4 (SD 10.6) mm Hg for diastolic BP. Mean absolute error was 11.3 (SD 10.0) mm Hg and 8.6 (SD 6.8) mm Hg, respectively. Conclusions: A calibration-free, software-only medical device was independently tested against ISO 81060-2:2018/AMD 1:2020. The safety and performance demonstrated in this study suggest that this technique could be a potential solution for rapid and scalable screening and management of hypertension. ", doi="10.2196/57241", url="https://cardio.jmir.org/2024/1/e57241", url="http://www.ncbi.nlm.nih.gov/pubmed/39102277" } @Article{info:doi/10.2196/49515, author="Agyei, Frimponmaa Eunice Eno Yaa and Ekpezu, Akon and Oinas-Kukkonen, Harri", title="Persuasive Systems Design Trends in Coronary Heart Disease Management: Scoping Review of Randomized Controlled Trials", journal="JMIR Cardio", year="2024", month="Jun", day="19", volume="8", pages="e49515", keywords="coronary heart disease", keywords="persuasive systems design", keywords="behavior change", keywords="randomized controlled trial", keywords="RCT", keywords="controlled trials", keywords="heart", keywords="CHD", keywords="cardiovascular", abstract="Background: Behavior change support systems (BCSSs) have the potential to help people maintain healthy lifestyles and aid in the self-management of coronary heart disease (CHD). The Persuasive Systems Design (PSD) model is a framework for designing and evaluating systems designed to support lifestyle modifications and health behavior change using information and communication technology. However, evidence for the underlying design principles behind BCSSs for CHD has not been extensively reported in the literature. Objective: This scoping review aims to identify existing health BCSSs for CHD, report the characteristics of these systems, and describe the persuasion context and persuasive design principles of these systems based on the PSD framework. Methods: Using the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines, 3 digital databases (Scopus, Web of Science, and MEDLINE) were searched between 2010 to 2022. The major inclusion criteria for studies were in accordance with the PICO (Population, Intervention, Comparison, and Outcome) approach. Results: Searches conducted in the databases identified 1195 papers, among which 30 were identified as eligible for the review. The most interesting characteristics of the BCSSs were the predominant use of primary task support principles, followed by dialogue support and credibility support and the sparing use of social support principles. Theories of behavior change such as the Social Cognitive Theory and Self-Efficacy Theory were used often to underpin these systems. However, significant trends in the use of persuasive system features on par with behavior change theories could not be established from the reviewed studies. This points to the fact that there is still no theoretical consensus on how best to design interventions to promote behavior change in patients with CHD. Conclusions: Our results highlight key software features for designing BCSSs for the prevention and management of CHD. We encourage designers of behavior change interventions to evaluate the techniques that contributed to the success of the intervention. Future research should focus on evaluating the effectiveness of the interventions, persuasive design principles, and behavior change theories using research methodologies such as meta-analysis. ", doi="10.2196/49515", url="https://cardio.jmir.org/2024/1/e49515" } @Article{info:doi/10.2196/54946, author="Skolarus, E. Lesli and Lin, Chieh Chun and Mishra, Sonali and Meurer, William and Dinh, Mackenzie and Whitfield, Candace and Bi, Ran and Brown, Devin and Oteng, Rockefeller and Buis, R. Lorraine and Kidwell, Kelley", title="Engagement in mHealth-Prompted Self-Measured Blood Pressure Monitoring Among Participants Recruited From a Safety-Net Emergency Department: Secondary Analysis of the Reach Out Trial", journal="JMIR Mhealth Uhealth", year="2024", month="Jun", day="12", volume="12", pages="e54946", keywords="hypertension", keywords="self-measured blood pressure", keywords="mobile health", keywords="blood pressure", keywords="emergency", keywords="blood pressure monitoring", keywords="risk factor", keywords="cardiovascular", keywords="cardiovascular disease", keywords="utilization", keywords="feedback", keywords="care", keywords="systolic blood pressure", keywords="emergency department", keywords="mHealth", keywords="health disparities", keywords="engagement", abstract="Background: Hypertension, a key modifiable risk factor for cardiovascular disease, is more prevalent among Black and low-income individuals. To address this health disparity, leveraging safety-net emergency departments for scalable mobile health (mHealth) interventions, specifically using text messaging for self-measured blood pressure (SMBP) monitoring, presents a promising strategy. This study investigates patterns of engagement, associated factors, and the impact of engagement on lowering blood pressure (BP) in an underserved population. Objective: We aimed to identify patterns of engagement with prompted SMBP monitoring with feedback, factors associated with engagement, and the association of engagement with lowered BP. Methods: This is a secondary analysis of data from Reach Out, an mHealth, factorial trial among 488 hypertensive patients recruited from a safety-net emergency department in Flint, Michigan. Reach Out participants were randomized to weekly or daily text message prompts to measure their BP and text in their responses. Engagement was defined as a BP response to the prompt. The k-means clustering algorithm and visualization were used to determine the pattern of SMBP engagement by SMBP prompt frequency---weekly or daily. BP was remotely measured at 12 months. For each prompt frequency group, logistic regression models were used to assess the univariate association of demographics, access to care, and comorbidities with high engagement. We then used linear mixed-effects models to explore the association between engagement and systolic BP at 12 months, estimated using average marginal effects. Results: For both SMBP prompt groups, the optimal number of engagement clusters was 2, which we defined as high and low engagement. Of the 241 weekly participants, 189 (78.4\%) were low (response rate: mean 20\%, SD 23.4) engagers, and 52 (21.6\%) were high (response rate: mean 86\%, SD 14.7) engagers. Of the 247 daily participants, 221 (89.5\%) were low engagers (response rate: mean 9\%, SD 12.2), and 26 (10.5\%) were high (response rate: mean 67\%, SD 8.7) engagers. Among weekly participants, those who were older (>65 years of age), attended some college (vs no college), married or lived with someone, had Medicare (vs Medicaid), were under the care of a primary care doctor, and took antihypertensive medication in the last 6 months had higher odds of high engagement. Participants who lacked transportation to appointments had lower odds of high engagement. In both prompt frequency groups, participants who were high engagers had a greater decline in BP compared to low engagers. Conclusions: Participants randomized to weekly SMBP monitoring prompts responded more frequently overall and were more likely to be classed as high engagers compared to participants who received daily prompts. High engagement was associated with a larger decrease in BP. New strategies to encourage engagement are needed for participants with lower access to care. Trial Registration: ClinicalTrials.gov NCT03422718; https://clinicaltrials.gov/study/NCT03422718 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-020-04340-z ", doi="10.2196/54946", url="https://mhealth.jmir.org/2024/1/e54946" } @Article{info:doi/10.2196/52341, author="Hou, Ling Qiao and Liu, Yang Le and Wu, Ying", title="The Effects of mHealth Interventions on Quality of Life, Anxiety, and Depression in Patients With Coronary Heart Disease: Meta-Analysis of Randomized Controlled Trials", journal="J Med Internet Res", year="2024", month="Jun", day="11", volume="26", pages="e52341", keywords="mobile health", keywords="coronary heart disease", keywords="quality of life", keywords="anxiety", keywords="depression", keywords="meta-analysis", keywords="mobile phone", abstract="Background: Coronary heart disease (CHD) is the leading cause of death globally. In addition, 20\% to 40\% of the patients with CHD have comorbid mental health issues such as anxiety or depression, affecting the prognosis and quality of life (QoL). Mobile health (mHealth) interventions have been developed and are widely used; however, the evidence for the effects of mHealth interventions on QoL, anxiety, and depression in patients with CHD is currently ambiguous. Objective: In this study, we aimed to assess the effects of mHealth interventions on QoL, anxiety, and depression in patients with CHD. Methods: We searched the Cochrane Library, PubMed, Embase, CINAHL, Web of Science, China National Knowledge Infrastructure, and Wanfang databases from inception to August 12, 2023. Eligible studies were randomized controlled trials that involved patients with CHD who received mHealth interventions and that reported on QoL, anxiety, or depression outcomes. We used the Cochrane risk-of-bias tool for randomized trials to evaluate the risk of bias in the studies, ensuring a rigorous and methodologically sound analysis. Review Manager (desktop version 5.4; The Cochrane Collaboration) and Stata MP (version 17.0; StataCorp LLC) were used to conduct the meta-analysis. The effect size was calculated using the standardized mean difference (SMD) and its 95\% CI. Results: The meta-analysis included 23 studies (5406 participants in total) and showed that mHealth interventions significantly improved QoL in patients with CHD (SMD 0.49, 95\% CI 0.25-0.72; Z=4.07; P<.001) as well as relieved their anxiety (SMD ?0.46, 95\% CI ?0.83 to ?0.08; Z=2.38; P=.02) and depression (SMD ?0.34, 95\% CI ?0.56 to ?0.12; Z=3.00; P=.003) compared to usual care. The subgroup analyses indicated a significant effect favoring the mHealth intervention on reducing anxiety and depressive symptoms compared to usual care, especially when (1) the intervention duration was ?6 months (P=.04 and P=.001), (2) the mHealth intervention was a simple one (only 1 mHealth intervention was used) (P=.01 and P<.001), (3) it was implemented during the COVID-19 pandemic (P=.04 and P=.01), (4) it was implemented in low- or middle-income countries (P=.01 and P=.02), (5) the intervention focused on mental health (P=.01 and P=.007), and (6) adherence rates were high (?90\%; P=.03 and P=.002). In addition, comparing mHealth interventions to usual care, there was an improvement in QoL when (1) the mHealth intervention was a simple one (P<.001), (2) it was implemented in low- or middle-income countries (P<.001), and (3) the intervention focused on mental health (P<.001). Conclusions: On the basis of the existing evidence, mHealth interventions might be effective in improving QoL and reducing anxiety and depression in patients with CHD. However, large sample, high-quality, and rigorously designed randomized controlled trials are needed to provide further evidence. Trial Registration: PROSPERO CRD42022383858; https://tinyurl.com/3ea2npxf ", doi="10.2196/52341", url="https://www.jmir.org/2024/1/e52341", url="http://www.ncbi.nlm.nih.gov/pubmed/38861710" } @Article{info:doi/10.2196/48520, author="Tran, Dieu-My and Dingley, Catherine and Bonilla, Roger", title="mHealth Intervention for Elevated Blood Pressure Among College Students: Single-Arm Intervention Study", journal="JMIR Form Res", year="2024", month="Jun", day="7", volume="8", pages="e48520", keywords="blood pressure", keywords="mHealth", keywords="self-management", keywords="students", keywords="intervention", keywords="elevated blood pressure", keywords="college", keywords="hypertension", keywords="young adult", keywords="mobile app", keywords="smartphone", keywords="monitoring", keywords="text messaging", keywords="text mining", abstract="Background: Current evidence reveals a growing pattern of hypertension among young adults, significantly increasing their risk for cardiovascular disease later in life. Young adults, particularly those of college age, often develop risk factors related to lifestyle choices in diet, exercise, and alcohol consumption. Developing useful interventions that can assist with screening and possible behavioral modifications that are suitable and appealing to college-aged young adults could help with early identification and intervention for hypertension. Recent studies indicate mobile health (mHealth) apps are acceptable and effective for communication and message delivery among this population. Objective: The purpose of this study was to examine the feasibility of using a mobile smartphone delivery system that provides tailored messages based on participant self-measured blood pressure (BP) with college-aged young adults. Methods: Using a single-arm intervention, pilot study design, the mHealth to Optimize BP Improvement (MOBILE) intervention was implemented with college students aged 18 years to 39 years who had systolic BP >120 mm Hg and diastolic BP ?80 mm Hg. Participants were required to measure their BP daily for 28 days, submit the readings to the app, and receive preset educational text messages tailored to their BP value and related to encouraging healthy lifestyle modifications. Changes in a participant's BP was evaluated using a mixed regression model, and a postintervention survey evaluated their perspectives on the mHealth intervention. Results: The participants' (N=9) mean age was 22.64 (SD 4.54) years; 56\% (5/9) were overweight, and 11\% (1/9) were obese. The average daily participation rate was 86\%. Of the 9 participants, 8 completed the survey, and all indicated the intervention was easy to use, found it increased awareness of their individual BP levels, indicated the text messages were helpful, and reported making lifestyle changes based on the study intervention. They also provided suggestions for future implementation of the intervention and program. Overall, no significant changes were noted in BP over the 28 days. Conclusions: The mHealth-supported MOBILE intervention for BP monitoring and tailored text messaging was feasible to implement, as our study indicated high rates of participation and acceptability. These encouraging findings support further development and testing in a larger sample over a longer time frame and hold the potential for early identification and intervention among college-aged adults, filling a gap in current research. ", doi="10.2196/48520", url="https://formative.jmir.org/2024/1/e48520", url="http://www.ncbi.nlm.nih.gov/pubmed/38848120" } @Article{info:doi/10.2196/53815, author="Liliequist, E. Bj{\"o}rn and S{\"a}rnholm, Josefin and Sk{\'u}lad{\'o}ttir, Helga and {\'O}lafsd{\'o}ttir, Eva and Lj{\'o}tsson, Brj{\'a}nn and Braunschweig, Frieder", title="Cognitive Behavioral Therapy for Symptom Preoccupation Among Patients With Premature Ventricular Contractions: Nonrandomized Pretest-Posttest Study", journal="JMIR Cardio", year="2024", month="May", day="7", volume="8", pages="e53815", keywords="premature ventricular contractions", keywords="quality of life", keywords="symptom preoccupation", keywords="cognitive behavioral therapy: CBT", abstract="Background: Premature ventricular contractions (PVCs) are a common cardiac condition often associated with disabling symptoms and impaired quality of life (QoL). Current treatment strategies have limited effectiveness in reducing symptoms and restoring QoL for patients with PVCs. Symptom preoccupation, involving cardiac-related fear, hypervigilance, and avoidance behavior, is associated with disability in other cardiac conditions and can be effectively targeted by cognitive behavioral therapy (CBT). Objective: The aim of this study was to evaluate the effect of a PVC-specific CBT protocol targeting symptom preoccupation in patients with symptomatic idiopathic PVCs. Methods: Nineteen patients diagnosed with symptomatic idiopathic PVCs and symptom preoccupation underwent PVC-specific CBT over 10 weeks. The treatment was delivered by a licensed psychologist via videoconference in conjunction with online text-based information and homework assignments. The main components of the treatment were exposure to cardiac-related symptoms and reducing cardiac-related avoidance and control behavior. Self-rated measures were collected at baseline, post treatment, and at 3- and 6-month follow-ups. The primary outcome was PVC-specific QoL at posttreatment assessment measured with a PVC-adapted version of the Atrial Fibrillation Effects on Quality of Life questionnaire. Secondary measures included symptom preoccupation measured with the Cardiac Anxiety Questionnaire. PVC burden was evaluated with 5-day continuous electrocardiogram recordings at baseline, post treatment, and 6-month follow-up. Results: We observed large improvements in PVC-specific QoL (Cohen d=1.62, P<.001) and symptom preoccupation (Cohen d=1.73, P<.001) post treatment. These results were sustained at the 3- and 6-month follow-ups. PVC burden, as measured with 5-day continuous electrocardiogram, remained unchanged throughout follow-up. However, self-reported PVC symptoms were significantly lower at posttreatment assessment and at both the 3- and 6-month follow-ups. Reduction in symptom preoccupation had a statistically significant mediating effect of the intervention on PVC-specific QoL in an explorative mediation analysis. Conclusions: This uncontrolled pilot study shows preliminary promising results for PVC-specific CBT as a potentially effective treatment approach for patients with symptomatic idiopathic PVCs and symptom preoccupation. The substantial improvements in PVC-specific QoL and symptom preoccupation, along with the decreased self-reported PVC-related symptoms warrant further investigation in a larger randomized controlled trial. Trial Registration: ClinicalTrials.gov NCT05087238; https://clinicaltrials.gov/study/NCT05087238 ", doi="10.2196/53815", url="https://cardio.jmir.org/2024/1/e53815", url="http://www.ncbi.nlm.nih.gov/pubmed/38713500" } @Article{info:doi/10.2196/48756, author="Bernal-Jim{\'e}nez, {\'A}ngeles Mar{\'i}a and Calle, German and Guti{\'e}rrez Barrios, Alejandro and Gheorghe, Luciana Livia and Cruz-Cobo, Celia and Trujillo-Garrido, Nuria and Rodr{\'i}guez-Mart{\'i}n, Amelia and Tur, A. Josep and V{\'a}zquez-Garc{\'i}a, Rafael and Santi-Cano, Jos{\'e} Mar{\'i}a", title="Effectiveness of an Interactive mHealth App (EVITE) in Improving Lifestyle After a Coronary Event: Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2024", month="Apr", day="22", volume="12", pages="e48756", keywords="coronary artery disease", keywords="healthy lifestyle", keywords="mHealth", keywords="mobile health", keywords="percutaneous coronary intervention", keywords="randomized controlled trial", keywords="secondary prevention", keywords="therapeutic adherence", abstract="Background: Coronary heart disease is one of the leading causes of mortality worldwide. Secondary prevention is essential, as it reduces the risk of further coronary events. Mobile health (mHealth) technology could become a useful tool to improve lifestyles. Objective: This study aimed to evaluate the effect of an mHealth intervention on people with coronary heart disease who received percutaneous coronary intervention. Improvements in lifestyle regarding diet, physical activity, and smoking; level of knowledge of a healthy lifestyle and the control of cardiovascular risk factors (CVRFs); and therapeutic adherence and quality of life were analyzed. Methods: This was a randomized controlled trial with a parallel group design assigned 1:1 to either an intervention involving a smartphone app (mHealth group) or to standard health care (control group). The app was used for setting aims, the self-monitoring of lifestyle and CVRFs using measurements and records, educating people with access to information on their screens about healthy lifestyles and adhering to treatment, and giving motivation through feedback about achievements and aspects to improve. Both groups were assessed after 9 months. The primary outcome variables were adherence to the Mediterranean diet, frequency of food consumed, patient-reported physical activity, smoking, knowledge of healthy lifestyles and the control of CVRFs, adherence to treatment, quality of life, well-being, and satisfaction. Results: The study analyzed 128 patients, 67 in the mHealth group and 61 in the control group; most were male (92/128, 71.9\%), with a mean age of 59.49 (SD 8.97) years. Significant improvements were observed in the mHealth group compared with the control group regarding adherence to the Mediterranean diet (mean 11.83, SD 1.74 points vs mean 10.14, SD 2.02 points; P<.001), frequency of food consumption, patient-reported physical activity (mean 619.14, SD 318.21 min/week vs mean 471.70, SD 261.43 min/week; P=.007), giving up smoking (25/67, 75\% vs 11/61, 42\%; P=.01), level of knowledge of healthy lifestyles and the control of CVRFs (mean 118.70, SD 2.65 points vs mean 111.25, SD 9.05 points; P<.001), and the physical component of the quality of life 12-item Short Form survey (SF-12; mean 45.80, SD 10.79 points vs mean 41.40, SD 10.78 points; P=.02). Overall satisfaction was higher in the mHealth group (mean 48.22, SD 3.89 vs mean 46.00, SD 4.82 points; P=.002) and app satisfaction and usability were high (mean 44.38, SD 6.18 out of 50 points and mean 95.22, SD 7.37 out of 100). Conclusions: The EVITE app was effective in improving the lifestyle of patients in terms of adherence to the Mediterranean diet, frequency of healthy food consumption, physical activity, giving up smoking, knowledge of healthy lifestyles and controlling CVRFs, quality of life, and overall satisfaction. The app satisfaction and usability were excellent. Trial Registration: Clinicaltrials.gov NCT04118504; https://clinicaltrials.gov/study/NCT04118504 ", doi="10.2196/48756", url="https://mhealth.jmir.org/2024/1/e48756", url="http://www.ncbi.nlm.nih.gov/pubmed/38648103" } @Article{info:doi/10.2196/55432, author="Regan, Wherley Elizabeth and Toto, Pamela and Brach, Jennifer", title="A Community Needs Assessment and Implementation Planning for a Community Exercise Program for Survivors of Stroke: Protocol for a Pilot Hybrid Type I Clinical Effectiveness and Implementation Study", journal="JMIR Res Protoc", year="2024", month="Apr", day="11", volume="13", pages="e55432", keywords="community participatory research", keywords="need assessment", keywords="exercise", keywords="survivors of stroke", keywords="community", keywords="community need", keywords="exercise program", keywords="stroke", keywords="physical activity", keywords="PA", keywords="mobility impairments", keywords="impairment", keywords="mobility", keywords="health decline", keywords="group activity", keywords="group exercise", abstract="Background: Physical activity and exercise are important aspects of maintaining health. People with mobility impairments, including survivors of stroke, are less likely to exercise and at greater risk of developing or worsening chronic health conditions. Increasing accessible, desired options for exercise may address the gap in available physical activity programs, provide an opportunity for continued services after rehabilitation, and cultivate social connections for people after stroke and others with mobility impairments. Existing evidence-based community programs for people after stroke target cardiovascular endurance, mobility, walking ability, balance, and education. While much is known about the effectiveness of these programs, it is important to understand the local environment as implementation and sustainment strategies are context-specific. Objective: This study protocol aims to evaluate community needs and resources for exercise for adults living with mobility impairments with initial emphasis on survivors of stroke in Richland County, South Carolina. Results will inform a hybrid type I effectiveness and implementation pilot of an evidence-based group exercise program for survivors of stroke. Methods: The exploration and preparation phases of the EPIS (Exploration, Preparation, Implementation, and Sustainment) implementation model guide the study. A community needs assessment will evaluate the needs and desires of survivors of stroke through qualitative semistructured interviews with survivors of stroke, rehabilitation professionals, and fitness trainers serving people with mobility impairments. Additional data will be collected from survivors of stroke through a survey. Fitness center sites will be assessed through interviews and the Accessibility Instrument Measuring Fitness and Recreation Environments inventory. Qualitative data will be evaluated using content analysis and supported by mean survey results. Data will be categorized by the community (outer context), potential participants (outer context), and fitness center (inner context) and evaluate needs, resources, barriers, and facilitators. Results will inform evidence-based exercise program selection, adaptations, and specific local implementation strategies to influence success. Pilot outcome measures for participants (clinical effectiveness), process, and program delivery levels will be identified. An implementation logic model for interventions will be created to reflect the design elements for the pilot and their complex interactions. Results: The study was reviewed by the institutional review board and exempt approved on December 19, 2023. The study data collection began in January 2024 and is projected to be completed in June 2024. A total of 17 participants have been interviewed as of manuscript submission. Results are expected to be published in early 2025. Conclusions: Performing a needs assessment before implementing it in the community allows for early identification of complex relationships and preplanning to address problems that cannot be anticipated in controlled effectiveness research. Evaluation and preparation prior to implementation of a community exercise program enhance the potential to be successful, valued, and sustained in the community. International Registered Report Identifier (IRRID): DERR1-10.2196/55432 ", doi="10.2196/55432", url="https://www.researchprotocols.org/2024/1/e55432", url="http://www.ncbi.nlm.nih.gov/pubmed/38603776" } @Article{info:doi/10.2196/52035, author="Schulze Lammers, Sophia and Lawrenz, Thorsten and Lawin, Dennis and Hoyer, Annika and Stellbrink, Christoph and Albrecht, Urs-Vito", title="Prolonged mHealth-Based Arrhythmia Monitoring in Patients With Hypertrophic Cardiomyopathy (HCM-PATCH): Protocol for a Single-Center Cohort Study", journal="JMIR Res Protoc", year="2023", month="Dec", day="29", volume="12", pages="e52035", keywords="hypertrophic cardiomyopathy", keywords="nonsustained ventricular arrhythmia", keywords="sudden cardiac death", keywords="implantable cardioverter-defibrillator", keywords="long-term ECG", keywords="digital medicine", keywords="long-term electrocardiography", abstract="Background: Patients with hypertrophic cardiomyopathy (HCM) are at increased risk of sudden cardiac death (SCD) due to ventricular arrhythmias and other arrhythmias. Screening for arrhythmias is mandatory to assess the individual SCD risk, but long-term electrocardiography (ECG) is rarely performed in routine clinical practice. Intensified monitoring may increase the detection rate of ventricular arrhythmias and identify more patients with an increased SCD risk who are potential candidates for the primary prophylactic implantation of an implantable cardioverter-defibrillator. To date, reliable data on the clinical benefit of prolonged arrhythmia monitoring in patients with HCM are rare. Objective: This prospective study aims to measure the prevalence of ventricular arrhythmias in patients with HCM observed by mobile health (mHealth)--based continuous rhythm monitoring over 14 days compared to standard practice (a 24- and 48-h long-term ECG). The frequency of ventricular arrhythmias in this 14-day period is compared with the frequency in the first 24 or 48 hours for the same patient (intraindividual comparison). Methods: Following the sample size calculation, 34 patients with a low or intermediate risk for SCD, assessed by the HCM Risk--SCD calculator, will need to be recruited in this single-center cohort study between June 2023 and February 2024. All patients will receive an ECG patch that records their heart activity over 14 days. In addition, cardiac magnetic resonance imaging and genetic testing data will be integrated into risk stratification. All patients will be asked to complete questionnaires about their symptoms; previous therapy; family history; and, at the end of the study, their experience with the ECG patch-based monitoring. Results: The Hypertrophic Cardiomyopathy: Clinical Impact of a Prolonged mHealth-Based Arrhythmia Monitoring by Single-Channel ECG (HCM-PATCH) study investigates the prevalence of nonsustained ventricular tachycardia (ie, ?3 consecutive ventricular beats at a rate of 120 beats per minute, lasting for <30 seconds) in low- to intermediate-risk patients with HCM (according to the HCM Risk--SCD calculator) with additional mHealth-based prolonged rhythm monitoring. The study was funded by third-party funding from the Department of Cardiology and Intensive Care Medicine, University Hospital Ostwestfalen-Lippe of Bielefeld University in June 2023 and approved by the institutional review board in May 2023. Data collection began in June 2023, and we plan to end the study in February 2024. Of the 34 patients, 26 have been recruited. Data analysis has not yet taken place. Publication of the results is planned for the fall of 2024. Conclusions: Prolonged mHealth-based rhythm monitoring could lead to differences in the prevalence of arrhythmias compared to 24- and 48-hour long-term ECGs. This may lead to improved identification of patients at high risk and trigger therapeutic interventions that may provide better protection from SCD or atrial fibrillation--related complications such as embolic stroke. Trial Registration: Deutsches Register Klinischer Studien DRKS00032144; https://tinyurl.com/498bkrx8 International Registered Report Identifier (IRRID): DERR1-10.2196/52035 ", doi="10.2196/52035", url="https://www.researchprotocols.org/2023/1/e52035", url="http://www.ncbi.nlm.nih.gov/pubmed/38157231" } @Article{info:doi/10.2196/39019, author="Huang, Xiting and Xiang, Xinyue and Liu, Yang and Wang, Zhiqian and Jiang, Zhili and Huang, Lihua", title="The Use of Gamification in the Self-Management of Patients With Chronic Diseases: Scoping Review", journal="JMIR Serious Games", year="2023", month="Dec", day="22", volume="11", pages="e39019", keywords="gamification", keywords="chronic diseases", keywords="self-management", keywords="scoping review", keywords="mobile phone", abstract="Background: Chronic disease self-management is a public health issue of worldwide concern, and gamification is an emerging strategy to improve patients' participation in chronic disease self-management. Some studies have summarized designs for the gamification of chronic disease self-management from the perspective of eHealth technology, but they have not mentioned differences in design methods, functions, and evaluation methods of gamified designs for self-management in different chronic diseases. Objective: This scoping review aims to synthesize the characteristics of realization forms, functions, and evaluation methods in chronic disease self-management gamification to improve self-management among the chronic disease population. Methods: We applied a methodological framework for scoping reviews and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. As of January 7, 2023, we systematically searched 9 databases for relevant studies from January 2012 to December 2022. Related data were extracted based on the research questions. We calculated the frequencies, charted the quantitative data, and coded the extracted material for qualitative content analysis. Results: We retrieved 16,221 records, of which 70 (0.43\%) met the eligibility criteria. In the included research, the target populations for gamified designs for self-management of chronic diseases included patients with stroke, cancer, diabetes, chronic obstructive pulmonary disease, coronary heart disease, obesity, and hypertension. Almost all studies mentioned technical support for gamification (68/70, 97\%), mainly in the form of active video games (58/70, 83\%); however, less than half of the studies mentioned the theoretical basis for gamification (31/70, 44\%). There were 37 concepts or theories relevant to gamification design, most of which were in the field of psychology or were cross-disciplinary (n=33, 89\%). Gamification for the self-management of chronic diseases has been widely recognized, including for promoting physical exercise and rehabilitation training (48/99, 48\%), increasing initiative for symptom management (18/99, 18\%), providing psychological support (14/99, 14\%), improving cognitive function (12/99, 12\%), and improving medication adherence (7/99, 7\%). A total of 39 studies mentioned the gamification effect; however, we did not find a unified evaluation standard. Conclusions: This scoping review focuses on gamification designs for chronic disease self-management and summarizes the realization forms and functions of gamification in self-management for different patient populations. With practice in a gamified internet-based environment, patients can not only master the knowledge and skills of self-management in fascinating scenarios but also benefit from gaming experience and make better health-related decisions in real life. It is worth noting that a comprehensive evaluation of the users as well as a personalized and targeted intervention should be developed before gamification. ", doi="10.2196/39019", url="https://games.jmir.org/2023/1/e39019", url="http://www.ncbi.nlm.nih.gov/pubmed/38133907" } @Article{info:doi/10.2196/49892, author="Pelly, Louise Melissa and Fatehi, Farhad and Liew, Danny and Verdejo-Garcia, Antonio", title="Digital Health Secondary Prevention Using Co-Design Procedures: Focus Group Study With Health Care Providers and Patients With Myocardial Infarction", journal="JMIR Cardio", year="2023", month="Oct", day="30", volume="7", pages="e49892", keywords="co-design", keywords="digital health", keywords="myocardial infarction", keywords="qualitative", keywords="participatory", keywords="mobile health", abstract="Background: Myocardial infarction (MI) is a debilitating condition and a leading cause of morbidity and mortality worldwide. Digital health is a promising approach for delivering secondary prevention to support patients with a history of MI and for reducing risk factors that can lead to a future event. However, its potential can only be fulfilled when the technology meets the needs of the end users who will be interacting with this secondary prevention. Objective: We aimed to gauge the opinions of patients with a history of MI and health professionals concerning the functions, features, and characteristics of a digital health solution to support post-MI care. Methods: Our approach aligned with the gold standard participatory co-design procedures enabling progressive refinement of feedback via exploratory, confirmatory, and prototype-assisted feedback from participants. Patients with a history of MI and health professionals from Australia attended focus groups over a videoconference system. We engaged with 38 participants across 3 rounds of focus groups using an iterative co-design approach. Round 1 included 8 participants (4 patients and 4 health professionals), round 2 included 24 participants (11 patients and 13 health professionals), and round 3 included 22 participants (14 patients and 8 health professionals). Results: Participants highlighted the potential of digital health in addressing the unmet needs of post-MI care. Both patients with a history of MI and health professionals agreed that mental health is a key concern in post-MI care that requires further support. Participants agreed that family members can be used to support postdischarge care and require support from the health care team. Participants agreed that incorporating simple games with a points system can increase long-term engagement. However, patients with a history of MI emphasized a lack of support from their health care team, family, and community more strongly than health professionals. They also expressed some openness to using artificial intelligence, whereas health professionals expressed that users should not be aware of artificial intelligence use. Conclusions: These results provide valuable insights into the development of digital health secondary preventions aimed at supporting patients with a history of MI. Future research can implement a pilot study in the population with MI to trial these recommendations in a real-world setting. ", doi="10.2196/49892", url="https://cardio.jmir.org/2023/1/e49892", url="http://www.ncbi.nlm.nih.gov/pubmed/37902821" } @Article{info:doi/10.2196/43889, author="Kazi, Samia and Truesdale, Chloe and Ryan, Pauline and Wiesner, Glen and Jennings, Garry and Chow, Clara", title="Initial Implementation of the My Heart, My Life Program by the National Heart Foundation of Australia: Pilot Mixed Methods Evaluation Study", journal="JMIR Cardio", year="2023", month="Oct", day="5", volume="7", pages="e43889", keywords="cardiology", keywords="prevention", keywords="digital health", keywords="heart", keywords="text message", keywords="text messaging", keywords="SMS", keywords="health communication", keywords="demographic", keywords="preventative", keywords="cardio", abstract="Background: Coronary heart disease (CHD) remains the leading cause of death in Australia, with a high residual risk of repeat events in survivors. Secondary prevention therapy is crucial for reducing the risk of both death and other major adverse cardiac events. The National Heart Foundation of Australia has developed a consumer-facing support program called My Heart, My Life (MHML) to address the gap in the secondary prevention of CHD in Australia. The MHML pilot program supplies advice and support for both patients and their caregivers, and it was conducted over 8 months from November 2019 to June 2020. Objective: This study aims to describe and examine the implementation of a novel multimodality secondary CHD prevention pilot program called MHML, which was delivered through booklets, text messages, emails, and telephone calls. Methods: This pilot study consists of a mixed methods evaluation involving surveys of participants (patients and caregivers) and health professionals, in-depth interviews, and digital communication (SMS text message, electronic direct mail, and call record analytics). This study was performed in people older than 18 years with acute coronary syndrome or angina and their caregivers in 38 Australian hospitals from November 2019 to June 2020 through the National Heart Foundation of Australia web page. The main outcome measures were reach, accessibility, feasibility, barriers, and enablers to implementation of this program. Results: Of the 1004 participants (838 patients and 164 caregivers; 2 missing), 60.9\% (608/1001) were males, 50.7\% (491/967) were aged between 45 and 64 years, 27.4\% (276/1004) were from disadvantaged areas, 2.5\% (24/946) were from Aboriginal or Torres Strait Islander background, and 16.9\% (170/1004) reported English as their second language. The participants (patients and their caregivers) and health professionals reported high satisfaction with the MHML program (55/62, 88.7\% and 33/38, 87\%, respectively). Of the 62 participants who took the survey, 88\% (55/62) used the text messaging service and reported a very high level of satisfaction. Approximately 94\% (58/62) and 89\% (55/62) of the participants were satisfied with the quick guide booklets 1 and 2, respectively; 79\% (49/62) were satisfied with the monthly email journey and 71\% (44/62) were satisfied with the helpline calls. Most participants reported that the MHML program improved preventive behaviors, that is, 73\% (45/62) of them reported that they maintained increased physical activity and 84\% (52/62) reported that they maintained a healthy diet even after the MHML program. Conclusions: The findings of our pilot study suggest that a multimodal support program, including digital, print, phone, and web-based media, for the secondary prevention of CHD is useful and could be a potential means of providing customized at-scale secondary prevention support for survivors of acute coronary syndrome. ", doi="10.2196/43889", url="https://cardio.jmir.org/2023/1/e43889", url="http://www.ncbi.nlm.nih.gov/pubmed/37796544" } @Article{info:doi/10.2196/44983, author="Stremmel, Christopher and Breitschwerdt, R{\"u}diger", title="Digital Transformation in the Diagnostics and Therapy of Cardiovascular Diseases: Comprehensive Literature Review", journal="JMIR Cardio", year="2023", month="Aug", day="30", volume="7", pages="e44983", keywords="cardiovascular", keywords="digital medicine", keywords="telehealth", keywords="artificial intelligence", keywords="telemedicine", keywords="mobile phone", keywords="review", abstract="Background: The digital transformation of our health care system has experienced a clear shift in the last few years due to political, medical, and technical innovations and reorganization. In particular, the cardiovascular field has undergone a significant change, with new broad perspectives in terms of optimized treatment strategies for patients nowadays. Objective: After a short historical introduction, this comprehensive literature review aimed to provide a detailed overview of the scientific evidence regarding digitalization in the diagnostics and therapy of cardiovascular diseases (CVDs). Methods: We performed an extensive literature search of the PubMed database and included all related articles that were published as of March 2022. Of the 3021 studies identified, 1639 (54.25\%) studies were selected for a structured analysis and presentation (original articles: n=1273, 77.67\%; reviews or comments: n=366, 22.33\%). In addition to studies on CVDs in general, 829 studies could be assigned to a specific CVD with a diagnostic and therapeutic approach. For data presentation, all 829 publications were grouped into 6 categories of CVDs. Results: Evidence-based innovations in the cardiovascular field cover a wide medical spectrum, starting from the diagnosis of congenital heart diseases or arrhythmias and overoptimized workflows in the emergency care setting of acute myocardial infarction to telemedical care for patients having chronic diseases such as heart failure, coronary artery disease, or hypertension. The use of smartphones and wearables as well as the integration of artificial intelligence provides important tools for location-independent medical care and the prevention of adverse events. Conclusions: Digital transformation has opened up multiple new perspectives in the cardiovascular field, with rapidly expanding scientific evidence. Beyond important improvements in terms of patient care, these innovations are also capable of reducing costs for our health care system. In the next few years, digital transformation will continue to revolutionize the field of cardiovascular medicine and broaden our medical and scientific horizons. ", doi="10.2196/44983", url="https://cardio.jmir.org/2023/1/e44983", url="http://www.ncbi.nlm.nih.gov/pubmed/37647103" } @Article{info:doi/10.2196/46351, author="Estrella, Tony and Alfonso, Carla and Ramos-Castro, Juan and Alsina, Aitor and Capdevila, Lluis", title="A Serious Game to Self-Regulate Heart Rate Variability as a Technique to Manage Arousal Level Through Cardiorespiratory Biofeedback: Development and Pilot Evaluation Study", journal="JMIR Serious Games", year="2023", month="Aug", day="24", volume="11", pages="e46351", keywords="serious game", keywords="heart rate variability", keywords="biofeedback", keywords="mobile health", keywords="mHealth", keywords="app", keywords="mobile phone", abstract="Background: Heart rate variability biofeedback (HRVB) is an established intervention for increasing heart rate variability (HRV) in the clinical context. Using this technique, participants become aware of their HRV through real-time feedback and can self-regulate it. Objective: The aim of this study was 2-fold: first, to develop a serious game that applies the HRVB technique to teach participants to self-regulate HRV and, second, to test the app with participants in a pilot study. Methods: An HRVB app called the FitLab Game was developed for this study. To play the game, users must move the main character up and down the screen, avoiding collisions with obstacles. The wavelength that users must follow to avoid these obstacles is based on the user's basal heart rate and changes in instantaneous heart rate. To test the FitLab Game, a total of 16 participants (mean age 23, SD 0.69 years) were divided into a control group (n=8) and an experimental group (n=8). A 2 {\texttimes} 2 factorial design was used in each session. Participants in the experimental condition were trained in breathing techniques. Results: Changes in the frequency and time domain parameters of HRV and the game's performance features were evaluated. Significant changes in the average RR intervals and root mean square of differences between adjacent RR intervals (RMSSD) were found between the groups (P=.02 and P=.04, respectively). Regarding performance, both groups showed a tendency to increase the evaluated outcomes from baseline to the test condition. Conclusions: The results may indicate that playing different levels leads to an improvement in the game's final score by repeated training. The tendency of changes in HRV may reflect a higher activation of the mental system of attention and control in the experimental group versus the control group. In this context, learning simple, voluntary strategies through a serious game can aid the improvement of self-control and arousal management. The FitLab Game appears to be a promising serious game owing to its ease of use, high engagement, and enjoyability provided by the instantaneous feedback. ", doi="10.2196/46351", url="https://games.jmir.org/2023/1/e46351", url="http://www.ncbi.nlm.nih.gov/pubmed/37616033" } @Article{info:doi/10.2196/43489, author="Wu, Justin and Napoleone, Jenna and Linke, Sarah and Noble, Madison and Turken, Michael and Rakotz, Michael and Kirley, Kate and Folk Akers, Jennie and Juusola, Jessie and Jasik, Bradner Carolyn", title="Long-Term Results of a Digital Hypertension Self-Management Program: Retrospective Cohort Study", journal="JMIR Cardio", year="2023", month="Aug", day="24", volume="7", pages="e43489", keywords="hypertension", keywords="digital health program", keywords="home measurement", keywords="self-management", keywords="behavior change", abstract="Background: Digital health programs that incorporate frequent blood pressure (BP) self-monitoring and support for behavior change offer a scalable solution for hypertension management. Objective: We examined the impact of a digital hypertension self-management and lifestyle change support program on BP over 12 months. Methods: Data were analyzed from a retrospective observational cohort of commercially insured members (n=1117) that started the Omada for Hypertension program between January 1, 2019, and September 30, 2021. Paired t tests and linear regression were used to measure the changes in systolic blood pressure (SBP) over 12 months overall and by SBP control status at baseline (?130 mm Hg vs <130 mm Hg). Results: Members were on average 50.9 years old, 50.8\% (n=567) of them were female, 60.5\% (n=675) of them were White, and 70.5\% (n=788) of them had uncontrolled SBP at baseline (?130 mm Hg). At 12 months, all members (including members with controlled and uncontrolled BP at baseline) and those with uncontrolled SBP at baseline experienced significant mean reductions in SBP (mean --4.8 mm Hg, 95\% CI --5.6 to --4.0; --8.1 mm Hg, 95\% CI --9.0 to --7.1, respectively; both P<.001). Members with uncontrolled SBP at baseline also had significant reductions in diastolic blood pressure (--4.7 mm Hg; 95\% CI --5.3 to --4.1), weight (--6.5 lbs, 95\% CI --7.7 to --5.3; 2.7\% weight loss), and BMI (--1.1 kg/m2; 95\% CI --1.3 to --0.9; all P<.001). Those with controlled SBP at baseline maintained within BP goal range. Additionally, 48\% (418/860) of members with uncontrolled BP at baseline experienced enough change in BP to improve their BP category. Conclusions: This study provides real-world evidence that a comprehensive digital health program involving hypertension education, at-home BP monitoring, and behavior change coaching support was effective for self-managing hypertension over 12 months. ", doi="10.2196/43489", url="https://cardio.jmir.org/2023/1/e43489", url="http://www.ncbi.nlm.nih.gov/pubmed/37463311" } @Article{info:doi/10.2196/39525, author="Madujibeya, Ifeanyi and Lennie, A. Terry and Pelzel, Jamie and Moser, K. Debra", title="Patients' Experiences Using a Mobile Health App for Self-Care of Heart Failure in a Real-World Setting: Qualitative Analysis", journal="JMIR Form Res", year="2023", month="Aug", day="15", volume="7", pages="e39525", keywords="heart failure", keywords="patients' experiences", keywords="experience", keywords="satisfaction", keywords="facilitator", keywords="mobile health apps", keywords="mobile app", keywords="health app", keywords="app feature", keywords="mobile health", keywords="cardiology", keywords="cardiovascular", keywords="patient care", keywords="self-management", keywords="patient", keywords="heart", keywords="mHealth", keywords="self-care", keywords="medication", keywords="performance", keywords="feedback", keywords="personalized", abstract="Background: Publicly available patient-focused mobile health (mHealth) apps are being increasingly integrated into routine heart failure (HF)--related self-care. However, there is a dearth of research on patients' experiences using mHealth apps for self-care in real-world settings. Objective: The purpose of this study was to explore patients' experiences using a commercially available mHealth app, OnTrack to Health, for HF self-care in a real-world setting. Methods: Patient satisfaction, measured with a 5-point Likert scale, and an open-ended survey were used to gather data from 23 patients with HF who were provided the OnTrack to Health app as a part of routine HF management. A content analysis of patients' responses was conducted with the qualitative software Atlas.ti (version 8; ATLAS.ti Scientific Software Development GmbH). Results: Patients (median age 64, IQR 57-71 years; 17/23, 74\% male) used OnTrack to Health for a median 164 (IQR 51-640) days before the survey. All patients reported excellent experiences related to app use and would recommend the app to other patients with HF. Five themes emerged from the responses to the open-ended questions: (1) features that enhanced self-care of HF (medication tracker, graphic performance feedback and automated alerts, secured messaging features, and HF self-care education); (2) perceived benefits (provided assurance of safety, improved HF self-care, and decreased hospitalization rates); (3) challenges with using apps for self-care (giving up previous self-care strategies); (4) facilitators (perceived ease of use and availability of technical support); and (5) suggested improvements (streamlining data entry, integration of apps with an electronic medical record, and personalization of app features). Conclusions: Patients were satisfied with using OnTrack to Health for self-care. They perceived the features of the app as valuable tools for improving self-care ability and decreasing hospitalization rates. The development of apps in collaboration with end users is essential to ensure high-quality patient experiences related to app use for self-care. ", doi="10.2196/39525", url="https://formative.jmir.org/2023/1/e39525", url="http://www.ncbi.nlm.nih.gov/pubmed/37581912" } @Article{info:doi/10.2196/43940, author="Shibuta, Tomomi and Waki, Kayo and Miyake, Kana and Igarashi, Ayumi and Yamamoto-Mitani, Noriko and Sankoda, Akiko and Takeuchi, Yoshinori and Sumitani, Masahiko and Yamauchi, Toshimasa and Nangaku, Masaomi and Ohe, Kazuhiko", title="Preliminary Efficacy, Feasibility, and Perceived Usefulness of a Smartphone-Based Self-Management System With Personalized Goal Setting and Feedback to Increase Step Count Among Workers With High Blood Pressure: Before-and-After Study", journal="JMIR Cardio", year="2023", month="Jul", day="21", volume="7", pages="e43940", keywords="behavior change", keywords="blood pressure", keywords="feasibility studies", keywords="goal setting", keywords="mobile health", keywords="mHealth", keywords="self-control", keywords="self-efficacy", keywords="self-regulation", keywords="smartphone", keywords="step count", keywords="walking", keywords="workplace", keywords="mobile phone", abstract="Background: High blood pressure (BP) and physical inactivity are the major risk factors for cardiovascular diseases. Mobile health is expected to support patients' self-management for improving cardiovascular health; the development of fully automated systems is necessary to minimize the workloads of health care providers. Objective: The objective of our study was to evaluate the preliminary efficacy, feasibility, and perceived usefulness of an intervention using a novel smartphone-based self-management system (DialBetes Step) in increasing steps per day among workers with high BP. Methods: On the basis of the Social Cognitive Theory, we developed personalized goal-setting and feedback functions and information delivery functions for increasing step count. Personalized goal setting and feedback consist of 4 components to support users' self-regulation and enhance their self-efficacy: goal setting for daily steps, positive feedback, action planning, and barrier identification and problem-solving. In the goal-setting component, users set their own step goals weekly in gradual increments based on the system's suggestion. We added these fully automated functions to an extant system with the function of self-monitoring daily step count, BP, body weight, blood glucose, exercise, and diet. We conducted a single-arm before-and-after study of workers with high BP who were willing to increase their physical activity. After an educational group session, participants used only the self-monitoring function for 2 weeks (baseline) and all functions of DialBetes Step for 24 weeks. We evaluated changes in steps per day, self-reported frequencies of self-regulation and self-management behavior, self-efficacy, and biomedical characteristics (home BP, BMI, visceral fat area, and glucose and lipid parameters) around week 6 (P1) of using the new functions and at the end of the intervention (P2). Participants rated the usefulness of the system using a paper-based questionnaire. Results: We analyzed 30 participants (n=19, 63\% male; mean age 52.9, SD 5.3 years); 1 (3\%) participant dropped out of the intervention. The median percentage of step measurement was 97\%. Compared with baseline (median 10,084 steps per day), steps per day significantly increased at P1 (median +1493 steps per day; P<.001), but the increase attenuated at P2 (median +1056 steps per day; P=.04). Frequencies of self-regulation and self-management behavior increased at P1 and P2. Goal-related self-efficacy tended to increase at P2 (median +5\%; P=.05). Home BP substantially decreased only at P2. Of the other biomedical characteristics, BMI decreased significantly at P1 (P<.001) and P2 (P=.001), and high-density lipoprotein cholesterol increased significantly only at P1 (P<.001). DialBetes Step was rated as useful or moderately useful by 97\% (28/29) of the participants. Conclusions: DialBetes Step intervention might be a feasible and useful way of increasing workers' step count for a short period and, consequently, improving their BP and BMI; self-efficacy--enhancing techniques of the system should be improved. ", doi="10.2196/43940", url="https://cardio.jmir.org/2023/1/e43940", url="http://www.ncbi.nlm.nih.gov/pubmed/37477976" } @Article{info:doi/10.2196/45611, author="Zaman, Sameer and Padayachee, Yorissa and Shah, Moulesh and Samways, Jack and Auton, Alice and Quaife, M. Nicholas and Sweeney, Mark and Howard, P. James and Tenorio, Indira and Bachtiger, Patrik and Kamalati, Tahereh and Pabari, A. Punam and Linton, F. Nick W. and Mayet, Jamil and Peters, S. Nicholas and Barton, Carys and Cole, D. Graham and Plymen, M. Carla", title="Smartphone-Based Remote Monitoring in Heart Failure With Reduced Ejection Fraction: Retrospective Cohort Study of Secondary Care Use and Costs", journal="JMIR Cardio", year="2023", month="Jun", day="23", volume="7", pages="e45611", keywords="heart failure", keywords="remote monitoring", keywords="smartphone care", keywords="telemonitoring", keywords="self-management", keywords="admission prevention", keywords="cohort study", keywords="hospitalization", keywords="noninvasive", keywords="smartphone", keywords="vital signs", keywords="diagnosis", abstract="Background: Despite effective therapies, the economic burden of heart failure with reduced ejection fraction (HFrEF) is driven by frequent hospitalizations. Treatment optimization and admission avoidance rely on frequent symptom reviews and monitoring of vital signs. Remote monitoring (RM) aims to prevent admissions by facilitating early intervention, but the impact of noninvasive, smartphone-based RM of vital signs on secondary health care use and costs in the months after a new diagnosis of HFrEF is unknown. Objective: The purpose of this study is to conduct a secondary care health use and health-economic evaluation for patients with HFrEF using smartphone-based noninvasive RM and compare it with matched controls receiving usual care without RM. Methods: We conducted a retrospective study of 2 cohorts of newly diagnosed HFrEF patients, matched 1:1 for demographics, socioeconomic status, comorbidities, and HFrEF severity. They are (1) the RM group, with patients using the RM platform for >3 months and (2) the control group, with patients referred before RM was available who received usual heart failure care without RM. Emergency department (ED) attendance, hospital admissions, outpatient use, and the associated costs of this secondary care activity were extracted from the Discover data set for a 3-month period after diagnosis. Platform costs were added for the RM group. Secondary health care use and costs were analyzed using Kaplan-Meier event analysis and Cox proportional hazards modeling. Results: A total of 146 patients (mean age 63 years; 42/146, 29\% female) were included (73 in each group). The groups were well-matched for all baseline characteristics except hypertension (P=.03). RM was associated with a lower hazard of ED attendance (hazard ratio [HR] 0.43; P=.02) and unplanned admissions (HR 0.26; P=.02). There were no differences in elective admissions (HR 1.03, P=.96) or outpatient use (HR 1.40; P=.18) between the 2 groups. These differences were sustained by a univariate model controlling for hypertension. Over a 3-month period, secondary health care costs were approximately 4-fold lower in the RM group than the control group, despite the additional cost of RM itself (mean cost per patient GBP {\textsterling}465, US \$581 vs GBP {\textsterling}1850, US \$2313, respectively; P=.04). Conclusions: This retrospective cohort study shows that smartphone-based RM of vital signs is feasible for HFrEF. This type of RM was associated with an approximately 2-fold reduction in ED attendance and a 4-fold reduction in emergency admissions over just 3 months after a new diagnosis with HFrEF. Costs were significantly lower in the RM group without increasing outpatient demand. This type of RM could be adjunctive to standard care to reduce admissions, enabling other resources to help patients unable to use RM. ", doi="10.2196/45611", url="https://cardio.jmir.org/2023/1/e45611", url="http://www.ncbi.nlm.nih.gov/pubmed/37351921" } @Article{info:doi/10.2196/42455, author="Lahtio, Heli and Heinonen, Ari and Paajanen, Teemu and Sj{\"o}gren, Tuulikki", title="The Added Value of Remote Technology in Cardiac Rehabilitation on Physical Function, Anthropometrics, and Quality of Life: Cluster Randomized Controlled Trial", journal="J Med Internet Res", year="2023", month="Apr", day="12", volume="25", pages="e42455", keywords="weight loss", keywords="cardiac rehabilitation", keywords="remote technology", keywords="physical function", keywords="6-minute walk test", keywords="overweight", keywords="obesity", keywords="body mass", keywords="BMI", keywords="waist circumference", keywords="quality of life", keywords="QoL", keywords="mobile phone", abstract="Background: Cardiovascular diseases (CVDs) cause most deaths globally and can reduce quality of life (QoL) of rehabilitees with cardiac disease. The risk factors of CVDs are physical inactivity and increased BMI. With physical activity, it is possible to prevent CVDs, improve QoL, and help maintain a healthy body mass. Current literature shows the possibilities of digitalization and advanced technology in supporting independent self-rehabilitation. However, the interpretation of the results is complicated owing to the studies' high heterogeneity. In addition, the added value of this technology has not been studied well, especially in cardiac rehabilitation. Objective: We aimed to examine the effectiveness of added remote technology in cardiac rehabilitation on physical function, anthropometrics, and QoL in rehabilitees with CVD compared with conventional rehabilitation. Methods: Rehabilitees were cluster randomized into 3 remote technology intervention groups (n=29) and 3 reference groups (n=30). The reference group received conventional cardiac rehabilitation, and the remote technology intervention group received conventional cardiac rehabilitation with added remote technology, namely, the Movendos mCoach app and Fitbit charge accelerometer. The 12 months of rehabilitation consisted of three 5-day in-rehabilitation periods in the rehabilitation center. Between these periods were two 6-month self-rehabilitation periods. Outcome measurements included the 6-minute walk test, body mass, BMI, waist circumference, and World Health Organization QoL-BREF questionnaire at baseline and at 6 and 12 months. Between-group differences were assessed using 2-tailed t tests and Mann-Whitney U test. Within-group differences were analyzed using a paired samples t test or Wilcoxon signed-rank test. Results: Overall, 59 rehabilitees aged 41 to 66 years (mean age 60, SD 6 years; n=48, 81\% men) were included in the study. Decrement in waist circumference (6 months: 1.6 cm; P=.04; 12 months: 3 cm; P<.001) and increment in self-assessed QoL were greater (environmental factors: 0.5; P=.02) in the remote technology intervention group than the reference group. Both groups achieved statistically significant improvements in the 6-minute walk test in both time frames (P=.01-.03). Additionally, the remote technology intervention group achieved statistically significant changes in the environmental domain at 0-6 months (P=.03) and waist circumference at both time frames (P=.01), and reference group achieve statistically significant changes in waist circumference at 0-6 months (P=.02). Conclusions: Remote cardiac rehabilitation added value to conventional cardiac rehabilitation in terms of waist circumference and QoL. The results were clinically small, but the findings suggest that adding remote technology to cardiac rehabilitation may increase beneficial health outcomes. There was some level of systematic error during rehabilitation intervention, and the sample size was relatively small. Therefore, care must be taken when generalizing the study results beyond the target population. To confirm assumptions of the added value of remote technology in rehabilitation interventions, more studies involving different rehabilitees with cardiac disease are required. Trial Registration: ISRCTN Registry ISRCTN61225589; https://www.isrctn.com/ISRCTN61225589 ", doi="10.2196/42455", url="https://www.jmir.org/2023/1/e42455", url="http://www.ncbi.nlm.nih.gov/pubmed/37043264" } @Article{info:doi/10.2196/38900, author="Hellem, Katherine Abby and Whitfield, Candace and Casetti, Amanda and Robles, Cielito Maria and Dinh, Mackenzie and Meurer, William and Skolarus, Lesli", title="Engagement in Self-measured Blood Pressure Monitoring Among Medically Underresourced Participants (the Reach Out Trial): Digital Framework Qualitative Study", journal="JMIR Cardio", year="2023", month="Apr", day="7", volume="7", pages="e38900", keywords="mobile health", keywords="mHealth", keywords="cardiovascular disease", keywords="hypertension", keywords="blood pressure", keywords="semistructured interviews", keywords="intervention engagement", keywords="social determinants of health", keywords="DBCI framework", abstract="Background: Mobile health (mHealth) interventions serve as a scalable opportunity to engage people with hypertension in self-measured blood pressure (SMBP) monitoring, an evidence-based approach to lowering blood pressure (BP) and improving BP control. Reach Out is an SMS text messaging--based SMBP mHealth trial that aims to reduce BP among hypertensive patients recruited from the emergency department of a safety net hospital in a low-income, predominately Black city. Objective: As the benefits of Reach Out are predicated on participants' engagement with the intervention, we sought to understand participants' determinants of engagement via prompted SMBP with personalized feedback (SMBP+feedback). Methods: We conducted semistructured telephone interviews based on the digital behavior change interventions framework. Participants were purposively sampled from 3 engagement categories: high engagers (?80\% response to SMBP prompts), low engagers (?20\% response to BP prompts), and early enders (participants who withdrew from the trial). Results: We conducted interviews with 13 participants, of whom 7 (54\%) were Black, with a mean age of 53.6 (SD 13.25) years. Early enders were less likely to be diagnosed with hypertension prior to Reach Out, less likely to have a primary care provider, and less likely to be taking antihypertensive medications than their counterparts. Overall, participants liked the SMS text messaging design of the intervention, including the SMBP+feedback. Several participants across all levels of engagement expressed interest in and identified the benefit of enrolling in the intervention with a partner of their choice. High engagers expressed the greatest understanding of the intervention, the least number of health-related social needs, and the greatest social support to engage in SMBP. Low engagers and early enders shared a mixed understanding of the intervention and less social support compared to high engagers. Participation decreased as social needs increased, with early enders sharing the greatest amount of resource insecurity apart from a notable exception of a high engager with high health-related social needs. Conclusions: Prompted SMBP+feedback was perceived favorably by all participants. To enhance SMBP engagement, future studies could consider greater support in the initiation of SMBP, evaluating and addressing participants' unmet health-related social needs, as well as strategies to cultivate social norms. ", doi="10.2196/38900", url="https://cardio.jmir.org/2023/1/e38900", url="http://www.ncbi.nlm.nih.gov/pubmed/37027200" } @Article{info:doi/10.2196/42845, author="Yu, Tianzhuo and Xu, Haiyan and Sui, Xin and Zhang, Xin and Pang, Yue and Yu, Tianyue and Lian, Xiaoqian and Zeng, Ting and Wu, Yuejin and Leng, Xin and Li, Feng", title="Effectiveness of eHealth Interventions on Moderate-to-Vigorous Intensity Physical Activity Among Patients in Cardiac Rehabilitation: Systematic Review and Meta-analysis", journal="J Med Internet Res", year="2023", month="Mar", day="29", volume="25", pages="e42845", keywords="cardiac rehabilitation", keywords="cardiorespiratory fitness", keywords="cardiovascular diseases", keywords="exercise", keywords="physical activity", keywords="heart disease risk factors", keywords="meta-analysis", keywords="systematic review", keywords="eHealth", keywords="telemedicine", abstract="Background: Cardiac rehabilitation is a class IA recommendation for patients with cardiovascular diseases. Physical activity is the core component and core competency of a cardiac rehabilitation program. However, many patients with cardiovascular diseases are failing to meet cardiac rehabilitation guidelines that recommend moderate-to-vigorous intensity physical activity. Objective: The major objective of this study was to review the evidence of the effectiveness of eHealth interventions in increasing moderate-to-vigorous intensity physical activity among patients in cardiac rehabilitation. The secondary objective was to examine the effectiveness of eHealth interventions in improving cardiovascular-related outcomes, that is, cardiorespiratory fitness, waist circumference, and systolic blood pressure. Methods: A comprehensive search strategy was developed, and a systematic search of 4 electronic databases (PubMed, Web of Science, Embase, and Cochrane Library) was conducted for papers published from the start of the creation of the database until November 27, 2022. Experimental studies reporting on eHealth interventions designed to increase moderate-to-vigorous intensity physical activity among patients in cardiac rehabilitation were included. Multiple unblinded reviewers determined the study eligibility and extracted data. Risk of bias was evaluated using the Cochrane Collaboration Tool for randomized controlled trials and the Cochrane Effective Practice and Organization of Care group methods for nonrandomized controlled trials. A random-effect model was used to provide the summary measures of effect (ie, standardized mean difference and 95\% CI). All statistical analyses were performed using Stata 17. Results: We screened 3636 studies, but only 29 studies were included in the final review, of which 18 were included in the meta-analysis. The meta-analysis demonstrated that eHealth interventions improved moderate-to-vigorous intensity physical activity (standardized mean difference=0.18, 95\% CI 0.07-0.28; P=.001) and vigorous-intensity physical activity (standardized mean difference=0.2, 95\% CI 0.00-0.39; P=.048) but did not improve moderate-intensity physical activity (standardized mean difference=0.19, 95\% CI --0.12 to 0.51; P=.23). No changes were observed in the cardiovascular-related outcomes. Post hoc subgroup analyses identified that wearable-based, web-based, and communication-based eHealth intervention delivery methods were effective. Conclusions: eHealth interventions are effective at increasing minutes per week of moderate-to-vigorous intensity physical activity among patients in cardiac rehabilitation. There was no difference in the effectiveness of the major eHealth intervention delivery methods, thereby providing evidence that in the future, health care professionals and researchers can personalize convenient and affordable interventions tailored to patient characteristics and needs to eliminate the inconvenience of visiting center-based cardiac rehabilitation programs during the COVID-19 pandemic and to provide better support for home-based maintenance of cardiac rehabilitation. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42021278029; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=278029 ", doi="10.2196/42845", url="https://www.jmir.org/2023/1/e42845", url="http://www.ncbi.nlm.nih.gov/pubmed/36989017" } @Article{info:doi/10.2196/43781, author="Bente, E. Britt and Wentzel, Jobke and Schepers, Celina and Breeman, D. Linda and Janssen, R. Veronica and Pieterse, E. Marcel and Evers, M. Andrea W. and van Gemert-Pijnen, Lisette", title="Implementation and User Evaluation of an eHealth Technology Platform Supporting Patients With Cardiovascular Disease in Managing Their Health After a Cardiac Event: Mixed Methods Study", journal="JMIR Cardio", year="2023", month="Mar", day="24", volume="7", pages="e43781", keywords="patient needs", keywords="health behavior", keywords="lifestyle support", keywords="user-centered design", keywords="implementation", keywords="evaluation", keywords="cardiovascular disease", keywords="app", keywords="web-based platform", keywords="intervention", abstract="Background: eHealth technology can help patients with cardiovascular disease adopt and maintain a healthy lifestyle by supporting self-management and offering guidance, coaching, and tailored information. However, to support patients over time, eHealth needs to blend in with their needs, treatment, and daily lives. Just as needs can differ between patients, needs can change within patients over time. To better adapt technology features to patients' needs, it is necessary to account for these changes in needs and contexts of use. Objective: This study aimed to identify and monitor patients' needs for support from a web-based health management platform and how these needs change over time. It aimed to answer the following research questions: ``How do novice and more advanced users experience an online health management platform?'' ``What user expectations support or hinder the adoption of an online health management platform, from a user perspective?'' and ``How does actual usage relate to user experiences and adoption?'' Methods: A mixed methods design was adopted. The first method involved 2 rounds of usability testing, followed by interviews, with 10 patients at 0 months (round 1) and 12 patients at 6 months (round 2). In the second method, log data were collected to describe the actual platform use. Results: After starting cardiac rehabilitation, the platform was used frequently. The patients mentioned that they need to have an incentive, set goals, self-monitor their health data, and feel empowered by the platform. However, soon after the rehabilitation program stopped, use of the platform declined or patients even quit because of the lack of continued tailored or personalized advice. The reward system motivated them to log data, but most participants indicated that being healthy should be the main focus, not receiving gifts. A web-based platform is flexible, accessible, and does not have any obligations; however, it should be implemented as an addition to regular care. Conclusions: Although use of the platform declined in the longer term, patients quitting the technology did not directly indicate that the technology was not functioning well or that patients no longer focused on achieving their values. The key to success should not be user adherence to a platform but adherence to healthy lifestyle habits. Therefore, the implementation of eHealth should include the transition to a stage where patients might no longer need support from a technology platform to be independently and sustainably adherent to their healthy lifestyle habits. This emphasizes the importance of conducting multi-iterative evaluations to continuously monitor whether and how patients' needs and contexts of use change over time. Future research should focus on how this transition can be identified and monitored and how these insights can inform the design and implementation of the technology. ", doi="10.2196/43781", url="https://cardio.jmir.org/2023/1/e43781", url="http://www.ncbi.nlm.nih.gov/pubmed/36961491" } @Article{info:doi/10.2196/44830, author="Dalcin, Taylor Arlene and Yuan, T. Christina and Jerome, J. Gerald and Goldsholl, Stacy and Minahan, Eva and Gennusa, Joseph and Fink, Tyler and Gudzune, A. Kimberly and Daumit, Lois Gail and Dickerson, Faith and Thompson, A. David and Wang, Nae-Yuh and Martino, Steve", title="Designing Practical Motivational Interviewing Training for Mental Health Practitioners Implementing Behavioral Lifestyle Interventions: Protocol for 3 Pilot Intervention Studies", journal="JMIR Res Protoc", year="2023", month="Mar", day="16", volume="12", pages="e44830", keywords="motivational interviewing", keywords="training", keywords="cardiovascular disease", keywords="lifestyle interventions", keywords="community mental health", abstract="Background: Motivational interviewing (MI) is an evidence-based, patient-centered communication method shown to be effective in helping persons with serious mental illness (SMI) to improve health behaviors. In clinical trials where study staff conducted lifestyle interventions incorporating an MI approach, cardiovascular disease (CVD) risk profiles of participants with SMI showed improvement. Given the disproportionate burden of CVD in this population, practitioners who provide somatic and mental health care to persons with SMI are ideally positioned to deliver patient-centered CVD risk reduction interventions. However, the time for MI training (traditionally 16-24 hours), follow-up feedback, and the coaching required to develop and maintain patient-centered skills are significant barriers to incorporating MI when scaling up these evidence-based practices. Objective: We describe the design and development of the following 2 scalable MI training approaches for community mental health practitioners: real-time brief workshops and follow-up asynchronous avatar training. These approaches are being used in 3 different pilot implementation research projects that address weight loss, smoking cessation, and CVD risk reduction in people with SMI who are a part of ALACRITY Center, a research-to-practice translation center funded by the National Institute of Mental Health. Methods: Clinicians and staff in community mental health clinics across Maryland were trained to deliver 3 distinct evidence-based physical health lifestyle interventions using an MI approach to persons with SMI. The real-time brief MI workshop training for ACHIEVE-D weight loss coaches was 4 hours; IMPACT smoking cessation counselors received 2-hour workshops and prescribers received 1-hour workshops; and RHYTHM CVD risk reduction program staff received 4 hours of MI. All workshop trainings occurred over videoconference. The asynchronous avatar training includes 1 common didactic instructional module for the 3 projects and 1 conversation simulation unique to each study's target behavior. Avatar training is accessible on a commercial website. We plan to assess practitioners' attitudes and beliefs about MI and evaluate the impact of the 2 MI training approaches on their MI skills 3, 6, and 12 months after training using the MI Treatment Integrity 4.2.1 coding tool and the data generated by the avatar-automated scoring system. Results: The ALACRITY Center was funded in August 2018. We have implemented the MI training for 126 practitioners who are currently delivering the 3 implementation projects. We expect the studies to be complete in May 2023. Conclusions: This study will contribute to knowledge about the effect of brief real-time training augmented with avatar skills practice on clinician MI skills. If MI Treatment Integrity scoring shows it to be effective, brief videoconference trainings supplemented with avatar skills practice could be used to train busy community mental health practitioners to use an MI approach when implementing physical health interventions. International Registered Report Identifier (IRRID): DERR1-10.2196/44830 ", doi="10.2196/44830", url="https://www.researchprotocols.org/2023/1/e44830", url="http://www.ncbi.nlm.nih.gov/pubmed/36927501" } @Article{info:doi/10.2196/40283, author="Giggins, M. Oonagh and Doyle, Julie and Smith, Suzanne and Vavasour, Grainne and Moran, Orla and Gavin, Shane and Sojan, Nisanth and Boyle, Gordon", title="Remotely Delivered Cardiac Rehabilitation Exercise for Coronary Heart Disease: Nonrandomized Feasibility Study", journal="JMIR Cardio", year="2023", month="Feb", day="10", volume="7", pages="e40283", keywords="cardiac rehabilitation", keywords="exercise", keywords="coronary heart disease", keywords="CHD", keywords="coronary", keywords="cardiovascular", keywords="virtual rehabilitation", keywords="remote rehabilitation", keywords="digital health", keywords="heart", keywords="rehabilitation", keywords="cardiac", keywords="digital platform", keywords="digital", keywords="intervention", keywords="program", keywords="physical activity", keywords="fitness", abstract="Background: Exercise-based cardiac rehabilitation (CR) is recommended for coronary heart disease (CHD). However, poor uptake of and poor adherence to CR exercise programs have been reported globally. Delivering CR exercise classes remotely may remove some of the barriers associated with traditional hospital- or center-based CR. Objective: We have developed a bespoke platform, Eastern Corridor Medical Engineering Centre--Cardiac Rehabilitation (ECME-CR), to support remotely delivered CR exercise. This pilot trial sought to test the ECME-CR platform and examine the efficacy and feasibility of a remote CR exercise program compared to a traditional center-based program. Methods: In all, 21 participants with CHD were recruited and assigned to either the intervention or control group. Both groups performed the same 8-week exercise program. Participants in the intervention group took part in web-based exercise classes and used the ECME-CR platform during the intervention period, whereas participants in the control group attended in-person classes. Outcomes were assessed at baseline and following the 8-week intervention period. The primary outcome measure was exercise capacity, assessed using a 6-minute walk test (6MWT). Secondary outcomes included measurement of grip strength, self-reported quality of life, heart rate, blood pressure, and body composition. A series of mixed between-within subjects ANOVA were conducted to examine the mean differences in study outcomes between and within groups. Participant adherence to the exercise program was also analyzed. Results: In all, 8 participants (male: n=5; age: mean 69.7, SD 7.2 years; height: mean 163.9, SD 5.4 cm; weight: mean 81.6, SD 14.1 kg) in the intervention group and 9 participants (male: n=9; age: mean 69.8, SD 8.2 years; height: mean 173.8, SD 5.2 cm; weight: mean 94.4, SD 18.0 kg) in the control group completed the exercise program. Although improvements in 6MWT distance were observed from baseline to follow-up in both the intervention (mean 490.1, SD 80.2 m to mean 504.5, SD 93.7 m) and control (mean 510.2, SD 48.3 m to mean 520.6, SD 49.4 m) group, no significant interaction effect (F1,14=.026; P=.87) nor effect for time (F1,14=2.51; P=.14) were observed. No significant effects emerged for any of the other secondary end points (all P>.0275). Adherence to the exercise program was high in both the intervention (14.25/16, 89.1\%) and control (14.33/16, 89.6\%) group. No adverse events or safety issues were reported in either group during the study. Conclusions: This pilot trial did not show evidence of significant positive effect for either the remotely delivered or center-based program. The 6MWT may not have been sufficiently sensitive to identify a change in this cohort of participants with stable CHD. This trial does provide evidence that remote CR exercise, supported with digital self-monitoring, is feasible and may be considered for individuals less likely to participate in traditional center-based programs. International Registered Report Identifier (IRRID): RR2-10.2196/31855 ", doi="10.2196/40283", url="https://cardio.jmir.org/2023/1/e40283", url="http://www.ncbi.nlm.nih.gov/pubmed/36763453" } @Article{info:doi/10.2196/36773, author="Nourse, Rebecca and Lobo, Elton and McVicar, Jenna and Kensing, Finn and Islam, Shariful Sheikh Mohammed and Kayser, Lars and Maddison, Ralph", title="Characteristics of Smart Health Ecosystems That Support Self-care Among People With Heart Failure: Scoping Review", journal="JMIR Cardio", year="2022", month="Nov", day="2", volume="6", number="2", pages="e36773", keywords="digital health", keywords="review", keywords="chronic diseases", keywords="cardiovascular disease", keywords="information technology", keywords="digital technology", keywords="mobile phone", keywords="self-management", abstract="Background: The management of heart failure is complex. Innovative solutions are required to support health care providers and people with heart failure with decision-making and self-care behaviors. In recent years, more sophisticated technologies have enabled new health care models, such as smart health ecosystems. Smart health ecosystems use data collection, intelligent data processing, and communication to support the diagnosis, management, and primary and secondary prevention of chronic conditions. Currently, there is little information on the characteristics of smart health ecosystems for people with heart failure. Objective: We aimed to identify and describe the characteristics of smart health ecosystems that support heart failure self-care. Methods: We conducted a scoping review using the Joanna Briggs Institute methodology. The MEDLINE, Embase, CINAHL, PsycINFO, IEEE Xplore, and ACM Digital Library databases were searched from January 2008 to September 2021. The search strategy focused on identifying articles describing smart health ecosystems that support heart failure self-care. A total of 2 reviewers screened the articles and extracted relevant data from the included full texts. Results: After removing duplicates, 1543 articles were screened, and 34 articles representing 13 interventions were included in this review. To support self-care, the interventions used sensors and questionnaires to collect data and used tailoring methods to provide personalized support. The interventions used a total of 34 behavior change techniques, which were facilitated by a combination of 8 features for people with heart failure: automated feedback, monitoring (integrated and manual input), presentation of data, education, reminders, communication with a health care provider, and psychological support. Furthermore, features to support health care providers included data presentation, alarms, alerts, communication tools, remote care plan modification, and health record integration. Conclusions: This scoping review identified that there are few reports of smart health ecosystems that support heart failure self-care, and those that have been reported do not provide comprehensive support across all domains of self-care. This review describes the technical and behavioral components of the identified interventions, providing information that can be used as a starting point for designing and testing future smart health ecosystems. ", doi="10.2196/36773", url="https://cardio.jmir.org/2022/2/e36773", url="http://www.ncbi.nlm.nih.gov/pubmed/36322112" } @Article{info:doi/10.2196/40546, author="Sivakumar, Bridve and Lemonde, Manon and Stein, Matthew and Goldstein, Sarah and Mak, Susanna and Arcand, JoAnne", title="Evaluating Health Care Provider Perspectives on the Use of Mobile Apps to Support Patients With Heart Failure Management: Qualitative Descriptive Study", journal="JMIR Cardio", year="2022", month="Oct", day="26", volume="6", number="2", pages="e40546", keywords="heart failure", keywords="mobile health", keywords="mHealth", keywords="eHealth", keywords="mobile apps", keywords="adherence", keywords="self-management", keywords="mobile phone", abstract="Background: Nonadherence to diet and medical therapies in heart failure (HF) contributes to poor HF outcomes. Mobile apps may be a promising way to improve adherence because they increase knowledge and behavior change via education and monitoring. Well-designed apps with input from health care providers (HCPs) can lead to successful adoption of such apps in practice. However, little is known about HCPs' perspectives on the use of mobile apps to support HF management. Objective: The aim of this study is to determine HCPs' perspectives (needs, motivations, and challenges) on the use of mobile apps to support patients with HF management. Methods: A qualitative descriptive study using one-on-one semistructured interviews, informed by the diffusion of innovation theory, was conducted among HF HCPs, including cardiologists, nurses, and nurse practitioners. Transcripts were independently coded by 2 researchers and analyzed using content analysis. Results: The 21 HCPs (cardiologists: n=8, 38\%; nurses: n=6, 29\%; and nurse practitioners: n=7, 33\%) identified challenges and opportunities for app adoption across 5 themes: participant-perceived factors that affect app adoption---these include patient age, technology savviness, technology access, and ease of use; improved delivery of care---apps can support remote care; collect, share, and assess health information; identify adverse events; prevent hospitalizations; and limit clinic visits; facilitating patient engagement in care---apps can provide feedback and reinforcement, facilitate connection and communication between patients and their HCPs, support monitoring, and track self-care; providing patient support through education---apps can provide HF-related information (ie, diet and medications); and participant views on app features for their patients---HCPs felt that useful apps would have reminders and alarms and participative elements (gamification, food scanner, and quizzes). Conclusions: HCPs had positive views on the use of mobile apps to support patients with HF management. These findings can inform effective development and implementation strategies of HF management apps in clinical practice. ", doi="10.2196/40546", url="https://cardio.jmir.org/2022/2/e40546", url="http://www.ncbi.nlm.nih.gov/pubmed/36287588" } @Article{info:doi/10.2196/39188, author="Gutenberg, Johanna and Kulnik, Tino Stefan and Niebauer, Josef and Crutzen, Rik", title="Determinants of Physical Activity in the Cardiac Population: Protocol for a Systematic Review", journal="JMIR Res Protoc", year="2022", month="Sep", day="7", volume="11", number="9", pages="e39188", keywords="behavior change", keywords="cardiac rehabilitation", keywords="cardiovascular disease", keywords="determinants", keywords="heart healthy", keywords="physical activity", keywords="protocol", keywords="secondary prevention", keywords="systematic review", keywords="cardiac disease", keywords="heart disease", keywords="clinician", keywords="health care worker", keywords="health intervention", keywords="decision-making", keywords="health promotion", abstract="Background: Lack of physical activity is a critical contributing risk factor to cardiovascular disease. Hence, regular physical activity is a mainstay in the primary and secondary prevention of cardiovascular disease. Despite the extensive promotion of physical activity in both primary and secondary prevention programs, including cardiac rehabilitation, physical activity levels in the cardiac population remain low. Therefore, it is crucial to understand critical determinants that influence physical activity behavior. Objective: This study aims to deliver a systematic review of studies with collated observational data exploring the association between determinants and physical activity behavior in the target population. These new insights inform the design of future interventions targeted at lasting heart-healthy physical activity behavior in the cardiac population. Methods: Primary studies with observational quantitative data on determinants and their association with physical activity behavior in the cardiac population will be included. Information on relevant primary studies will be retrieved from various databases, including Embase, CINAHL, MEDLINE, PsycInfo, and Web of Science Core Collection. Six reviewers will independently double-screen articles. Studies will be selected according to the prespecified inclusion and exclusion criteria. Data will be extracted and entered into suitable worksheets. The US-based National Heart, Lung, and Blood Institute's Study Quality Assessment Tool for Observational Studies will be used to assess the quality of all eligible primary studies. The results will be presented in a descriptive and narrative synthesis. If the type and quality of data are suitable, meta-analyses will be conducted. Study reporting will follow the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. Results: Data collection started in September 2020, and the literature search was updated in July 2021. Data synthesis is ongoing, and the literature search will be updated in October 2022. Conclusions: This review will be valuable to relevant stakeholders, including clinicians and health care professionals, intervention developers, and decision makers in health care. It lays a comprehensive foundation for understanding the determinants of physical activity to inform the design of secondary prevention interventions relevant to the cardiac population. Trial Registration: PROSPERO CRD42020206637; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=206637 International Registered Report Identifier (IRRID): RR1-10.2196/39188 ", doi="10.2196/39188", url="https://www.researchprotocols.org/2022/9/e39188", url="http://www.ncbi.nlm.nih.gov/pubmed/36069762" } @Article{info:doi/10.2196/29035, author="Knittle, Keegan and Charman, J. Sarah and O'Connell, Sophie and Avery, Leah and Catt, Michael and Sniehotta, F. Falko and Trenell, I. Michael", title="Movement as Medicine for Cardiovascular Disease Prevention: Pilot Feasibility Study of a Physical Activity Promotion Intervention for At-Risk Patients in Primary Care", journal="JMIR Cardio", year="2022", month="Jun", day="29", volume="6", number="1", pages="e29035", keywords="primary care", keywords="physical activity", keywords="cardiovascular disease", keywords="prevention", keywords="internet-based intervention", keywords="motivational interviewing", keywords="self-regulation", abstract="Background: Physical activity (PA) can reduce cardiovascular disease (CVD) risk factors, and although primary care settings offer a large reach to promote PA and reduce CVD risk, primary health care professionals may lack self-efficacy and tools to effectively promote PA in practice. Movement as Medicine for CVD Prevention is a suite of 2 theory-based, web-based behavioral interventions---one for health care professionals and one for patients---which may offer a pathway for promoting PA and reducing CVD risk in primary care. Objective: This study aims to examine the feasibility and possible effects of Movement as Medicine for CVD Prevention. Methods: This nonrandomized pilot study recruited participants from primary care organizations in the Northeast of England. Enrolled health care professionals followed a theory-based, web-based course on PA counseling and motivational interviewing techniques. After the course, health care professionals delivered behavior change consultations based on motivational interviewing to inactive individuals with >20\% risk of developing CVD within 10 years. Patients were then given access to a website based on self-determination and self-regulation theories, which targeted increased levels of PA. Outcomes were assessed at baseline and after 3 months, and patient data were analyzed on an intention-to-treat basis in a multiple imputation data set. Results: Recruitment rates of primary care organizations fell below expectations. A total of 11 health care professionals from 3 enrolled primary care organizations completed the web-based course and reported increases in important theoretical determinants of PA promotion in practice (eg, self-efficacy, Cohen d=1.24, 95\% CI 0.67-1.80; and planning, Cohen d=0.85, 95\% CI ?0.01 to 1.69). A total of 83 patients were enrolled in the study, and 58 (70\%) completed both the baseline and 3-month assessments. Compared with baseline, patients had higher levels of objective (Cohen d=0.77, 95\% CI 0.13-1.41) but not subjective (Cohen d=0.40, 95\% CI ?0.03 to 0.83) moderate to vigorous PA at 3 months. Patients also reported higher levels of the PA determinants of intention, self-efficacy, intrinsic motivation, and action planning and action control at 3 months (effect sizes ranged from Cohen d=0.39 to 0.60). Conclusions: The Movement as Medicine for CVD Prevention intervention seems to have the potential to improve patient PA behaviors and important determinants of health care professionals' PA promotion practices. However, the recruitment rates of primary care organizations in this study were low and would need to be increased to examine the efficacy of the program. This study offers several insights into improving the feasibility of this primary care PA promotion pathway. Trial Registration: ISRCTN Registry ISRCTN14582348; http://www.isrctn.com/ISRCTN14582348 ", doi="10.2196/29035", url="https://cardio.jmir.org/2022/1/e29035", url="http://www.ncbi.nlm.nih.gov/pubmed/35767316" } @Article{info:doi/10.2196/35945, author="Bas-Sarmiento, Pilar and Fern{\'a}ndez-Guti{\'e}rrez, Martina and Poza-M{\'e}ndez, Miriam and Mar{\'i}n-Paz, Jes{\'u}s Antonio and Paloma-Castro, Olga and Romero-S{\'a}nchez, Manuel Jos{\'e} and ", title="Development and Effectiveness of a Mobile Health Intervention in Improving Health Literacy and Self-management of Patients With Multimorbidity and Heart Failure: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="Apr", day="29", volume="11", number="4", pages="e35945", keywords="complex health needs", keywords="health literacy", keywords="heart failure", keywords="mHealth", keywords="multimorbidity", abstract="Background: Patients with multimorbidity and complex health needs are defined as a priority by the World Health Organization (WHO) and the European Union. There is a need to develop appropriate strategies with effective measures to meet the challenge of chronicity, reorienting national health systems. The increasing expansion of mobile health (mHealth) interventions in patient communication, the reduction of health inequalities, improved access to health care resources, adherence to treatment, and self-care of chronic diseases all point to an optimistic outlook. However, only few mobile apps demonstrate their effectiveness in these patients, which is diminished when they are not based on evidence, or when they are not designed by and for users with different levels of health literacy (HL). Objective: This study aims to evaluate the efficacy of an mHealth intervention relative to routine clinical practice in improving HL and self-management in patients with multimorbidity with heart failure (HF) and complex health needs. Methods: This is a randomized, multicenter, blinded clinical trial evaluating 2 groups, namely, a control group (standard clinical practice) and an intervention group (standard clinical practice and an ad hoc designed mHealth intervention previously developed), for 12 months. Results: The contents of the mHealth intervention will address user-perceived needs based on the development of user stories regarding diet, physical exercise, cardiac rehabilitation, therapeutic adherence, warning signs and symptoms, and emotional management. These contents have been validated by expert consensus. The creation and development of the contents of the mHealth intervention (app) took 18 months and was completed during 2021. The mobile app is expected to be developed by the end of 2022, after which it will be applied to the experimental group as an adjunct to standard clinical care during 12 months. Conclusions: The trial will demonstrate whether the mobile app improves HL and self-management in patients with HF and complex health needs, improves therapeutic adherence, and reduces hospital admissions. This study can serve as a starting point for developing other mHealth tools in other pathologies and for their generalization to other contexts. Trial Registration: ClinicalTrials.gov NCT04725526; https://tinyurl.com/bd8va27w International Registered Report Identifier (IRRID): DERR1-10.2196/35945 ", doi="10.2196/35945", url="https://www.researchprotocols.org/2022/4/e35945", url="http://www.ncbi.nlm.nih.gov/pubmed/35486437" } @Article{info:doi/10.2196/30236, author="Treskes, Willem Roderick and van den Akker-van Marle, Elske M. and van Winden, Louise and van Keulen, Nicole and van der Velde, Tjeerd Enno and Beeres, Saskia and Atsma, Douwe and Schalij, Jan Martin", title="The Box---eHealth in the Outpatient Clinic Follow-up of Patients With Acute Myocardial Infarction: Cost-Utility Analysis", journal="J Med Internet Res", year="2022", month="Apr", day="25", volume="24", number="4", pages="e30236", keywords="smart technology", keywords="myocardial infarction", keywords="cost-utility", keywords="outpatients", keywords="cost-effectiveness", keywords="eHealth", keywords="remote monitoring", keywords="cost of care", keywords="quality of life", abstract="Background: Smartphone compatible wearables have been released on the consumers market, enabling remote monitoring. Remote monitoring is often named as a tool to reduce the cost of care. Objective: The primary purpose of this paper is to describe a cost-utility analysis of an eHealth intervention compared to regular follow-up in patients with acute myocardial infarction (AMI). Methods: In this trial, of which clinical results have been published previously, patients with an AMI were randomized in a 1:1 fashion between an eHealth intervention and regular follow-up. The remote monitoring intervention consisted of a blood pressure monitor, weight scale, electrocardiogram device, and step counter. Furthermore, two in-office outpatient clinic visits were replaced by e-visits. The control group received regular care. The differences in mean costs and quality of life per patient between both groups during one-year follow-up were calculated. Results: Mean costs per patient were {\texteuro}2417{\textpm}2043 (US \$2657{\textpm}2246) for the intervention and {\texteuro}2888{\textpm}2961 (US \$3175{\textpm}3255) for the control group. This yielded a cost reduction of {\texteuro}471 (US \$518) per patient. This difference was not statistically significant (95\% CI --{\texteuro}275 to {\texteuro}1217; P=.22, US \$--302 to \$1338). The average quality-adjusted life years in the first year of follow-up was 0.74 for the intervention group and 0.69 for the control (difference --0.05, 95\% CI --0.09 to --0.01; P=.01). Conclusions: eHealth in the outpatient clinic setting for patients who suffered from AMI is likely to be cost-effective compared to regular follow-up. Further research should be done to corroborate these findings in other patient populations and different care settings. Trial Registration: ClinicalTrials.gov NCT02976376; https://clinicaltrials.gov/ct2/show/NCT02976376 International Registered Report Identifier (IRRID): RR2-10.2196/resprot.8038 ", doi="10.2196/30236", url="https://www.jmir.org/2022/4/e30236", url="http://www.ncbi.nlm.nih.gov/pubmed/35468091" } @Article{info:doi/10.2196/30661, author="Brasca, Angelo Francesco Maria and Casale, Carla Maria and Canevese, Lorenzo Fabio and Tortora, Giovanni and Pagano, Giulia and Botto, Luca Giovanni", title="Physical Activity in Patients With Heart Failure During and After COVID-19 Lockdown: Single-Center Observational Retrospective Study", journal="JMIR Cardio", year="2022", month="Apr", day="19", volume="6", number="1", pages="e30661", keywords="heart failure", keywords="physical activity", keywords="COVID-19", keywords="remote monitoring", keywords="implantable cardiac device", keywords="monitoring", keywords="exercise", keywords="surveillance", keywords="lockdown", keywords="cardiovascular", keywords="heart", keywords="retrospective", keywords="burden", abstract="Background: The COVID-19 pandemic forced several European governments to impose severe lockdown measures. The reduction of physical activity during the lockdown could have been deleterious. Objective: The aim of this observational, retrospective study was to investigate the effect of the lockdown strategy on the physical activity burden and subsequent reassessment in a group of patients with heart failure who were followed by means of remote monitoring. Methods: We analyzed remote monitoring transmissions during the 3-month period immediately preceding the lockdown, 69 days of lockdown, and 3-month period after the first lockdown in a cohort of patients with heart failure from a general hospital in Lombardy, Italy. We compared variation of daily physical activity measured by cardiac implantable electrical devices with clinical variables collected in a hospital database. Results: We enrolled 41 patients with heart failure that sent 176 transmissions. Physical activity decreased during the lockdown period (mean 3.4, SD 1.9 vs mean 2.9, SD 1.8 hours/day; P<.001) but no significant difference was found when comparing the period preceding and following the lockdown (--0.0007 hours/day; P=.99). We found a significant correlation between physical activity reduction during and after the lockdown (R2=0.45, P<.001). The only significant predictor of exercise variation in the postlockdown period was the lockdown to prelockdown physical activity ratio. Conclusions: An excessive reduction of exercise in patients with heart failure decreased the tolerance to exercise, especially in patients with more comorbidities. Remote monitoring demonstrated exercise reduction, suggesting its potential utility to encourage patients to maintain their usual physical activity levels. ", doi="10.2196/30661", url="https://cardio.jmir.org/2022/1/e30661", url="http://www.ncbi.nlm.nih.gov/pubmed/35103602" } @Article{info:doi/10.2196/34142, author="Bonner, Carissa and Batcup, Carys and Ayre, Julie and Cvejic, Erin and Trevena, Lyndal and McCaffery, Kirsten and Doust, Jenny", title="The Impact of Health Literacy--Sensitive Design and Heart Age in a Cardiovascular Disease Prevention Decision Aid: Randomized Controlled Trial and End-User Testing", journal="JMIR Cardio", year="2022", month="Apr", day="15", volume="6", number="1", pages="e34142", keywords="decision aids", keywords="shared decision-making", keywords="risk communication", keywords="heart age", keywords="cardiovascular disease prevention", keywords="behavior change", keywords="health literacy", abstract="Background: Shared decision-making is an essential principle for the prevention of cardiovascular disease (CVD), where asymptomatic people consider lifelong medication and lifestyle changes. Objective: This study aims to develop and evaluate the first literacy-sensitive CVD prevention decision aid (DA) developed for people with low health literacy, and investigate the impact of literacy-sensitive design and heart age. Methods: We developed a standard DA based on international standards. The standard DA was based on our existing general practitioner DA. The literacy-sensitive DA included simple language, supporting images, white space, and a lifestyle action plan. The control DA used Heart Foundation materials. A randomized trial included 859 people aged 45-74 years using a 3 (DA: standard, literacy-sensitive, control) {\texttimes}2 (heart age: heart age + percentage risk, percentage risk only) factorial design, with outcomes including prevention intentions and behaviors, gist and verbatim knowledge of risk, credibility, emotional response, and decisional conflict. We iteratively improved the literacy-sensitive version based on end-user testing interviews with 20 people with varying health literacy levels. Results: Immediately after the intervention (n=859), there were no differences in any outcome among the DA groups. The heart age group was less likely to have a positive emotional response, perceived the message as less credible, and had higher gist and verbatim knowledge of heart age risk but not percentage risk. After 4 weeks (n=596), the DA group had better gist knowledge of percentage risk than the control group. The literacy-sensitive DA group had higher fruit consumption, and the standard DA group had better verbatim knowledge of percentage risk. Verbatim knowledge was higher for heart age than for percentage risk among those who received both. Conclusions: The literacy-sensitive DA resulted in increased knowledge of CVD risk and increased fruit consumption in participants with varying health literacy levels and CVD risk results. Adding heart age did not increase lifestyle change intentions or behavior but did affect psychological outcomes, consistent with previous findings. This tool will be integrated with additional resources to improve other lifestyle outcomes. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12620000806965; https://tinyurl.com/226yhk8a ", doi="10.2196/34142", url="https://cardio.jmir.org/2022/1/e34142", url="http://www.ncbi.nlm.nih.gov/pubmed/35436208" } @Article{info:doi/10.2196/34470, author="Laranjo, Liliana and Shaw, Tim and Trivedi, Ritu and Thomas, Stuart and Charlston, Emma and Klimis, Harry and Thiagalingam, Aravinda and Kumar, Saurabh and Tan, C. Timothy and Nguyen, N. Tu and Marschner, Simone and Chow, Clara", title="Coordinating Health Care With Artificial Intelligence--Supported Technology for Patients With Atrial Fibrillation: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="Apr", day="13", volume="11", number="4", pages="e34470", keywords="atrial fibrillation", keywords="interactive voice response", keywords="artificial intelligence", keywords="conversational agent", keywords="mobile phone", abstract="Background: Atrial fibrillation (AF) is an increasingly common chronic health condition for which integrated care that is multidisciplinary and patient-centric is recommended yet challenging to implement. Objective: The aim of Coordinating Health Care With Artificial Intelligence--Supported Technology in AF is to evaluate the feasibility and potential efficacy of a digital intervention (AF-Support) comprising preprogrammed automated telephone calls (artificial intelligence conversational technology), SMS text messages, and emails, as well as an educational website, to support patients with AF in self-managing their condition and coordinate primary and secondary care follow-up. Methods: Coordinating Health Care With Artificial Intelligence--Supported Technology in AF is a 6-month randomized controlled trial of adult patients with AF (n=385), who will be allocated in a ratio of 4:1 to AF-Support or usual care, with postintervention semistructured interviews. The primary outcome is AF-related quality of life, and the secondary outcomes include cardiovascular risk factors, outcomes, and health care use. The 4:1 allocation design enables a detailed examination of the feasibility, uptake, and process of the implementation of AF-Support. Participants with new or ongoing AF will be recruited from hospitals and specialist-led clinics in Sydney, New South Wales, Australia. AF-Support has been co-designed with clinicians, researchers, information technologists, and patients. Automated telephone calls will occur 7 times, with the first call triggered to commence 24 to 48 hours after enrollment. Calls follow a standard flow but are customized to vary depending on patients' responses. Calls assess AF symptoms, and participants' responses will trigger different system responses based on prespecified protocols, including the identification of red flags requiring escalation. Randomization will be performed electronically, and allocation concealment will be ensured. Because of the nature of this trial, only outcome assessors and data analysts will be blinded. For the primary outcome, groups will be compared using an analysis of covariance adjusted for corresponding baseline values. Randomized trial data analysis will be performed according to the intention-to-treat principle, and qualitative data will be thematically analyzed. Results: Ethics approval was granted by the Western Sydney Local Health District Human Ethics Research Committee, and recruitment started in December 2020. As of December 2021, a total of 103 patients had been recruited. Conclusions: This study will address the gap in knowledge with respect to the role of postdischarge digital care models for supporting patients with AF. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12621000174886; https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12621000174886 International Registered Report Identifier (IRRID): DERR1-10.2196/34470 ", doi="10.2196/34470", url="https://www.researchprotocols.org/2022/4/e34470", url="http://www.ncbi.nlm.nih.gov/pubmed/35416784" } @Article{info:doi/10.2196/16141, author="van Lieshout, Jan and Lacroix, Joyca and van Halteren, Aart and Teichert, Martina", title="Effectiveness of a Pharmacist-Led Web-Based Medication Adherence Tool With Patient-Centered Communication: Results of a Clustered Randomized Controlled Trial", journal="J Med Internet Res", year="2022", month="Apr", day="7", volume="24", number="4", pages="e16141", keywords="medication adherence", keywords="improvement", keywords="intervention", keywords="web-based", keywords="tailored intervention", keywords="patient centered", keywords="barriers", keywords="primary care", keywords="cardiovascular diseases", keywords="diabetes", abstract="Background: Growing numbers of people use medication for chronic conditions; nonadherence is common, leading to poor disease control. A web-based tool to identify an increased risk for nonadherence with related potential individual barriers might facilitate tailored interventions and improve adherence. Objective: This study aims to assess the effectiveness of a newly developed tool aimed at improving medication adherence. Methods: We performed a cluster randomized controlled trial in patients initiating cardiovascular or oral blood glucose--lowering medication. Participants were recruited from community pharmacies. They completed an online questionnaire comprising assessments of their risk for medication nonadherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients with high nonadherence risk in face-to-face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by pharmacists. Barriers of control patients were not presented nor discussed and these patients received usual care. The primary outcome was the effectiveness of the intervention on medication adherence at 8 months' follow-up between patients with an increased nonadherence risk from the intervention and control groups, calculated from dispensing data. Results: Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (B=--0.01; 95\% CI --0.59 to 0.57; P=.96), nor in the post hoc per-protocol analysis (B=0.19; 95\% CI --0.50 to 0.89; P=.58). Conclusions: This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effectiveness were identified. These explanations relate, for instance, to high medication adherence in the control group, study power, and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. Trial Registration: The Netherlands National Trial Register NTR5186; https://tinyurl.com/5d8w99hk ", doi="10.2196/16141", url="https://www.jmir.org/2022/4/e16141", url="http://www.ncbi.nlm.nih.gov/pubmed/35389359" } @Article{info:doi/10.2196/33783, author="Moran, Orla and Doyle, Julie and Giggins, Oonagh and McHugh, Louise and Gould, Evelyn and Smith, Suzanne and Gavin, Shane and Sojan, Nisanth and Boyle, Gordon", title="Efficacy of a Digital Acceptance and Commitment Therapy Intervention for the Improvement of Self-management Behaviors and Psychological Flexibility in Adults With Cardiac Disease: Protocol for a Single Case Experimental Design", journal="JMIR Res Protoc", year="2022", month="Apr", day="1", volume="11", number="4", pages="e33783", keywords="cardiac disease", keywords="acceptance and commitment therapy", keywords="distress management", keywords="self-management", keywords="single case experimental design", keywords="digital health", abstract="Background: Research indicates that the management of distress levels in those with cardiac disease is not only important for improving quality of life and functioning but also critical for condition management; adherence to treatment; and, ultimately, disease prognosis and progression. Acceptance and commitment therapy (ACT) has consistently demonstrated positive long-term outcomes across a wide array of conditions, including chronic illness. However, most empirical investigations conducted to date have also involved in-person therapy, which can be difficult to access, particularly for those dealing with the demands of chronic disease. Objective: The objective of our research is to evaluate a digital ACT intervention for improving self-management behaviors and distress levels in those with cardiac conditions. Methods: The digital ACT intervention will be delivered via a digital health self-management platform over 6 sessions. This will involve a randomized, multiple baseline, single case experimental design with approximately 3 to 15 adults with cardiac disease. The independent variable for each participant will be the pre-post intervention phase. The dependent variables will be a daily self-report measure of psychological flexibility as well as objective measures of condition self-management (eg, blood pressure readings) and engagement with the app (eg, completing guided mindfulness). One-to-one qualitative interviews will also be conducted to further examine participants' experiences with using the intervention and what factors contribute to or impede successful outcomes. Results: Participant recruitment and data collection began in October 2021, and it is projected that the study findings will be available for dissemination by spring 2022. Conclusions: The findings will be discussed in terms of how a digital ACT intervention can best meet the needs of cardiac patients. International Registered Report Identifier (IRRID): PRR1-10.2196/33783 ", doi="10.2196/33783", url="https://www.researchprotocols.org/2022/4/e33783", url="http://www.ncbi.nlm.nih.gov/pubmed/35363156" } @Article{info:doi/10.2196/25224, author="{\"O}gmundsd{\'o}ttir Michelsen, Halld{\'o}ra and Sj{\"o}lin, Ingela and B{\"a}ck, Maria and Gonzalez Garcia, Manuel and Olsson, Anneli and Sandberg, Camilla and Schiopu, Alexandru and Le{\'o}sd{\'o}ttir, Margr{\'e}t", title="Effect of a Lifestyle-Focused Web-Based Application on Risk Factor Management in Patients Who Have Had a Myocardial Infarction: Randomized Controlled Trial", journal="J Med Internet Res", year="2022", month="Mar", day="31", volume="24", number="3", pages="e25224", keywords="eHealth", keywords="cardiac rehabilitation", keywords="cardiovascular", keywords="mobile device app", keywords="risk factors", keywords="web-based application", keywords="mobile phone", abstract="Background: Cardiac rehabilitation is central in reducing mortality and morbidity after myocardial infarction. However, the fulfillment of guideline-recommended cardiac rehabilitation targets is unsatisfactory. eHealth offers new possibilities to improve clinical care. Objective: This study aims to assess the effect of a web-based application designed to support adherence to lifestyle advice and self-control of risk factors (intervention) in addition to center-based cardiac rehabilitation, compared with cardiac rehabilitation only (usual care). Methods: All 150 patients participated in cardiac rehabilitation. Patients randomized to the intervention group (n=101) received access to the application for 25 weeks where information about lifestyle (eg, diet and physical activity), risk factors (eg, weight and blood pressure [BP]), and symptoms could be registered. The software provided feedback and lifestyle advice. The primary outcome was a change in submaximal exercise capacity (Watts [W]) between follow-up visits. Secondary outcomes included changes in modifiable risk factors between baseline and follow-up visits and uptake and adherence to the application. Regression analysis was used, adjusting for relevant baseline variables. Results: There was a nonsignificant trend toward a larger change in exercise capacity in the intervention group (n=66) compared with the usual care group (n=40; +14.4, SD 19.0 W, vs +10.3, SD 16.1 W; P=.22). Patients in the intervention group achieved significantly larger BP reduction compared with usual care patients at 2 weeks (systolic ?27.7 vs ?16.4 mm?Hg; P=.006) and at 6 to 10 weeks (systolic ?25.3 vs ?16.4 mm Hg; P=.02, and diastolic ?13.4 vs ?9.1 mm Hg; P=.05). A healthy diet index score improved significantly more between baseline and the 2-week follow-up in the intervention group (+2.3 vs +1.4 points; P=.05), mostly owing to an increase in the consumption of fish and fruit. At 6 to 10 weeks, 64\% (14/22) versus 46\% (5/11) of smokers in the intervention versus usual care groups had quit smoking, and at 12 to 14 months, the respective percentages were 55\% (12/22) versus 36\% (4/11). However, the number of smokers in the study was low (33/149, 21.9\%), and the differences were nonsignificant. Attendance in cardiac rehabilitation was high, with 96\% (96/100) of patients in the intervention group and 98\% (48/49) of patients receiving usual care only attending 12- to 14-month follow-up. Uptake (logging data in the application at least once) was 86.1\% (87/101). Adherence (logging data at least twice weekly) was 91\% (79/87) in week 1 and 56\% (49/87) in week 25. Conclusions: Complementing cardiac rehabilitation with a web-based application improved BP and dietary habits during the first months after myocardial infarction. A nonsignificant tendency toward better exercise capacity and higher smoking cessation rates was observed. Although the study group was small, these positive trends support further development of eHealth in cardiac rehabilitation. Trial Registration: ClinicalTrials.gov NCT03260582; https://clinicaltrials.gov/ct2/show/NCT03260582 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-018-3118-1 ", doi="10.2196/25224", url="https://www.jmir.org/2022/3/e25224", url="http://www.ncbi.nlm.nih.gov/pubmed/35357316" } @Article{info:doi/10.2196/33057, author="Wilson-Anumudu, Folasade and Quan, Ryan and Cerrada, Christian and Juusola, Jessie and Castro Sweet, Cynthia and Bradner Jasik, Carolyn and Turken, Michael", title="Pilot Results of a Digital Hypertension Self-management Program Among Adults With Excess Body Weight: Single-Arm Nonrandomized Trial", journal="JMIR Form Res", year="2022", month="Mar", day="30", volume="6", number="3", pages="e33057", keywords="hypertension", keywords="self-management", keywords="digital health", keywords="home measurement", keywords="lifestyle", abstract="Background: Home-measured blood pressure (HMBP) in combination with comprehensive medication support and lifestyle change are the mainstays of evidence-based hypertension (HTN) management. To date, the precise components needed for effective HTN self-management programs have yet to be defined, and access to multicomponent targeted support for HTN management that include telemonitoring remain inaccessible and costly. Objective: The aim of this pilot study was to evaluate the impact of a digital HTN self-management program on blood pressure (BP) control among adults with excess body weight. Methods: A single-arm, nonrandomized trial was performed to evaluate a digital HTN self-management program that combines comprehensive lifestyle counseling with HTN education, guided HMBP, support for taking medications, and led by either a registered nurse or certified diabetes care and education specialist. A sample of 151 participants were recruited using a web-based research platform (Achievement Studies, Evidation Health Inc). The primary outcome was change in systolic BP from baseline to 3 months, and secondary outcomes included change in diastolic BP and medication adherence. Results: Participants' mean age was 44.0 (SD 9.3) years and mean BP was 139/85 mm Hg. At follow-up, systolic and diastolic BP decreased by 7 mm Hg (P<.001, 95\% CI --9.3 to --4.7) and 4.7 mm Hg (P<.001, 95\% CI --6.3 to --3.2), respectively. Participants who started with baseline BP at goal remained at goal. For participants with stage 1 HTN, systolic and diastolic BP decreased by 3.6 mm Hg (P=.09, 95\% CI --7.8 to 0.6) and 2.5 mm Hg (P=.03, 95\% CI --4.9 to --0.3). Systolic and diastolic BP decreased by 10.3 mm Hg (P<.001, 95\% CI --13.4 to --7.1) and 6.5 mm Hg (P<.001, 95\% CI --8.6 to --4.4), respectively, for participants with stage 2 HTN. Medication adherence significantly improved (P=.02). Conclusions: This pilot study provides initial evidence that a digital HTN self-management program improves BP and medication adherence. ", doi="10.2196/33057", url="https://formative.jmir.org/2022/3/e33057", url="http://www.ncbi.nlm.nih.gov/pubmed/35353040" } @Article{info:doi/10.2196/34294, author="Lunde, Pernille and Bye, Asta and Bruusgaard, Anette Kari and Hellem, Elisabet and Nilsson, Blakstad Birgitta", title="Patients' Experiences of Using a Smartphone App After Cardiac Rehabilitation: Qualitative Study", journal="JMIR Hum Factors", year="2022", month="Mar", day="23", volume="9", number="1", pages="e34294", keywords="mHealth", keywords="mobile health", keywords="cardiac rehabilitation", keywords="mobile phone app", keywords="smartphone", keywords="lifestyle", abstract="Background: Exercise-based cardiac rehabilitation (CR) is a crucial part of the treatment of patients with cardiac diseases, and adherence to healthy behavior is a prerequisite to improve long-term prognosis. Unfortunately, adherence to healthy behavior adapted in CR is challenging for many cardiac patients in the long term. Recently, we demonstrated that follow-up conducted via an app for 1 year significantly improved adherence to healthy behavior after CR. To increase the knowledge and understanding of mobile Health (mHealth) interventions that can promote acceptance and adherence, qualitative research investigating patients' experiences with these interventions is warranted. Objective: The aim was to investigate patient experiences with individualized long-term follow-up conducted via an app for 1 year and their thoughts about what features promoted adherence to healthy behavior after CR. The purpose was to increase the understanding of significant findings previously reported and to guide future development of similar interventions in the field of adherence. Methods: A qualitative study with individual interviews was conducted from November 2018 to May 2019. A thematic interview guide was used when conducting the semistructured in-depth interviews. The interviews were audio recorded and transcribed successively during the period in which the interviews were conducted. Texts were managed and systematized by NVivo. Interviews were analyzed by qualitative content analysis. Codes and themes were inductively developed. Results: Ten patients who had participated in a randomized controlled trial evaluating the effect of follow-up conducted via an app on adherence to healthy behavior after CR were included. The median patient age was 65 years (range 46-72 years), and both genders were represented. The analysis resulted in the following 4 themes describing the patients' experiences: (1) The person behind the app is crucial for motivation and adherence; (2) The app as a commitment; (3) The app as a path to independence; and (4) Suggestions for improvements. Features experienced as beneficial to promote adherence were individualized feedback and the use of goal setting. The significance of the person behind the app (the supervisor) who provided individualized feedback was a consistent finding. This person seemed to promote motivation in general and to enable other known behavioral change techniques. Conclusions: The person behind the app (the supervisor) seems to be one of the most significant success factors in promoting adherence to healthy behavior after CR. This indicates that a health care provider must actively participate in a patient's process of adherence to healthy behavior, even when using interventions, including an app. Future development of interventions in the field of adherence should strive to create tools that enable an ongoing collaborative relationship between the patient and the health care provider. The follow-up should be based on the patient's own goals, and individualized feedback should be provided. ", doi="10.2196/34294", url="https://humanfactors.jmir.org/2022/1/e34294", url="http://www.ncbi.nlm.nih.gov/pubmed/35319476" } @Article{info:doi/10.2196/33286, author="Johnson, E. Amber and Routh, Shuvodra and Taylor, N. Christy and Leopold, Meagan and Beatty, Kathryn and McNamara, M. Dennis and Davis, M. Esa", title="Developing and Implementing an mHealth Heart Failure Self-care Program to Reduce Readmissions: Randomized Controlled Trial", journal="JMIR Cardio", year="2022", month="Mar", day="21", volume="6", number="1", pages="e33286", keywords="mHealth", keywords="heart failure", keywords="self-care", keywords="remote monitoring", keywords="telehealth", keywords="cardiology", keywords="hospital readmission", keywords="self-management", keywords="mobile health", keywords="patient-centered", abstract="Background: Patients admitted with decompensated heart failure (HF) are at risk for hospital readmission and poor quality of life during the discharge period. Lifestyle behavior modifications that promote the self-management of chronic cardiac diseases have been associated with an improved quality of life. However, whether a mobile health (mHealth) program can assist patients in the self-management of HF during the acute posthospital discharge period is unknown. Objective: We aimed to develop an mHealth program designed to enhance patients' self-management of HF by increasing knowledge, self-efficacy, and symptom detection. We hypothesized that patients hospitalized with HF would be willing to use a feasibly deployed mHealth program after their hospital discharge. Methods: We employed a patient-centered outcomes research methodology to design a stakeholder-informed mHealth program. Adult patients with HF admitted to a large academic hospital were enrolled and randomized to receive the mHealth intervention versus usual care. Our feasibility outcomes included ease of program deployment, use of the clinical escalation process, duration of participant recruitment, and participant attrition. Surveys assessing the demographics and clinical characteristics of HF were measured at baseline and at 30 and 90 days after discharge. Results: The study period was between July 1, 2019, and April 7, 2020. The mean cohort (N=31) age was 60.4 (range 22-85) years. Over half of the participants were men (n=18, 58\%) and 77\% (n=24) were White. There were no significant differences in baseline measures. We determined that an educational mHealth program tailored for patients with HF is feasibly deployed and acceptable by patients. Though not significant, we found notable trends including a higher mean quality of life at 30 days posthospitalization among program users and a longer duration before rehospitalization, which are suggestive of better HF prognosis. Conclusions: Our mHealth tool should be further assessed in a larger comparative effectiveness trial. Our pilot intervention offers promise as an innovative means to help HF patients lead healthy, independent lives. These preliminary data suggest that patient-centered mHealth tools can enable high-risk patients to play a role in the management of their HF after discharge. Trial Registration: ClinicalTrials.gov NCT03982017; https://clinicaltrials.gov/ct2/show/NCT03982017 ", doi="10.2196/33286", url="https://cardio.jmir.org/2022/1/e33286", url="http://www.ncbi.nlm.nih.gov/pubmed/35311679" } @Article{info:doi/10.2196/31974, author="Sawa, Ryuichi and Saitoh, Masakazu and Morisawa, Tomoyuki and Takahashi, Tetsuya and Morimoto, Yuh and Kagiyama, Nobuyuki and Kasai, Takatoshi and Dinesen, Birthe and Daida, Hiroyuki", title="The Potential Application of Commercially Available Active Video Games to Cardiac Rehabilitation: Scoping Review", journal="JMIR Serious Games", year="2022", month="Mar", day="18", volume="10", number="1", pages="e31974", keywords="active video game", keywords="cardiac rehabilitation", keywords="physical exercise", keywords="rehabilitation", keywords="serious games", keywords="CVD", keywords="AVG", keywords="cardiovascular disease", keywords="exercise", keywords="safety", keywords="adherence", abstract="Background: Commercially available active video games (AVGs) have recently been used for rehabilitation in some specific patient populations but rarely in those with cardiovascular disease (CVD). Commercially available AVGs are designed to increase motivation for continuous play, which could be applicable to the long-term cardiac rehabilitation process. Objective: The objective of this scoping review was to assess the effectiveness of AVG-induced physical exercise, safety management, and patient adherence by applying commercially available AVGs to cardiac rehabilitation. Methods: Four databases (CINAHL, MEDLINE, PubMed, and SPORTDiscus) were searched for all years up to August 12, 2020. Articles were retained if they were written in English, included patients with CVD who were aged 18 years or older, and used AVGs as part of a physical exercise program. The included studies were then evaluated from the viewpoints of effectiveness as physical exercise, safety, and adherence management. Results: Among 120 nonduplicate articles reviewed, 5 (4.2\%) were eligible for inclusion, of which 3 (2.5\%) were reported by the same research group. The AVG consoles used were Xbox Kinect and Nintendo Wii, and sports-related programs were adopted for the intervention. No adverse cardiac events occurred in the identified studies, and dropout rates tended to be low. Conclusions: AVGs appear to be safe and feasible for promoting an active lifestyle in patients with CVD. However, the effectiveness of AVGs alone as a therapeutic exercise to improve physical function may be limited. ", doi="10.2196/31974", url="https://games.jmir.org/2022/1/e31974", url="http://www.ncbi.nlm.nih.gov/pubmed/35302503" } @Article{info:doi/10.2196/27202, author="Ni, Zhao and Wu, Bei and Yang, Qing and Yan, L. Lijing and Liu, Changqing and Shaw, J. Ryan", title="An mHealth Intervention to Improve Medication Adherence and Health Outcomes Among Patients With Coronary Heart Disease: Randomized Controlled Trial", journal="J Med Internet Res", year="2022", month="Mar", day="9", volume="24", number="3", pages="e27202", keywords="mHealth", keywords="medication adherence", keywords="coronary disease", keywords="blood pressure", keywords="China", keywords="randomized controlled trial", abstract="Background: The treatment of many chronic illnesses involves long-term pharmaceutical therapy, but it is an ongoing challenge to find effective ways to improve medication adherence to promote good health outcomes. Cardioprotective medications can prevent the enlargement of harmful clots, cardiovascular symptoms, and poor therapeutic outcomes, such as uncontrolled high blood pressure and hyperlipidemia, for patients with coronary heart disease. Poor adherence to cardioprotective medications, however, has been reported as a global health concern among patients with coronary heart disease, and it is particularly a concern in China. Objective: This study aimed to evaluate the efficacy of a mobile health (mHealth) intervention using 2 mobile apps to improve medication adherence and health outcomes. Methods: A randomized, placebo-controlled, 2-arm parallel study was conducted in a major university-affiliated medical center located in Chengdu, China. Participants were recruited by flyers and health care provider referrals. Each participant was observed for 90 days, including a 60-day period of mHealth intervention and a 30-day period of nonintervention follow-up. The study coordinator used WeChat and Message Express to send educational materials and reminders to take medication, respectively. Participants used WeChat to receive both the educational materials and reminders. Participants in the control group only received educational materials. This study received ethics approval from the Duke Health Institutional Review Board (Pro00073395) on May 5, 2018, and was approved by West China Hospital (20170331180037). Recruitment began on May 20, 2018. The pilot phase of this study was registered on June 8, 2016, and the current, larger-scale study was retrospectively registered on January 11, 2021 (ClinicalTrials.gov). Results: We recruited 230 patients with coronary heart disease. Of these patients, 196 completed the baseline survey and received the intervention. The majority of participants were married (181/196, 92.4\%), male (157/196, 80.1\%), and lived in urban China (161/196, 82.1\%). Participants' average age was 61 years, and half were retired (103/191, 53.9\%). More than half the participants (121/196, 61.7\%) were prescribed at least 5 medications. The mean decrease in medication nonadherence score was statistically significant at both 60 days (t179=2.04, P=.04) and 90 days (t155=3.48, P<.001). Systolic blood pressure and diastolic blood pressure decreased in the experimental group but increased in the control group. The mean decrease in diastolic blood pressure was statistically significant at both 60 days (t160=2.07, P=.04) and 90 days (t164=2.21, P=.03). The mean decrease in systolic blood pressure was significantly different in the groups at 90 days (t165=3.12, P=.002). Conclusions: The proposed mHealth intervention can improve medication adherence and health outcomes, including systolic blood pressure and diastolic blood pressure. Trial Registration: ClinicalTrials.gov NCT02793830; https://clinicaltrials.gov/ct2/show/NCT02793830 and ClinicalTrials.gov NCT04703439; https://clinicaltrials.gov/ct2/show/NCT04703439 ", doi="10.2196/27202", url="https://www.jmir.org/2022/3/e27202", url="http://www.ncbi.nlm.nih.gov/pubmed/35262490" } @Article{info:doi/10.2196/33579, author="de Freitas Gon{\c{c}}alves, Shelry Kamila and Queiroz Godoy Daniel, Carolina Ana and Tatagiba Lamas, Luiz Jos{\'e} and Ceretta Oliveira, Henrique and Silveira, P. Renata C. C. and Cloutier, Lyne and Velludo Veiga, Eugenia", title="Device- and Nondevice-Guided Slow Breathing to Reduce Blood Pressure in Patients with Hypertension: Protocol for a Systematic Review and Meta-analysis", journal="JMIR Res Protoc", year="2022", month="Mar", day="4", volume="11", number="3", pages="e33579", keywords="hypertension", keywords="breathing exercises", keywords="device-guided breathing", keywords="respirate", keywords="systematic review", keywords="physical therapy", keywords="blood pressure", keywords="clinical decision making", keywords="health care professional", keywords="physiotherapy", abstract="Background: Physiotherapy can include both device-guided slow breathing (DGSB) and nondevice-guided slow breathing (NDGSB) in the treatment of systemic arterial hypertension. Objective: The aim of this study is to summarize the effects of DGSB on blood pressure levels of patients with hypertension based on the published literature to date. Methods: A systematic search of all published randomized controlled trials (RCTs) on the effects of device-guided and nondevice-guided slow breathing in patients with hypertension, without language restriction, was carried out up to a publication date of January 2020 in nine databases: PubMed/MEDLINE, Latin American and Caribbean Health Sciences Literature (LILACS), EMBASE, CENTRAL (Cochrane Central Register of Controlled Trials), Physiotherapy Evidence Database (PEDro), CINAHL (Cumulative Index to Nursing and Allied Health Literature), Scopus, Web of Science, and Livivo. Clinical trial records databases (ClinicalTrials.gov), and bases for the open gray literature, including Gray Literature Report and ProQuest Central (Citation, Abstract or Indexing, and Dissertations and Theses), were also searched for potentially eligible RCTs. The quality assessment of the included studies will be performed using the Cochrane Risk of Bias Tool for Randomized Trials. The overall quality of the evidence for each outcome will be assessed using the GRADE (Grading of Recommendations, Development and Evaluation) system. Results: As of December 2021, the review was completed and all data from continuous variables referring to blood pressure values (mmHg) were synthesized. Conclusions: This systematic review will provide a summary of the current evidence on the effects of both DGSB and NDGSB on blood pressure levels. This information can contribute to decision-making by health professionals related to the use of these interventions in patients with hypertension. Trial Registration: PROSPERO (Prospective International Register of Systematic Reviews) CRD42020147554; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=147554 International Registered Report Identifier (IRRID): RR1-10.2196/33579 ", doi="10.2196/33579", url="https://www.researchprotocols.org/2022/3/e33579", url="http://www.ncbi.nlm.nih.gov/pubmed/35254284" } @Article{info:doi/10.2196/32946, author="Morken, Margreta Ingvild and Storm, Marianne and S{\o}reide, Arne Jon and Urstad, Hjorthaug Kristin and Karlsen, Bj{\o}rg and Huseb{\o}, Lunde Anne Marie", title="Posthospitalization Follow-Up of Patients With Heart Failure Using eHealth Solutions: Restricted Systematic Review", journal="J Med Internet Res", year="2022", month="Feb", day="15", volume="24", number="2", pages="e32946", keywords="adherence", keywords="eHealth", keywords="heart failure", keywords="posthospitalization follow-up", keywords="patient outcome", keywords="review", abstract="Background: Heart failure (HF) is a clinical syndrome with high incidence rates, a substantial symptom and treatment burden, and a significant risk of readmission within 30 days after hospitalization. The COVID-19 pandemic has revealed the significance of using eHealth interventions to follow up on the care needs of patients with HF to support self-care, increase quality of life (QoL), and reduce readmission rates during the transition between hospital and home. Objective: The aims of this review are to summarize research on the content and delivery modes of HF posthospitalization eHealth interventions, explore patient adherence to the interventions, and examine the effects on the patient outcomes of self-care, QoL, and readmissions. Methods: A restricted systematic review study design was used. Literature searches and reviews followed the (PRISMA-S) Preferred Reporting Items for Systematic Reviews and Meta-Analyses literature search extension checklist, and the CINAHL, MEDLINE, Embase, and Cochrane Library databases were searched for studies published between 2015 and 2020. The review process involved 3 groups of researchers working in pairs. The Mixed Methods Appraisal Tool was used to assess the included studies' methodological quality. A thematic analysis method was used to analyze data extracted from the studies. Results: A total of 18 studies were examined in this review. The studies were published between 2015 and 2019, with 56\% (10/18) of them published in the United States. Of the 18 studies, 16 (89\%) were randomized controlled trials, and 14 (78\%) recruited patients upon hospital discharge to eHealth interventions lasting from 14 days to 12 months. The studies involved structured telephone calls, interactive voice response, and telemonitoring and included elements of patient education, counseling, social and emotional support, and self-monitoring of symptoms and vital signs. Of the 18 studies, 11 (61\%) provided information on patient adherence, and the adherence levels were 72\%-99\%. When used for posthospitalization follow-up of patients with HF, eHealth interventions can positively affect QoL, whereas its impact is less evident for self-care and readmissions. Conclusions: This review suggests that patients with HF should receive prompt follow-up after hospitalization and eHealth interventions have the potential to improve these patients' QoL. Patient adherence in eHealth follow-up trials shows promise for successful future interventions and adherence research. Further studies are warranted to examine the effects of eHealth interventions on self-care and readmissions among patients with HF. ", doi="10.2196/32946", url="https://www.jmir.org/2022/2/e32946", url="http://www.ncbi.nlm.nih.gov/pubmed/35166680" } @Article{info:doi/10.2196/29434, author="Naseri Jahfari, Arman and Tax, David and Reinders, Marcel and van der Bilt, Ivo", title="Machine Learning for Cardiovascular Outcomes From Wearable Data: Systematic Review From a Technology Readiness Level Point of View", journal="JMIR Med Inform", year="2022", month="Jan", day="19", volume="10", number="1", pages="e29434", keywords="mHealth", keywords="wearable", keywords="machine learning", keywords="cardiovascular disease", keywords="digital health", keywords="review", keywords="mobile phone", abstract="Background: Wearable technology has the potential to improve cardiovascular health monitoring by using machine learning. Such technology enables remote health monitoring and allows for the diagnosis and prevention of cardiovascular diseases. In addition to the detection of cardiovascular disease, it can exclude this diagnosis in symptomatic patients, thereby preventing unnecessary hospital visits. In addition, early warning systems can aid cardiologists in timely treatment and prevention. Objective: This study aims to systematically assess the literature on detecting and predicting outcomes of patients with cardiovascular diseases by using machine learning with data obtained from wearables to gain insights into the current state, challenges, and limitations of this technology. Methods: We searched PubMed, Scopus, and IEEE Xplore on September 26, 2020, with no restrictions on the publication date and by using keywords such as ``wearables,'' ``machine learning,'' and ``cardiovascular disease.'' Methodologies were categorized and analyzed according to machine learning--based technology readiness levels (TRLs), which score studies on their potential to be deployed in an operational setting from 1 to 9 (most ready). Results: After the removal of duplicates, application of exclusion criteria, and full-text screening, 55 eligible studies were included in the analysis, covering a variety of cardiovascular diseases. We assessed the quality of the included studies and found that none of the studies were integrated into a health care system (TRL<6), prospective phase 2 and phase 3 trials were absent (TRL<7 and 8), and group cross-validation was rarely used. These issues limited these studies' ability to demonstrate the effectiveness of their methodologies. Furthermore, there seemed to be no agreement on the sample size needed to train these studies' models, the size of the observation window used to make predictions, how long participants should be observed, and the type of machine learning model that is suitable for predicting cardiovascular outcomes. Conclusions: Although current studies show the potential of wearables to monitor cardiovascular events, their deployment as a diagnostic or prognostic cardiovascular clinical tool is hampered by the lack of a realistic data set and proper systematic and prospective evaluation. ", doi="10.2196/29434", url="https://medinform.jmir.org/2022/1/e29434", url="http://www.ncbi.nlm.nih.gov/pubmed/35044316" } @Article{info:doi/10.2196/22957, author="Chen, Ying-Hsien and Hung, Chi-Sheng and Huang, Ching-Chang and Lee, Jen-Kuang and Yu, Jiun-Yu and Ho, Yi-Lwun", title="The Impact of Synchronous Telehealth Services With a Digital Platform on Day-by-Day Home Blood Pressure Variability in Patients with Cardiovascular Diseases: Retrospective Cohort Study", journal="J Med Internet Res", year="2022", month="Jan", day="10", volume="24", number="1", pages="e22957", keywords="blood pressure", keywords="variability", keywords="telehealth", keywords="hypertension", keywords="cardiovascular disease", keywords="chronic disease", keywords="heart", keywords="digital platform", keywords="cohort", keywords="management", keywords="intervention", abstract="Background: Hypertension is associated with a large global disease burden with variable control rates across different regions and races. Telehealth has recently emerged as a health care strategy for managing chronic diseases, but there are few reports regarding the effects of synchronous telehealth services on home blood pressure (BP) control and variability. Objective: The objective of this study is to investigate the effect of synchronous telehealth services with a digital platform on home BP. Methods: This retrospective study was conducted by the Taiwan ELEctroHEALTH study group at the Telehealth Center of the National Taiwan University Hospital. We analyzed home BP data taken from 2888 patients with cardiovascular disease (CVD) enrolled in our telehealth program between 2009 to 2017. Of the 2888 patients with CVD, 348 (12.05\%) patients who received home BP surveillance for ?56 days were selected for BP analysis. Patients were stratified into three groups: (1) poorly controlled hypertension, (2) well-controlled hypertension, and (3) nonhypertension. The mean, SD, coefficient of variation (CV), and average real variability were calculated. Results: Telehealth interventions significantly and steadily reduced systolic blood pressure (SBP) in the poorly controlled hypertension group from 144.8.2{\textpm}9.2 to 133.7{\textpm}10.2 mmHg after 2 months (P<.001). BP variability reduced in all patients: SBP-SD decreased from 7.8{\textpm}3.4 to 7.3{\textpm}3.4 after 2 months (P=.004), and SBP-CV decreased from 6.3{\textpm}2.5 to 5.9{\textpm}2.6 after 2 months (P=.004). Event-free survival (admission) analysis stratified by SBP-SD showed longer time to first hospitalization for Q1 patients compared with Q4 patients (P=.02, odds ratio 2.15, 95\% CI 1.18-3.89). Conclusions: Synchronous telehealth intervention may improve home BP control and decrease day-by-day home BP variability in patients with CVD. ", doi="10.2196/22957", url="https://www.jmir.org/2022/1/e22957", url="http://www.ncbi.nlm.nih.gov/pubmed/35006089" } @Article{info:doi/10.2196/34534, author="Rogerson, C. Michelle and Jackson, C. Alun and Navaratnam, S. Hema and Le Grande, R. Michael and Higgins, O. Rosemary and Clarke, Joanne and Murphy, M. Barbara", title="Getting ``Back on Track'' After a Cardiac Event: Protocol for a Randomized Controlled Trial of a Web-Based Self-management Program", journal="JMIR Res Protoc", year="2021", month="Dec", day="23", volume="10", number="12", pages="e34534", keywords="coronary heart disease", keywords="heart disease", keywords="coronary", keywords="cardiovascular", keywords="prevention", keywords="RCT", keywords="randomized control trial", keywords="secondary prevention", keywords="self-management", keywords="online", keywords="randomised controlled trial", keywords="health behaviours", keywords="health behaviour", keywords="health behavior", keywords="depression", keywords="cognitive behaviour therapy", keywords="motivational interviewing", abstract="Background: After a cardiac event, a large majority of patients with cardiac conditions do not achieve recommended behavior change targets for secondary prevention. Mental health issues can also impact the ability to engage in health behavior change. There is a need for innovative, flexible, and theory-driven eHealth programs, which include evidence-based strategies to assist patients with cardiac conditions with their recovery, especially in behavioral and emotional self-management. Objective: The aim of this study is to determine the short- and longer-term behavioral and emotional well-being outcomes of the Back on Track web-based self-management program. In addition, this study will test whether there is enhanced benefit of providing one-on-one telephone support from a trained lifestyle counselor, over and above benefit obtained through completing the web-based program alone. Methods: People who have experienced a cardiac event in the previous 12 months and have access to the internet will be eligible for this study (N=120). Participants will be randomly assigned to one of the two study conditions: either ``self-directed'' completion of the Back on Track program (without assistance) or ``supported'' completion of the Back on Track program (additional 2 telephone sessions with a lifestyle counselor). All participants will have access to the web-based Back on Track program for 2 months. Telephone sessions with the supported arm participants will occur at approximately 2 and 6 weeks post enrollment. Measures will be assessed at baseline, and then 2 and 6 months later. Outcome measures assessed at all 3 timepoints include dietary intake, physical activity and sitting time, smoking status, anxiety and depression, stage of change, and self-efficacy in relation to behavioral and emotional self-management, quality of life, and self-rated health and well-being. A demographic questionnaire will be included at baseline only and program acceptability at 2 months only. Results: Recruitment began in May 2020 and concluded in August 2021. Data collection for the 6-month follow-up will be completed by February 2022, and data analysis and publication of results will be completed by June 2022. A total of 122 participants were enrolled in this study. Conclusions: The Back on Track trial will enable us to quantify the behavioral and emotional improvements obtained and maintained for patients with cardiac conditions and, in particular, to compare two modes of delivery: (1) fully self-directed delivery and (2) supported by a lifestyle counselor. We anticipate that the web-based Back on Track program will assist patients in their recovery and self-management after an acute event, and represents an effective, flexible, and easily accessible adjunct to center-based rehabilitation programs. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12620000102976; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378920\&isReview=true International Registered Report Identifier (IRRID): DERR1-10.2196/34534 ", doi="10.2196/34534", url="https://www.researchprotocols.org/2021/12/e34534", url="http://www.ncbi.nlm.nih.gov/pubmed/34941550" } @Article{info:doi/10.2196/26072, author="Biersteker, Tom and Hilt, Alexander and van der Velde, Enno and Schalij, Jan Martin and Treskes, Willem Roderick", title="Real-World Experience of mHealth Implementation in Clinical Practice (the Box): Design and Usability Study", journal="JMIR Cardio", year="2021", month="Dec", day="16", volume="5", number="2", pages="e26072", keywords="eHealth", keywords="mHealth", keywords="remote patient monitoring", keywords="cardiology", keywords="patient satisfaction", keywords="patient empowerment", keywords="mobile phone", abstract="Background: Mobile health (mHealth) is an emerging field of scientific interest worldwide. Potential benefits include increased patient engagement, improved clinical outcomes, and reduced health care costs. However, mHealth is often studied in projects or trials, and structural implantation in clinical practice is less common. Objective: The purpose of this paper is to outline the design of the Box and its implementation and use in an outpatient clinic setting. The impact on logistical outcomes and patient and provider satisfaction is discussed. Methods: In 2016, an mHealth care track including smartphone-compatible devices, named the Box, was implemented in the cardiology department of a tertiary medical center in the Netherlands. Patients with myocardial infarction, rhythm disorders, cardiac surgery, heart failure, and congenital heart disease received devices to measure daily weight, blood pressure, heart rate, temperature, and oxygen saturation. In addition, professional and patient user comments on the experience with the care track were obtained via structured interviews. Results: From 2016 to April 2020, a total of 1140 patients were connected to the mHealth care track. On average, a Box cost {\texteuro}350 (US \$375), not including extra staff costs. The median patient age was 60.8 (IQR 52.9-69.3) years, and 73.59\% (839/1140) were male. A median of 260 (IQR 105-641) measurements was taken on a median of 189 (IQR 98-372) days. Patients praised the ease of use of the devices and felt more involved with their illness and care. Professionals reported more productive outpatient consultations as well as improved insight into health parameters such as blood pressure and weight. A feedback loop from the hospital to patient to focus on measurements was commented as an important improvement by both patients and professionals. Conclusions: In this study, the design and implementation of an mHealth care track for outpatient follow-up of patients with various cardiovascular diseases is described. Data from these 4 years indicate that mHealth is feasible to incorporate in outpatient management and is generally well-accepted by patients and providers. Limitations include the need for manual measurement data checks and the risk of data overload. Moreover, the tertiary care setting in which the Box was introduced may limit the external validity of logistical and financial end points to other medical centers. More evidence is needed to show the effects of mHealth on clinical outcomes and on cost-effectiveness. ", doi="10.2196/26072", url="https://cardio.jmir.org/2021/2/e26072", url="http://www.ncbi.nlm.nih.gov/pubmed/34642159" } @Article{info:doi/10.2196/26794, author="Ali, Lilas and Wallstr{\"o}m, Sara and Fors, Andreas and Barenfeld, Emmelie and Fredholm, Eva and Fu, Michael and Goudarzi, Mahboubeh and Gyllensten, Hanna and Lindstr{\"o}m Kjellberg, Irma and Swedberg, Karl and Vanfleteren, W. Lowie E. G. and Ekman, Inger", title="Effects of Person-Centered Care Using a Digital Platform and Structured Telephone Support for People With Chronic Obstructive Pulmonary Disease and Chronic Heart Failure: Randomized Controlled Trial", journal="J Med Internet Res", year="2021", month="Dec", day="13", volume="23", number="12", pages="e26794", keywords="chronic heart failure", keywords="chronic obstructive pulmonary disease", keywords="digital platform", keywords="eHealth", keywords="patient-centered care", keywords="person-centered care", keywords="randomized controlled trial", keywords="telehealth", abstract="Background: Chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) are characterized by severe symptom burden and common acute worsening episodes that often require hospitalization and affect prognosis. Although many studies have shown that person-centered care (PCC) increases self-efficacy in patients with chronic conditions, studies on patients with COPD and CHF treated in primary care and the effects of PCC on the risk of hospitalization in these patients are scarce. Objective: The aim of this study is to evaluate the effects of PCC through a combined digital platform and telephone support for people with COPD and CHF. Methods: A multicenter randomized trial was conducted from 2018 to 2020. A total of 222 patients were recruited from 9 primary care centers. Patients diagnosed with COPD, CHF, or both and with internet access were eligible. Participants were randomized into either usual care (112/222, 50.5\%) or PCC combined with usual care (110/222, 49.5\%). The intervention's main component was a personal health plan cocreated by the participants and assigned health care professionals. The health care professionals called the participants in the intervention group and encouraged narration to establish a partnership using PCC communication skills. A digital platform was used as a communication tool. The primary end point, divided into 2 categories (improved and deteriorated or unchanged), was a composite score of change in general self-efficacy and hospitalization or death 6 months after randomization. Data from the intention-to-treat group at 3- and 6-month follow-ups were analyzed. In addition, a per-protocol analysis was conducted on the participants who used the intervention. Results: No significant differences were found in composite scores between the groups at the 3- and 6-month follow-ups. However, the per-protocol analysis of the 3-month follow-up revealed a significant difference in composite scores between the study groups (P=.047), although it was not maintained until the end of the 6-month follow-up (P=.24). This effect was driven by a change in general self-efficacy from baseline. Conclusions: PCC using a combined digital platform and structured telephone support seems to be an option to increase the short-term self-efficacy of people with COPD and CHF. This study adds to the knowledge of conceptual innovations in primary care to support patients with COPD and CHF. Trial Registration: ClinicalTrials.gov NCT03183817; http://clinicaltrials.gov/ct2/show/NCT03183817 ", doi="10.2196/26794", url="https://www.jmir.org/2021/12/e26794", url="http://www.ncbi.nlm.nih.gov/pubmed/34898447" } @Article{info:doi/10.2196/26439, author="Chen, Yuling and Ji, Meihua and Wu, Ying and Wang, Qingyu and Deng, Ying and Liu, Yong and Wu, Fangqin and Liu, Mingxuan and Guo, Yiqiang and Fu, Ziyuan and Zheng, Xiaoying", title="An Intelligent Individualized Cardiovascular App for Risk Elimination (iCARE) for Individuals With Coronary Heart Disease: Development and Usability Testing Analysis", journal="JMIR Mhealth Uhealth", year="2021", month="Dec", day="13", volume="9", number="12", pages="e26439", keywords="mobile health", keywords="health behavior", keywords="system", keywords="development", keywords="usability", keywords="coronary heart disease", abstract="Background: Death and disability from coronary heart disease (CHD) can be largely reduced by improving risk factor management. However, adhering to evidence-based recommendations is challenging and requires interventions at the level of the patient, provider, and health system. Objective: The aim of this study was to develop an Intelligent Individualized Cardiovascular App for Risk Elimination (iCARE) to facilitate adherence to health behaviors and preventive medications, and to test the usability of iCARE. Methods: We developed iCARE based on a user-centered design approach, which included 4 phases: (1) function design, (2) iterative design, (3) expert inspections and walkthroughs of the prototypes, and (4) usability testing with end users. The usability testing of iCARE included 2 stages: stage I, which included a task analysis and a usability evaluation (January to March 2019) of the iCARE patient app using the modified Health Information Technology Usability Survey (Health-ITUES); and stage II (June 2020), which used the Health-ITUES among end users who used the app for 6 months. The end users were individuals with a confirmed diagnosis of CHD from 2 university-affiliated hospitals in Beijing, China. Results: iCARE consists of a patient app, a care provider app, and a cloud platform. It has a set of algorithms that trigger tailored feedback and can send individualized interventions based on data from initial assessment and health monitoring via manual entry or wearable devices. For stage I usability testing, 88 hospitalized patients (72\% [63/88] male; mean age 60 [SD 9.9] years) with CHD were included in the study. The mean score of the usability testing was 90.1 (interquartile range 83.3-99.0). Among enrolled participants, 90\% (79/88) were satisfied with iCARE; 94\% (83/88) and 82\% (72/88) reported that iCARE was useful and easy to use, respectively. For stage II usability testing, 61 individuals with CHD (85\% [52/61] male; mean age 53 [SD 8.2] years) who were from an intervention arm and used iCARE for at least six months were included. The mean total score on usability testing based on the questionnaire was 89.0 (interquartile distance: 77.0-99.5). Among enrolled participants, 89\% (54/61) were satisfied with the use of iCARE, 93\% (57/61) perceived it as useful, and 70\% (43/61) as easy to use. Conclusions: This study developed an intelligent, individualized, evidence-based, and theory-driven app (iCARE) to improve patients' adherence to health behaviors and medication management. iCARE was identified to be highly acceptable, useful, and easy to use among individuals with a diagnosis of CHD. Trial Registration: Chinese Clinical Trial Registry ChiCTR-INR-16010242; https://tinyurl.com/2p8bkrew ", doi="10.2196/26439", url="https://mhealth.jmir.org/2021/12/e26439", url="http://www.ncbi.nlm.nih.gov/pubmed/34898449" } @Article{info:doi/10.2196/17839, author="Chatterjee, Pothik and Beck, M. Adam and Brager, Levenson Jenna Ashley and Durand, J. Daniel and D'Adamo, R. Christopher", title="The Effect of an Automated Mobile Patient Engagement Application on Emergency Department Revisits: Prospective Observational Study", journal="JMIR Form Res", year="2021", month="Dec", day="13", volume="5", number="12", pages="e17839", keywords="patient engagement", keywords="value-based care", keywords="digital health", keywords="mobile app", keywords="automation", keywords="readmission", keywords="revisit", keywords="emergency department", abstract="Background: Revisits within 30 days to an emergency department (ED), observation care unit, or inpatient setting following patient discharge continue to be a challenge, especially in urban settings. In addition to the consequences for the patient, these revisits have a negative impact on a health system's finances in a value-based care or global budget environment. LifeBridge Health, a community health system in Maryland, United States, implemented an automated mobile patient engagement application as part of our enterprise-wide digital health strategy to improve patient engagement and reduce revisits to the ED. Objective: The aim of this paper was to evaluate the effectiveness of a customized automated digital patient engagement application (GetWell Loop) to reduce 30-day revisits after home discharge from an ED. Methods: The LifeBridge Health Innovation Department and ED staff from 2 participating health system hospitals collaborated with GetWellNetwork to customize their patient engagement application with automated check-in questions and other on-demand resources (eg, streaming content explaining aspects of self-care during COVID-19). An application link was emailed to adult patients discharged home from the ED. A study of ED visits for patients treated for general medicine and cardiology conditions between August 1, 2018, and July 31, 2019, was conducted using CRISP (Chesapeake Regional Information System for our Patients), Maryland's state-designated health information exchange. We also used data within GetWell Loop (GetWellNetwork) to track patient activation and engagement. The primary outcome was the number of ED patients who experienced a 30-day revisit and who did or did not activate their GetWell Loop account. Secondary outcomes included the overall activation rate and the rate of engagement as measured by the number of logins, alerts, and comments generated by patients through the application. Bivariate analysis comparing outcomes among patients who activated the GetWell Loop application to patients who did not was conducted using the Fisher exact test. Multivariate logistic regression modeling with elastic net regularization was also performed to account for potential confounders and potential collinearity of covariates. Results: During this 1-year study, 1062 (27.4\%) of 3866 of all emergency patients treated for general medicine or cardiology conditions, who received an invite to use the digital application, activated their account. The patients discharged from the ED, who were treated for general medicine conditions (n=2087) and who activated their GetWell Loop account, experienced a 30-day revisit rate of 17.3\% (n=101) compared with 24.6\% (n=369) for those who did not activate their account (P<.001). Of the patients treated for cardiology conditions (n=1779), 12.8\% (n=61) of those who activated their GetWell account experienced a 30-day revisit compared with 17.7\% (n=231) of those who did not activate their account (P=.01). The significance of these findings persisted after adjustment for confounding variables including age, race, sex, and payor in logistic regression modeling (adjusted odds ratio 0.75, 95\% CI 0.62-0.92; P=.006). Conclusions: Our results suggest that a significant percentage of patients are willing to utilize a digital application following ED discharge to better engage in their own care, and that usage of such digital applications may significantly reduce 30-day revisit rates. LifeBridge Health's experience demonstrates that health care systems can leverage automated mobile apps to improve patient engagement and successfully impact clinical outcomes at scale. ", doi="10.2196/17839", url="https://formative.jmir.org/2021/12/e17839", url="http://www.ncbi.nlm.nih.gov/pubmed/34898451" } @Article{info:doi/10.2196/22557, author="Ghorbani, Banafsheh and Jackson, C. Alun and Noorchenarboo, Mohammad and Mandegar, H. Mohammad and Sharifi, Farshad and Mirmoghtadaie, Zohrehsadat and Bahramnezhad, Fatemeh", title="Comparing the Effects of Gamification and Teach-Back Training Methods on Adherence to a Therapeutic Regimen in Patients After Coronary Artery Bypass Graft Surgery: Randomized Clinical Trial", journal="J Med Internet Res", year="2021", month="Dec", day="10", volume="23", number="12", pages="e22557", keywords="teach back", keywords="gamification", keywords="treatment regimen", keywords="coronary artery bypass graft", keywords="patient training", abstract="Background: Patients undergoing coronary artery bypass graft surgery (CABGS) may fail to adhere to their treatment regimen for many reasons. Among these, one of the most important reasons for nonadherence is the inadequate training of such patients or training using inappropriate methods. Objective: This study aimed to compare the effect of gamification and teach-back training methods on adherence to a therapeutic regimen in patients after CABGS. Methods: This randomized clinical trial was conducted on 123 patients undergoing CABGS in Tehran, Iran, in 2019. Training was provided to the teach-back group individually. In the gamification group, an app developed for the purpose was installed on each patient's smartphone, with training given via this device. The control group received usual care, or routine training. Adherence to the therapeutic regimen was assessed using a questionnaire on adherence to a therapeutic regimen (physical activity and dietary regimen) and an adherence scale as a pretest and a 1-month posttest. Results: One-way analysis of variance (ANOVA) for comparing the mean scores of teach-back and gamification training methods showed that the mean normalized scores for the dietary regimen (P<.001, F=71.80), movement regimen (P<.001, F=124.53), and medication regimen (P<.001, F=9.66) before and after intervention were significantly different between the teach-back, gamification, and control groups. In addition, the results of the Dunnett test showed that the teach-back and gamification groups were significantly different from the control group in all three treatment regimen methods. There was no statistically significant difference in adherence to the therapeutic regimen between the teach-back and control groups. Conclusions: Based on the results of this study, the use of teach-back and gamification training approaches may be suggested for patients after CABGS to facilitate adherence to the therapeutic regimen. Trial Registration: Iranian Registry of Clinical Trials IRCT20111203008286N8; https://en.irct.ir/trial/41507 ", doi="10.2196/22557", url="https://www.jmir.org/2021/12/e22557", url="http://www.ncbi.nlm.nih.gov/pubmed/34890346" } @Article{info:doi/10.2196/31985, author="Cruz-Mart{\'i}nez, Rafael Roberto and Wentzel, Jobke and Bente, Elise Britt and Sanderman, Robbert and van Gemert-Pijnen, EWC Julia", title="Toward the Value Sensitive Design of eHealth Technologies to Support Self-management of Cardiovascular Diseases: Content Analysis", journal="JMIR Cardio", year="2021", month="Dec", day="1", volume="5", number="2", pages="e31985", keywords="eHealth", keywords="self-management", keywords="self-care", keywords="cardiovascular diseases", keywords="value sensitive design", keywords="values", keywords="content analysis", abstract="Background: eHealth can revolutionize the way self-management support is offered to chronically ill individuals such as those with a cardiovascular disease (CVD). However, patients' fluctuating motivation to actually perform self-management is an important factor for which to account. Tailoring and personalizing eHealth to fit with the values of individuals promises to be an effective motivational strategy. Nevertheless, how specific eHealth technologies and design features could potentially contribute to values of individuals with a CVD has not been explicitly studied before. Objective: This study sought to connect a set of empirically validated, health-related values of individuals with a CVD with existing eHealth technologies and their design features. The study searched for potential connections between design features and values with the goal to advance knowledge about how eHealth technologies can actually be more meaningful and motivating for end users. Methods: Undertaking a technical investigation that fits with the value sensitive design framework, a content analysis of existing eHealth technologies was conducted. We matched 11 empirically validated values of CVD patients with 70 design features from 10 eHealth technologies that were previously identified in a systematic review. The analysis consisted mainly of a deductive coding stage performed independently by 3 members of the study team. In addition, researchers and developers of 6 of the 10 reviewed technologies provided input about potential feature-value connections. Results: In total, 98 connections were made between eHealth design features and patient values. This meant that some design features could contribute to multiple values. Importantly, some values were more often addressed than others. CVD patients' values most often addressed were related to (1) having or maintaining a healthy lifestyle, (2) having an overview of personal health data, (3) having reliable information and advice, (4) having extrinsic motivators to accomplish goals or health-related activities, and (5) receiving personalized care. In contrast, values less often addressed concerned (6) perceiving low thresholds to access health care, (7) receiving social support, (8) preserving a sense of autonomy over life, and (9) not feeling fear, anxiety, or insecurity about health. Last, 2 largely unaddressed values were related to (10) having confidence and self-efficacy in the treatment or ability to achieve goals and (11) desiring to be seen as a person rather than a patient. Conclusions: Positively, existing eHealth technologies could be connected with CVD patients' values, largely through design features that relate to educational support, self-monitoring support, behavior change support, feedback, and motivational incentives. Other design features such as reminders, prompts or cues, peer-based or expert-based human support, and general system personalization were also connected with values but in narrower ways. In future studies, the inferred feature-value connections must be validated with empirical data from individuals with a CVD or similar chronic conditions. ", doi="10.2196/31985", url="https://cardio.jmir.org/2021/2/e31985", url="http://www.ncbi.nlm.nih.gov/pubmed/34855608" } @Article{info:doi/10.2196/29423, author="DeLaughter, L. Kathryn and Fix, M. Gemmae and McDannold, E. Sarah and Pope, Charlene and Bokhour, G. Barbara and Shimada, L. Stephanie and Calloway, Rodney and Gordon, S. Howard and Long, A. Judith and Miano, A. Danielle and Cutrona, L. Sarah", title="Incorporating African American Veterans' Success Stories for Hypertension Management: Developing a Behavioral Support Texting Protocol", journal="JMIR Res Protoc", year="2021", month="Dec", day="1", volume="10", number="12", pages="e29423", keywords="texting", keywords="African American", keywords="hypertension", keywords="self-management", keywords="mobile phone", abstract="Background: Peer narratives engage listeners through personally relevant content and have been shown to promote lifestyle change and effective self-management among patients with hypertension. Incorporating key quotations from these stories into follow-up text messages is a novel way to continue the conversation, providing reinforcement of health behaviors in the patients' daily lives. Objective: In our previous work, we developed and tested videos in which African American Veterans shared stories of challenges and success strategies related to hypertension self-management. This study aims to describe our process for developing a text-messaging protocol intended for use after viewing videos that incorporate the voices of these Veterans. Methods: We used a multistep process, transforming video-recorded story excerpts from 5 Veterans into 160-character texts. We then integrated these into comprehensive 6-month texting protocols. We began with an iterative review of story transcripts to identify vernacular features and key self-management concepts emphasized by each storyteller. We worked with 2 Veteran consultants who guided our narrative text message development in substantive ways, as we sought to craft culturally sensitive content for texts. Informed by Veteran input on timing and integration, supplementary educational and 2-way interactive assessment text messages were also developed. Results: Within the Veterans Affairs texting system Annie, we programmed five 6-month text-messaging protocols that included cycles of 3 text message types: narrative messages, nonnarrative educational messages, and 2-way interactive messages assessing self-efficacy and behavior related to hypertension self-management. Each protocol corresponds to a single Veteran storyteller, allowing Veterans to choose the story that most resonates with their own life experiences. Conclusions: We crafted a culturally sensitive text-messaging protocol using narrative content referenced in Veteran stories to support effective hypertension self-management. Integrating narrative content into a mobile health texting intervention provides a low-cost way to support longitudinal behavior change. A randomized trial is underway to test its impact on the lifestyle changes and blood pressure of African American Veterans. Trial Registration: ClinicalTrials.gov NCT03970590; https://clinicaltrials.gov/ct2/show/NCT03970590 International Registered Report Identifier (IRRID): DERR1-10.2196/29423 ", doi="10.2196/29423", url="https://www.researchprotocols.org/2021/12/e29423", url="http://www.ncbi.nlm.nih.gov/pubmed/34855617" } @Article{info:doi/10.2196/32351, author="Montgomery, M. Robert and Boucher, M. Eliane and Honomichl, D. Ryan and Powell, A. Tyler and Guyton, L. Sharelle and Bernecker, L. Samantha and Stoeckl, Elizabeth Sarah and Parks, C. Acacia", title="The Effects of a Digital Mental Health Intervention in Adults With Cardiovascular Disease Risk Factors: Analysis of Real-World User Data", journal="JMIR Cardio", year="2021", month="Nov", day="19", volume="5", number="2", pages="e32351", keywords="digital mental health", keywords="digital health", keywords="mobile apps", keywords="mobile health", keywords="internet-based intervention", keywords="happiness", keywords="subjective well-being", keywords="anxiety", keywords="cardiovascular health", keywords="high blood pressure", keywords="high cholesterol", keywords="diabetes", keywords="cardiovascular disease risk", keywords="real-world data", abstract="Background: The American Heart Association has identified poor mental health as a key barrier to healthy behavior change for those with cardiovascular disease (CVD) risk factors such as high blood pressure, high cholesterol, and diabetes. Digital mental health interventions, like those delivered via the internet to computers or smartphones, may provide a scalable solution to improving the mental and physical health of this population. Happify is one such intervention and has demonstrated evidence of efficacy for improving aspects of mental health in both the general population and in users with chronic conditions. Objective: The objectives of this analysis of real-world data from Happify users with self-reported CVD risk factors, including high blood pressure and cholesterol, diabetes, and heart disease, were to examine whether these users would report improvements in subjective well-being and anxiety over time (H1) and use of Happify as recommended would be associated with significantly greater improvement in subjective well-being and anxiety over time compared to less-than-recommended usage (H2). Methods: Data were obtained from existing Happify users who reported the aforementioned CVD risk factors. The sample included 1803 users receiving at least 6 weeks' exposure to Happify (ranging from 42 days to 182 days) who completed at least one activity and two assessments within the app during that time. Subjective well-being was assessed with the Happify Scale, a 9-item measure of positive emotionality and life satisfaction, and anxiety was assessed with the Generalized Anxiety Disorder 2 (GAD-2). To evaluate H1, changes over time in both outcomes were assessed using mixed effects linear regression models, controlling for demographics and usage. For H2, an interaction term was added to the models to assess whether usage as recommended was associated with greater improvement over time. Results: Both hypotheses were supported. For both the Happify scale and GAD-2, the initial multivariable model without an interaction demonstrated an effect for time from baseline, and the addition of the interaction term between time and recommended use was significant as well. Conclusions: This analysis of real-world data provides preliminary evidence that Happify users with self-reported CVD risk factors including high blood pressure or cholesterol, diabetes, and heart disease experienced improved well-being and anxiety over time and that those who used Happify as recommended experienced greater improvements in these aspects of mental health than those who completed fewer activities. These findings extend previous research, which demonstrated that engagement with Happify as recommended was associated with improved well-being among physically healthy users and in those with chronic conditions, to a new population for whom mental health is especially critical: those at risk of developing CVD. ", doi="10.2196/32351", url="https://cardio.jmir.org/2021/2/e32351", url="http://www.ncbi.nlm.nih.gov/pubmed/34806986" } @Article{info:doi/10.2196/27016, author="Kapoor, Alok and Hayes, Anna and Patel, Jay and Patel, Harshal and Andrade, Andreza and Mazor, Kathleen and Possidente, Carl and Nolen, Kimberly and Hegeman-Dingle, Rozelle and McManus, David", title="Usability and Perceived Usefulness of the AFib 2gether Mobile App in a Clinical Setting: Single-Arm Intervention Study", journal="JMIR Cardio", year="2021", month="Nov", day="19", volume="5", number="2", pages="e27016", keywords="shared decision-making", keywords="mobile health", keywords="stroke risk", keywords="anticoagulation risk", keywords="anticoagulation", keywords="atrial fibrillation", keywords="anticoagulation therapy", keywords="atrial flutter", keywords="mobile phone", abstract="Background: Although the American Heart Association and other professional societies have recommended shared decision-making as a way for patients with atrial fibrillation (AF) or atrial flutter to make informed decisions about using anticoagulation (AC), the best method for facilitating shared decision-making remains uncertain. Objective: The aim of this study is to assess the AFib 2gether mobile app for usability, perceived usefulness, and the extent and nature of shared decision-making that occurred for clinical encounters between patients with AF and their cardiology providers in which the app was used. Methods: We identified patients visiting a cardiology provider between October 2019 and May 2020. We measured usability from patients and providers using the Mobile App Rating Scale. From the 8 items of the Mobile App Rating Scale, we reported the average score (out of 5) for domains of functionality, esthetics, and overall quality. We administered a 3-item questionnaire to patients relating to their perceived usefulness of the app and a separate 3-item questionnaire to providers to measure their perceived usefulness of the app. We performed a chart review to track the occurrence of AC within 6 months of the index visit. We also audio recorded a subset of the encounters to identify evidence of shared decision-making. Results: We facilitated shared decision-making visits for 37 patients visiting 13 providers. In terms of usability, patients' average ratings of functionality, esthetics, and overall quality were 4.51 (SD 0.61), 4.26 (SD 0.51), and 4.24 (SD 0.89), respectively. In terms of usefulness, 41\% (15/37) of patients agreed that the app improved their knowledge regarding AC, and 62\% (23/37) agreed that the app helped clarify to their provider their preferences regarding AC. Among providers, 79\% (27/34) agreed that the app helped clarify their patients' preferences, 82\% (28/34) agreed that the app saved them time, and 59\% (20/34) agreed that the app helped their patients make decisions about AC. In addition, 32\% (12/37) of patients started AC after their shared decision-making visits. We audio recorded 25 encounters. Of these, 84\% (21/25) included the mention of AC for AF, 44\% (11/25) included the discussion of multiple options for AC, 72\% (18/25) included a provider recommendation for AC, and 48\% (12/25) included the evidence of patient involvement in the discussion. Conclusions: Patients and providers rated the app with high usability and perceived usefulness. Moreover, one-third of the patients began AC, and approximately 50\% (12/25) of the encounters showed evidence of patient involvement in decision-making. In the future, we plan to study the effect of the app on a larger sample and with a controlled study design. Trial Registration: ClinicalTrials.gov NCT04118270; https://clinicaltrials.gov/ct2/show/NCT04118270 International Registered Report Identifier (IRRID): RR2-21986 ", doi="10.2196/27016", url="https://cardio.jmir.org/2021/2/e27016", url="http://www.ncbi.nlm.nih.gov/pubmed/34806997" } @Article{info:doi/10.2196/28024, author="Cyriac, Jissy and Jenkins, Sarah and Patten, A. Christi and Hayes, N. Sharonne and Jones, Clarence and Cooper, A. Lisa and Brewer, C. LaPrincess", title="Improvements in Diet and Physical Activity--Related Psychosocial Factors Among African Americans Using a Mobile Health Lifestyle Intervention to Promote Cardiovascular Health: The FAITH! (Fostering African American Improvement in Total Health) App Pilot Study", journal="JMIR Mhealth Uhealth", year="2021", month="Nov", day="12", volume="9", number="11", pages="e28024", keywords="African Americans", keywords="cardiovascular health disparities", keywords="mHealth lifestyle intervention", keywords="diet", keywords="physical activity", keywords="mobile phone", abstract="Background: African Americans continue to have suboptimal cardiovascular health (CVH) related to diet and physical activity (PA) behaviors compared with White people. Mobile health (mHealth) interventions are innovative platforms to improve diet and PA and have the potential to mitigate these disparities. However, these are understudied among African Americans. Objective: This study aims to examine whether an mHealth lifestyle intervention is associated with improved diet and PA-related psychosocial factors in African Americans and whether these changes correlate with diet and PA behavioral change. Methods: This study is a retrospective analysis evaluating changes in diet and PA-related self-regulation, social support, perceived barriers, and CVH behaviors (daily fruit and vegetable intake and moderate-intensity PA [MPA] per week) in 45 African American adults (mean age 48.7 years, SD 12.9 years; 33/45, 73\% women) enrolled in the FAITH! (Fostering African American Improvement in Total Health) app pilot study. The intervention is a 10-week, behavioral theory--informed, community-based mHealth lifestyle intervention delivered through a mobile app platform. Participants engaged with 3 core FAITH! app features: multimedia education modules focused on CVH with self-assessments of CVH knowledge, self-monitoring of daily fruit and vegetable intake and PA, and a sharing board for social networking. Changes in self-reported diet and PA-related self-regulation, social support, perceived barriers, and CVH behaviors were assessed by electronic surveys collected at baseline and 28 weeks postintervention. Changes in diet and PA-related psychosocial factors from pre- to postintervention were assessed using paired 2-tailed t tests. The association of changes in diet and PA-related psychosocial variables with daily fruit and vegetable intake and MPA per week was assessed using Spearman correlation. Associations between baseline and 28-week postintervention changes in diet and PA-related psychosocial measures and CVH behaviors with covariates were assessed by multivariable linear regression. Results: Participants reported improvements in 2 subscales of diet self-regulation (decrease fat and calorie intake, P=.01 and nutrition tracking, P<.001), one subscale of social support for healthy diet (friend discouragement, P=.001), perceived barriers to healthy diet (P<.001), and daily fruit and vegetable intake (P<.001). Improvements in diet self-regulation (increase fruit, vegetable, and grain intake, and nutrition tracking) and social support for healthy diet (friend encouragement) had moderate positive correlations with daily fruit and vegetable intake (r=0.46, r=0.34, and r=0.43, respectively). A moderate negative correlation was observed between perceived barriers to healthy diet and daily fruit and vegetable intake (r=?0.25). Participants reported increases in PA self-regulation (P<.001). Increase in social support subscales for PA (family and friend participation) had a moderate positive correlation with MPA per week (r=0.51 and r=0.61, respectively). Conclusions: Our findings highlight key diet and PA-related psychosocial factors to target in future mHealth lifestyle interventions aimed at promoting CVH in African Americans. ", doi="10.2196/28024", url="https://mhealth.jmir.org/2021/11/e28024", url="http://www.ncbi.nlm.nih.gov/pubmed/34766917" } @Article{info:doi/10.2196/29044, author="Radhakrishnan, Kavita and Julien, Christine and Baranowski, Tom and O'Hair, Matthew and Lee, Grace and Sagna De Main, Atami and Allen, Catherine and Viswanathan, Bindu and Thomaz, Edison and Kim, Miyong", title="Feasibility of a Sensor-Controlled Digital Game for Heart Failure Self-management: Randomized Controlled Trial", journal="JMIR Serious Games", year="2021", month="Nov", day="8", volume="9", number="4", pages="e29044", keywords="heart failure", keywords="digital game", keywords="sensor", keywords="self-management", keywords="older adults", keywords="weight monitoring", keywords="physical activity", keywords="behaviors", keywords="mobile phone", abstract="Background: Poor self-management of heart failure (HF) contributes to devastating health consequences. Our innovative sensor-controlled digital game (SCDG) integrates data from sensors to trigger game rewards, progress, and feedback based on the real-time behaviors of individuals with HF. Objective: The aim of this study is to compare daily weight monitoring and physical activity behavior adherence by older adults using an SCDG intervention versus a sensors-only intervention in a feasibility randomized controlled trial. Methods: English-speaking adults with HF aged 55 years or older who owned a smartphone and could walk unassisted were recruited from Texas and Oklahoma from November 2019 to August 2020. Both groups were given activity trackers and smart weighing scales to track behaviors for 12 weeks. The feasibility outcomes of recruitment, retention, intervention engagement, and satisfaction were assessed. In addition to daily weight monitoring and physical activity adherence, the participants' knowledge, functional status, quality of life, self-reported HF behaviors, motivation to engage in behaviors, and HF-related hospitalization were also compared between the groups at baseline and at 6, 12, and 24 weeks. Results: A total of 38 participants with HF---intervention group (IG; 19/38, 50\%) and control group (CG; 19/38, 50\%)---were enrolled in the study. Of the 38 participants, 18 (47\%) were women, 18 (47\%) were aged 65 years or older, 21 (55\%) had been hospitalized with HF in the past 6 months, and 29 (76\%) were White. Furthermore, of these 38 participants, 31 (82\%)---IG (15/19, 79\%) and CG (16/19, 84\%)---had both weight monitoring and physical activity data at the end of 12 weeks, and 27 (71\%)---IG (14/19, 74\%) and CG (13/19, 68\%)---participated in follow-up assessments at 24 weeks. For the IG participants who installed the SCDG app (15/19, 79\%), the number of days each player opened the game app was strongly associated with the number of days the player engaged in weight monitoring (r=0.72; P=.04) and the number of days with physical activity step data (r=0.9; P<.001). The IG participants who completed the satisfaction survey (13/19, 68\%) reported that the SCDG was easy to use. Trends of improvement in daily weight monitoring and physical activity in the IG, as well as within-group improvements in HF functional status, quality of life, knowledge, self-efficacy, and HF hospitalization in both groups, were observed in this feasibility trial. Conclusions: Playing an SCDG on smartphones was feasible and acceptable for older adults with HF for motivating daily weight monitoring and physical activity. A larger efficacy trial of the SCDG intervention will be needed to validate trends of improvement in daily weight monitoring and physical activity behaviors. Trial Registration: ClinicalTrials.gov NCT03947983; https://clinicaltrials.gov/ct2/show/NCT03947983 ", doi="10.2196/29044", url="https://games.jmir.org/2021/4/e29044", url="http://www.ncbi.nlm.nih.gov/pubmed/34747701" } @Article{info:doi/10.2196/16864, author="Anttila, Marjo-Riitta and Soderlund, Anne and Paajanen, Teemu and Kivist{\"o}, Heikki and Kokko, Katja and Sj{\"o}gren, Tuulikki", title="Biopsychosocial Profiles of Patients With Cardiac Disease in Remote Rehabilitation Processes: Mixed Methods Grounded Theory Approach", journal="JMIR Rehabil Assist Technol", year="2021", month="Nov", day="3", volume="8", number="4", pages="e16864", keywords="coronary disease", keywords="experience", keywords="biopsychosocial model", keywords="digital cardiac rehabilitation", keywords="mixed methods grounded theory", keywords="web-based program", keywords="physical activity", keywords="self-efficacy", keywords="quality of life", abstract="Background: Digital development has caused rehabilitation services and rehabilitees to become increasingly interested in using technology as a part of rehabilitation. This study was based on a previously published study that categorized 4 groups of patients with cardiac disease based on different experiences and attitudes toward technology (e-usage groups): feeling outsider, being uninterested, reflecting benefit, and enthusiastic using. Objective: This study identifies differences in the biopsychosocial profiles of patients with cardiac disease in e-usage groups and deepen the understanding of these profiles in cardiac rehabilitation. Methods: Focus group interviews and measurements were conducted with 39 patients with coronary heart disease, and the mean age was 54.8 (SD 9.4, range 34-77) years. Quantitative data were gathered during a 12-month rehabilitation period. First, we used analysis of variance and Tukey honestly significant difference test, a t test, or nonparametric tests---Mann--Whitney and Kruskal--Wallis tests---to compare the 4 e-usage groups---feeling outsider, being uninterested, reflecting benefit, and enthusiastic using---in biopsychosocial variables. Second, we compared the results of the 4 e-groups in terms of recommended and reference values. This analysis contained 13 variables related to biomedical, psychological, and social functioning. Finally, we formed biopsychosocial profiles based on the integration of the findings by constant comparative analysis phases through classic grounded theory. Results: The biomedical variables were larger for waistline (mean difference [MD] 14.2; 95\% CI 1.0-27.5; P=.03) and lower for physical fitness (MD ?0.72; 95\% CI ?1.4 to ?0.06; P=.03) in the being uninterested group than in the enthusiastic using group. The feeling outsider group had lower physical fitness (MD ?55.8; 95\% CI ?110.7 to ?0.92; P=.047) than the enthusiastic using group. For psychosocial variables, such as the degree of self-determination in exercise (MD ?7.3; 95\% CI ?13.5 to ?1.1; P=.02), the being uninterested group had lower values than the enthusiastic using group. Social variables such as performing guided tasks in the program (P=.03) and communicating via messages (P=.03) were lower in the feeling outsider group than in the enthusiastic using group. The feeling outsider and being uninterested groups had high-risk lifestyle behaviors, and adherence to the web-based program was low. In contrast, members of the being uninterested group were interested in tracking their physical activity. The reflecting benefit and enthusiastic using groups had low-risk lifestyle behavior and good adherence to web-based interventions; however, the enthusiastic using group had low self-efficacy in exercise. These profiles showed how individuals reflected their lifestyle risk factors differently. We renamed the 4 groups as building self-awareness, increasing engagement, maintaining a healthy lifestyle balance, and strengthening self-confidence. Conclusions: The results facilitate more effective and meaningful personalization guidance and inform the remote rehabilitation. Professionals can tailor individual web-based lifestyle risk interventions using these biopsychosocial profiles. ", doi="10.2196/16864", url="https://rehab.jmir.org/2021/4/e16864", url="http://www.ncbi.nlm.nih.gov/pubmed/34730548" } @Article{info:doi/10.2196/25646, author="Cohen Rodrigues, R. Talia and de Buisonj{\'e}, R. David and Keesman, Mike and Reijnders, Thomas and van der Geer, E. Jessica and Janssen, R. Veronica and Kraaijenhagen, A. Roderik and Atsma, E. Douwe and Evers, M. Andrea W.", title="Facilitators of and Barriers to Lifestyle Support and eHealth Solutions: Interview Study Among Health Care Professionals Working in Cardiac Care", journal="J Med Internet Res", year="2021", month="Oct", day="15", volume="23", number="10", pages="e25646", keywords="eHealth", keywords="digital health", keywords="cardiovascular disease", keywords="cardiac care", keywords="lifestyle change", keywords="lifestyle support", keywords="intervention", keywords="health care professionals", keywords="implementation", keywords="interview", keywords="facilitators", keywords="barriers", abstract="Background: Cardiovascular diseases (CVDs) pose a significant health threat and reduce both people's life expectancy and quality of life. Healthy living is a key component in the effective prevention and treatment of CVD. However, health care professionals (HCPs) experience difficulties in supporting lifestyle changes among their patients. eHealth can provide a solution to these barriers. Objective: This study aims to provide insights into the factors HCPs find important in the support of patients with CVD in the uptake of and adherence to a healthy lifestyle and the perceived facilitators of and barriers to using eHealth to provide lifestyle support to patients with CVD. Methods: In-depth interviews were conducted with 16 Dutch HCPs specializing in lifestyle support in cardiac care. Results: We identified 13 themes, of which the first 12 concerned lifestyle support in general and were related to intervention, patient, or health care. Throughout these themes, the use of eHealth reoccurred as a potential facilitator of or solution to barriers to lifestyle support. Our final theme specifically concerned barriers to the adoption and usability of eHealth. Conclusions: HCPs do recognize the potential advantages of eHealth while experiencing barriers to using digital tools. Incorporating their needs and values in the development of lifestyle support programs, especially eHealth, could increase their use and lead to a more widespread adoption of eHealth into health care. ", doi="10.2196/25646", url="https://www.jmir.org/2021/10/e25646", url="http://www.ncbi.nlm.nih.gov/pubmed/34652280" } @Article{info:doi/10.2196/30428, author="Tadas, Shreya and Pretorius, Claudette and Foster, J. Emma and Gorely, Trish and Leslie, J. Stephen and Coyle, David", title="Transitions in Technology-Mediated Cardiac Rehabilitation and Self-management: Qualitative Study Using the Theoretical Domains Framework", journal="JMIR Cardio", year="2021", month="Oct", day="14", volume="5", number="2", pages="e30428", keywords="cardiac rehabilitation", keywords="self-management", keywords="self-care", keywords="behavioral change", keywords="Theoretical Domains Framework", keywords="qualitative methods", keywords="mobile phone", abstract="Background: An acute cardiac incident is a life-changing event that often necessitates surgery. Although surgery has high success rates, rehabilitation, behavioral changes, and self-care are critical to long-term health. Recent systematic reviews have highlighted the potential of technology in this area; however, significant shortcomings have also been identified, particularly with regard to patient experience. Objective: This study aims to improve future systems and to explore the experiences of cardiac patients during key phases after hospitalization: recuperation, initial rehabilitation, and long-term self-management. The key objective is to provide a holistic understanding of behavioral factors that impact people across these phases, understand how experiences evolve over time, and provide user-centered recommendations to improve the design of cardiac rehabilitation and self-management technologies. Methods: Semistructured interviews were conducted with people who attended rehabilitation programs following hospitalization for acute cardiac events. Interviews were developed and data were analyzed via the Theoretical Domains Framework, a pragmatic framework that synthesizes prior theories of behavioral change. Results: Three phases that arise posthospitalization were examined, namely, recuperation, rehabilitation, and long-term self-management. Through these phases, we describe the impact of key factors and important changes that occur in patients' experiences over time, including the desire for and redefinition of normal life, the need for different types of formal and informal knowledge, the benefits of safe zoning and connectedness, and the need to recognize capability. The use of the Theoretical Domains Framework allows us to show how factors that influence behavior evolve over time and to identify potential sources of tension. Conclusions: This study provides empirically grounded recommendations for the design of technology-mediated cardiac rehabilitation and self-management systems. Key recommendations include the use of technology to support a normal life, leveraging social influences to extend participants' sense of normality, the use of technology to provide a safe zone, the need to support both emotional and physical well-being, and a focus on recognizing capability and providing recommendations that are positive and reinforce this capability. ", doi="10.2196/30428", url="https://cardio.jmir.org/2021/2/e30428", url="http://www.ncbi.nlm.nih.gov/pubmed/34647892" } @Article{info:doi/10.2196/26224, author="Choi, Michael and Raeside, Rebecca and Hyun, Karice and Partridge, R. Stephanie and Thiagalingam, Aravinda and Redfern, Julie", title="Understanding Preferences for Lifestyle-Focused Visual Text Messages in Patients With Cardiovascular and Chronic Respiratory Disease: Discrete Choice Experiment", journal="J Med Internet Res", year="2021", month="Sep", day="20", volume="23", number="9", pages="e26224", keywords="mHealth", keywords="cardiovascular disease", keywords="respiratory disease", keywords="visual communication", keywords="lifestyle change", keywords="consumer preferences", keywords="secondary prevention", keywords="rehabilitation", keywords="persuasive health technology", abstract="Background: Supporting healthy lifestyle changes is a key aim of cardiovascular and pulmonary rehabilitation programs. SMS text messaging programs have demonstrated effectiveness in cardiovascular disease risk reduction, weight loss, increasing physical activity, and smoking cessation. The optimization of SMS text messaging programs may deliver greater population benefits as mobile phone use becomes ubiquitous. Visual messaging (ie, image-based messages) has the potential to communicate health messages via digital technology and result in enhanced engagement. Objective: This study aims to determine and understand patient preferences for lifestyle-focused visual text messages that support cardiovascular and pulmonary rehabilitation. Methods: A discrete choice experiment was conducted in a 4-stage iterative process to elicit patient preferences for visual message features. Attribute and level development yielded 3 attributes (purpose, image type, and web address), and 16 choice sets were subsequently constructed according to a full factorial design. Patients participating in cardiovascular and pulmonary rehabilitation were surveyed (on the web) for their preferences regarding the visual message choice sets. Respondents were asked to choose among 16 pairs of visual messages regarding key lifestyle behaviors, namely, physical activity and nutrition. The data were analyzed using a conditional logit model. Results: There was a total of 1728 observations from 54 unique respondents. Two factors that were associated with patient preference were gain-framed purpose compared with no purpose (odds ratio [OR] 1.93, 95\% CI 1.40-2.65) and real images compared with cartoon images (OR 1.26, 95\% CI 1.04-1.54). A loss-framed purpose was less preferred than no purpose (OR 0.55, 95\% CI 0.42-0.74). Overall, patients preferred positive images that were colorful and engaged with text that supported the image and had a preference for images of real people rather than cartoons. Conclusions: A discrete choice experiment is a scientific method for eliciting patient preferences for a visual messaging intervention that is designed to support changes in lifestyle behaviors. SMS text messaging programs that use visual aids may result in greater patient satisfaction by using a gain frame, using real images, and avoiding a loss frame. Further research is needed to explore the feasibility of implementation and the health and behavioral outcomes associated with such visual messaging programs. ", doi="10.2196/26224", url="https://www.jmir.org/2021/9/e26224", url="http://www.ncbi.nlm.nih.gov/pubmed/34542413" } @Article{info:doi/10.2196/21906, author="Tuttle, Katherine and Kelemen, Arpad and Liang, Yulan", title="Use of Smartphone Apps for Improving Physical Function Capacity in Cardiac Patient Rehabilitation: Systematic Review", journal="JMIRx Med", year="2021", month="Sep", day="17", volume="2", number="3", pages="e21906", keywords="cardiac rehabilitation", keywords="physical capacity", keywords="exercise", keywords="smartphone apps", abstract="Background: Cardiac rehabilitation (CR) is an evidence-based approach for preventing secondary cardiac events. Smartphone apps are starting to be used in CR to give patients real-time feedback on their health, connect them remotely with their medical team, and allow them to perform their rehabilitation at home. The use of smartphone apps is becoming omnipresent and has real potential in impacting patients in need of CR. Objective: This paper provides critical examinations and summaries of existing research studies with an in-depth analysis of not only the individual studies but also the larger patterns that have emerged with smartphone apps in CR as well as their significance for practice change. Methods: A systematic review was conducted through broad database searches that focused on evaluating randomized controlled trials, in compliance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) expectations. A total of 43 articles were evaluated, and 6 were chosen for this review. The dates of the articles ranged from 2014-2020, and the studies focused on the population of cardiac outpatients who needed CR after suffering a cardiac event, with interventions using a smartphone that incorporated the CR standards of the American Heart Association. The outcomes measured were directed at focusing on improved exercise function capacity, valued at a significance level of P<.05, for improved 6-minute walk test (6MWT) and peak oxygen uptake (PVO2) results. Results: In the evaluated articles, the results were inconsistent for significant positive effects of CR smartphone apps on cardiac patients' physical function capacity in terms of the 6MWT and PVO2 when using a smartphone app to aid in CR. Conclusions: Because evidence in the literature suggests nonhomogeneous results for successful use of smartphone apps in CR, it is crucial to investigate the potential reasons for this inconsistency. An important observation from this systematic review is that smartphone apps used in CR have better clinical outcomes related to physical function capacity if the app automatically records information or provides real-time feedback to participants about their progress, compared to apps that only educate and encourage use while requiring the participant to manually log their CR activities. Additional factors to consider during these studies include the starting health of the patients, the sample sizes, and the specific components of CR that the smartphone apps are using. Overall, more clinical trials are needed that implement smartphone apps with these factors in mind, while placing stronger emphasis on using biosensing capabilities that can automatically log results and send them to providers on a real-time dashboard. ", doi="10.2196/21906", url="https://med.jmirx.org/2021/3/e21906", url="http://www.ncbi.nlm.nih.gov/pubmed/37725554" } @Article{info:doi/10.2196/27985, author="Cheung, Ting Yin and Lam, Hong Pok and Lam, Tai-Ning Teddy and Lam, Wai Henry Hon and Li, Kong Chi", title="Technology Acceptance Among Patients With Hemophilia in Hong Kong and Their Expectations of a Mobile Health App to Promote Self-management: Survey Study", journal="JMIR Form Res", year="2021", month="Sep", day="9", volume="5", number="9", pages="e27985", keywords="mobile health", keywords="mHealth", keywords="patients", keywords="expectations", keywords="hemophilia", keywords="chronic diseases", keywords="rare diseases", keywords="self-management", abstract="Background: The lifelong management of hemophilia is demanding and complex. In July 2019, we published a review in the Journal of Medical Internet Research, summarizing telehealth interventions that facilitate monitoring of bleeding events and promoting the appropriate use of clotting factors among patients with hemophilia. This work has led to the development of a community program that aims to harness technology to promote self-management among patients with hemophilia in Hong Kong. Objective: Before the inception of this program, we conducted a cross-sectional survey to evaluate the patients' level of technology acceptance and identify their expectations of the use of mobile technology for self-management of hemophilia. Methods: In total, 56 participants (75\% adult patients and 25\% parents of pediatric patients; 87.5\% with moderate to severe disease) were recruited from a local nongovernmental organization that serves patients with hemophilia. They rated their perceived confidence and acceptance in using the new mobile technology (score 1 to 5 for each item, with a higher score indicating better acceptance) using a structured questionnaire (adapted from the Technology Acceptance Model). They also identified the top features that they perceived to be the most important components of a mobile app for the self-management of hemophilia. The Mann--Whitney U test was used to compare technology acceptance scores across subgroups of different clinical and socioeconomic characteristics. Results: In general, the participants considered themselves skilled in using mobile apps (mean 4.3, 95\% CI 4.1-4.5). They were willing to learn to use the new mobile app to organize their bleeding records (mean 4.0, 95\% CI 3.7-4.3) and to manage their health (mean 4.2, 95\% CI 4.1-4.5). Participants who lived in public housing (a surrogate marker for lower socioeconomic status in Hong Kong) reported lower technology acceptance than those who lived in private housing (P=.04). The most important features identified by the participants concerned documenting of infusion logs (n=49, 87.5\%), bleeding events (n=48, 85.7\%), and the secure delivery of the bleeding information to health care professionals (n=40, 71.4\%). Conclusions: It is encouraging to infer that patients with hemophilia in Hong Kong are receptive to the use of mobile health technology. The findings of this survey are applicable in designing the key features of a patient-centered, multimodal program harnessing mobile technology to promote self-management among patients with hemophilia. Future studies should evaluate participants' acceptability and perceived usability of the mobile app via user metrics and assess clinical and humanistic outcomes of this program. ", doi="10.2196/27985", url="https://formative.jmir.org/2021/9/e27985", url="http://www.ncbi.nlm.nih.gov/pubmed/34499034" } @Article{info:doi/10.2196/25356, author="Elnaggar, Abdelaziz and von Oppenfeld, Julia and Whooley, A. Mary and Merek, Stephanie and Park, G. Linda", title="Applying Mobile Technology to Sustain Physical Activity After Completion of Cardiac Rehabilitation: Acceptability Study", journal="JMIR Hum Factors", year="2021", month="Sep", day="2", volume="8", number="3", pages="e25356", keywords="physical activity", keywords="cardiac rehabilitation", keywords="digital health", keywords="mobile app", keywords="wearable device, mHealth", keywords="mobile phone", abstract="Background: Many patients do not meet the recommended levels of physical activity after completing a cardiac rehabilitation (CR) program. Wearable activity trackers and mobile phone apps are promising potential self-management tools for maintaining physical activity after CR completion. Objective: This study aims to evaluate the acceptability of a wearable device, mobile app, and push messages to facilitate physical activity following CR completion. Methods: We used semistructured interviews to assess the acceptability of various mobile technologies after participation in a pilot randomized controlled trial. Intervention patients in the randomized controlled trial wore the Fitbit Charge 2, used the Movn mobile app, and received push messages on cardiovascular disease prevention and physical activity for over 2 months. We asked 26 intervention group participants for feedback about their experience with the technology and conducted semistructured individual interviews with 7 representative participants. We used thematic analysis to create the main themes from individual interviews. Results: Our sample included participants with a mean age of 66.7 (SD 8.6) years; 23\% (6/26) were female. Overall, there were varying levels of satisfaction with different technology components. There were 7 participants who completed the satisfaction questionnaires and participated in the interviews. The Fitbit and Movn mobile app received high satisfaction scores of 4.86 and 4.5, respectively, whereas push messages had a score of 3.14 out of 5. We identified four main themes through the interviews: technology use increased motivation to be physically active, technology use served as a reminder to be physically active, recommendations for technology to improve user experience, and desire for personal feedback. Conclusions: By applying a wearable activity tracker, mobile phone app, and push messages, our study showed strong potential for the adoption of new technologies by older adults to maintain physical activity after CR completion. Future research should include a larger sample over a longer period using a mixed methods approach to assess the efficacy of technology use for promoting long-term physical activity behavior in older adults. ", doi="10.2196/25356", url="https://humanfactors.jmir.org/2021/3/e25356", url="http://www.ncbi.nlm.nih.gov/pubmed/34473064" } @Article{info:doi/10.2196/27867, author="de Buisonj{\'e}, David and Van der Geer, Jessica and Keesman, Mike and Van der Vaart, Roos and Reijnders, Thomas and Wentzel, Jobke and Kemps, Hareld and Kraaijenhagen, Roderik and Janssen, Veronica and Evers, Andrea", title="Financial Incentives for Healthy Living for Patients With Cardiac Disease From the Perspective of Health Care Professionals: Interview Study", journal="JMIR Cardio", year="2021", month="Aug", day="30", volume="5", number="2", pages="e27867", keywords="financial incentives", keywords="material rewards", keywords="healthy lifestyle", keywords="cardiovascular disease", keywords="cardiac rehabilitation", keywords="CVD", abstract="Background: A promising new approach to support lifestyle changes in patients with cardiovascular disease (CVD) is the use of financial incentives. Although financial incentives have proven to be effective, their implementation remains controversial, and ethical objections have been raised. It is unknown whether health care professionals (HCPs) involved in CVD care find it acceptable to provide financial incentives to patients with CVD as support for lifestyle change. Objective: This study aims to investigate HCPs' perspectives on using financial incentives to support healthy living for patients with CVD. More specifically, we aim to provide insight into attitudes toward using financial incentives as well as obstacles and facilitators of implementing financial incentives in current CVD care. Methods: A total of 16 semistructured, in-depth, face-to-face interviews were conducted with Dutch HCPs involved in supporting patients with CVD with lifestyle changes. The topics discussed were attitudes toward an incentive system, obstacles to using an incentive system, and possible solutions to facilitate the use of an incentive system. Results: HCPs perceived an incentive system for healthy living for patients with CVD as possibly effective and showed generally high acceptance. However, there were concerns related to focusing too much on the extrinsic aspects of lifestyle change, disengagement when rewards are insignificant, paternalization and threatening autonomy, and low digital literacy in the target group. According to HCPs, solutions to mitigate these concerns included emphasizing intrinsic aspects of healthy living while giving extrinsic rewards, integrating social aspects to increase engagement, supporting autonomy by allowing freedom of choice in rewards, and aiming for a target group that can work with the necessary technology. Conclusions: This study mapped perspectives of Dutch HCPs and showed that attitudes are predominantly positive, provided that contextual factors, design, and target groups are accurately considered. Concerns about digital literacy in the target group are novel findings that warrant further investigation. Follow-up research is needed to validate these insights among patients with CVD. ", doi="10.2196/27867", url="https://cardio.jmir.org/2021/2/e27867", url="http://www.ncbi.nlm.nih.gov/pubmed/34459748" } @Article{info:doi/10.2196/30951, author="Martorella, Geraldine and Hanley, W. Adam and Pickett, M. Scott and Gelinas, C{\'e}line", title="Web- and Mindfulness-Based Intervention to Prevent Chronic Pain After Cardiac Surgery: Protocol for a Pilot Randomized Controlled Trial", journal="JMIR Res Protoc", year="2021", month="Aug", day="30", volume="10", number="8", pages="e30951", keywords="postoperative pain", keywords="cardiac surgery", keywords="chronic pain", keywords="web-based", keywords="mindfulness", keywords="mobile phone", abstract="Background: Cardiac surgery is a frequently performed procedure. However, pain after cardiac surgery may become chronic (lasting >3 months) in adults. Once discharged from the hospital, patients are at greater risk of developing chronic postsurgical pain (CPSP) and of prolonged opioid use, as they need to self-manage their pain. Psychological risk and protective factors such as pain-related catastrophic thoughts and pain acceptance determine their ability to cope and their use of opioids, which is crucial for self-management of pain. Studies on mindfulness-based cognitive therapy (MBCT) have multiplied their potential effects on pain acceptance and catastrophic thoughts. However, web-based MBCT for the prevention of CPSP has not yet been examined. Objective: The aim of this study is to pilot test a 4-week-long web-based MBCT intervention for adults following discharge from the hospital by assessing the acceptability or feasibility of the intervention and examining preliminary effects on pain intensity, pain interference with activities and opioid use, and pain acceptance and catastrophic thoughts in the 6 months following surgery. Methods: A double-blinded pilot randomized controlled trial will be used to assess a web-based MBCT intervention. Patients will be selected according to the following criteria: age ?18 years; first-time elective cardiac surgery via a median sternotomy; worst pain in the past week score ?4/10; ability to understand and complete questionnaires in English; and ability to use an electronic device such as a smartphone, computer, or tablet. After baseline measures, 32 participants will be randomized into two groups: one receiving both the brief, 4-week-long web-based MBCT intervention and usual care (experimental group) and the other receiving only one standardized, web-based educational session with weekly reminders and usual care (attention control group). Peer-reviewed competitive funding was received from Florida State University's Council on Research \& Creativity in January 2021, as well as research ethics approval from Florida State University's institutional review board. Results: Recruitment began in June 2021. Unfortunately, because of the current COVID-19 pandemic, recruitment is not progressing as expected. Recruitment strategies are constantly monitored and updated according to latest data and restrictions surrounding the pandemic. Conclusions: This research is significant because it targets the trajectory of CPSP, a leading cause of disability and opioid misuse. This is the first study to assess MBCT for the prevention of CPSP after cardiac surgery in the recovery phase. This approach is innovative because it promotes self-management of pain through the modulation of individual factors. If successful, the intervention could be expanded to numerous populations at risk of chronic pain. International Registered Report Identifier (IRRID): DERR1-10.2196/30951 ", doi="10.2196/30951", url="https://www.researchprotocols.org/2021/8/e30951", url="http://www.ncbi.nlm.nih.gov/pubmed/34459749" } @Article{info:doi/10.2196/28974, author="Nazarian, Scarlet and Lam, Kyle and Darzi, Ara and Ashrafian, Hutan", title="Diagnostic Accuracy of Smartwatches for the Detection of Cardiac Arrhythmia: Systematic Review and Meta-analysis", journal="J Med Internet Res", year="2021", month="Aug", day="27", volume="23", number="8", pages="e28974", keywords="wearables", keywords="smartwatch", keywords="cardiac arrhythmia", keywords="atrial fibrillation", keywords="cardiology", keywords="mHealth", keywords="wearable devices", keywords="screening", keywords="diagnostics", keywords="accuracy", abstract="Background: Significant morbidity, mortality, and financial burden are associated with cardiac rhythm abnormalities. Conventional investigative tools are often unsuccessful in detecting cardiac arrhythmias because of their episodic nature. Smartwatches have gained popularity in recent years as a health tool for the detection of cardiac rhythms. Objective: This study aims to systematically review and meta-analyze the diagnostic accuracy of smartwatches in the detection of cardiac arrhythmias. Methods: A systematic literature search of the Embase, MEDLINE, and Cochrane Library databases was performed in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines to identify studies reporting the use of a smartwatch for the detection of cardiac arrhythmia. Summary estimates of sensitivity, specificity, and area under the curve were attempted using a bivariate model for the diagnostic meta-analysis. Studies were examined for quality using the Quality Assessment of Diagnostic Accuracy Studies 2 tool. Results: A total of 18 studies examining atrial fibrillation detection, bradyarrhythmias and tachyarrhythmias, and premature contractions were analyzed, measuring diagnostic accuracy in 424,371 subjects in total. The signals analyzed by smartwatches were based on photoplethysmography. The overall sensitivity, specificity, and accuracy of smartwatches for detecting cardiac arrhythmias were 100\% (95\% CI 0.99-1.00), 95\% (95\% CI 0.93-0.97), and 97\% (95\% CI 0.96-0.99), respectively. The pooled positive predictive value and negative predictive value for detecting cardiac arrhythmias were 85\% (95\% CI 0.79-0.90) and 100\% (95\% CI 1.0-1.0), respectively. Conclusions: This review demonstrates the evolving field of digital disease detection. The current diagnostic accuracy of smartwatch technology for the detection of cardiac arrhythmias is high. Although the innovative drive of digital devices in health care will continue to gain momentum toward screening, the process of accurate evidence accrual and regulatory standards ready to accept their introduction is strongly needed. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42020213237; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=213237. ", doi="10.2196/28974", url="https://www.jmir.org/2021/8/e28974", url="http://www.ncbi.nlm.nih.gov/pubmed/34448706" } @Article{info:doi/10.2196/24952, author="Maddison, Ralph and Jiang, Yannan and Stewart, Ralph and Scott, Tony and Kerr, Andrew and Whittaker, Robyn and Benatar, Jocelyn and Rolleston, Anna and Estabrooks, Paul and Dale, Leila", title="An Intervention to Improve Medication Adherence in People With Heart Disease (Text4HeartII): Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2021", month="Jun", day="9", volume="9", number="6", pages="e24952", keywords="cardiovascular disease", keywords="self-management", keywords="text messaging", keywords="risk factors", abstract="Background: Mobile health technologies have the potential to improve the reach and delivery of interventions for promoting long-term secondary prevention of coronary heart disease. Objective: This study aims to determine the effectiveness of an SMS text messaging intervention (Text4HeartII) for improving adherence to medication and lifestyle changes over and above usual care in people with coronary heart disease at 24 and 52 weeks. Methods: A two-arm, parallel, randomized controlled trial was conducted in New Zealand. Participants with a recent acute coronary syndrome were randomized to receive usual cardiac services alone (control, n=153) or a 24-week SMS text message program for supporting self-management plus usual cardiac services (n=153). The primary outcome was adherence to medication at 24 weeks, defined as a medication possession ratio of 80\% or more for aspirin, statin, and antihypertensive therapy. Secondary outcomes included medication possession ratio at 52 weeks, self-reported medication adherence, adherence to healthy lifestyle behaviors, and health-related quality of life at 24 and 52 weeks. Results: Participants were predominantly male (113/306, 80.3\%) and European New Zealanders (210/306, 68.6\%), with a mean age of 61 years (SD 11 years). Groups were comparable at baseline. National hospitalization and pharmacy dispensing recordswere available for all participants; 92\% (282/306, 92.1\%) of participants completed a 24-week questionnaire and 95.1\% (291/306) of participants completed a 52-week questionnaire. Adherence with 3 medication classes were lower in the intervention group than in the control group (87/153, 56.8\% vs 105/153, 68.6\%, odds ratio 0.60, 95\% CI 0.38-0.96; P=.03) and 52 weeks (104/153, 67.9\% vs 83/153, 54.2\%; odds ratio 0.56, 95\% CI 0.35-0.89; P=.01). Self-reported medication adherence scores showed the same trend at 52 weeks (mean difference 0.3; 95\% CI 0.01-0.59; P=.04). Moreover, self-reported adherence to health-related behaviors was similar between groups. Conclusions: Text4HeartII did not improve dispensed medication or adherence to a favorable lifestyle over and above usual care. This finding contrasts with previous studies and highlights that the benefits of text interventions may depend on the context in which they are used. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12616000422426; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370398. International Registered Report Identifier (IRRID): RR2-10.1186/s13063-018-2468-z ", doi="10.2196/24952", url="https://mhealth.jmir.org/2021/6/e24952", url="http://www.ncbi.nlm.nih.gov/pubmed/34106081" } @Article{info:doi/10.2196/29101, author="Friedman, M. Daniel and Goldberg, M. Jana and Molinsky, L. Rebecca and Hanson, A. Mark and Casta{\~n}o, Adam and Raza, Syed-Samar and Janas, Nodar and Celano, Peter and Kapoor, Karen and Telaraja, Jina and Torres, L. Maria and Jain, Nayan and Wessler, D. Jeffrey", title="A Virtual Cardiovascular Care Program for Prevention of Heart Failure Readmissions in a Skilled Nursing Facility Population: Retrospective Analysis", journal="JMIR Cardio", year="2021", month="Jun", day="1", volume="5", number="1", pages="e29101", keywords="heart failure", keywords="readmissions", keywords="skilled nursing facilities", keywords="posthospitalization", keywords="cardiovascular", keywords="cardiology", keywords="outcome", keywords="cost", keywords="virtual care", keywords="telehealth", keywords="telemedicine", keywords="mobile health", keywords="mHealth", keywords="digital health", abstract="Background: Patients with heart failure (HF) in skilled nursing facilities (SNFs) have 30-day hospital readmission rates as high as 43\%. A virtual cardiovascular care program, consisting of patient selection, initial televisit, postconsultation care planning, and follow-up televisits, was developed and delivered by Heartbeat Health, Inc., a cardiovascular digital health company, to 11 SNFs (3510 beds) in New York. The impact of this program on the expected SNF 30-day HF readmission rate is unknown, particularly in the COVID-19 era. Objective: The aim of the study was to assess whether a virtual cardiovascular care program could reduce the 30-day hospital readmission rate for patients with HF discharged to SNF relative to the expected rate for this population. Methods: We performed a retrospective case review of SNF patients who received a virtual cardiology consultation between August 2020 and February 2021. Virtual cardiologists conducted 1 or more telemedicine visit via smartphone, tablet, or laptop for cardiac patients identified by a SNF care team. Postconsult care plans were communicated to SNF clinical staff. Patients included in this analysis had a preceding index admission for HF. Results: We observed lower hospital readmission among patients who received 1 or more virtual consultations compared with the expected readmission rate for both cardiac (3\% vs 10\%, respectively) and all-cause etiologies (18\% vs 27\%, respectively) in a population of 3510 patients admitted to SNF. A total of 185/3510 patients (5.27\%) received virtual cardiovascular care via the Heartbeat Health program, and 40 patients met study inclusion criteria and were analyzed, with 26 (65\%) requiring 1 televisit and 14 (35\%) requiring more than 1. Cost savings associated with this reduction in readmissions are estimated to be as high as US \$860 per patient. Conclusions: The investigation provides initial evidence for the potential effectiveness and efficiency of virtual and digitally enabled virtual cardiovascular care on 30-day hospital readmissions. Further research is warranted to optimize the use of novel virtual care programs to transform delivery of cardiovascular care to high-risk populations. ", doi="10.2196/29101", url="https://cardio.jmir.org/2021/1/e29101", url="http://www.ncbi.nlm.nih.gov/pubmed/34061037" } @Article{info:doi/10.2196/24190, author="Al-Arkee, Shahd and Mason, Julie and Lane, A. Deirdre and Fabritz, Larissa and Chua, Winnie and Haque, Sayeed M. and Jalal, Zahraa", title="Mobile Apps to Improve Medication Adherence in Cardiovascular Disease: Systematic Review and Meta-analysis", journal="J Med Internet Res", year="2021", month="May", day="25", volume="23", number="5", pages="e24190", keywords="mobile health care applications", keywords="medication adherence", keywords="cardiovascular disease", keywords="systematic review", keywords="mobile phone", abstract="Background: Adherence rates of preventative medication for cardiovascular disease (CVD) have been reported as 57\%, and approximately 9\% of all CVD events in Europe are attributable to poor medication adherence. Mobile health technologies, particularly mobile apps, have the potential to improve medication adherence and clinical outcomes. Objective: The objective of this study is to assess the effects of mobile health care apps on medication adherence and health-related outcomes in patients with CVD. This study also evaluates apps' functionality and usability and the involvement of health care professionals in their use. Methods: Electronic databases (MEDLINE [Ovid], PubMed Central, Cochrane Library, CINAHL Plus, PsycINFO [Ovid], Embase [Ovid], and Google Scholar) were searched for randomized controlled trials (RCTs) to investigate app-based interventions aimed at improving medication adherence in patients with CVD. RCTs published in English from inception to January 2020 were reviewed. The Cochrane risk of bias tool was used to assess the included studies. Meta-analysis was performed for clinical outcomes and medication adherence, with meta-regression analysis used to evaluate the impact of app intervention duration on medication adherence. Results: This study included 16 RCTs published within the last 6 years. In total, 12 RCTs reported medication adherence as the primary outcome, which is the most commonly self-reported adherence. The duration of the interventions ranged from 1 to 12 months, and sample sizes ranged from 24 to 412. Medication adherence rates showed statistically significant improvements in 9 RCTs when compared with the control, and meta-analysis of the 6 RCTs reporting continuous data showed a significant overall effect in favor of the app intervention (mean difference 0.90, 95\% CI 0.03-1.78) with a high statistical heterogeneity (I2=93.32\%). Moreover, 9 RCTs assessed clinical outcomes and reported an improvement in systolic blood pressure, diastolic blood pressure, total cholesterol, and low-density lipoprotein cholesterol levels in the intervention arm. Meta-analysis of these clinical outcomes from 6 RCTs favored app interventions, but none were significant. In the 7 trials evaluating app usability, all were found to be acceptable. There was a great variation in the app characteristics. A total of 10 RCTs involved health care professionals, mainly physicians and nurses, in the app-based interventions. The apps had mixed functionality: 2 used education, 7 delivered reminders, and 7 provided reminders in combination with educational support. Conclusions: Apps tended to increase medication adherence, but interventions varied widely in design, content, and delivery. Apps have an acceptable degree of usability; yet the app characteristics conferring usability and effectiveness are ill-defined. Future large-scale studies should focus on identifying the essential active components of successful apps. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42019121385; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=121385 ", doi="10.2196/24190", url="https://www.jmir.org/2021/5/e24190", url="http://www.ncbi.nlm.nih.gov/pubmed/34032583" } @Article{info:doi/10.2196/24530, author="Ross, S. Emily and Sakakibara, M. Brodie and Mackay, H. Martha and Whitehurst, T. David G. and Singer, Joel and Toma, Mustafa and Corbett, K. Kitty and Van Spall, C. Harriette G. and Rutherford, Kimberly and Gheorghiu, Bobby and Code, Jillianne and Lear, A. Scott", title="The Use of SMS Text Messaging to Improve the Hospital-to-Community Transition in Patients With Acute Coronary Syndrome (Txt2Prevent): Results From a Pilot Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2021", month="May", day="14", volume="9", number="5", pages="e24530", keywords="SMS text messaging", keywords="mHealth", keywords="acute coronary syndrome", keywords="cardiovascular disease", abstract="Background: Acute coronary syndrome (ACS) is a leading cause of hospital admission in North America. Many patients with ACS experience challenges after discharge that impact their clinical outcomes and psychosocial well-being. SMS text messaging has the potential to provide support to patients during this postdischarge period. Objective: This study pilot tested a 60-day SMS text messaging intervention (Txt2Prevent) for patients with ACS. The primary objective was to compare self-management domains between usual care and usual care plus Txt2Prevent. The secondary objectives were to compare medication adherence, health-related quality of life, self-efficacy, and health care resource use between groups. The third objective was to assess the feasibility of the study protocol and the acceptability of the intervention. Methods: This was a randomized controlled trial with blinding of outcome assessors. We recruited 76 patients with ACS from St. Paul's Hospital in Vancouver, Canada, and randomized them to 1 of 2 groups within 7 days of discharge. The Txt2Prevent program included automated 1-way SMS text messages about follow-up care, self-management, and healthy living. Data were collected during the index admission and at 60 days after randomization. The primary outcome was measured with the Health Education Impact Questionnaire (heiQ). Other outcomes included the EQ-5D-5L, EQ-5D-5L Visual Analog Scale, a modified Sullivan Cardiac Self-Efficacy Scale, and Morisky Medication Adherence Scale scores, and self-reported health care resource use. Analyses of covariance were used to test the effect of group assignment on follow-up scores (controlling for baseline) and were considered exploratory in nature. Feasibility was assessed with descriptive characteristics of the study protocol. Acceptability was assessed with 2 survey questions and semistructured interviews. Results: There were no statistically significant differences between the groups for the heiQ domains (adjusted mean difference [Txt2Prevent minus usual care] for each domain---Health-directed activity: --0.13, 95\% CI --0.39 to 0.13, P=.31; Positive and active engagement in life: 0.03, 95\% CI --0.19 to 0.25, P=.76; Emotional distress: 0.04, 95\% CI --0.22 to 0.29, P=.77; Self-monitoring and insight: --0.14, 95\% CI --0.33 to 0.05, P=.15; Constructive attitudes and approaches: --0.10, 95\% CI --0.36 to 0.17, P=.47; Skill technique and acquisition: 0.05, 95\% CI --0.18 to 0.27, P=.69; Social integration and support: --0.12, 95\% CI --0.34 to 0.10, P=.27; and Health services navigation: --0.05, 95\% CI --0.29 to 0.19, P=.69). For the secondary outcomes, there were no statistically significant differences in adjusted analyses except in 1 self-efficacy domain (Total plus), where the Txt2Prevent group had lower scores (mean difference --0.36, 95\% CI --0.66 to --0.50, P=.03). The study protocol was feasible, but recruitment took longer than expected. Over 90\% (29/31 [94\%]) of participants reported they were satisfied with the program. Conclusions: The Txt2Prevent study was feasible to implement; however, although exploratory, there were no differences between the 2 groups in adjusted analyses except for 1 self-efficacy domain. As the intervention appeared acceptable, there is potential in using SMS text messages in this context. The design of the intervention may need to be reconsidered to have more impact on outcome measures. Trial Registration: ClinicalTrials.gov NCT02336919; https://clinicaltrials.gov/ct2/show/NCT02336919 International Registered Report Identifier (IRRID): RR2-10.2196/resprot.6968 ", doi="10.2196/24530", url="https://mhealth.jmir.org/2021/5/e24530", url="http://www.ncbi.nlm.nih.gov/pubmed/33988519" } @Article{info:doi/10.2196/25333, author="Coorey, Genevieve and Peiris, David and Scaria, Anish and Mulley, John and Neubeck, Lis and Hafiz, Nashid and Redfern, Julie", title="An Internet-Based Intervention for Cardiovascular Disease Management Integrated With Primary Care Electronic Health Records: Mixed Methods Evaluation of Implementation Fidelity and User Engagement", journal="J Med Internet Res", year="2021", month="Apr", day="26", volume="23", number="4", pages="e25333", keywords="eHealth", keywords="electronic health record", keywords="web-based intervention", keywords="implementation fidelity", keywords="user engagement", keywords="mixed methods", keywords="cardiovascular disease", keywords="primary health care", keywords="mobile phone", abstract="Background: Growing evidence supports the benefits of eHealth interventions to increase patient engagement and improve outcomes for a range of conditions. However, ineffective program delivery and usage attrition limit exposure to these interventions and may reduce their effectiveness. Objective: This study aims to evaluate the delivery fidelity of an eHealth intervention, describe use patterns, compare outcomes between low and high users, and identify mediating factors on intervention delivery and receipt. Methods: This is a mixed methods study of an internet-based intervention being evaluated for effectiveness in a randomized controlled trial (RCT). The intervention comprised medication and cardiovascular disease (CVD) risk data uploaded from the primary care electronic health record (EHR); interactive, personalized CVD risk score estimation; goal setting and self-monitoring; an interactive social forum; and optional receipt of heart health messages. Fidelity was assessed over 12 months. Trial outcomes were compared between low and high users. Data sources included program delivery records, web log data, trial data, and thematic analysis of communication records. Results: Most participants in the intervention group (451/486, 93\%) had an initial training session conducted by telephone (413/447, 92.4\% of participants trained), with a mean duration of 44 minutes (range 10-90 minutes). Staff conducted 98.45\% (1776/1804) of the expected follow-ups, mostly by telephone or email. Of the 451 participants who commenced log-ins, 46.8\% (211) were categorized as low users (defined as at least one log-in in 3 or fewer months of follow-up), 40.4\% (182) were categorized as high users (at least one log-in in more than 3 months of follow-up), and 12.8\% (58) were nonadopters (no log-ins after their training session). The mean log-in frequency was 3-4 per month in ongoing users. There was no significant difference between the groups in the primary trial outcome of adherence to guideline-recommended medications (P=.44). In unadjusted analyses, high users had significantly greater eHealth literacy scores (P=.003) and were more likely to meet recommended weekly targets for fruit (P=.03) and fish (P=.004) servings; however, the adjusted findings were not significant. Interactive screen use was highest for goal tracking and lowest for the chat forum. Screens with EHR-derived data held only an early interest for most users. Fidelity measures (reach, content, dose delivered, and dose received) were influenced by the facilitation strategies used by staff, invisible qualities of staff-participant communication, and participants' responsiveness to intervention attributes. Conclusions: A multifeature internet-based intervention was delivered with high fidelity to the RCT protocol and was regularly used by 40.4\% (182/451) of users over 12 months. Higher log-in frequency as an indicator of greater intervention exposure was not associated with statistically significant improvements in eHealth literacy scores, lifestyle changes, or clinical outcomes. Attributes of the intervention and individualized support influenced initial and ongoing use. ", doi="10.2196/25333", url="https://www.jmir.org/2021/4/e25333", url="http://www.ncbi.nlm.nih.gov/pubmed/33900204" } @Article{info:doi/10.2196/21061, author="Akinosun, Samuel Adewale and Polson, Rob and Diaz - Skeete, Yohanca and De Kock, Hendrikus Johannes and Carragher, Lucia and Leslie, Stephen and Grindle, Mark and Gorely, Trish", title="Digital Technology Interventions for Risk Factor Modification in Patients With Cardiovascular Disease: Systematic Review and Meta-analysis", journal="JMIR Mhealth Uhealth", year="2021", month="Mar", day="3", volume="9", number="3", pages="e21061", keywords="digital technologies", keywords="mHealth", keywords="eHealth", keywords="risk factors", keywords="cardiovascular diseases", keywords="telehealth", keywords="cardiac rehabilitation", keywords="behavior", keywords="systematic review", keywords="meta-analysis", keywords="mobile phone", abstract="Background: Approximately 50\% of cardiovascular disease (CVD) cases are attributable to lifestyle risk factors. Despite widespread education, personal knowledge, and efficacy, many individuals fail to adequately modify these risk factors, even after a cardiovascular event. Digital technology interventions have been suggested as a viable equivalent and potential alternative to conventional cardiac rehabilitation care centers. However, little is known about the clinical effectiveness of these technologies in bringing about behavioral changes in patients with CVD at an individual level. Objective: The aim of this study is to identify and measure the effectiveness of digital technology (eg, mobile phones, the internet, software applications, wearables, etc) interventions in randomized controlled trials (RCTs) and determine which behavior change constructs are effective at achieving risk factor modification in patients with CVD. Methods: This study is a systematic review and meta-analysis of RCTs designed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analysis) statement standard. Mixed data from studies extracted from selected research databases and filtered for RCTs only were analyzed using quantitative methods. Outcome hypothesis testing was set at 95\% CI and P=.05 for statistical significance. Results: Digital interventions were delivered using devices such as cell phones, smartphones, personal computers, and wearables coupled with technologies such as the internet, SMS, software applications, and mobile sensors. Behavioral change constructs such as cognition, follow-up, goal setting, record keeping, perceived benefit, persuasion, socialization, personalization, rewards and incentives, support, and self-management were used. The meta-analyzed effect estimates (mean difference [MD]; standard mean difference [SMD]; and risk ratio [RR]) calculated for outcomes showed benefits in total cholesterol SMD at ?0.29 [?0.44, ?0.15], P<.001; high-density lipoprotein SMD at --0.09 [--0.19, 0.00], P=.05; low-density lipoprotein SMD at ?0.18 [?0.33, ?0.04], P=.01; physical activity (PA) SMD at 0.23 [0.11, 0.36], P<.001; physical inactivity (sedentary) RR at 0.54 [0.39, 0.75], P<.001; and diet (food intake) RR at 0.79 [0.66, 0.94], P=.007. Initial effect estimates showed no significant benefit in body mass index (BMI) MD at ?0.37 [?1.20, 0.46], P=.38; diastolic blood pressure (BP) SMD at ?0.06 [?0.20, 0.08], P=.43; systolic BP SMD at ?0.03 [?0.18, 0.13], P=.74; Hemoglobin A1C blood sugar (HbA1c) RR at 1.04 [0.40, 2.70], P=.94; alcohol intake SMD at ?0.16 [?1.43, 1.10], P=.80; smoking RR at 0.87 [0.67, 1.13], P=.30; and medication adherence RR at 1.10 [1.00, 1.22], P=.06. Conclusions: Digital interventions may improve healthy behavioral factors (PA, healthy diet, and medication adherence) and are even more potent when used to treat multiple behavioral outcomes (eg, medication adherence plus). However, they did not appear to reduce unhealthy behavioral factors (smoking, alcohol intake, and unhealthy diet) and clinical outcomes (BMI, triglycerides, diastolic and systolic BP, and HbA1c). ", doi="10.2196/21061", url="https://mhealth.jmir.org/2021/3/e21061", url="http://www.ncbi.nlm.nih.gov/pubmed/33656444" } @Article{info:doi/10.2196/18025, author="Tadas, Shreya and Coyle, David", title="Barriers to and Facilitators of Technology in Cardiac Rehabilitation and Self-Management: Systematic Qualitative Grounded Theory Review", journal="J Med Internet Res", year="2020", month="Nov", day="11", volume="22", number="11", pages="e18025", keywords="telemedicine", keywords="cardiovascular diseases", keywords="self-management", keywords="self-care", keywords="systematic review", keywords="grounded theory", keywords="mobile phone", abstract="Background: Dealing with cardiovascular disease is challenging, and people often struggle to follow rehabilitation and self-management programs. Several systematic reviews have explored quantitative evidence on the potential of digital interventions to support cardiac rehabilitation (CR) and self-management. However, although promising, evidence regarding the effectiveness and uptake of existing interventions is mixed. This paper takes a different but complementary approach, focusing on qualitative data related to people's experiences of technology in this space. Objective: Through a qualitative approach, this review aims to engage more directly with people's experiences of technology that supports CR and self-management. The primary objective of this paper is to provide answers to the following research question: What are the primary barriers to and facilitators and trends of digital interventions to support CR and self-management? This question is addressed by synthesizing evidence from both medical and computer science literature. Given the strong evidence from the field of human-computer interaction that user-centered and iterative design methods increase the success of digital health interventions, we also assess the degree to which user-centered and iterative methods have been applied in previous work. Methods: A grounded theory literature review of articles from the following major electronic databases was conducted: ACM Digital Library, PsycINFO, Scopus, and PubMed. Papers published in the last 10 years, 2009 to 2019, were considered, and a systematic search with predefined keywords was conducted. Papers were screened against predefined inclusion and exclusion criteria. Comparative and in-depth analysis of the extracted qualitative data was carried out through 3 levels of iterative coding and concept development. Results: A total of 4282 articles were identified in the initial search. After screening, 61 articles remained, which were both qualitative and quantitative studies and met our inclusion criteria for technology use and health condition. Of the 61 articles, 16 qualitative articles were included in the final analysis. Key factors that acted as barriers and facilitators were background knowledge and in-the-moment understanding, personal responsibility and social connectedness, and the need to support engagement while avoiding overburdening people. Although some studies applied user-centered methods, only 6 involved users throughout the design process. There was limited evidence of studies applying iterative approaches. Conclusions: The use of technology is acceptable to many people undergoing CR and self-management. Although background knowledge is an important facilitator, technology should also support greater ongoing and in-the-moment understanding. Connectedness is valuable, but to avoid becoming a barrier, technology must also respect and enable individual responsibility. Personalization and gamification can also act as facilitators of engagement, but care must be taken to avoid overburdening people. Further application of user-centered and iterative methods represents a significant opportunity in this space. ", doi="10.2196/18025", url="http://www.jmir.org/2020/11/e18025/", url="http://www.ncbi.nlm.nih.gov/pubmed/33174847" } @Article{info:doi/10.2196/17422, author="Engelen, M. Marscha and van Dulmen, Sandra and Puijk-Hekman, Saskia and Vermeulen, Hester and Nijhuis-van der Sanden, WG Maria and Bredie, JH Sebastian and van Gaal, GI Betsie", title="Evaluation of a Web-Based Self-Management Program for Patients With Cardiovascular Disease: Explorative Randomized Controlled Trial", journal="J Med Internet Res", year="2020", month="Jul", day="24", volume="22", number="7", pages="e17422", keywords="explorative randomized controlled trial", keywords="cardiovascular diseases", keywords="self-management", keywords="eHealth support programs", keywords="internet", keywords="lifestyle", keywords="nursing", abstract="Background: Web-based self-management programs have the potential to support patients with cardiovascular disease (CVD) in their self-management (eg, by focusing on behavior change and improving physical activity). The intervention mapping framework was used to develop a web-based program called Vascular View. The Vascular View program contained 6 modules (coping with CVD, setting boundaries, lifestyle, healthy nutrition, being physically active, interaction with health professionals) aiming to increase self-management behavior by tailoring to the perceived problems and (support) needs of patients after CVD. Objective: The aim was to test the effectiveness of Vascular View before embarking on a full-scale randomized clinical trial (RCT) by evaluating the potential effectiveness and effect sizes of the Vascular View program and identifying outcome measures most likely to capture the potential benefits. Methods: An explorative RCT was performed. Both control and intervention groups received care as usual and, in addition, the intervention group received 12 months of access to a web-based self-management program. Assessment occurred at baseline, 6 months, and 12 months. Outcome measures included general patient-reported outcome measurements: Illness Perception Questionnaire (IPQ), Rand-36, Patient Activation Measure, and patient self-efficacy. Module-specific patient-reported outcome measurements were Beliefs about Medicines Questionnaire, International Physical Activity Questionnaire, Dutch Healthy Diet Index, Fagerstr{\"o}m Test for Nicotine Dependence (FTND), Alcohol Use Disorders Identification Test, and Perceived Efficacy in Patient-Physician Interaction. Linear mixed models for repeated measures using intention-to-treat and per-protocol analysis were applied to study differences between the patients in the intervention and control groups. Floor and ceiling effects were explored to give insight into the outcome measures most likely to capture the potential benefits. Results: A total of 105 patients in the control group and 103 patients in the intervention group participated in the study. A positive direction of change between baseline and 12 months was shown for most outcome measurements in favor of the intervention group, of which 2 out of 10 outcomes showed a significant effect: attribution of cause of the disease to risk factors and immunity factors (IPQ) and dependency of nicotine (FTND). Floor and ceiling effects were seen in the IPQ, Rand-36, and the self-efficacy questionnaire. Conclusions: No conclusion for the efficacy of the Vascular View program or selection of outcome measurements can be taken yet. A process evaluation will be conducted to gain thorough insight into the working elements of the program, patient needs in eHealth, and the use of the program by patients. This can determine for whom web-based self-management programs will work and help to adapt the program. Trial Registration: Dutch Trial Register NTR5412; https://www.trialregister.nl/trial/5303 International Registered Report Identifier (IRRID): RR2-10.2196/resprot.6352 ", doi="10.2196/17422", url="http://www.jmir.org/2020/7/e17422/", url="http://www.ncbi.nlm.nih.gov/pubmed/32706708" } @Article{info:doi/10.2196/16157, author="Cruz-Mart{\'i}nez, Rafael Roberto and Wentzel, Jobke and Asbj{\o}rnsen, Aune Rikke and Noort, Daniel Peter and van Niekerk, Magnus Johan and Sanderman, Robbert and van Gemert-Pijnen, EWC Julia", title="Supporting Self-Management of Cardiovascular Diseases Through Remote Monitoring Technologies: Metaethnography Review of Frameworks, Models, and Theories Used in Research and Development", journal="J Med Internet Res", year="2020", month="May", day="21", volume="22", number="5", pages="e16157", keywords="eHealth", keywords="telemedicine", keywords="development", keywords="implementation", keywords="evaluation", keywords="multidisciplinary", keywords="qualitative evidence synthesis", keywords="meta-ethnography", keywords="systematic review", keywords="remote monitoring", keywords="self-management", keywords="cardiovascular diseases", keywords="framework", keywords="model", keywords="theory", abstract="Background: Electronic health (eHealth) is a rapidly evolving field informed by multiple scientific disciplines. Because of this, the use of different terms and concepts to explain the same phenomena and lack of standardization in reporting interventions often leaves a gap that hinders knowledge accumulation. Interventions focused on self-management support of cardiovascular diseases through the use of remote monitoring technologies are a cross-disciplinary area potentially affected by this gap. A review of the underlying frameworks, models, and theories that have informed projects at this crossroad could advance future research and development efforts. Objective: This research aimed to identify and compare underlying approaches that have informed interventions focused on self-management support of cardiovascular diseases through the use of remote monitoring technologies. The objective was to achieve an understanding of the distinct approaches by highlighting common or conflicting principles, guidelines, and methods. Methods: The metaethnography approach was used to review and synthesize researchers' reports on how they applied frameworks, models, and theories in their projects. Literature was systematically searched in 7 databases: Scopus, Web of Science, EMBASE, CINAHL, PsycINFO, Association for Computing Machinery Digital Library, and Cochrane Library. Included studies were thoroughly read and coded to extract data for the synthesis. Studies were mainly related by the key ingredients of the underlying approaches they applied. The key ingredients were finally translated across studies and synthesized into thematic clusters. Results: Of 1224 initial results, 17 articles were included. The articles described research and development of 10 different projects. Frameworks, models, and theories (n=43) applied by the projects were identified. Key ingredients (n=293) of the included articles were mapped to the following themes of eHealth development: (1) it is a participatory process; (2) it creates new infrastructures for improving health care, health, and well-being; (3) it is intertwined with implementation; (4) it integrates theory, evidence, and participatory approaches for persuasive design; (5) it requires continuous evaluation cycles; (6) it targets behavior change; (7) it targets technology adoption; and (8) it targets health-related outcomes. Conclusions: The findings of this review support and exemplify the numerous possibilities in the use of frameworks, models, and theories to guide research and development of eHealth. Participatory, user-centered design, and integration with empirical evidence and theoretical modeling were widely identified principles in the literature. On the contrary, less attention has been given to the integration of implementation in the development process and supporting novel eHealth-based health care infrastructures. To better integrate theory and evidence, holistic approaches can combine patient-centered studies with consolidated knowledge from expert-based approaches. Trial Registration: PROSPERO CRD42018104397; https://tinyurl.com/y8ajyajt International Registered Report Identifier (IRRID): RR2-10.2196/13334 ", doi="10.2196/16157", url="http://www.jmir.org/2020/5/e16157/", url="http://www.ncbi.nlm.nih.gov/pubmed/32436852" } @Article{info:doi/10.2196/14466, author="Duan, Huilong and Wang, Zheyu and Ji, Yumeng and Ma, Li and Liu, Fang and Chi, Mingwei and Deng, Ning and An, Jiye", title="Using Goal-Directed Design to Create a Mobile Health App to Improve Patient Compliance With Hypertension Self-Management: Development and Deployment", journal="JMIR Mhealth Uhealth", year="2020", month="Feb", day="25", volume="8", number="2", pages="e14466", keywords="goal-directed design", keywords="smartphone", keywords="mobile health", keywords="patients", keywords="hypertension self-management", keywords="mobile phone", abstract="Background: Hypertension is a lifestyle-induced chronic disease that threatens the lives of patients. Control of hypertension requires patients to follow self-management regimes; unfortunately, however, patient compliance with hypertension self-management is low, especially in developing countries. Improvement of patient compliance is premised on meeting patient needs. Mobile health apps are becoming increasingly popular for self-management of chronic diseases. However, few mobile apps have been designed to meet patient needs for hypertension self-management. Objective: The goal of this study was to develop a mobile health app to improve patient compliance with hypertension self-management and evaluate the effectiveness of the app in terms of patient compliance. Methods: The goal-directed design method was applied to guide study design. We divided the study into 4 stages. Stages 1 to 3 comprised the development process. To improve the applicability of the goal-directed design method to chronic disease management, we extracted elements of user models concerned with patient compliance and defined a concrete process for user modeling. In stage 1, personas of hypertensive patients were built using qualitative and quantitative methods. Clustering methods based on questionnaire responses were used to group patients. Qualitative interviews were conducted to identify the needs of different groups. In stage 2, several functional modules were designed to meet the needs of different groups based on the results from stage 1. In stage 3, prototypes of functional modules were designed and implemented as a real app. Stage 4 was the deployment process, in which we conducted a pilot study to investigate patient compliance after using the app. Patient compliance was calculated through the frequency with which they took blood pressure measurements. In addition, qualitative interviews were conducted to learn the underlying reasons for the compliance results. Results: In stage 1, patients were divided into 3 groups based on 82 valid questionnaire responses. Eighteen patients from the different groups (7, 5, and 6 patients) were interviewed, and the needs of the groups were summarized as follows: improve self-management ability, enhance self-management motivation, and receive self-management support. In stages 2 and 3, 6 functional modules were designed and implemented based on specified needs, and the usability of the app was improved through usability tests. In stage 4, 143 patients were recruited to use different versions of the app for 2 months. Results show that patient compliance improved as functional modules were added (P<.001) and was maintained at a high level (rate of 0.73). Interview results from 32 patients show that the design of the app met different needs; thus, patients were more compliant with it. Conclusions: This study developed a mobile health app for hypertension self-management using the goal-directed design method. The app proved to be effective for improving patient compliance with hypertension self-management. ", doi="10.2196/14466", url="http://mhealth.jmir.org/2020/2/e14466/", url="http://www.ncbi.nlm.nih.gov/pubmed/32130161" } @Article{info:doi/10.2196/14275, author="Wali, Sahr and Hussain-Shamsy, Neesha and Ross, Heather and Cafazzo, Joseph", title="Investigating the Use of Mobile Health Interventions in Vulnerable Populations for Cardiovascular Disease Management: Scoping Review", journal="JMIR Mhealth Uhealth", year="2019", month="Oct", day="7", volume="7", number="10", pages="e14275", keywords="mobile health", keywords="health services", keywords="indigenous", keywords="low- and middle-income countries", keywords="cardiovascular disease", keywords="self-care", abstract="Background: Cardiovascular disease (CVD) has grown to become one of the leading causes of mortality worldwide. The advancements of CVD-related treatments have led to a decline in CVD prevalence among individuals in high-income countries (HICs). However, these improvements do not reflect the state of individuals in low- and middle-income countries (LMICs) and vulnerable subgroup populations in HICs, such as the Indigenous. To help minimize the health disparities in these populations, technology-based interventions have been offered as a potential solution, but there is concern regarding if they will be effective, or even needed, as these tools have been designed for use in HICs. Objective: The objective of this study was to explore how mobile health (mHealth) interventions currently assist individuals in Indigenous communities and LMICs with CVD management. Methods: A scoping review guided by the methods outlined by Arksey and O'Malley was conducted. A comprehensive search was completed by 2 reviewers in 5 electronic databases using keywords related to mobile health, cardiovascular disease, self-care, Indigenous communities, and LMICs. Studies were screened over 2 rounds and critically reviewed using a descriptive-analytical narrative method. Descriptive data were categorized into thematic groups reflecting the major findings related to the study objective. Results: We identified a total of 11 original articles and 11 review papers that met the criteria for this scoping review. The majority of the studies included a telemonitoring- and text messaging (short message service, SMS)--related feature associated with the intervention. The use of SMS was the most common approach to effectively promote disease management among individuals in both LMICs and Indigenous communities. However, customizing for cultural considerations within the design of the intervention was highlighted as a pivotal component to encourage CVD management. Specifically, individuals emphasized that the inclusion of collaborative partnerships with community members would strengthen the effectiveness of the intervention by ensuring it was designed with the appropriate context. Conclusions: Technology-based interventions used within Indigenous communities and LMICs have shown their potential to assist individuals with managing their condition. Although the literature available regarding this topic is limited, this review outlines key components to promote the effective use of these tools in the context of these vulnerable populations. ", doi="10.2196/14275", url="https://mhealth.jmir.org/2019/10/e14275", url="http://www.ncbi.nlm.nih.gov/pubmed/31593547" } @Article{info:doi/10.2196/14648, author="Johansson, Peter and Westas, Mats and Andersson, Gerhard and Alehagen, Urban and Brostr{\"o}m, Anders and Jaarsma, Tiny and Mourad, Ghassan and Lundgren, Johan", title="An Internet-Based Cognitive Behavioral Therapy Program Adapted to Patients With Cardiovascular Disease and Depression: Randomized Controlled Trial", journal="JMIR Ment Health", year="2019", month="Oct", day="3", volume="6", number="10", pages="e14648", keywords="cardiovascular disease", keywords="depression", keywords="cognitive behavior therapy", keywords="internet", keywords="randomized controlled trial", abstract="Background: Depression is a common cause of reduced well-being and prognosis in patients with cardiovascular disease (CVD). However, there is a lack of effective intervention strategies targeting depression. Objective: The study aimed to evaluate the effects of a nurse-delivered and adapted internet-based cognitive behavioral therapy (iCBT) program aimed at reducing depression in patients with CVD. Methods: A randomized controlled trial was conducted. A total of 144 patients with CVD with at least mild depression (Patient Health Questionnaire--9 [PHQ-9] score ?5) were randomized 1:1 to a 9-week program of iCBT (n=72) or an active control participating in a Web-based discussion forum (online discussion forum [ODF], n=72). The iCBT program, which included 7 modules, was adapted to fit patients with CVD. Nurses with an experience of CVD care provided feedback and a short introduction to cognitive behavioral therapy. The primary outcome, depression, was measured using PHQ-9. Secondary outcomes were depression measured using the Montgomery-{\AA}sberg Depression Rating Scale--self-rating version (MADRS-S), health-related quality of life (HRQoL) measured using Short Form 12 (SF-12) survey and EuroQol Visual Analogue Scale (EQ-VAS), and the level of adherence. An intention-to-treat analysis with multiple imputations was used. Between-group differences in the primary and secondary outcomes were determined by the analysis of covariance, and a sensitivity analysis was performed using mixed models. Results: Compared with ODF, iCBT had a significant and moderate treatment effect on the primary outcome depression (ie, PHQ-9; mean group difference=?2.34 [95\% CI ?3.58 to ?1.10], P<.001, Cohen d=0.62). In the secondary outcomes, compared with ODF, iCBT had a significant and large effect on depression (ie, MADRS-S; P<.001, Cohen d=0.86) and a significant and moderate effect on the mental component scale of the SF-12 (P<.001, Cohen d=0.66) and the EQ-VAS (P<.001, Cohen d=0.62). Overall, 60\% (n=43) of the iCBT group completed all 7 modules, whereas 82\% (n=59) completed at least half of the modules. No patients were discontinued from the study owing to a high risk of suicide or deterioration in depression. Conclusions: Nurse-delivered iCBT can reduce depression and improve HRQoL in patients with CVD, enabling treatment for depression in their own homes and at their preferred time. Trial Registration: ClinicalTrials.gov NCT02778074; https://clinicaltrials.gov/ct2/show/NCT02778074 ", doi="10.2196/14648", url="https://mental.jmir.org/2019/10/e14648", url="http://www.ncbi.nlm.nih.gov/pubmed/31584000" } @Article{info:doi/10.2196/13334, author="Cruz-Mart{\'i}nez, Rafael Roberto and Noort, Daniel Peter and Asbj{\o}rnsen, Aune Rikke and van Niekerk, Magnus Johan and Wentzel, Jobke and Sanderman, Robbert and van Gemert-Pijnen, Lisette", title="Frameworks, Models, and Theories Used in Electronic Health Research and Development to Support Self-Management of Cardiovascular Diseases Through Remote Monitoring Technologies: Protocol for a Metaethnography Review", journal="JMIR Res Protoc", year="2019", month="Jul", day="16", volume="8", number="7", pages="e13334", keywords="eHealth", keywords="telemedicine", keywords="research and development", keywords="implementation", keywords="evaluation", keywords="multidisciplinary approach", keywords="meta-ethnography", keywords="systematic review", keywords="remote monitoring", keywords="self-management", keywords="cardiovascular diseases", abstract="Background: Electronic health (eHealth) is a multidisciplinary and rapidly evolving field, and thus requires research focused on knowledge accumulation, curation, and translation. Cardiovascular diseases constitute a global health care crisis in which eHealth can provide novel solutions to improve the efficiency and reach of self-management support for patients where they most need it: their homes and communities. A holistic understanding of eHealth projects focused on such case is required to bridge the multidisciplinary gap formed by the wide range of aims and approaches taken by the various disciplines involved. Objective: The primary objective of this review is to facilitate a holistic interpretation of eHealth projects aimed at providing self-management support of cardiovascular diseases in the natural setting of patients, thus priming the use of remote monitoring technologies. The review aims to synthesize the operationalization of frameworks, models, and theories applied to the research and development process of eHealth. Methods: We will use Noblit and Hare's metaethnography approach to review and synthesize researchers' and practitioners' reports on how they applied frameworks, models, and theories in their projects. We will systematically search the literature in 7 databases: Scopus, Web of Science, EMBASE, CINAHL, PsycINFO, ACM Digital Library, and the Cochrane Library. We will thoroughly read and code selected studies to extract both raw and contextual data for the synthesis. The relation of the studies will be determined according to the elements of the frameworks, models, or theories the studies applied. We will translate these elements between each other and intend to synthesize holistic principles for eHealth development for the case at hand. Results: The search strategy has been completed, data extraction is almost finalized, and the first synthesis approaches are underway. The search yielded 1224 citations and, after we applied the selection criteria, 17 articles remained. We expect to submit the final results for publication in 2019. Conclusions: This review is important because it aims to create a holistic understanding of a multidisciplinary topic at the crossroads of eHealth, cardiovascular diseases, and self-management. The value of metaethnography in contrast to other systematic review methods is that its synthesis approach seeks to generate a new understanding of a topic, while preserving the social and theoretical contexts in which findings emerge. Our results will show how useful this method can be in bridging the multidisciplinary gap of eHealth research and development, to inform and advance the importance of holistic approaches, while showcasing this approach for the case of self-management in cardiovascular diseases. Trial Registration: PROSPERO CRD42018104397; https://www.crd.york.ac.uk/PROSPERO/display\_record.php? RecordID=104397 (Archived by WebCite at http://www.webcitation.org/75H1kP1Mm) International Registered Report Identifier (IRRID): DERR1-10.2196/13334 ", doi="10.2196/13334", url="http://www.researchprotocols.org/2019/7/e13334/", url="http://www.ncbi.nlm.nih.gov/pubmed/31313659" } @Article{info:doi/10.2196/12052, author="Duan, Ping Yan and Liang, Wei and Guo, Lan and Wienert, Julian and Si, Yan Gang and Lippke, Sonia", title="Evaluation of a Web-Based Intervention for Multiple Health Behavior Changes in Patients With Coronary Heart Disease in Home-Based Rehabilitation: Pilot Randomized Controlled Trial", journal="J Med Internet Res", year="2018", month="Nov", day="19", volume="20", number="11", pages="e12052", keywords="eHealth", keywords="physical activity", keywords="diet", keywords="cardiac rehabilitation", keywords="health resources", abstract="Background: Web-based and theory-based interventions for multiple health behaviors appears to be a promising approach with respect to the adoption and maintenance of a healthy lifestyle in cardiac patients who have been discharged from the hospital. Until now, no randomized controlled trials have tested this assumption among Chinese rehabilitation patients with coronary heart disease using a Web-based intervention. Objective: The study aim was to evaluate the effect of an 8-week Web-based intervention in terms of physical activity (PA), fruit and vegetable consumption (FVC), lifestyle changes, social-cognitive outcomes, and health outcomes compared with a waiting control group in Chinese cardiac patients. The intervention content was theory-based on the health action process approach. Self-reported data were evaluated, including PA, FVC, healthy lifestyle (the synthesis of PA and FVC), internal resources (combination of intention, self-efficacy, and planning), and an external resource (social support) of PA and FVC behaviors, as well as perceived health outcomes (body mass index, quality of life, and depression). Methods: In a randomized controlled trial, 136 outpatients with coronary heart disease from the cardiac rehabilitation center of a hospital in China were recruited. After randomization and exclusion of unsuitable participants, 114 patients were assigned to 1 of the 2 groups: (1) the intervention group: first 4 weeks on PA and subsequent 4 weeks on FVC and (2) the waiting control group. A total of 2 Web-based assessments were conducted, including 1 at the beginning of the intervention (T1, N=114), and 1 at the end of the 8-week intervention (T2, N=83). The enrollment and follow-up took place from December 2015 to May 2016. Results: The Web-based intervention outperformed the control condition for PA, FVC, internal resources of PA and FVC, and an external resource of FVC, with an eta-squared effect size ranging from 0.06 to 0.43. Furthermore, the intervention effect was seen in the improvement of quality of life (F1,79=16.36, P<.001, $\eta$2=.17). When predicting a healthy lifestyle at follow-up, baseline lifestyle (odds ratio, OR 145.60, 95\% CI 11.24-1886; P<.001) and the intervention (OR 21.32, 95\% CI 2.40-189.20; P=.006) were found to be significant predictors. Internal resources for FVC mediated the effect of the intervention on the adoption of a healthy lifestyle (R2adj=.29; P=.001), indicating that if the intervention increased the internal resource of behavior, the adoption of a healthy lifestyle was more likely. Conclusions: Patients' psychological resources such as motivation, self-efficacy, planning, and social support as well as lifestyle can be improved by a Web-based intervention that focuses on both PA and FVC. Such an intervention enriches extended rehabilitation approaches for cardiac patients to be active and remain healthy in daily life after hospital discharge. Trial Registration: ClinicalTrials.gov NCT01909349; https://clinicaltrials.gov/ct2/show/NCT01909349 (Archived by WebCite at http://www.webcitation.org/6pHV1A0G1) ", doi="10.2196/12052", url="http://www.jmir.org/2018/11/e12052/", url="http://www.ncbi.nlm.nih.gov/pubmed/30455167" } @Article{info:doi/10.2196/10183, author="Bashi, Nazli and Hassanzadeh, Hamed and Varnfield, Marlien and Wee, Yong and Walters, Darren and Karunanithi, Mohanraj", title="Multidisciplinary Smartphone-Based Interventions to Empower Patients With Acute Coronary Syndromes: Qualitative Study on Health Care Providers' Perspectives", journal="JMIR Cardio", year="2018", month="Oct", day="31", volume="2", number="2", pages="e10183", keywords="acute coronary syndrome", keywords="focus group", keywords="health care professionals", keywords="mobile phone", keywords="multidisciplinary", keywords="thematic analysis", abstract="Background: Postdischarge interventions are limited in patients with acute coronary syndrome (ACS) due to few scheduled visits to outpatient clinics and travel from remote areas. Smartphones have become a viable lifestyle technology to deliver educational and health interventions following discharge from hospital. Objective: The purpose of this study was to identify the requirements for the delivery of a mobile health intervention for the postdischarge management of patients with ACS via a multidisciplinary focus group. Methods: We conducted a focus group among health care professionals (n=10) from a large metropolitan hospital in May 2017. These participants from a multidisciplinary team contributed to a 1-hour discussion by responding to 8 questions relating to the applicability of smartphone-based educational and health interventions. Descriptive statistics of the focus group data were analyzed using SPSS. The qualitative data were analyzed according to relevant themes extracted from the focus group transcription, using a qualitative description software program (NVivo 11) and an ontology-based concept mapping approach. Results: The mean age of the participants was 47 (SD 8) years: 3 cardiologists; 2 nurse practitioners; 2 clinical nurses; 2 research scientists; and 1 physiotherapist. Of these participants, 70\% (7/10) had experience using electronic health intervention during their professional practice. A total of 7 major themes and their subthemes emerged from the qualitative analysis. Health care providers indicated that comprehensive education on diet, particularly providing daily meal plans, is critical for patients with ACS. In terms of ACS symptoms, a strong recommendation was to focus on educating patients instead of daily monitoring of chest pain and shortness of breathing due to subjectivity and insufficient information for clinicians. Participants pointed that monitoring health measures such as blood pressure and body weight may result in increased awareness of patient physical health, yet may not be sufficient to support patients with ACS via the smartphone-based intervention. Therefore, monitoring pain and emotional status along with other health measures was recommended. Real-time support via FaceTime or video conferencing was indicated as motivational and supportive for patient engagement and self-monitoring. The general demographics of patients with ACS being older, having a low educational level, and a lack of computer skills were identified as potential barriers for engagement with the smartphone-based intervention. Conclusions: A smartphone-based program that incorporates the identified educational materials and health interventions would motivate patients with ACS to engage in the multidisciplinary intervention and improve their health outcomes following discharge from hospital. ", doi="10.2196/10183", url="http://cardio.jmir.org/2018/2/e10183/", url="http://www.ncbi.nlm.nih.gov/pubmed/31758781" } @Article{info:doi/10.2196/10771, author="Bashi, Nazli and Fatehi, Farhad and Fallah, Mina and Walters, Darren and Karunanithi, Mohanraj", title="Self-Management Education Through mHealth: Review of Strategies and Structures", journal="JMIR Mhealth Uhealth", year="2018", month="Oct", day="19", volume="6", number="10", pages="e10771", keywords="health education", keywords="mHealth", keywords="mobile apps", keywords="mobile phone", keywords="patient education", keywords="self-management education", abstract="Background: Despite the plethora of evidence on mHealth interventions for patient education, there is a lack of information regarding their structures and delivery strategies. Objective: This review aimed to investigate the structures and strategies of patient education programs delivered through smartphone apps for people with diverse conditions and illnesses. We also examined the aim of educational interventions in terms of health promotion, disease prevention, and illness management. Methods: We searched PubMed, Cumulative Index to Nursing and Allied Health Literature, Embase, and PsycINFO for peer-reviewed papers that reported patient educational interventions using mobile apps and published from 2006 to 2016. We explored various determinants of educational interventions, including the content, mode of delivery, interactivity with health care providers, theoretical basis, duration, and follow-up. The reporting quality of studies was evaluated according to the mHealth evidence and reporting assessment criteria. Results: In this study, 15 papers met the inclusion criteria and were reviewed. The studies mainly focused on the use of mHealth educational interventions for chronic disease management, and the main format for delivering interventions was text. Of the 15 studies, 6 were randomized controlled trials (RCTs), which have shown statistically significant effects on patients' health outcomes, including patients' engagement level, hemoglobin A1c, weight loss, and depression. Although the results of RCTs were mostly positive, we were unable to identify any specific effective structure and strategy for mHealth educational interventions owing to the poor reporting quality and heterogeneity of the interventions. Conclusions: Evidence on mHealth interventions for patient education published in peer-reviewed journals demonstrates that current reporting on essential mHealth criteria is insufficient for assessing, understanding, and replicating mHealth interventions. There is a lack of theory or conceptual framework for the development of mHealth interventions for patient education. Therefore, further research is required to determine the optimal structure, strategies, and delivery methods of mHealth educational interventions. ", doi="10.2196/10771", url="https://mhealth.jmir.org/2018/10/e10771/", url="http://www.ncbi.nlm.nih.gov/pubmed/30341042" } @Article{info:doi/10.2196/humanfactors.8820, author="Tanaka, Rika and Banerjee, Anita and Surikova, Jelena and Tracey, Jacqueline and Payne, Ada and Ross, Heather and Nolan, Robert", title="A Moderated e-Forum for Adults With Cardiovascular Disease: Usability Study", journal="JMIR Hum Factors", year="2018", month="May", day="18", volume="5", number="2", pages="e20", keywords="support groups", keywords="cardiovascular disease", keywords="qualitative research", abstract="Background: Self-care behaviors are commonly prescribed to manage both cardiovascular disease and hypertension to reduce modifiable risk factors and improve quality of life. Nevertheless, long-term adherence to self-care recommendations for cardiac patients has been problematic. In cardiac patients, moderated online forums have been found to be particularly useful in supporting maintenance of heart-healthy diet and fewer hospital visits. As such, we developed the e-Forum, a Web-based moderated forum designed to promote continued user engagement and long-term self-care adherence. Objective: The objective of this study was to assess the usability of the user interface for the newly designed e-Forum. In addition to overall user satisfaction, we obtained feedback from our target users on the key features of this newly developed interface. Methods: An iterative design tested the usability of the e-Forum. On the basis of the user feedback, adjustments were made to the design of our e-Forum, and these changes were then tested in the succeeding group. Participants were recruited from the Heart Function Clinic at the Peter Munk Cardiac Center, University Health Network. After consenting to participate in our study, patients were asked to complete a set of goal-oriented tasks and a feedback interview for the e-Forum. A content analysis of the transcripts from the set of goal-oriented tasks and feedback interviews identified several themes, including general feedback and comments regarding 3 key areas of the e-Forum: layout, navigation, and content. Results: Overall, 13 cardiac patients (aged 32-81 years) participated in 3 rounds of testing. Participants across all 3 rounds were highly satisfied with our e-Forum and indicated that they would find such a forum useful in managing their health. Expressions of overall satisfaction with the e-Forum and positive comments regarding layout increased between the initial and the final round. As improvements were made to the e-Forum based on participant feedback, potential barriers, negative comments related to the content, and the number of navigation errors decreased between rounds 1 and 3. Conclusions: We found evidence to support the usability of the user interface for our e-Forum. These results indicate that the e-Forum will likely be a successful tool to support an online community of cardiac patients in their efforts to sustain long-term lifestyle behavior change. ", doi="10.2196/humanfactors.8820", url="http://humanfactors.jmir.org/2018/2/e20/", url="http://www.ncbi.nlm.nih.gov/pubmed/29776901" } @Article{info:doi/10.2196/jmir.9181, author="Walsh, MJ Deirdre and Moran, Kieran and Cornelissen, V{\'e}ronique and Buys, Roselien and Cornelis, Nils and Woods, Catherine", title="Electronic Health Physical Activity Behavior Change Intervention to Self-Manage Cardiovascular Disease: Qualitative Exploration of Patient and Health Professional Requirements", journal="J Med Internet Res", year="2018", month="May", day="08", volume="20", number="5", pages="e163", keywords="telemedicine", keywords="exercise", keywords="cardiovascular diseases", keywords="rehabilitation", abstract="Background: Cardiovascular diseases are a leading cause of premature death worldwide. International guidelines recommend routine delivery of all phases of cardiac rehabilitation. Uptake of traditional cardiac rehabilitation remains suboptimal, as attendance at formal hospital-based cardiac rehabilitation programs is low, with community-based cardiac rehabilitation rates and individual long-term exercise maintenance even lower. Home-based cardiac rehabilitation programs have been shown to be equally effective in clinical and health-related quality of life outcomes and yet are not readily available. Objective: Given the potential that home-based cardiac rehabilitation programs have, it is important to explore how to appropriately design any such intervention in conjunction with key stakeholders. The aim of this study was to engage with individuals with cardiovascular disease and other professionals within the health ecosystem to (1) understand the personal, social, and physical factors that inhibit or promote their capacity to engage with physical activity and (2) explore their technology competencies, needs, and wants in relation to an eHealth intervention. Methods: Fifty-four semistructured interviews were conducted across two countries. Interviews were audiotaped, transcribed verbatim, and analyzed using thematic analysis. Barriers to the implementation of PATHway were also explored specifically in relation to physical capability and safety as well as technology readiness and further mapped onto the COM-B model for future intervention design. Results: Key recommendations included collection of patient data and use of measurements, harnessing hospital based social connections, and advice to utilize a patient-centered approach with personalization and tailoring to facilitate optimal engagement. Conclusions: In summary, a multifaceted, personalizable intervention with an inclusively designed interface was deemed desirable for use among cardiovascular disease patients both by end users and key stakeholders. In-depth understanding of core needs of the population can aid intervention development and acceptability. ", doi="10.2196/jmir.9181", url="http://www.jmir.org/2018/5/e163/", url="http://www.ncbi.nlm.nih.gov/pubmed/29739740" } @Article{info:doi/10.2196/formative.9550, author="Duff, Orlaith and Walsh, Deirdre and Malone, Shauna and McDermott, Lauri and Furlong, Brona and O'Connor, Noel and Moran, Kieran and Woods, Catherine", title="MedFit App, a Behavior-Changing, Theoretically Informed Mobile App for Patient Self-Management of Cardiovascular Disease: User-Centered Development", journal="JMIR Formativ Res", year="2018", month="Apr", day="27", volume="2", number="1", pages="e8", keywords="app development", keywords="cardiac rehabilitation", keywords="telemedicine", keywords="exercise", keywords="mHealth", keywords="focus groups", keywords="usability testing", abstract="Background: The MedFit app is designed to facilitate participation of people with cardiovascular disease (CVD) in an exercise-based rehabilitation program remotely. This paper details the development for the MedFit app. Objective: The aim of this research was to develop a behavior change, theoretically informed exercise rehabilitation mobile app for adults with CVD by following the early stages of the formative research: development and feasibility testing. Methods: Adhering to the mobile health (mHealth) development evaluation framework, the stages of the formative research process including (1) development and (2) feasibility were undertaken. The content and format of the MedFit app were developed based on (1) theory, (2) usability testing, and (3) content design. Results: A systematic review of the literature was undertaken to identify the most appropriate theories from which to develop the app. This led to the creation of the MedFit app. The app went through iterative rounds of usability focus group testing with adults with CVD to provide feedback on the app. This process was framed by the unified theory of acceptance and use of technology model. Feedback was then translated into feasible technical improvements to be executed through close collaboration with the technical team, who adapted and made modifications to the app based on this codesign process. Conclusions: The formative research process of the app development involved theoretical underpinning, usability testing, and content design. mHealth interventions may play a key role in the future of health care, potentially addressing the barriers to participation in cardiac rehabilitation. This work will provide guidance for future research aiming to develop mobile apps by incorporating a best practice framework for mHealth intervention development and a user-centered design approach. ", doi="10.2196/formative.9550", url="http://formative.jmir.org/2018/1/e8/", url="http://www.ncbi.nlm.nih.gov/pubmed/30684426" } @Article{info:doi/10.2196/cardio.9000, author="Baek, Hyunyoung and Suh, Jung-Won and Kang, Si-Hyuck and Kang, Seungjin and Lim, Ho Tae and Hwang, Hee and Yoo, Sooyoung", title="Enhancing User Experience Through User Study: Design of an mHealth Tool for Self-Management and Care Engagement of Cardiovascular Disease Patients", journal="JMIR Cardio", year="2018", month="Feb", day="09", volume="2", number="1", pages="e3", keywords="cardiovascular disease", keywords="mHealth", keywords="mobile application", keywords="app", keywords="user-centered design", abstract="Background: As patient communication, engagement, personal health data tracking, and up-to-date information became more efficient through mobile health (mHealth), cardiovascular diseases (CVD) and other diseases that require behavioral improvements in daily life are now capable of being managed and prevented more effectively. However, to increase patient engagement through mHealth, it is important for the initial design to consider functionality and usability factors and accurately assess user demands during the developmental process so that the app can be used continuously. Objective: The purpose of the study was to provide insightful information for developing mHealth service for patients with CVD based on user research to help enhance communication between patients and doctors. Methods: To drive the mobile functions and services needed to manage diseases in CVD patients, user research was conducted on patients and doctors at a tertiary general university hospital located in the Seoul metropolitan area of South Korea. Interviews and a survey were performed on patients (35 participants) and a focus group interview was conducted with doctors (5 participants). A mock-up mobile app was developed based on the user survey results, and a usability test was then conducted (8 participants) to identify factors that should be considered to improve usability. Results: The majority of patients showed a positive response in terms of their interest or intent to use an app for managing CVD. Functional features, such as communication with doctors, self-risk assessment, exercise, tailored education, blood pressure management, and health status recording had a score of 4.0 or higher on a 5-point Likert scale, showing that these functions were perceived to be useful to patients. The results of the mock-up usability test showed that inputting and visualizing blood pressure and other health conditions was required to be easier. The doctors requested a function that offered a comprehensive view of the patient's daily health status by linking the mHealth app data with the hospital's electronic health record system. Conclusions: Insights derived from a user study for developing an mHealth tool for CVD management, such as self-assessment and a communication channel between patients and doctors, may be helpful to improve patient engagement in care. ", doi="10.2196/cardio.9000", url="http://cardio.jmir.org/2018/1/e3/", url="http://www.ncbi.nlm.nih.gov/pubmed/31758783" } @Article{info:doi/10.2196/resprot.8406, author="Habibovi{\'c}, Mirela and Broers, Eva and Piera-Jimenez, Jordi and Wetzels, Mart and Ayoola, Idowu and Denollet, Johan and Widdershoven, Jos", title="Enhancing Lifestyle Change in Cardiac Patients Through the Do CHANGE System (``Do Cardiac Health: Advanced New Generation Ecosystem''): Randomized Controlled Trial Protocol", journal="JMIR Res Protoc", year="2018", month="Feb", day="08", volume="7", number="2", pages="e40", keywords="cardiac health", keywords="lifestyle", keywords="behavior change", keywords="eHealth", keywords="mHealth", abstract="Background: Promoting a healthy lifestyle (eg, physical activity, healthy diet) is crucial for the primary and secondary prevention of cardiac disease in order to decrease disease burden and mortality. Objective: The current trial aims to evaluate the effectiveness of the Do Cardiac Health: Advanced New Generation Ecosystem (Do CHANGE) service, which is developed to assist cardiac patients in adopting a healthy lifestyle and improving their quality of life. Methods: Cardiac patients (ie, people who have been diagnosed with heart failure, coronary artery disease, and/or hypertension) will be recruited at three pilot sites (Badalona Serveis Assistencials, Badalona, Spain [N=75]; Buddhist Tzu Chi Dalin General Hospital, Dalin, Taiwan [N=100] and Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands [N=75]). Patients will be assisted by the Do Something Different (DSD) program to change their unhealthy habits and/or lifestyle. DSD has been developed to increase behavioral flexibility and subsequently adopt new (healthier) habits. In addition, patients' progress will be monitored with a number of (newly developed) devices (eg, Fitbit, Beddit, COOKiT, FLUiT), which will be integrated in one application. Results: The Do CHANGE trial will provide us with new insights regarding the effectiveness of the proposed intervention in different cultural settings. In addition, it will give insight into what works for whom and why. Conclusions: The Do CHANGE service integrates new technologies into a behavior change intervention in order to change the unhealthy lifestyles of cardiac patients. The program is expected to facilitate long-term, sustainable behavioral change. Trial Registration: Clinicaltrials.gov NCT03178305; https://clinicaltrials.gov/ct2/show/NCT03178305 (Archived by WebCite at http://www.webcitation.org/6wfWHvuyU). ", doi="10.2196/resprot.8406", url="http://www.researchprotocols.org/2018/2/e40/", url="http://www.ncbi.nlm.nih.gov/pubmed/29422454" } @Article{info:doi/10.2196/jmir.7558, author="Partridge, R. Stephanie and Gallagher, Patrick and Freeman, Becky and Gallagher, Robyn", title="Facebook Groups for the Management of Chronic Diseases", journal="J Med Internet Res", year="2018", month="Jan", day="17", volume="20", number="1", pages="e21", keywords="social media, prevention, intervention, Facebook", doi="10.2196/jmir.7558", url="http://www.jmir.org/2018/1/e21/", url="http://www.ncbi.nlm.nih.gov/pubmed/29343460" } @Article{info:doi/10.2196/mhealth.8873, author="Marcolino, Soriano Milena and Oliveira, Queiroz Jo{\~a}o Antonio and D'Agostino, Marcelo and Ribeiro, Luiz Antonio and Alkmim, Moreira Maria Beatriz and Novillo-Ortiz, David", title="The Impact of mHealth Interventions: Systematic Review of Systematic Reviews", journal="JMIR Mhealth Uhealth", year="2018", month="Jan", day="17", volume="6", number="1", pages="e23", keywords="telemedicine", keywords="medical informatics", keywords="mobile phones", abstract="Background: Mobile phone usage has been rapidly increasing worldwide. mHealth could efficiently deliver high-quality health care, but the evidence supporting its current effectiveness is still mixed. Objective: We performed a systematic review of systematic reviews to assess the impact or effectiveness of mobile health (mHealth) interventions in different health conditions and in the processes of health care service delivery. Methods: We used a common search strategy of five major scientific databases, restricting the search by publication date, language, and parameters in methodology and content. Methodological quality was evaluated using the Measurement Tool to Assess Systematic Reviews (AMSTAR) checklist. Results: The searches resulted in a total of 10,689 articles. Of these, 23 systematic reviews (371 studies; more than 79,665 patients) were included. Seventeen reviews included studies performed in low- and middle-income countries. The studies used diverse mHealth interventions, most frequently text messaging (short message service, SMS) applied to different purposes (reminder, alert, education, motivation, prevention). Ten reviews were rated as low quality (AMSTAR score 0-4), seven were rated as moderate quality (AMSTAR score 5-8), and six were categorized as high quality (AMSTAR score 9-11). A beneficial impact of mHealth was observed in chronic disease management, showing improvement in symptoms and peak flow variability in asthma patients, reducing hospitalizations and improving forced expiratory volume in 1 second; improving chronic pulmonary diseases symptoms; improving heart failure symptoms, reducing deaths and hospitalization; improving glycemic control in diabetes patients; improving blood pressure in hypertensive patients; and reducing weight in overweight and obese patients. Studies also showed a positive impact of SMS reminders in improving attendance rates, with a similar impact to phone call reminders at reduced cost, and improved adherence to tuberculosis and human immunodeficiency virus therapy in some scenarios, with evidence of decrease of viral load. Conclusions: Although mHealth is growing in popularity, the evidence for efficacy is still limited. In general, the methodological quality of the studies included in the systematic reviews is low. For some fields, its impact is not evident, the results are mixed, or no long-term studies exist. Exceptions include the moderate quality evidence of improvement in asthma patients, attendance rates, and increased smoking abstinence rates. Most studies were performed in high-income countries, implying that mHealth is still at an early stage of development in low-income countries. ", doi="10.2196/mhealth.8873", url="http://mhealth.jmir.org/2018/1/e23/", url="http://www.ncbi.nlm.nih.gov/pubmed/29343463" } @Article{info:doi/10.2196/mhealth.8549, author="Xie, Bo and Su, Zhaohui and Zhang, Wenhui and Cai, Run", title="Chinese Cardiovascular Disease Mobile Apps' Information Types, Information Quality, and Interactive Functions for Self-Management: Systematic Review", journal="JMIR Mhealth Uhealth", year="2017", month="Dec", day="14", volume="5", number="12", pages="e195", keywords="mobile health", keywords="mHealth", keywords="cardiovascular disease", keywords="CVD", keywords="patient preferences", keywords="information quality", keywords="self-management", keywords="mobile applications", keywords="mobile apps", keywords="China", abstract="Background: China has a large population with cardiovascular disease (CVD) that requires extensive self-management. Mobile health (mHealth) apps may be a useful tool for CVD self-management. Little is currently known about the types and quality of health information provided in Chinese CVD mobile apps and whether app functions are conducive to promoting CVD self-management. Objective: We undertook a systematic review to evaluate the types and quality of health information provided in Chinese CVD mobile apps and interactive app functions for promoting CVD self-management. Methods: Mobile apps targeting end users in China with CVD conditions were selected in February 2017 through a multi-stage process. Three frameworks were used to evaluate the selected apps: (1) types of health information offered were assessed using our Health Information Wants framework, which encompasses 7 types of information; (2) quality of information provided in the apps was assessed using the 11 guidelines recommended by the National Library of Medicine of the National Institutes of Health; and (3) types of interactive app functions for CVD self-management were assessed using a 15-item framework adapted from the literature, including our own prior work. Results: Of 578 apps identified, 82 were eligible for final review. Among these, information about self-care (67/82, 82\%) and information specifically regarding CVD (63/82, 77\%) were the most common types of information provided, while information about health care providers (22/82, 27\%) and laboratory tests (5/82, 6\%) were least common. The most common indicators of information quality were the revealing of apps' providers (82/82, 100\%) and purpose (82/82, 100\%), while the least common quality indicators were the revealing of how apps' information was selected (1/82, 1\%) and app sponsorship (0/82, 0\%). The most common interactive functions for CVD self-management were those that enabled user interaction with the app provider (57/82, 70\%) and with health care providers (36/82, 44\%), while the least common interactive functions were those that enabled lifestyle management (13/82, 16\%) and psychological health management (6/82, 7\%). None of the apps covered all 7 types of health information, all 11 indicators of information quality, or all 15 interactive functions for CVD self-management. Conclusions: Chinese CVD apps are insufficient in providing comprehensive health information, high-quality information, and interactive functions to facilitate CVD self-management. End users should exercise caution when using existing apps. Health care professionals and app developers should collaborate to better understand end users' preferences and follow evidence-based guidelines to develop mHealth apps conducive to CVD self-management. ", doi="10.2196/mhealth.8549", url="http://mhealth.jmir.org/2017/12/e195/", url="http://www.ncbi.nlm.nih.gov/pubmed/29242176" } @Article{info:doi/10.2196/cardio.8543, author="Magnani, W. Jared and Schlusser, L. Courtney and Kimani, Everlyne and Rollman, L. Bruce and Paasche-Orlow, K. Michael and Bickmore, W. Timothy", title="The Atrial Fibrillation Health Literacy Information Technology System: Pilot Assessment", journal="JMIR Cardio", year="2017", month="Dec", day="12", volume="1", number="2", pages="e7", keywords="atrial fibrillation", keywords="mHealth", keywords="health-related quality of life", keywords="medication adherence", abstract="Background: Atrial fibrillation (AF) is a highly prevalent heart rhythm condition that has significant associated morbidity and requires chronic treatment. Mobile health (mHealth) technologies have the potential to enhance multiple aspects of AF care, including education, monitoring of symptoms, and encouraging and tracking medication adherence. We have previously implemented and tested relational agents to improve outcomes in chronic disease and sought to develop a smartphone-based relational agent for improving patient-centered outcomes in AF. Objective: The objective of this study was to pilot a smartphone-based relational agent as preparation for a randomized clinical trial, the Atrial Fibrillation Health Literacy Information Technology Trial (AF-LITT). Methods: We developed the relational agent for use by a smartphone consistent with our prior approaches. We programmed the relational agent as a computer-animated agent to simulate a face-to-face conversation and to serve as a health counselor or coach specific to AF. Relational agent's dialogue content, informed by a review of literature, focused on patient-centered domains and qualitative interviews with patients with AF, encompassed AF education, common symptoms, adherence challenges, and patient activation. We established that the content was accessible to individuals with limited health or computer literacy. Relational agent content coordinated with use of the smartphone AliveCor Kardia heart rate and rhythm monitor. Participants (N=31) were recruited as a convenience cohort from ambulatory clinical sites and instructed to use the relational agent and Kardia for 30 days. We collected demographic, social, and clinical characteristics and conducted baseline and 30-day assessments of health-related quality of life (HRQoL) with the Atrial Fibrillation Effect on Quality of life (AFEQT) measure; self-reported medication adherence with the Morisky 8-item Medication Adherence Scale (MMAS-8); and patient activation with the Patient Activation Measure (PAM). Results: Participants (mean age 68 [SD 11]; 39\% [12/31] women) used the relational agent for an average 17.8 (SD 10.0) days. The mean number of independent log-ins was 19.6 (SD 10.7), with a median of 20 times over 30 days. The mean number of Kardia uses was 26.5 (SD 5.9), and participants using Kardia were in AF for 14.3 (SD 11.0) days. AFEQT scores improved significantly from 64.5 (SD 22.9) at baseline to 76.3 (SD 19.4) units at 30 days (P<.01). We observed marginal but statistically significant improvement in self-reported medication adherence (baseline: 7.3 [SD 0.9], 30 days: 7.7 [SD 0.5]; P=.01). Assessments of acceptability identified that most of the participants found the relational agent useful, informative, and trustworthy. Conclusions: We piloted a 30-day smartphone-based intervention that combined a relational agent with dedicated content for AF alongside Kardia heart rate and rhythm monitoring. Pilot participants had favorable improvements in HRQoL and self-reported medication adherence, as well as positive responses to the intervention. These data will guide a larger, enhanced randomized trial implementing the smartphone relational agent and the Kardia monitor system. ", doi="10.2196/cardio.8543", url="http://cardio.jmir.org/2017/2/e7/", url="http://www.ncbi.nlm.nih.gov/pubmed/29473644" } @Article{info:doi/10.2196/medinform.6603, author="Mileski, Michael and Kruse, Scott Clemens and Catalani, Justin and Haderer, Tara", title="Adopting Telemedicine for the Self-Management of Hypertension: Systematic Review", journal="JMIR Med Inform", year="2017", month="Oct", day="24", volume="5", number="4", pages="e41", keywords="hypertension", keywords="telemedicine", keywords="eHealth", keywords="mHealth", keywords="disease management", abstract="Background: Hypertension is a chronic condition that affects adults of all ages. In the United States, 1 in 3 adults has hypertension, and about half of the hypertensive population is adequately controlled. This costs the nation US \$46 billion each year in health care services and medications required for treatment and missed workdays. Finding easier ways of managing this condition is key to successful treatment. Objective: A solution to reduce visits to physicians for chronic conditions is to utilize telemedicine. Research is limited on the effects of utilizing telemedicine in health care facilities. There are potential benefits for implementing telemedicine programs with patients dealing with chronic conditions. The purpose of this review was to weigh the facilitators against the barriers for implementing telemedicine. Methods: Searches were methodically conducted in the Cumulative Index to Nursing and Allied Health Literature Complete (CINAHL Complete) via Elton B Stephens Company (EBSCO) and PubMed (which queries MEDLINE) to collect information about self-management of hypertension through the use of telemedicine. Results: Results identify facilitators and barriers corresponding to the implementation of self-management of hypertension using telemedicine. The most common facilitators include increased access, increase in health and quality, patient knowledge and involvement, technology growth with remote monitoring, cost-effectiveness, and increased convenience/ease. The most prevalent barriers include lack of evidence, self-management difficult to maintain, no long-term results/more areas to address, and long-term added workload commitment. Conclusions: This review guides health care professionals in incorporating new practices and identifying the best methods to introduce telemedicine into their practices. Understanding the facilitators and barriers to implementation is important, as is understanding how these factors will impact a successful implementation of telemedicine in the area of self-management of hypertension. ", doi="10.2196/medinform.6603", url="http://medinform.jmir.org/2017/4/e41/", url="http://www.ncbi.nlm.nih.gov/pubmed/29066424" } @Article{info:doi/10.2196/jmir.7697, author="Usher-Smith, A. Juliet and Winther, R. Laura and Shefer, S. Guy and Silarova, Barbora and Payne, A. Rupert and Griffin, J. Simon", title="Factors Associated With Engagement With a Web-Based Lifestyle Intervention Following Provision of Coronary Heart Disease Risk: Mixed Methods Study", journal="J Med Internet Res", year="2017", month="Oct", day="16", volume="19", number="10", pages="e351", keywords="Web-based intervention", keywords="cardiovascular disease", keywords="engagement", keywords="risk", keywords="qualitative research", abstract="Background: Web-based interventions provide the opportunity to combine the tailored approach of face-to-face interventions with the scalability and cost-effectiveness of public health interventions. This potential is often limited by low engagement. A number of studies have described the characteristics of individuals who engage more in Web-based interventions but few have explored the reasons for these variations. Objective: We aimed to explore individual-level factors associated with different degrees of engagement with a Web-based behavior change intervention following provision of coronary heart disease (CHD) risk information, and the barriers and facilitators to engagement. Methods: This study involved the secondary analysis of data from the Information and Risk Modification Trial, a randomized controlled trial of a Web-based lifestyle intervention alone, or alongside information on estimated CHD risk. The intervention consisted of three interactive sessions, each lasting up to 60 minutes, delivered at monthly intervals. Participants were characterized as high engagers if they completed all three sessions. Thematic analysis of qualitative data from interviews with 37 participants was combined with quantitative data on usage of the Web-based intervention using a mixed-methods matrix, and data on the views of the intervention itself were analyzed across all participants. Results: Thirteen participants were characterized as low engagers and 24 as high engagers. There was no difference in age (P=.75), gender (P=.95), or level of risk (P=.65) between the groups. Low engagement was more often associated with: (1) reporting a negative emotional reaction in response to the risk score (P=.029), (2) perceiving that the intervention did not provide any new lifestyle information (P=.011), and (3) being less likely to have reported feeling an obligation to complete the intervention as part of the study (P=.019). The mixed-methods matrix suggested that there was also an association between low engagement and less success with previous behavior change attempts, but the statistical evidence for this association was weak (P=.16). No associations were seen between engagement and barriers or facilitators to health behavior change, or comments about the design of the intervention itself. The most commonly cited barriers related to issues with access to the intervention itself: either difficulties remembering the link to the site or passwords, a perceived lack of flexibility within the website, or lack of time. Facilitators included the nonjudgmental presentation of lifestyle information, the use of simple language, and the personalized nature of the intervention. Conclusions: This study shows that the level of engagement with a Web-based intervention following provision of CHD risk information is not influenced by the level of risk but by the individual's response to the risk information, their past experiences of behavior change, the extent to which they consider the lifestyle information helpful, and whether they felt obliged to complete the intervention as part of a research study. A number of facilitators and barriers to Web-based interventions were also identified, which should inform future interventions. ", doi="10.2196/jmir.7697", url="http://www.jmir.org/2017/10/e351/", url="http://www.ncbi.nlm.nih.gov/pubmed/29038095" } @Article{info:doi/10.2196/jmir.8081, author="Partridge, R. Stephanie and Grunseit, C. Anne and Gallagher, Patrick and Freeman, Becky and O'Hara, J. Blythe and Neubeck, Lis and Due, Sarah and Paull, Glenn and Ding, Ding and Bauman, Adrian and Phongsavan, Philayrath and Roach, Kellie and Sadler, Leonie and Glinatsis, Helen and Gallagher, Robyn", title="Cardiac Patients' Experiences and Perceptions of Social Media: Mixed-Methods Study", journal="J Med Internet Res", year="2017", month="Sep", day="15", volume="19", number="9", pages="e323", keywords="cardiovascular disease", keywords="cardiac rehabilitation", keywords="qualitative research", keywords="secondary prevention", keywords="social media", abstract="Background: Traditional in-person cardiac rehabilitation has substantial benefits for cardiac patients, which are offset by poor attendance. The rapid increase in social media use in older adults provides an opportunity to reach patients who are eligible for cardiac rehabilitation but unable to attend traditional face-to-face groups. However, there is a paucity of research on cardiac patients' experiences and perspectives on using social media to support their health. Objective: The aim of this study was to describe cardiac rehabilitation patients' experiences in using social media in general and their perspective on using social media, particularly Facebook, to support their cardiac health and secondary prevention efforts. Methods: A mixed-methods study was undertaken among cardiac rehabilitation patients in both urban and rural areas. First, this study included a survey (n=284) on social media use and capability. Second, six focus group interviews were conducted with current Facebook users (n=18) to elucidate Facebook experience and perspectives. Results: Social media use was low (28.0\%, 79/282) but more common in participants who were under 70 years of age, employed, and had completed high school. Social media users accessed Web-based information on general health issues (65\%, 51/79), medications (56\%, 44/79), and heart health (43\%, 34/79). Participants were motivated to invest time in using Facebook for ``keeping in touch'' with family and friends and to be informed by expert cardiac health professionals and fellow cardiac participants if given the opportunity. It appeared that participants who had a higher level of Facebook capability (understanding of features and the consequences of their use and efficiency in use) spent more time on Facebook and reported higher levels of ``liking,'' commenting, or sharing posts. Furthermore, higher Facebook capability appeared to increase a participants' willingness to participate in a cardiac Facebook support group. More capable users were more receptive to the use of Facebook for cardiac rehabilitation and more likely to express interest in providing peer support. Recommended features for a cardiac rehabilitation Facebook group included a closed group, expert cardiac professional involvement, provision of cardiac health information, and ensuring trustworthiness of the group. Conclusions: Cardiac health professionals have an opportunity to capitalize on cardiac patients' motivations and social media, mostly Facebook, as well as the capability for supporting cardiac rehabilitation and secondary prevention. Participants' favored purposeful time spent on Facebook and their cardiac health provides such a purpose for a Facebook intervention. The study results will inform the development of a Facebook intervention for secondary prevention of cardiovascular disease. ", doi="10.2196/jmir.8081", url="http://www.jmir.org/2017/9/e323/", url="http://www.ncbi.nlm.nih.gov/pubmed/28916507" } @Article{info:doi/10.2196/cardio.7342, author="Cossette, Sylvie and C{\^o}t{\'e}, Jos{\'e} and Rouleau, Genevi{\`e}ve and Robitaille, Marie and Heppell, Sonia and Mailhot, Tanya and Fontaine, Guillaume and Cournoyer, Catherine and Gagnon, Marie-Pierre and Gallani, Maria-Cecilia and Tanguay, Jean-Francois and Dupuis, Jocelyn and Nigam, Anil and Guertin, Marie-Claude", title="A Web-Based Tailored Intervention to Support Illness Management in Patients With an Acute Coronary Syndrome: Pilot Study", journal="JMIR Cardio", year="2017", month="Sep", day="06", volume="1", number="2", pages="e4", keywords="nursing informatics", keywords="health behavior", keywords="self-care", keywords="acute coronary syndrome", keywords="pilot study", abstract="Background: Illness management after an acute coronary syndrome (ACS) is crucial to prevent cardiac complications, to foster participation in a cardiac rehabilitation (CR) program, and to optimize recovery. Web-based tailored interventions have the potential to provide individualized information and counseling to optimize patient's illness management after hospital discharge. Objective: We aimed to assess the feasibility and acceptability of a Web-based tailored intervention (TAVIE@COEUR) designed to improve illness management in patients hospitalized for an ACS. Illness management outcomes were operationalized by self-care, medication adherence, anxiety management, cardiac risk factors reduction, and enrollment in a CR program. Methods: This posttest pilot study was conducted with one group (N=30) of patients hospitalized for an ACS on the coronary care unit of a tertiary cardiology center. TAVIE@COEUR comprises three Web-based sessions, with a duration ranging from 10 to 45 min and is structured around an algorithm to allow the tailoring of the intervention to different pathways according to patients' responses to questions. TAVIE@COEUR includes 90 pages, 85 videos, and 47 PDF documents divided across session 1 (S1), session 2 (S2), and session 3 (S3). These sessions concern self-care and self-observation skills related to medication-taking (S1), emotional control and problem-solving skills (S2), and social skills and interacting with health professionals (S3). Throughout the videos, a virtual nurse (providing the intervention virtually) guides the participants in the acquisition of self-care skills. Patients completed S1 of TAVIE@COEUR before hospital discharge and were asked to complete S2 and S3 within 2 weeks after discharge. Feasibility indicators were extracted from the TAVIE@COEUR system. Data regarding acceptability (satisfaction and appreciation of the platform) and preliminary effect (self-care, medication adherence, anxiety management, risk factor reduction, and CR enrollment) were assessed through questionnaires at 1 month following discharge. Preliminary effect was assessed by comparing baseline and 1-month illness management variables. Results: Of the 30 participants, 20 completed S1, 10 completed S2, and 5 completed S3. Good acceptability scores were observed for ease of navigation (mean=3.58, standard deviation [SD]=0.70; scale=0-4), ease of understanding (mean=3.46, SD=0.63; scale=0-4), and applicability (mean=3.55, SD=0.74; scale=0-4). The lowest acceptability scores were observed for information tailoring (mean=2.93, SD=0.68; scale=0-4) and individual relevance (mean=2.56, SD=0.96; scale=0-4). With regard to preliminary effect, we observed an overall self-care at 1 month following discharge score higher than at baseline (mean at 1 month=54.07, SD=3.99 vs mean at baseline=49.09, SD=6.92; scale-0-60). Conclusions: Although participants reported general satisfaction and appreciation of TAVIE@COEUR, acceptability and feasibility results show the need for further development of the Web-based intervention to enhance its tailoring before undertaking a full-fledged randomized controlled trial. This may be accomplished by optimizing the adaptability of TAVIE@COEUR to patients' knowledge, needs, interests, individual capabilities, and emotional and cognitive responses during session completion. ", doi="10.2196/cardio.7342", url="http://cardio.jmir.org/2017/2/e4/", url="http://www.ncbi.nlm.nih.gov/pubmed/31758758" } @Article{info:doi/10.2196/cardio.7848, author="Athilingam, Ponrathi and Jenkins, Bradlee and Johansson, Marcia and Labrador, Miguel", title="A Mobile Health Intervention to Improve Self-Care in Patients With Heart Failure: Pilot Randomized Control Trial", journal="JMIR Cardio", year="2017", month="Aug", day="11", volume="1", number="2", pages="e3", keywords="heart failure", keywords="mobile applications", keywords="self-care", keywords="quality of life", abstract="Background: Heart failure (HF) is a progressive chronic disease affecting 6.5 million Americans and over 15 million individuals globally. Patients with HF are required to engage in complex self-care behaviors. Although the advancements in medicine have enabled people with HF to live longer, they often have poor health-related quality of life and experience severe and frequent symptoms that limit several aspects of their lives. Mobile phone apps have not only created new and interactive ways of communication between patients and health care providers but also provide a platform to enhance adherence to self-care management. Objective: The aim of this pilot study was to test the feasibility of a newly developed mobile app (HeartMapp) in improving self-care behaviors and quality of life of patients with HF and to calculate effect sizes for sample size calculation for a larger study. Methods: This was a pilot feasibility randomized controlled trial. Participants were enrolled in the hospital before discharge and followed at home for 30 days. The intervention group used HeartMapp (n=9), whereas the control group (n=9) received HF education. These apps were downloaded onto their mobile phones for daily use. Results: A total of 72\% (13/18) participants completed the study; the mean age of the participants was 53 (SD 4.02) years, 56\% (10/18) were females, 61\% (11/18) lived alone, 33\% (6/18) were African Americans, and 61\% (11/18) used mobile phone to get health information. The mean engagement with HeartMapp was 78\%. Results were promising with a trend that participants in the HeartMapp group had a significant mean score change on self-care management (8.7 vs 2.3; t3.38=11, P=.01), self-care confidence (6.7 vs 1.8; t2.53=11, P=.28), and HF knowledge (3 vs ?0.66; t2.37=11, P=.04. Depression improved among both groups, more so in the control group (?1.14 vs ?5.17; t1.97=11, P=.07). Quality of life declined among both groups, more so in the control group (2.14 vs 9.0; t?1.43=11, P=.18). Conclusions: The trends demonstrated in this pilot feasibility study warrant further exploration on the use of HeartMapp to improve HF outcomes. Trial Registration: Pilot study, no funding from National agencies, hence not registered. ", doi="10.2196/cardio.7848", url="http://cardio.jmir.org/2017/2/e3/", url="http://www.ncbi.nlm.nih.gov/pubmed/31758759" } @Article{info:doi/10.2196/jmir.4944, author="Pfaeffli Dale, Leila and Whittaker, Robyn and Jiang, Yannan and Stewart, Ralph and Rolleston, Anna and Maddison, Ralph", title="Text Message and Internet Support for Coronary Heart Disease Self-Management: Results From the Text4Heart Randomized Controlled Trial", journal="J Med Internet Res", year="2015", month="Oct", day="21", volume="17", number="10", pages="e237", keywords="text messaging", keywords="mHealth", keywords="cellular phone", keywords="cardiovascular diseases", keywords="intervention", keywords="lifestyle change", keywords="behavior", abstract="Background: Mobile technology has the potential to deliver behavior change interventions (mHealth) to reduce coronary heart disease (CHD) at modest cost. Previous studies have focused on single behaviors; however, cardiac rehabilitation (CR), a component of CHD self-management, needs to address multiple risk factors. Objective: The aim was to investigate the effectiveness of a mHealth-delivered comprehensive CR program (Text4Heart) to improve adherence to recommended lifestyle behaviors (smoking cessation, physical activity, healthy diet, and nonharmful alcohol use) in addition to usual care (traditional CR). Methods: A 2-arm, parallel, randomized controlled trial was conducted in New Zealand adults diagnosed with CHD. Participants were recruited in-hospital and were encouraged to attend center-based CR (usual care control). In addition, the intervention group received a personalized 24-week mHealth program, framed in social cognitive theory, sent by fully automated daily short message service (SMS) text messages and a supporting website. The primary outcome was adherence to healthy lifestyle behaviors measured using a self-reported composite health behavior score (?3) at 3 and 6 months. Secondary outcomes included clinical outcomes, medication adherence score, self-efficacy, illness perceptions, and anxiety and/or depression at 6 months. Baseline and 6-month follow-up assessments (unblinded) were conducted in person. Results: Eligible patients (N=123) recruited from 2 large metropolitan hospitals were randomized to the intervention (n=61) or the control (n=62) group. Participants were predominantly male (100/123, 81.3\%), New Zealand European (73/123, 59.3\%), with a mean age of 59.5 (SD 11.1) years. A significant treatment effect in favor of the intervention was observed for the primary outcome at 3 months (AOR 2.55, 95\% CI 1.12-5.84; P=.03), but not at 6 months (AOR 1.93, 95\% CI 0.83-4.53; P=.13). The intervention group reported significantly greater medication adherence score (mean difference: 0.58, 95\% CI 0.19-0.97; P=.004). The majority of intervention participants reported reading all their text messages (52/61, 85\%). The number of visits to the website per person ranged from zero to 100 (median 3) over the 6-month intervention period. Conclusions: A mHealth CR intervention plus usual care showed a positive effect on adherence to multiple lifestyle behavior changes at 3 months in New Zealand adults with CHD compared to usual care alone. The effect was not sustained to the end of the 6-month intervention. A larger study is needed to determine the size of the effect in the longer term and whether the change in behavior reduces adverse cardiovascular events. Trial Registration: ACTRN 12613000901707; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364758\&isReview=true (Archived by WebCite at http://www.webcitation.org/6c4qhcHKt) ", doi="10.2196/jmir.4944", url="http://www.jmir.org/2015/10/e237/", url="http://www.ncbi.nlm.nih.gov/pubmed/26490012" } @Article{info:doi/10.2196/jmir.3434, author="Schweier, Rebecca and Romppel, Matthias and Richter, Cynthia and Hoberg, Eike and Hahmann, Harry and Scherwinski, Inge and Kosm{\"u}tzky, Gregor and Grande, Gesine", title="A Web-Based Peer-Modeling Intervention Aimed at Lifestyle Changes in Patients With Coronary Heart Disease and Chronic Back Pain: Sequential Controlled Trial", journal="J Med Internet Res", year="2014", month="Jul", day="23", volume="16", number="7", pages="e177", keywords="coronary artery disease", keywords="lifestyle", keywords="health behavior", keywords="back pain", keywords="personal narratives as topic", keywords="Internet", keywords="diet", keywords="exercise", keywords="Web-based intervention", abstract="Background: Traditional secondary prevention programs often fail to produce sustainable behavioral changes in everyday life. Peer-modeling interventions and integration of peer experiences in health education are a promising way to improve long-term effects in behavior modification. However, effects of peer support modeling on behavioral change have not been evaluated yet. Therefore, we implemented and evaluated a website featuring patient narratives about successful lifestyle changes. Objective: Our aim is to examine the effects of using Web-based patient narratives about successful lifestyle change on improvements in physical activity and eating behavior for patients with coronary heart disease and chronic back pain 3 months after participation in a rehabilitation program. Methods: The lebensstil-aendern (``lifestyle-change'') website is a nonrestricted, no-cost, German language website that provides more than 1000 video, audio, and text clips from interviews with people with coronary heart disease and chronic back pain. To test efficacy, we conducted a sequential controlled trial and recruited patients with coronary heart disease and chronic back pain from 7 inpatient rehabilitation centers in Germany. The intervention group attended a presentation on the website; the control group did not. Physical activity and eating behavior were assessed by questionnaire during the rehabilitation program and 12 weeks later. Analyses were conducted based on an intention-to-treat and an as-treated protocol. Results: A total of 699 patients were enrolled and 571 cases were included in the analyses (control: n=313, intervention: n=258; female: 51.1\%, 292/571; age: mean 53.2, SD 8.6 years; chronic back pain: 62.5\%, 357/571). Website usage in the intervention group was 46.1\% (119/258). In total, 141 trial participants used the website. Independent t tests based on the intention-to-treat protocol only demonstrated nonsignificant trends in behavioral change related to physical activity and eating behavior. Multivariate regression analyses confirmed belonging to the intervention group was an independent predictor of self-reported improvements in physical activity regularity ($\beta$=.09, P=.03) and using less fat for cooking ($\beta$=.09, P=.04). In independent t tests based on the as-treated protocol, website use was associated with higher self-reported improvements in integrating physical activity into daily routine (d=0.22, P=.02), in physical activity regularity (d=0.23, P=.02), and in using less fat for cooking (d=0.21, P=.03). Multivariate regression analyses revealed that using the website at least 3 times was the only factor associated with improved lifestyle behaviors. Conclusions: Usage of the lebensstil-aendern website corresponds to more positive lifestyle changes. However, as-treated analyses do not allow for differentiating between causal effects and selection bias. Despite these limitations, the trial indicates that more than occasional website usage is necessary to reach dose-response efficacy. Therefore, future studies should concentrate on strategies to improve adherence to Web-based interventions and to encourage more frequent usage of these programs. ", doi="10.2196/jmir.3434", url="http://www.jmir.org/2014/7/e177/", url="http://www.ncbi.nlm.nih.gov/pubmed/25057119" }