@Article{info:doi/10.2196/25374, author="Ranta, Annemarei and Thompson, Stephanie and Harwood, Ngarongoa Matire Louise and Cadilhac, Ann-Michele Dominique and Barber, Alan Peter and Davis, John Alan and Gommans, Henry John and Fink, Newton John and McNaughton, Karel Harry and Denison, Hayley and Corbin, Marine and Feigin, Valery and Abernethy, Virginia and Levack, William and Douwes, Jeroen and Girvan, Jacqueline and Wilson, Andrew", title="Reducing Ethnic and Geographic Inequities to Optimise New Zealand Stroke Care (REGIONS Care): Protocol for a Nationwide Observational Study", journal="JMIR Res Protoc", year="2021", month="Jan", day="12", volume="10", number="1", pages="e25374", keywords="stroke", keywords="protocols", keywords="stroke units", keywords="rehabilitation", keywords="M?ori", keywords="Pacific people", keywords="health inequities", keywords="cost-efficacy", keywords="rural", keywords="observational study", abstract="Background: Stroke systems of care differ between larger urban and smaller rural settings and it is unclear to what extent this may impact on patient outcomes. Ethnicity influences stroke risk factors and care delivery as well as patient outcomes in nonstroke settings. Little is known about the impact of ethnicity on poststroke care, especially in M?ori and Pacific populations. Objective: Our goal is to describe the protocol for the Reducing Ethnic and Geographic Inequities to Optimise New Zealand Stroke Care (REGIONS Care) study. Methods: This large, nationwide observational study assesses the impact of rurality and ethnicity on best practice stroke care access and outcomes involving all 28 New Zealand hospitals caring for stroke patients, by capturing every stroke patient admitted to hospital during the 2017-2018 study period. In addition, it explores current access barriers through consumer focus groups and consumer, carer, clinician, manager, and policy-maker surveys. It also assesses the economic impact of care provided at different types of hospitals and to patients of different ethnicities and explores the cost-efficacy of individual interventions and care bundles. Finally, it compares manual data collection to routine health administrative data and explores the feasibility of developing outcome models using only administrative data and the cost-efficacy of using additional manually collected registry data. Regarding sample size estimates, in Part 1, Study A, 2400 participants are needed to identify a 10\% difference between up to four geographic subgroups at 90\% power with an $\alpha$ value of .05 and 10\% to 20\% loss to follow-up. In Part 1, Study B, a sample of 7645 participants was expected to include an estimated 850 M?ori and 419 Pacific patients and to provide over 90\% and over 80\% power, respectively. Regarding Part 2, 50\% of the patient or carer surveys, 40 provider surveys, and 10 focus groups were needed to achieve saturation of themes. The main outcome is the modified Rankin Scale (mRS) score at 3 months. Secondary outcomes include mRS scores; EQ-5D-3L (5-dimension, 3-level EuroQol questionnaire) scores; stroke recurrence; vascular events; death; readmission at 3, 6, and 12 months; cost of care; and themes around access barriers. Results: The study is underway, with national and institutional ethics approvals in place. A total of 2379 patients have been recruited for Part 1, Study A; 6837 patients have been recruited for Part 1, Study B; 10 focus groups have been conducted and 70 surveys have been completed in Part 2. Data collection has essentially been completed, including follow-up assessment; however, primary and secondary analyses, data linkage, data validation, and health economics analysis are still underway. Conclusions: The methods of this study may provide the basis for future epidemiological studies that will guide care improvements in other countries and populations. International Registered Report Identifier (IRRID): DERR1-10.2196/25374 ", doi="10.2196/25374", url="https://www.researchprotocols.org/2021/1/e25374", url="http://www.ncbi.nlm.nih.gov/pubmed/33433396" } @Article{info:doi/10.2196/20456, author="Kowalska, Ma?gorzata and G?ady?, Aleksandra and Kala?ska-?ukasik, Barbara and Gruz-Kwapisz, Monika and Wojakowski, Wojciech and Jadczyk, Tomasz", title="Readiness for Voice Technology in Patients With Cardiovascular Diseases: Cross-Sectional Study", journal="J Med Internet Res", year="2020", month="Dec", day="17", volume="22", number="12", pages="e20456", keywords="voice technology", keywords="smart speaker", keywords="acceptance", keywords="telehealth", keywords="cardiovascular diseases", keywords="chatbot", abstract="Background: The clinical application of voice technology provides novel opportunities in the field of telehealth. However, patients' readiness for this solution has not been investigated among patients with cardiovascular diseases (CVD). Objective: This paper aims to evaluate patients' anticipated experiences regarding telemedicine, including voice conversational agents combined with provider-driven support delivered by phone. Methods: A cross-sectional study enrolled patients with chronic CVD who were surveyed using a validated investigator-designed questionnaire combining 19 questions (eg, demographic data, medical history, preferences for using telehealth services). Prior to the survey, respondents were educated on the telemedicine services presented in the questionnaire while being assisted by a medical doctor. Responses were then collected and analyzed, and multivariate logistic regression was used to identify predictors of willingness to use voice technology. Results: In total, 249 patients (mean age 65.3, SD 13.8 years; 158 [63.5\%] men) completed the questionnaire, which showed good repeatability in the validation procedure. Of the 249 total participants, 209 (83.9\%) reported high readiness to receive services allowing for remote contact with a cardiologist (176/249, 70.7\%) and telemonitoring of vital signs (168/249, 67.5\%). The voice conversational agents combined with provider-driven support delivered by phone were shown to be highly anticipated by patients with CVD. The readiness to use telehealth was statistically higher in people with previous difficulties accessing health care (OR 2.920, 95\% CI 1.377-6.192) and was most frequent in city residents and individuals reporting a higher education level. The age and sex of the respondents did not impact the intention to use voice technology (P=.20 and P=.50, respectively). Conclusions: Patients with cardiovascular diseases, including both younger and older individuals, declared high readiness for voice technology. ", doi="10.2196/20456", url="http://www.jmir.org/2020/12/e20456/", url="http://www.ncbi.nlm.nih.gov/pubmed/33331824" } @Article{info:doi/10.2196/18716, author="Hou, Ying-Hui and Yang, Feng-Jung and Lai, I-Chun and Lin, Shih-Pi and Wan, TH Thomas and Chang, Ray-E", title="Effects of Erythropoietin Payment Policy on Cardiovascular Outcomes of Peritoneal Dialysis Patients: Observational Study", journal="JMIR Med Inform", year="2020", month="Dec", day="17", volume="8", number="12", pages="e18716", keywords="erythropoietin", keywords="cardiovascular disease", keywords="peritoneal dialysis", keywords="diabetes mellitus", abstract="Background: The change in the reimbursement policy of erythropoietin administration to patients receiving peritoneal dialysis by the Taiwan National Health Insurance (NHI) system provided a natural experimental venue to examine whether cardiovascular risk differs when maintaining the hematocrit (Hct) level below or above 30\%. Objective: The aim of this study was to analyze the impact of loosening the erythropoietin payment criteria for peritoneal dialysis patients on their cardiovascular outcomes. Methods: Two cohorts of incident peritoneal dialysis patients were identified according to the time before and after relaxation of the NHI's erythropoietin payment criteria, designated cohort 1 (n=1759) and cohort 2 (n=2981), respectively. The cohorts were matched according to propensity scores (1754 patients in each cohort) and then followed up for cardiovascular events, which were analyzed with Cox regressions. Results: For the composite cardiovascular endpoint, patients in cohort 2 had a significantly lower risk than those in cohort 1. However, subgroup analysis showed that this risk reduction was observed only in patients with diabetes. Conclusions: After loosening erythropoietin payment criteria, reduced cardiovascular risks were observed, particularly for patients with diabetes. These results indicate that it is crucial to maintain an Hct level above 30\% to reduce the cardiovascular risk in patients with diabetes undergoing peritoneal dialysis. ", doi="10.2196/18716", url="http://medinform.jmir.org/2020/12/e18716/", url="http://www.ncbi.nlm.nih.gov/pubmed/33331829" } @Article{info:doi/10.2196/18567, author="Bell Ngan, Williams and Essama Eno Belinga, Lawrence and Essam Nlo'o, Patrick Alain Serges and Roche, Frederic and Goethals, Luc and Mandengue, Honor{\'e} Samuel and Bongue, Bienvenu", title="Surveillance of Cardiovascular Risk Factors in the Fifth Military Sector Health Center, Ngaound{\'e}r{\'e}, Cameroon: Observational Study", journal="JMIR Form Res", year="2020", month="Nov", day="26", volume="4", number="11", pages="e18567", keywords="prevention", keywords="noncommunicable disease", keywords="cardiovascular diseases", keywords="cardiovascular risk", keywords="soldiers", abstract="Background: Noncommunicable diseases (NCDs) are the leading causes of death worldwide. They were responsible for 40 million of the 57 million deaths recorded worldwide in 2016. In Cameroon, epidemiological studies have been devoted to NCDs and their risk factors. However, none provides specific information on their extent or the distribution of their risk factors within the Cameroonian defense forces. Objective: The objective of our study was to assess the cardiovascular risk of a Cameroonian military population compared with that of its neighboring civilian population. Methods: We conducted a cross-sectional study that involved subjects aged 18 to 58 years, recruited from October 2017 to November 2018 at the Fifth Military Sector Health Center in Ngaound{\'e}r{\'e}, Cameroon. Data collection and assessment were done according to the World Health Organization (WHO)'s STEPS manual for surveillance of risk factors for chronic NCDs and the Alcohol Use Disorders Identification Test. Five cardiovascular risk factors were assessed: smoking, harmful alcohol consumption, obesity/overweight, hypertension, and diabetes. The risk was considered high in subjects with 3 or more of the factors. Univariate analysis and multivariate logistic regression were carried out according to their indications. Results: Our study sample of 566 participants included 295 soldiers and 271 civilians of the same age group (median age 32 years versus 33 years, respectively; P=.57). The military sample consisted of 31 officers and 264 noncommissioned officers (NCOs). Soldiers were more exposed to behavioral risk factors than civilians, with a prevalence of smoking of 13.9\% versus 4.4\% (P<.001) and excessive alcohol consumption of 61.7\% versus 14.8\% (P<.001). They also presented with a higher cardiovascular risk than civilians (odds ratio 2.7, 95\% CI 1.50-4.81; P<.001), and among the military participants, the cardiovascular risk was higher for officers than for NCOs (51.6\% versus 14.0\%, respectively; P<.001). Conclusions: Cameroonian soldiers are particularly exposed to cardiovascular behavioral risk factors and consequently are at higher risk of NCDs. Trial Registration: ClinicalTrials.gov NCT04315441; https://clinicaltrials.gov/ct2/show/NCT04315441 ", doi="10.2196/18567", url="http://formative.jmir.org/2020/11/e18567/", url="http://www.ncbi.nlm.nih.gov/pubmed/33242013" } @Article{info:doi/10.2196/21450, author="Brewer, C. LaPrincess and Kumbamu, Ashok and Smith, Christina and Jenkins, Sarah and Jones, Clarence and Hayes, N. Sharonne and Burke, Lora and Cooper, A. Lisa and Patten, A. Christi", title="A Cardiovascular Health and Wellness Mobile Health Intervention Among Church-Going African Americans: Formative Evaluation of the FAITH! App", journal="JMIR Form Res", year="2020", month="Nov", day="17", volume="4", number="11", pages="e21450", keywords="mobile health", keywords="eHealth", keywords="community-based participatory research", keywords="health promotion", keywords="African Americans", keywords="mobile phone", abstract="Background: In light of the scarcity of culturally tailored mobile health (mHealth) lifestyle interventions for African Americans, we designed and pilot tested the Fostering African-American Improvement in Total Health (FAITH!) App in a community-based participatory research partnership with African American churches to promote cardiovascular health and wellness in this population. Objective: This report presents the results of a formative evaluation of the FAITH! App from participants in an intervention pilot study. Methods: We included 2 semistructured focus groups (n=4 and n=5) to explore participants' views on app functionality, utility, and satisfaction as well as its impact on healthy lifestyle change. Sessions were audio-recorded and transcribed verbatim, and qualitative data were analyzed by using general inductive analysis to generate themes. Results: In total, 6 overarching themes emerged among the 9 participants: overall impression, content usefulness, formatting, implementation, impact, and suggestions for improvement. Underpinning the themes was a high level of agreement that the intervention facilitated healthy behavioral change through cultural tailoring, multimedia education modules, and social networking. Suggestions for improvement were streamlining the app self-monitoring features, prompts to encourage app use, and personalization based on individuals' cardiovascular risk. Conclusions: This formative evaluation found that the FAITH! App had high reported satisfaction and impact on the health-promoting behaviors of African Americans, thereby improving their overall cardiovascular health. Further development and testing of the app among African Americans is warranted. Trial Registration: ClinicalTrials.gov NCT03084822; https://clinicaltrials.gov/ct2/show/NCT03084822. ", doi="10.2196/21450", url="http://formative.jmir.org/2020/11/e21450/", url="http://www.ncbi.nlm.nih.gov/pubmed/33200999" } @Article{info:doi/10.2196/18981, author="Schwalm, D. J. and Ivers, M. Noah and Bouck, Zachary and Taljaard, Monica and Natarajan, K. Madhu and Dolovich, Lisa and Thavorn, Kednapa and McCready, Tara and O'Brien, Erin and Grimshaw, M. Jeremy", title="Length of Initial Prescription at Hospital Discharge and Long-Term Medication Adherence for Elderly, Post-Myocardial Infarction Patients: Protocol for an Interrupted Time Series Study", journal="JMIR Res Protoc", year="2020", month="Nov", day="4", volume="9", number="11", pages="e18981", keywords="post-myocardial infarction", keywords="adherence", keywords="standardized discharge prescription form", keywords="secondary prevention", keywords="policy change", keywords="medication", keywords="elderly", keywords="intervention", keywords="prescription", keywords="discharge", keywords="prevention", keywords="cardiology", keywords="heart", abstract="Background: Based on high-quality evidence, guidelines recommend the long-term use of secondary prevention medications post-myocardial infarction (MI) to avoid recurrent cardiovascular events and death. Unfortunately, discontinuation of recommended medications post-MI is common. Observational evidence suggests that prescriptions covering a longer duration at discharge from hospital are associated with greater long-term medication adherence. The following is a proposal for the first interventional study to evaluate the impact of longer prescription duration at discharge post-MI on long-term medication adherence. Objective: The overarching goal of this study is to reduce morbidity and mortality among post-MI patients through improved long-term cardiac medication adherence. The specific objectives include the following. First, we will assess whether long-term cardiac medication adherence improves among elderly, post-MI patients following the implementation of (1) standardized discharge prescription forms with 90-day prescriptions and 3 repeats for recommended cardiac medication classes, in combination with education and (2) education alone compared to (3) usual care. Second, we will assess the cost implications of prolonged initial discharge prescriptions compared with usual care. Third, we will compare clinical outcomes between longer (>60 days) versus shorter prescription durations. Fourth, we will collect baseline information to inform a multicenter interventional study. Methods: We will conduct a quasiexperimental, interrupted time series design to evaluate the impact of a multifaceted intervention to implement longer duration prescriptions versus usual care on long-term cardiac medication adherence among post-MI patients. Intervention groups and their corresponding settings include: (1) intervention group 1: 1 cardiac center and 1 noncardiac hospital allocated to receive standardized discharge prescription forms supporting the dispensation of 90 days' worth of cardiac medications with 3 repeats, coupled with education; (2) intervention group 2: 4 sites (including 1 cardiac center) allocated to receive education only; and (3) control group: all remaining hospitals within the province that did not receive an intervention (ie, usual care). Administrative databases will be used to measure all outcomes. Adherence to 4 classes of cardiac medications --- statins, beta blockers, angiotensin system inhibitors, and secondary antiplatelets (ie, prasugrel, clopidogrel, or ticagrelor) --- will be assessed. Results: Enrollment began in September 2017, and results are expected to be analyzed in late 2020. Conclusions: The results have the potential to redefine best practices regarding discharge prescribing policies for patients post-MI. A policy of standardized maximum-duration prescriptions at the time of discharge post-MI is a simple intervention that has the potential to significantly improve long-term medication adherence, thus decreasing cardiac morbidity and mortality. If effective, this low-cost intervention to implement longer duration prescriptions post-MI could be easily scaled. Trial Registration: ClinicalTrials.gov NCT03257579; https://clinicaltrials.gov/ct2/show/NCT03257579 International Registered Report Identifier (IRRID): DERR1-10.2196/18981 ", doi="10.2196/18981", url="https://www.researchprotocols.org/2020/11/e18981", url="http://www.ncbi.nlm.nih.gov/pubmed/33146624" } @Article{info:doi/10.2196/21159, author="Buss, Helen Vera and Leesong, Stuart and Barr, Margo and Varnfield, Marlien and Harris, Mark", title="Primary Prevention of Cardiovascular Disease and Type 2 Diabetes Mellitus Using Mobile Health Technology: Systematic Review of the Literature", journal="J Med Internet Res", year="2020", month="Oct", day="29", volume="22", number="10", pages="e21159", keywords="systematic review", keywords="mobile health", keywords="telemedicine", keywords="primary prevention", keywords="cardiovascular diseases", keywords="diabetes mellitus, type 2", abstract="Background: Digital technology is an opportunity for public health interventions to reach a large part of the population. Objective: This systematic literature review aimed to assess the effectiveness of mobile health--based interventions in reducing the risk of cardiovascular disease and type 2 diabetes mellitus. Methods: We conducted the systematic search in 7 electronic databases using a predefined search strategy. We included articles published between inception of the databases and March 2019 if they reported on the effectiveness of an intervention for prevention of cardiovascular disease or type 2 diabetes via mobile technology. One researcher performed the search, study selection, data extraction, and methodological quality assessment. The steps were validated by the other members of the research team Results: The search yielded 941 articles for cardiovascular disease, of which 3 met the inclusion criteria, and 732 for type 2 diabetes, of which 6 met the inclusion criteria. The methodological quality of the studies was low, with the main issue being nonblinding of participants. Of the selected studies, 4 used SMS text messaging, 1 used WhatsApp, and the remaining ones used specific smartphone apps. Weight loss and reduction in BMI were the most reported successful outcomes (reported in 4 studies). Conclusions: Evidence on the effectiveness of mobile health-based interventions in reducing the risk for cardiovascular disease and type 2 diabetes is low due to the quality of the studies and the small effects that were measured. This highlights the need for further high-quality research to investigate the potential of mobile health interventions. Trial Registration: International Prospective Register of Systematic Reviews (PROSPERO) CRD42019135405; https://www.crd.york.ac.uk/PROSPERO/display\_record.php?RecordID=135405 ", doi="10.2196/21159", url="http://www.jmir.org/2020/10/e21159/", url="http://www.ncbi.nlm.nih.gov/pubmed/33118936" } @Article{info:doi/10.2196/20488, author="Gazi, H. Asim and Gurel, Z. Nil and Richardson, S. Kristine L. and Wittbrodt, T. Matthew and Shah, J. Amit and Vaccarino, Viola and Bremner, Douglas J. and Inan, T. Omer", title="Digital Cardiovascular Biomarker Responses to Transcutaneous Cervical Vagus Nerve Stimulation: State-Space Modeling, Prediction, and Simulation", journal="JMIR Mhealth Uhealth", year="2020", month="Sep", day="22", volume="8", number="9", pages="e20488", keywords="vagus nerve stimulation", keywords="noninvasive", keywords="wearable sensing", keywords="digital biomarkers", keywords="dynamic models", keywords="state space", keywords="biomarker", keywords="cardiovascular", keywords="neuromodulation", keywords="bioelectronic medicine", abstract="Background: Transcutaneous cervical vagus nerve stimulation (tcVNS) is a promising alternative to implantable stimulation of the vagus nerve. With demonstrated potential in myriad applications, ranging from systemic inflammation reduction to traumatic stress attenuation, closed-loop tcVNS during periods of risk could improve treatment efficacy and reduce ineffective delivery. However, achieving this requires a deeper understanding of biomarker changes over time. Objective: The aim of the present study was to reveal the dynamics of relevant cardiovascular biomarkers, extracted from wearable sensing modalities, in response to tcVNS. Methods: Twenty-four human subjects were recruited for a randomized double-blind clinical trial, for whom electrocardiography and photoplethysmography were used to measure heart rate and photoplethysmogram amplitude responses to tcVNS, respectively. Modeling these responses in state-space, we (1) compared the biomarkers in terms of their predictability and active vs sham differentiation, (2) studied the latency between stimulation onset and measurable effects, and (3) visualized the true and model-simulated biomarker responses to tcVNS. Results: The models accurately predicted future heart rate and photoplethysmogram amplitude values with root mean square errors of approximately one-fifth the standard deviations of the data. Moreover, (1) the photoplethysmogram amplitude showed superior predictability (P=.03) and active vs sham separation compared to heart rate; (2) a consistent delay of greater than 5 seconds was found between tcVNS onset and cardiovascular effects; and (3) dynamic characteristics differentiated responses to tcVNS from the sham stimulation. Conclusions: This work furthers the state of the art by modeling pertinent biomarker responses to tcVNS. Through subsequent analysis, we discovered three key findings with implications related to (1) wearable sensing devices for bioelectronic medicine, (2) the dominant mechanism of action for tcVNS-induced effects on cardiovascular physiology, and (3) the existence of dynamic biomarker signatures that can be leveraged when titrating therapy in closed loop. Trial Registration: ClinicalTrials.gov NCT02992899; https://clinicaltrials.gov/ct2/show/NCT02992899 International Registered Report Identifier (IRRID): RR2-10.1016/j.brs.2019.08.002 ", doi="10.2196/20488", url="http://mhealth.jmir.org/2020/9/e20488/", url="http://www.ncbi.nlm.nih.gov/pubmed/32960179" } @Article{info:doi/10.2196/15156, author="Krzyzanowski, C. Michelle and Kizakevich, N. Paul and Duren-Winfield, Vanessa and Eckhoff, Randall and Hampton, Joel and Blackman Carr, T. Loneke and McCauley, Georgia and Roberson, B. Kristina and Onsomu, O. Elijah and Williams, John and Price, Alise Amanda", title="Rams Have Heart, a Mobile App Tracking Activity and Fruit and Vegetable Consumption to Support the Cardiovascular Health of College Students: Development and Usability Study", journal="JMIR Mhealth Uhealth", year="2020", month="Aug", day="5", volume="8", number="8", pages="e15156", keywords="exercise", keywords="cardiovascular disease", keywords="diary", keywords="diet", keywords="mHealth", keywords="mobile phone", abstract="Background: With the increasing use of mobile devices to access the internet and as the main computing system of apps, there is a growing market for mobile health apps to provide self-care advice. Their effectiveness with regard to diet and fitness tracking, for example, needs to be examined. The majority of American adults fail to meet daily recommendations for healthy behavior. Testing user engagement with an app in a controlled environment can provide insight into what is effective and not effective in an app focused on improving diet and exercise. Objective: We developed Rams Have Heart, a mobile app, to support a cardiovascular disease (CVD) intervention course. The app tracks healthy behaviors, including fruit and vegetable consumption and physical activity, throughout the day. This paper aimed to present its functionality and evaluated adherence among the African American college student population. Methods: We developed the app using the Personal Health Informatics and Intervention Toolkit, a software framework. Rams Have Heart integrates self-reported health screening with health education, diary tracking, and user feedback modules to acquire data and assess progress. The parent study, conducted at a historically black college and university-designated institution in southeastern United States, consisted of a semester-long intervention administered as an academic course in the fall, for 3 consecutive years. Changes were made after the cohort 1 pilot study, so results only include cohorts 2 and 3, comprising a total of 115 students (n=55 intervention participants and n=54 control participants) aged from 17 to 24 years. Data collected over the study period were transferred using the secure Hypertext Transfer Protocol Secure protocol and stored in a secure Structured Query Language server database accessible only to authorized persons. SAS software was used to analyze the overall app usage and the specific results collected. Results: Of the 55 students in the intervention group, 27 (49\%) students in cohort 2 and 25 (45\%) in cohort 3 used the Rams Have Heart app at least once. Over the course of the fall semester, app participation dropped off gradually until exam week when most students no longer participated. The average fruit and vegetable intake increased slightly, and activity levels decreased over the study period. Conclusions: Rams Have Heart was developed to allow daily tracking of fruit and vegetable intake and physical activity to support a CVD risk intervention for a student demographic susceptible to obesity, heart disease, and type 2 diabetes. We conducted an analysis of app usage, function, and user results. Although a mobile app provides privacy and flexibility for user participation in a research study, Rams Have Heart did not improve compliance or user outcomes. Health-oriented research studies relying on apps in support of user goals need further evaluation. ", doi="10.2196/15156", url="https://mhealth.jmir.org/2020/8/e15156", url="http://www.ncbi.nlm.nih.gov/pubmed/32755883" } @Article{info:doi/10.2196/17351, author="Piera-Jim{\'e}nez, Jordi and Winters, Marjolein and Broers, Eva and Valero-Bover, Dami{\`a} and Habibovic, Mirela and Widdershoven, G. Jos W. M. and Folkvord, Frans and Lupi{\'a}{\~n}ez-Villanueva, Francisco", title="Changing the Health Behavior of Patients With Cardiovascular Disease Through an Electronic Health Intervention in Three Different Countries: Cost-Effectiveness Study in the Do Cardiac Health: Advanced New Generation Ecosystem (Do CHANGE) 2 Randomized Controlled Trial", journal="J Med Internet Res", year="2020", month="Jul", day="28", volume="22", number="7", pages="e17351", keywords="cost-effectiveness", keywords="randomized controlled trial", keywords="RCT", keywords="eHealth", keywords="cardiovascular disease", keywords="engagement", keywords="behavior change", keywords="digital health", abstract="Background: During the last few decades, preventing the development of cardiovascular disease has become a mainstay for reducing cardiovascular morbidity and mortality. It has been suggested that interventions should focus more on committed approaches of self-care, such as electronic health techniques. Objective: This study aimed to provide evidence to understand the financial consequences of implementing the ``Do Cardiac Health: Advanced New Generation Ecosystem'' (Do CHANGE 2) intervention, which was evaluated in a multisite randomized controlled trial to change the health behavior of patients with cardiovascular disease. Methods: The cost-effectiveness analysis of the Do CHANGE 2 intervention was performed with the Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Ageing tool, based on a Markov model of five health states. The following two types of costs were considered for both study groups: (1) health care costs (ie, costs associated with the time spent by health care professionals on service provision, including consultations, and associated unplanned hospitalizations, etc) and (2) societal costs (ie, costs attributed to the time spent by patients and informal caregivers on care activities). Results: The Do CHANGE 2 intervention was less costly in Spain (incremental cost was ?{\texteuro}2514.90) and more costly in the Netherlands and Taiwan (incremental costs were {\texteuro}1373.59 and {\texteuro}1062.54, respectively). Compared with treatment as usual, the effectiveness of the Do CHANGE 2 program in terms of an increase in quality-adjusted life-year gains was slightly higher in the Netherlands and lower in Spain and Taiwan. Conclusions: In general, we found that the incremental cost-effectiveness ratio strongly varied depending on the country where the intervention was applied. The Do CHANGE 2 intervention showed a positive cost-effectiveness ratio only when implemented in Spain, indicating that it saved financial costs in relation to the effect of the intervention. Trial Registration: ClinicalTrials.gov NCT03178305; https://clinicaltrials.gov/ct2/show/NCT03178305 ", doi="10.2196/17351", url="http://www.jmir.org/2020/7/e17351/", url="http://www.ncbi.nlm.nih.gov/pubmed/32720908" } @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/10.2196/16699, author="Taylor Jr, A. Herman and Francis, Sherilyn and Evans, Ray Chad and Harvey, Marques and Newton, A. Brittney and Jones, P. Camara and Akintobi, Henry Tabia and Clifford, Gari", title="Preventing Cardiovascular Disease Among Urban African Americans With a Mobile Health App (the MOYO App): Protocol for a Usability Study", journal="JMIR Res Protoc", year="2020", month="Jul", day="9", volume="9", number="7", pages="e16699", keywords="African Americans", keywords="mHealth", keywords="community-based participatory research", keywords="agile design", keywords="cardiovascular", abstract="Background: Cardiovascular disease (CVD) disparities are a particularly devastating manifestation of health inequity. Despite advancements in prevention and treatment, CVD is still the leading cause of death in the United States. Additionally, research indicates that African American (AA) and other ethnic-minority populations are affected by CVD at earlier ages than white Americans. Given that AAs are the fastest-growing population of smartphone owners and users, mobile health (mHealth) technologies offer the unparalleled potential to prevent or improve self-management of chronic disease among this population. Objective: To address the unmet need for culturally tailored primordial prevention CVD--focused mHealth interventions, the MOYO app was cocreated with the involvement of young people from this priority community. The overall project aims to develop and evaluate the effectiveness of a novel smartphone app designed to reduce CVD risk factors among urban-AAs, 18-29 years of age. Methods: The theoretical underpinning will combine the principles of community-based participatory research and the agile software development framework. The primary outcome goals of the study will be to determine the usability, acceptability, and functionality of the MOYO app, and to build a cloud-based data collection infrastructure suitable for digital epidemiology in a disparity population. Changes in health-related parameters over a 24-week period as determined by both passive (eg, physical activity levels, sleep duration, social networking) and active (eg, use of mood measures, surveys, uploading pictures of meals and blood pressure readings) measures will be the secondary outcome. Participants will be recruited from a majority AA ``large city'' school district, 2 historically black colleges or universities, and 1 urban undergraduate college. Following baseline screening for inclusion (administered in person), participants will receive the beta version of the MOYO app. Participants will be monitored during a 24-week pilot period. Analyses of varying data including social network dynamics, standard metrics of activity, percentage of time away from a given radius of home, circadian rhythm metrics, and proxies for sleep will be performed. Together with external variables (eg, weather, pollution, and socioeconomic indicators such as food access), these metrics will be used to train machine-learning frameworks to regress them on the self-reported quality of life indicators. Results: This 5-year study (2015-2020) is currently in the implementation phase. We believe that MOYO can build upon findings of classical epidemiology and longitudinal studies like the Jackson Heart Study by adding greater granularity to our knowledge of the exposures and behaviors that affect health and disease, and creating a channel for outreach capable of launching interventions, clinical trials, and enhancements of health literacy. Conclusions: The results of this pilot will provide valuable information about community cocreation of mHealth programs, efficacious design features, and essential infrastructure for digital epidemiology among young AA adults. International Registered Report Identifier (IRRID): DERR1-10.2196/16699 ", doi="10.2196/16699", url="https://www.researchprotocols.org/2020/7/e16699", url="http://www.ncbi.nlm.nih.gov/pubmed/32673258" } @Article{info:doi/10.2196/16695, author="Indraratna, Praveen and Tardo, Daniel and Yu, Jennifer and Delbaere, Kim and Brodie, Matthew and Lovell, Nigel and Ooi, Sze-Yuan", title="Mobile Phone Technologies in the Management of Ischemic Heart Disease, Heart Failure, and Hypertension: Systematic Review and Meta-Analysis", journal="JMIR Mhealth Uhealth", year="2020", month="Jul", day="6", volume="8", number="7", pages="e16695", keywords="mobile phone", keywords="text messaging", keywords="telemedicine", keywords="myocardial ischemia", keywords="heart failure", keywords="hypertension", abstract="Background: Cardiovascular disease (CVD) remains the leading cause of death worldwide. Mobile phones have become ubiquitous in most developed societies. Smartphone apps, telemonitoring, and clinician-driven SMS allow for novel opportunities and methods in managing chronic CVD, such as ischemic heart disease, heart failure, and hypertension, and in the conduct and support of cardiac rehabilitation. Objective: A systematic review was conducted using seven electronic databases, identifying all relevant randomized control trials (RCTs) featuring a mobile phone intervention (MPI) used in the management of chronic CVD. Outcomes assessed included mortality, hospitalizations, blood pressure (BP), and BMI. Methods: Electronic data searches were performed using seven databases from January 2000 to June 2019. Relevant articles were reviewed and analyzed. Meta-analysis was performed using standard techniques. The odds ratio (OR) was used as a summary statistic for dichotomous variables. A random effect model was used. Results: A total of 26 RCTs including 6713 patients were identified and are described in this review, and 12 RCTs were included in the meta-analysis. In patients with heart failure, MPIs were associated with a significantly lower rate of hospitalizations (244/792, 30.8\% vs 287/803, 35.7\%; n=1595; OR 0.77, 95\% CI 0.62 to 0.97; P=.03; I2=0\%). In patients with hypertension, patients exposed to MPIs had a significantly lower systolic BP (mean difference 4.3 mm Hg; 95\% CI ?7.8 to ?0.78 mm Hg; n=2023; P=.02). Conclusions: The available data suggest that MPIs may have a role as a valuable adjunct in the management of chronic CVD. ", doi="10.2196/16695", url="https://mhealth.jmir.org/2020/7/e16695", url="http://www.ncbi.nlm.nih.gov/pubmed/32628615" } @Article{info:doi/10.2196/19200, author="Lowres, Nicole and Duckworth, Andrew and Redfern, Julie and Thiagalingam, Aravinda and Chow, K. Clara", title="Use of a Machine Learning Program to Correctly Triage Incoming Text Messaging Replies From a Cardiovascular Text--Based Secondary Prevention Program: Feasibility Study", journal="JMIR Mhealth Uhealth", year="2020", month="Jun", day="16", volume="8", number="6", pages="e19200", keywords="eHealth", keywords="machine learning, secondary prevention, SMS text messaging, cardiovascular, mHealth, digital health, mobile phone", abstract="Background: SMS text messaging programs are increasingly being used for secondary prevention, and have been shown to be effective in a number of health conditions including cardiovascular disease. SMS text messaging programs have the potential to increase the reach of an intervention, at a reduced cost, to larger numbers of people who may not access traditional programs. However, patients regularly reply to the SMS text messages, leading to additional staffing requirements to monitor and moderate the patients' SMS text messaging replies. This additional staff requirement directly impacts the cost-effectiveness and scalability of SMS text messaging interventions. Objective: This study aimed to test the feasibility and accuracy of developing a machine learning (ML) program to triage SMS text messaging replies (ie, identify which SMS text messaging replies require a health professional review). Methods: SMS text messaging replies received from 2 clinical trials were manually coded (1) into ``Is staff review required?'' (binary response of yes/no); and then (2) into 12 general categories. Five ML models (Na{\"i}ve Bayes, OneVsRest, Random Forest Decision Trees, Gradient Boosted Trees, and Multilayer Perceptron) and an ensemble model were tested. For each model run, data were randomly allocated into training set (2183/3118, 70.01\%) and test set (935/3118, 29.98\%). Accuracy for the yes/no classification was calculated using area under the receiver operating characteristics curve (AUC), false positives, and false negatives. Accuracy for classification into 12 categories was compared using multiclass classification evaluators. Results: A manual review of 3118 SMS text messaging replies showed that 22.00\% (686/3118) required staff review. For determining need for staff review, the Multilayer Perceptron model had highest accuracy (AUC 0.86; 4.85\% false negatives; and 4.63\% false positives); with addition of heuristics (specified keywords) fewer false negatives were identified (3.19\%), with small increase in false positives (7.66\%) and AUC 0.79. Application of this model would result in 26.7\% of SMS text messaging replies requiring review (true + false positives). The ensemble model produced the lowest false negatives (1.43\%) at the expense of higher false positives (16.19\%). OneVsRest was the most accurate (72.3\%) for the 12-category classification. Conclusions: The ML program has high sensitivity for identifying the SMS text messaging replies requiring staff input; however, future research is required to validate the models against larger data sets. Incorporation of an ML program to review SMS text messaging replies could significantly reduce staff workload, as staff would not have to review all incoming SMS text messages. This could lead to substantial improvements in cost-effectiveness, scalability, and capacity of SMS text messaging--based interventions. ", doi="10.2196/19200", url="http://mhealth.jmir.org/2020/6/e19200/", url="http://www.ncbi.nlm.nih.gov/pubmed/32543439" } @Article{info:doi/10.2196/14570, author="Broers, Rosalinde Eva and Kop, Johan Willem and Denollet, Johan and Widdershoven, Jos and Wetzels, Mart and Ayoola, Idowu and Piera-Jimenez, Jordi and Habibovic, Mirela", title="A Personalized eHealth Intervention for Lifestyle Changes in Patients With Cardiovascular Disease: Randomized Controlled Trial", journal="J Med Internet Res", year="2020", month="May", day="22", volume="22", number="5", pages="e14570", keywords="cardiovascular diseases", keywords="lifestyle", keywords="habits", keywords="eHealth", keywords="mHealth", abstract="Background: Behavior change methods involving new ambulatory technologies may improve lifestyle and cardiovascular disease outcomes. Objective: This study aimed to provide proof-of-concept analyses of an intervention aiming to increase (1) behavioral flexibility, (2) lifestyle change, and (3) quality of life. The feasibility and patient acceptance of the intervention were also evaluated. Methods: Patients with cardiovascular disease (N=149; mean age 63.57, SD 8.30 years; 50/149, 33.5\% women) were recruited in the Do Cardiac Health Advanced New Generation Ecosystem (Do CHANGE) trial and randomized to the Do CHANGE intervention or care as usual (CAU). The intervention involved a 3-month behavioral program in combination with ecological momentary assessment and intervention technologies. Results: The intervention was perceived to be feasible and useful. A significant increase in lifestyle scores over time was found for both groups (F2,146.6=9.99; P<.001), which was similar for CAU and the intervention group (F1,149.9=0.09; P=.77). Quality of life improved more in the intervention group (mean 1.11, SD 0.11) than CAU (mean ?1.47, SD 0.11) immediately following the intervention (3 months), but this benefit was not sustained at the 6-month follow-up (interaction: P=.02). No significant treatment effects were observed for behavioral flexibility (F1,149.0=0.48; P=.07). Conclusions: The Do CHANGE 1 intervention was perceived as useful and easy to use. However, no long-term treatment effects were found on the outcome measures. More research is warranted to examine which components of behavioral interventions are effective in producing long-term behavior change. Trial Registration: ClinicalTrials.gov NCT02946281; https://www.clinicaltrials.gov/ct2/show/NCT02946281 ", doi="10.2196/14570", url="https://www.jmir.org/2020/5/e14570", url="http://www.ncbi.nlm.nih.gov/pubmed/32441658" } @Article{info:doi/10.2196/17669, author="Winchester, E. David and Cagino, Leigh", title="A Redesigned Order Entry System for Reducing Low-Value Preprocedural Cardiology Consultations: Quality-Improvement Cohort Study", journal="JMIR Perioper Med", year="2020", month="May", day="1", volume="3", number="1", pages="e17669", keywords="quality improvement", keywords="preoperative care", keywords="medical order entry systems", abstract="Background: Preprocedural cardiac evaluation is a common reason for outpatient cardiology visits. Many patients who are referred to cardiology clinics for preprocedural evaluation are at low risk of perioperative events and do not require any further management. Our facility treats patients over a large geographic area; avoiding low-value consultations reduces time and travel burdens for patients. Objective: Our study objective was to assess the impact of a novel algorithm in the electronic order entry system aimed to guide clinicians toward patients who may benefit from cardiovascular referral. Methods: We retrospectively reviewed in-person consultations and electronic consultations (e-consults) to our cardiology service before and after implementation of the novel algorithm to assess changes in patterns of care. Data were stored in a custom electronic database on internal servers. Results: We reviewed 603 consultations to our cardiology clinic and found that 89 (14.7\%) were sent for preprocedural evaluation. Of these, 39 (43.8\% of preprocedural consultations) were e-consults. After implementation, we reviewed 360 consultations. The proportion of consultations for preprocedural evaluation did not decrease (n=47, 13.0\%; P=.39). We observed an absolute increase of 13.6\% in the proportion of consultations ordered as e-consults (27/47, 57.4\%). During the postintervention period, we received no remarks, concerns, or criticisms from ordering clinicians about the process change and no reports of adverse events. Conclusions: Implementation of an ordering algorithm to reduce low-value preprocedural cardiology evaluations did not lead to a reduction in the number of overall preprocedural cardiology consultations. The number of patients seen electronically increased, potentially improving clinic access and reducing travel burden for patients. ", doi="10.2196/17669", url="https://periop.jmir.org/2020/1/e17669", url="http://www.ncbi.nlm.nih.gov/pubmed/33393916" } @Article{info:doi/10.2196/16400, author="Groenhof, J. T. Katrien and Kofink, Daniel and Bots, L. Michiel and Nathoe, M. Hendrik and Hoefer, E. Imo and Van Solinge, W. Wouter and Lely, Titia A. and Asselbergs, W. Folkert and Haitjema, Saskia", title="Low-Density Lipoprotein Cholesterol Target Attainment in Patients With Established Cardiovascular Disease: Analysis of Routine Care Data", journal="JMIR Med Inform", year="2020", month="Apr", day="2", volume="8", number="4", pages="e16400", keywords="learning health care system", keywords="routine clinical data", keywords="cardiovascular risk management", keywords="LDL-c", abstract="Background: Direct feedback on quality of care is one of the key features of a learning health care system (LHS), enabling health care professionals to improve upon the routine clinical care of their patients during practice. Objective: This study aimed to evaluate the potential of routine care data extracted from electronic health records (EHRs) in order to obtain reliable information on low-density lipoprotein cholesterol (LDL-c) management in cardiovascular disease (CVD) patients referred to a tertiary care center. Methods: We extracted all LDL-c measurements from the EHRs of patients with a history of CVD referred to the University Medical Center Utrecht. We assessed LDL-c target attainment at the time of referral and per year. In patients with multiple measurements, we analyzed LDL-c trajectories, truncated at 6 follow-up measurements. Lastly, we performed a logistic regression analysis to investigate factors associated with improvement of LDL-c at the next measurement. Results: Between February 2003 and December 2017, 250,749 LDL-c measurements were taken from 95,795 patients, of whom 23,932 had a history of CVD. At the time of referral, 51\% of patients had not reached their LDL-c target. A large proportion of patients (55\%) had no follow-up LDL-c measurements. Most of the patients with repeated measurements showed no change in LDL-c levels over time: the transition probability to remain in the same category was up to 0.84. Sequence clustering analysis showed more women (odds ratio 1.18, 95\% CI 1.07-1.10) in the cluster with both most measurements off target and the most LDL-c measurements furthest from the target. Timing of drug prescription was difficult to determine from our data, limiting the interpretation of results regarding medication management. Conclusions: Routine care data can be used to provide feedback on quality of care, such as LDL-c target attainment. These routine care data show high off-target prevalence and little change in LDL-c over time. Registrations of diagnosis; follow-up trajectory, including primary and secondary care; and medication use need to be improved in order to enhance usability of the EHR system for adequate feedback. ", doi="10.2196/16400", url="https://medinform.jmir.org/2020/4/e16400", url="http://www.ncbi.nlm.nih.gov/pubmed/32238333" } @Article{info:doi/10.2196/15057, author="Yun, Ho Young and Kang, EunKyo and Cho, Min Young and Park, Min Sang and Kim, Yong-Jin and Lee, Hae-Young and Kim, Hyung Kyae and Lee, Kiheon and Koo, Yeon Hye and Kim, Soojeong and Rhee, YeEun and Lee, Jihye and Min, Hee Jeong and Sim, Jin-Ah", title="Efficacy of an Electronic Health Management Program for Patients With Cardiovascular Risk: Randomized Controlled Trial", journal="J Med Internet Res", year="2020", month="Jan", day="22", volume="22", number="1", pages="e15057", keywords="health", keywords="hypertension", keywords="diabetes", keywords="hypercholesterolemia", keywords="randomized controlled trial", abstract="Background: In addition to medication, health behavior management is crucial in patients with multiple risks of cardiovascular mortality. Objective: This study aimed to examine the efficacy of a 3-month Smart Management Strategy for Health--based electronic program (Smart Healthing). Methods: A 2-arm randomized controlled trial was conducted to assess the efficacy of Smart Healthing in 106 patients with at least one indicator of poor disease control and who had hypertension, diabetes, or hypercholesterolemia. The intervention group (n=53) took part in the electronic program, which was available in the form of a mobile app and a Web-based PC application. The program covered 4 areas: self-assessment, self-planning, self-learning, and self-monitoring by automatic feedback. The control group (n=53) received basic educational material concerning disease control. The primary outcome was the percentage of participants who achieved their clinical indicator goal after 12 weeks into the program: glycated hemoglobin (HbA1c) <7.0\%, systolic blood pressure (SBP) <140 mmHg, or low-density lipoprotein cholesterol <130 mg/dL. Results: The intervention group showed a significantly higher success rate (in comparison with the control group) for achieving each of 3 clinical indicators at the targeted goal levels (P<.05). Only the patients with hypertension showed a significant improvement in SBP from the baseline as compared with the control group (72.7\% vs 35.7\%; P<.05). There was a significant reduction in HbA1c in the intervention group compared with the control group (difference=0.54\%; P?.05). In the intervention group, 20\% of patients with diabetes exhibited a ?1\% decrease in HbA1c (vs 0\% among controls; P?.05). Conclusions: A short-term self-management strategy-based electronic program intervention may improve clinical outcomes among patients with cardiovascular risks. Trial Registration: ClinicalTrials.gov NCT03294044; https://clinicaltrials.gov/ct2/show/NCT03294044 ", doi="10.2196/15057", url="https://www.jmir.org/2020/1/e15057", url="http://www.ncbi.nlm.nih.gov/pubmed/32012053" } @Article{info:doi/10.2196/14963, author="Shan, Rongzi and Yanek, R. Lisa and Silverman-Lloyd, G. Luke and Kianoush, Sina and Blaha, J. Michael and German, A. Charles and Graham, N. Garth and Martin, S. Seth", title="Using Mobile Health Tools to Assess Physical Activity Guideline Adherence and Smoking Urges: Secondary Analysis of mActive-Smoke", journal="JMIR Cardio", year="2020", month="Jan", day="6", volume="4", number="1", pages="e14963", keywords="physical activity", keywords="smoking", keywords="mHealth", keywords="fitness trackers", keywords="short message service", abstract="Background: Rates of cigarette smoking are decreasing because of public health initiatives, pharmacological aids, and clinician focus on smoking cessation. However, a sedentary lifestyle increases cardiovascular risk, and therefore, inactive smokers have a particularly enhanced risk of cardiovascular disease. Objective: In this secondary analysis of mActive-Smoke, a 12-week observational study, we investigated adherence to guideline-recommended moderate-to-vigorous physical activity (MVPA) in smokers and its association with the urge to smoke. Methods: We enrolled 60 active smokers (?3 cigarettes per day) and recorded continuous step counts with the Fitbit Charge HR. MVPA was defined as a cadence of greater than or equal to 100 steps per minute. Participants were prompted to report instantaneous smoking urges via text message 3 times a day on a Likert scale from 1 to 9. We used a mixed effects linear model for repeated measures, controlling for demographics and baseline activity level, to investigate the association between MVPA and urge. Results: A total of 53 participants (mean age 40 [SD 12] years, 57\% [30/53] women, 49\% [26/53] nonwhite, and 38\% [20/53] obese) recorded 6 to 12 weeks of data. Data from 3633 person-days were analyzed, with a mean of 69 days per participant. Among all participants, median daily MVPA was 6 min (IQR 2-13), which differed by sex (12 min [IQR 3-20] for men vs 3.5 min [IQR 1-9] for women; P=.004) and BMI (2.5 min [IQR 1-8.3] for obese vs 10 min [IQR 3-15] for nonobese; P=.04). The median total MVPA minutes per week was 80 (IQR 31-162). Only 10\% (5/51; 95\% CI 4\% to 22\%) of participants met national guidelines of 150 min per week of MVPA on at least 50\% of weeks. Adjusted models showed no association between the number of MVPA minutes per day and mean daily smoking urge (P=.72). Conclusions: The prevalence of MVPA was low in adult smokers who rarely met national guidelines for MVPA. Given the poor physical activity attainment in smokers, more work is required to enhance physical activity in this population. ", doi="10.2196/14963", url="https://cardio.jmir.org/2020/1/e14963", url="http://www.ncbi.nlm.nih.gov/pubmed/31904575" } @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/10.2196/13166, author="Jiang, Xinchan and Ming, Wai-Kit and You, HS Joyce", title="The Cost-Effectiveness of Digital Health Interventions on the Management of Cardiovascular Diseases: Systematic Review", journal="J Med Internet Res", year="2019", month="Jun", day="17", volume="21", number="6", pages="e13166", keywords="telemedicine", keywords="cardiovascular diseases", keywords="stroke", keywords="heart failure", keywords="myocardial infarction", keywords="heart attack", keywords="cost-effectiveness", keywords="medical economics", keywords="decision modeling", keywords="systematic review", abstract="Background: With the advancement in information technology and mobile internet, digital health interventions (DHIs) are improving the care of cardiovascular diseases (CVDs). The impact of DHIs on cost-effective management of CVDs has been examined using the decision analytic model--based health technology assessment approach. Objective: The aim of this study was to perform a systematic review of the decision analytic model--based studies evaluating the cost-effectiveness of DHIs on the management of CVDs. Methods: A literature review was conducted in Medline, Embase, Cumulative Index to Nursing and Allied Health Literature Complete, PsycINFO, Scopus, Web of Science, Center for Review and Dissemination, and Institute for IEEE Xplore between 2001 and 2018. Studies were included if the following criteria were met: (1) English articles, (2) DHIs that promoted or delivered clinical interventions and had an impact on patients' cardiovascular conditions, (3) studies that were modeling works with health economic outcomes of DHIs for CVDs, (4) studies that had a comparative group for assessment, and (5) full economic evaluations including a cost-effectiveness analysis, cost-utility analysis, cost-benefit analysis, and cost-consequence analysis. The primary outcome collected was the cost-effectiveness of the DHIs, presented by incremental cost per additional quality-adjusted life year (QALY). The quality of each included study was evaluated using the Consolidated Health Economic Evaluation Reporting Standards. Results: A total of 14 studies met the defined criteria and were included in the review. Among the included studies, heart failure (7/14, 50\%) and stroke (4/14, 29\%) were two of the most frequent CVDs that were managed by DHIs. A total of 9 (64\%) studies were published between 2015 and 2018 and 5 (36\%) published between 2011 and 2014. The time horizon was ?1 year in 3 studies (21\%), >1 year in 10 studies (71\%), and 1 study (7\%) did not declare the time frame. The types of devices or technologies used to deliver the health interventions were short message service (1/14, 7\%), telephone support (1/14, 7\%), mobile app (1/14, 7\%), video conferencing system (5/14, 36\%), digital transmission of physiologic data (telemonitoring; 5/14, 36\%), and wearable medical device (1/14, 7\%). The DHIs gained higher QALYs with cost saving in 43\% (6/14) of studies and gained QALYs at a higher cost at acceptable incremental cost-effectiveness ratio (ICER) in 57\% (8/14) of studies. The studies were classified as excellent (0/14, 0\%), good (9/14, 64\%), moderate (4/14, 29\%), and low (1/14, 7\%) quality. Conclusions: This study is the first systematic review of decision analytic model--based cost-effectiveness analyses of DHIs in the management of CVDs. Most of the identified studies were published recently, and the majority of the studies were good quality cost-effectiveness analyses with an adequate duration of time frame. All the included studies found the DHIs to be cost-effective. ", doi="10.2196/13166", url="http://www.jmir.org/2019/6/e13166/", url="http://www.ncbi.nlm.nih.gov/pubmed/31210136" } @Article{info:doi/10.2196/13571, author="Su, Min and Haldane, Victoria and Upshur, Ross and Sullivan, Frank and L{\'e}gar{\'e}, France and Greiver, Michelle and Wei, Xiaolin", title="The Impact of Treatment Adherence for Patients With Diabetes and Hypertension on Cardiovascular Disease Risk: Protocol for a Retrospective Cohort Study, 2008-2018", journal="JMIR Res Protoc", year="2019", month="May", day="31", volume="8", number="5", pages="e13571", keywords="treatment adherence", keywords="cardiovascular disease", keywords="primary care", abstract="Background: Cardiovascular disease (CVD) is the leading cause of death globally and in Canada. Diabetes and hypertension are major risk factors for CVD events. Despite the increasing availability of effective treatments, the majority of diabetic and hypertensive patients do not have adequate blood pressure and glycemic control. One of the major contributors is poor treatment adherence. Objective: This study aims to evaluate the impact of treatment adherence for patients with both diabetes and hypertension on acute severe CVD events and intermediate clinical outcomes in Canadian primary care settings. Methods: We will conduct a population-based retrospective cohort study of patients living with both diabetes and hypertension in Ontario, Canada, between January 1, 2008, and March 31, 2018. The Social Cognitive Theory will be used as a conceptual framework by which to frame the reciprocal relationship between treatment adherence, personal factors, and environmental determinants and how this interplay impacts CVD events and clinical outcomes. Data will be derived from the Diabetes Action Canada National Data Repository. A time-varying Cox proportional hazards model will be used to estimate the impacts of treatment adherence on CVD morbidity and mortality. Multivariable linear regression models and hierarchical regression models will be used to estimate the associations between treatment adherence of different medication categories and intermediate clinical outcomes. Our primary outcome is the association between treatment adherence and the risk of acute severe CVD events, including CVD mortality. The secondary outcome is the association between treatment adherence and intermediate clinical outcomes including diastolic and systolic blood pressures, glycated hemoglobin, low-density lipoprotein cholesterol, and total cholesterol. Owing to data limitation, we use medication prescriptions as a proxy to estimate treatment adherence. We assume that a patient adhered to medications if she or he had any prescription record in the 4 preceding quarters and 1 quarter after each quarter of interest. Acute severe CVD events are defined based on the World Health Organization's Monitoring Trends and Determinants in Cardiovascular Disease Project, including acute coronary heart disease, stroke, and heart failure. As causes of death are not available, the number of CVD deaths will be computed using the most recent systolic blood pressure distributions and the population attributable risks related to systolic blood pressure level. Results: The project was funded by Diabetes Action Canada (reference number: 503854) and approved by the University of Toronto Research Ethics Board (reference number: 36065). The project started in June 2018 and is expected to be finished by September 2019. Conclusions: The findings will be helpful in identifying the challenges of treatment adherence for diabetic and hypertensive patients in primary care settings. This will also help to develop intervention strategies to promote treatment adherence for patients with multi-morbidities. International Registered Report Identifier (IRRID): DERR1-10.2196/13571 ", doi="10.2196/13571", url="http://www.researchprotocols.org/2019/5/e13571/", url="http://www.ncbi.nlm.nih.gov/pubmed/31152529" } @Article{info:doi/10.2196/10465, author="Haldane, Victoria and Koh, Kai Joel Jun and Srivastava, Aastha and Teo, Qi Krichelle Wei and Tan, Guo Yao and Cheng, Xiang Rui and Yap, Cheng Yi and Ong, Pei-Shi and Van Dam, M. Rob and Foo, Min Jie and M{\"u}ller-Riemenschneider, Falk and Koh, Choon-Huat Gerald and Foong, Sym Pin and Perel, Pablo and Legido-Quigley, Helena", title="User Preferences and Persona Design for an mHealth Intervention to Support Adherence to Cardiovascular Disease Medication in Singapore: A Multi-Method Study", journal="JMIR Mhealth Uhealth", year="2019", month="May", day="28", volume="7", number="5", pages="e10465", keywords="personas", keywords="biopsychosocial personas", keywords="qualitative", keywords="ASCVD", keywords="adherence", keywords="patient perspectives", abstract="Background: The use of mobile health (mHealth) has gained popularity globally, including for its use in a variety of health interventions, particularly through short message service (SMS) text messaging. However, there are challenges to the use of mHealth, particularly among older users who have a large heterogeneity in usability and accessibility barriers when using technology. Objective: In order to better understand and conceptualize the diversity of users and give insight into their particular needs, we turned to persona creation. Personas are user archetypes created through data generated from multi-method inquiry with actual target users. Personas are an appropriate yet largely underutilized component of current mHealth research. Methods: Leveraging data from a multi-method study conducted in Singapore with an ethnically diverse population including Chinese, Malay, and Indian participants, we used a proforma to analyze data from the qualitative component (ie, 20 in-depth interviews) and quantitative component (ie, 100 interviewer-guided surveys). We then identified key characteristics, including technology use and preferences as well as adherence factors, to synthesize five personas reflective of persons over the age of 40 years in Singapore with atherosclerotic cardiovascular disease (ASCVD) or ASCVD risk factors, such as hypertension. Results: We present five personas typologized as (1) The Quiet Analog, (2) The Busy Grandparent, (3) The Socializer, (4) The Newly Diagnosed, and (5) The Hard-to-Reach. We report on four key characteristics: health care access, medication adherence, mobile phone technology usage (ie, ownership, access, and utilization), and interest in mHealth. Finally, we provide insights into how these personas may be used in the design and implementation of an mHealth intervention. Our work demonstrates how multi-method data can create biopsychosocial personas that can be used to explore and address the diversity in behaviors, preferences, and needs in user groups. Conclusions: With wider adoption of mHealth, it is important that we consider user-centered design techniques and design thinking in order to create meaningful, patient-centered interventions for adherence to medications. Future research in this area should include greater exploration of how these five personas can be used to better understand how and when is best to deliver mHealth interventions in Singapore and beyond. ", doi="10.2196/10465", url="http://mhealth.jmir.org/2019/5/e10465/", url="http://www.ncbi.nlm.nih.gov/pubmed/31140445" } @Article{info:doi/10.2196/12191, author="Ricci-Cabello, Ignacio and Bobrow, Kirsten and Islam, Shariful Sheikh Mohammed and Chow, K. Clara and Maddison, Ralph and Whittaker, Robyn and Farmer, J. Andrew", title="Examining Development Processes for Text Messaging Interventions to Prevent Cardiovascular Disease: Systematic Literature Review", journal="JMIR Mhealth Uhealth", year="2019", month="Mar", day="29", volume="7", number="3", pages="e12191", keywords="systematic review", keywords="cardiovascular disease", keywords="telemedicine", keywords="text messaging", keywords="methods", abstract="Background: Interventions delivered by mobile phones have the potential to prevent cardiovascular disease (CVD) by supporting behavior change toward healthier lifestyles and treatment adherence. To allow replication and adaptation of these interventions across settings, it is important to fully understand how they have been developed. However, the development processes of these interventions have not previously been systematically examined. Objective: This study aimed to systematically describe and compare the development process of text messaging interventions identified in the Text2PreventCVD systematic review. Methods: We extracted data about the development process of the 9 interventions identified in the Text2PreventCVD systematic review. Data extraction, which was guided by frameworks for the development of complex interventions, considered the following development stages: intervention planning, design, development, and pretesting. Following data extraction, we invited the developers of the interventions to contribute to our study by reviewing the accuracy of the extracted data and providing additional data not reported in the available publications. Results: A comprehensive description of the development process was available for 5 interventions. Multiple methodologies were used for the development of each intervention. Intervention planning involved gathering information from stakeholder consultations, literature reviews, examination of relevant theory, and preliminary qualitative research. Intervention design involved the use of behavior change theories and behavior change techniques. Intervention development involved (1) generating message content based on clinical guidelines and expert opinions; (2) conducting literature reviews and primary qualitative research to inform decisions about message frequency, timing, and level of tailoring; and (3) gathering end-user feedback concerning message readability, intervention acceptability, and perceived utility. Intervention pretesting involved pilot studies with samples of 10 to 30 participants receiving messages for a period ranging from 1 to 4 weeks. Conclusions: The development process of the text messaging interventions examined was complex and comprehensive, involving multiple studies to guide decisions about the scope, content, and structure of the interventions. Additional research is needed to establish whether effective messaging systems can be adapted from work already done or whether this level of development is needed for application in other conditions and settings. ", doi="10.2196/12191", url="http://mhealth.jmir.org/2019/3/e12191/", url="http://www.ncbi.nlm.nih.gov/pubmed/30924790" } @Article{info:doi/10.2196/resprot.9017, author="Woringer, Maria and Dharmayat, I. Kanika and Greenfield, Geva and Bottle, Alex and Ray, K. Kausik", title="American Heart Association's Cholesterol CarePlan as a Smartphone-Delivered Web App for Patients Prescribed Cholesterol-Lowering Medication: Protocol for an Observational Feasibility Study", journal="JMIR Res Protoc", year="2019", month="Jan", day="24", volume="8", number="1", pages="e9017", keywords="behavioral change", keywords="cholesterol", keywords="lifestyle", keywords="mHealth", keywords="medication adherence", abstract="Background: Adoption of healthy lifestyle and compliance with cholesterol-lowering medication reduces the risk of cardiovascular disease (CVD). The use of digital tools and mobile technology may be important for sustaining positive behavioral change. Objective: The primary objective of this study is to evaluate the feasibility and acceptability of administering the Cholesterol CarePlan Web app developed by the American Heart Association aimed at improving lifestyle and medication adherence among patients prescribed cholesterol-lowering medication. The secondary objective is to assess the Web app's efficacy. Methods: A prospective, observational feasibility study will be conducted to demonstrate whether the Web app may be successfully taken up by patients and will be associated with improved clinical and behavioral outcomes. The study will aim to recruit 180 study participants being prescribed cholesterol-lowering medication for at least 30 days across 14 general practices in London, England. Potentially eligible patients will be invited to use the Web app on a smartphone and visit general practice for three 20-minute clinical assessments of blood pressure, height, weight, smoking, and nonfasting cholesterol over 24 weeks. The feasibility of administering the Web app will be judged by recruitment and dropout statistics and the sociodemographic and comorbidity profile of consenting study participants, consenting nonparticipants, and all potentially eligible patients. Acceptability will be assessed using patients' readiness to embrace new technologies, the usability of the Web app, and patient satisfaction. The efficacy of the Web app will be assessed by changes in medication adherence and clinical risk factors by levels of the Web app compliance. Results: This study is currently funded by the American Heart Association. Initial study recruitment will take place between February and July 2018 followed by patient follow-up. Patient level data will be obtained in January 2019. Data analysis will be completed by February 2019. Results will be submitted for publication in March 2019. Conclusions: The potential of an app to improve patients' lifestyle and management of cholesterol may inform the design of a randomized controlled trial and the delivery of more effective CVD prevention programs. International Registered Report Identifier (IRRID): PRR1-10.2196/9017 ", doi="10.2196/resprot.9017", url="https://www.researchprotocols.org/2019/1/e9017/", url="http://www.ncbi.nlm.nih.gov/pubmed/30679150" } @Article{info:doi/10.2196/12227, author="Plans, David and Morelli, Davide and S{\"u}tterlin, Stefan and Ollis, Lucie and Derbyshire, Georgia and Cropley, Mark", title="Use of a Biofeedback Breathing App to Augment Poststress Physiological Recovery: Randomized Pilot Study", journal="JMIR Formativ Res", year="2019", month="Jan", day="11", volume="3", number="1", pages="e12227", keywords="biofeedback", keywords="breathing", keywords="heart rate variability", keywords="recovery", keywords="rumination", keywords="stress", abstract="Background: The speed of physiological recovery from stress may be a marker for cardiovascular disease risk. Stress management programs that incorporate guided breathing have been shown to moderate the stress response and augment recovery. Objective: The aim of this study was to examine the effectiveness of an app-based brief relaxation intervention (BioBase) for facilitating physiological recovery in individuals exposed to a brief psychological stressor. Methods: A total of 75 participants (44 women) completed a stressor speech task and were randomly assigned to one of three conditions: control, rumination, or an app-based relaxation breathing (BioBase) conditions. Heart rate variability (HRV) was assessed as a measure of autonomic function at baseline (6 min), during stress (6 min), and during recovery (6 min). Results: There was a significant increase in subjective stress following stress exposure, but the ratings returned to baseline after recovery in all three groups. In addition, there was a significant decrease in vagally mediated HRV in the poststress period. During recovery, the root mean square of successive differences (P<.001), the percentage of successive interbeat (RR) intervals that differ by >50\thinspacems (pNN50; P<.001), and high-frequency (P<.02) HRV were significantly higher in the BioBase breathing condition than the rumination and control conditions. There was no difference in HRV values between the rumination and control conditions during recovery. Conclusions: App-based relaxed breathing interventions could be effective in reducing cardiovascular disease risk. These results provide additional utility of biofeedback breathing in augmenting physiological recovery from psychological stress. ", doi="10.2196/12227", url="https://formative.jmir.org/2019/1/e12227/", url="http://www.ncbi.nlm.nih.gov/pubmed/30684437" } @Article{info:doi/10.2196/11124, author="Storm, Vera and Reinwand, Alexandra Dominique and Wienert, Julian and Tan, Shu-Ling and Lippke, Sonia", title="The Mediating Role of Perceived Social Support Between Physical Activity Habit Strength and Depressive Symptoms in People Seeking to Decrease Their Cardiovascular Risk: Cross-Sectional Study", journal="JMIR Ment Health", year="2018", month="Nov", day="14", volume="5", number="4", pages="e11124", keywords="physical activity", keywords="habit", keywords="social support", keywords="depressive symptoms", keywords="cardiac diseases", abstract="Background: Regular physical activity treatment has been advocated for the prevention and rehabilitation of patients at risk of cardiovascular diseases and depressive symptoms. How physical activity is related to depressive symptoms is widely discussed. Objective: The aim of this internet-based study was to investigate the role of perceived social support in the relationship between physical activity habit strength and depressive symptoms. Methods: In total, 790 participants (mean 50.9 years, SD 12.2, range 20-84 years) who were interested in reducing their cardiovascular risk were recruited in Germany and the Netherlands. Data collection was conducted via an internet-based questionnaire addressing physical activity habit strength, depressive symptoms, and perceived social support. Cross-sectional data analysis was done with SPSS version 24 using the Macro PROCESS version 2 16.3 by Hayes with bootstrapping (10,000 samples), providing 95\% CIs. Results: Physical activity habit strength was negatively related to depressive symptoms (r=--.13, P=.006), but this interrelation disappeared when controlling for perceived social support (beta=--.14, SE 0.09, P=.11). However, there was an indirect relationship between physical activity habit strength and depressive symptoms, which was mediated via perceived social support (beta=--.13; SE 0.04, 95\% CI --0.21 to 0.06). The negative relationship between physical activity habit strength and depressive symptoms was fully mediated by perceived social support. Conclusions: We suggest that physical activity treatment in people interested in reducing their cardiovascular risk should also embed social support to target depressive symptoms. Internet-based interventions and electronic health may provide a good option for doing so. Trial Registration: ClinicalTrials.gov NCT01909349; https://clinicaltrials.gov/ct2/show/NCT01909349 (Archived by WebCite at http://www.webcitation.org/73Y9RfdiY) ", doi="10.2196/11124", url="http://mental.jmir.org/2018/4/e11124/", url="http://www.ncbi.nlm.nih.gov/pubmed/30429112" } @Article{info:doi/10.2196/11289, author="Byrne, L. Jo and Dallosso, M. Helen and Rogers, Stephen and Gray, J. Laura and Waheed, Ghazala and Patel, Prashanth and Gupta, Pankaj and Doherty, Yvonne and Davies, Melanie and Khunti, Kamlesh", title="The Ready to Reduce Risk (3R) Study for a Group Educational Intervention With Telephone and Text Messaging Support to Improve Medication Adherence for the Primary Prevention of Cardiovascular Disease: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2018", month="Nov", day="12", volume="7", number="11", pages="e11289", keywords="medication adherence", keywords="cardiovascular diseases", keywords="primary prevention", keywords="educational intervention", keywords="telephone support", keywords="text messaging support", abstract="Background: Poor adherence to cardiovascular medications is associated with worse clinical outcomes. Evidence for effective education interventions that address medication adherence for the primary prevention of cardiovascular disease is lacking. The Ready to Reduce Risk (3R) study aims to investigate whether a complex intervention, involving group education plus telephone and text messaging follow-up support, can improve medication adherence and reduce cardiovascular risk. Objective: This protocol paper details the design and rationale for the development of the 3R intervention and the study methods used. Methods: This is an open and pragmatic randomized controlled trial with 12 months of follow-up. We recruited participants from primary care and randomly assigned them at a 1:1 frequency, stratified by sex and age, to either a control group (usual care from a general practitioner) or an intervention group involving 2 facilitated group education sessions with telephone and text messaging follow-up support, with a theoretical underpinning and using recognized behavioral change techniques. The primary outcome was medication adherence to statins. The primary measure was an objective, novel, urine-based biochemical measure of medication adherence. We also used the 8-item Morisky Medication Adherence Scale to assess medication adherence. Secondary outcomes were changes in total cholesterol, blood pressure, high-density lipoprotein, total cholesterol to high-density lipoprotein ratio, body mass index, waist to hip ratio, waist circumference, smoking behavior, physical activity, fruit and vegetable intake, patient activation level, quality of life, health status, health and medication beliefs, and overall cardiovascular disease risk score. We also considered process outcomes relating to acceptability and feasibility of the 3R intervention. Results: We recruited 212 participants between May 2015 and March 2017. The 12-month follow-up data collection clinics were completed in April 2018, and data analysis will commence once all study data have been collected and verified. Conclusions: This study will identify a potentially clinically useful and effective educational intervention for the primary prevention of cardiovascular disease. Medication adherence to statins is being assessed using a novel urine assay as an objective measure, in conjunction with other validated measures. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN16863160; http://www.isrctn.com/ISRCTN16863160 (Archived by WebCite at http://www.webcitation.org/734PqfdQw) International Registered Report Identifier (IRRID): DERR1-10.2196/11289 ", doi="10.2196/11289", url="http://www.researchprotocols.org/2018/11/e11289/", url="http://www.ncbi.nlm.nih.gov/pubmed/30425027" } @Article{info:doi/10.2196/10228, author="Thornton, Louise and Kay-Lambkin, Frances and Tebbutt, Bree and Hanstock, L. Tanya and Baker, L. Amanda", title="A Mobile Phone--Based Healthy Lifestyle Monitoring Tool for People With Mental Health Problems (MyHealthPA): Development and Pilot Testing", journal="JMIR Cardio", year="2018", month="Oct", day="1", volume="2", number="2", pages="e10228", keywords="telemedicine", keywords="mental health", keywords="cardiovascular diseases", keywords="mhealth", keywords="smartphone", keywords="mobile phone", abstract="Background: People with mental health disorders live, on average, 20 years less than those without, often because of poor physical health including cardiovascular disease (CVD). Evidence-based interventions are required to reduce this lifespan gap. Objective: This study aimed to develop, test, and evaluate a mobile phone--based lifestyle program (MyHealthPA) to help people with mental health problems improve key health risk behaviors and reduce their risk of CVD. Methods: The development of MyHealthPA occurred in 3 stages: (1) scoping of the literature, (2) a survey (n=251) among people with and without the experience of mental health problems, and (3) program development informed by stages 1 and 2. A small pilot trial among young people with and without mental health disorders was also conducted. Participants completed a baseline assessment and were given access to the MyHealthPA program for a period of 8 weeks. They were then asked to complete an end-of-treatment assessment and a follow-up assessment 1 month later. Results: In the study, 28 young people aged 19 to 25 years were recruited to the pilot trial. Of these, 12 (12/28, 43\%) had been previously diagnosed with a mental illness. Overall, 12 participants (12/28, 43\%) completed the end-of-treatment assessment and 6 (6/28, 21\%) completed the follow-up assessment. Small improvements in fruit and vegetable consumption, level of physical activity, alcohol use, and mood were found between baseline and end of treatment and follow-up, particularly among people with experience of mental health issues. Most participants (history of mental illness: 4/7, 57\%; no history of mental illness: 3/5, 60\%) reported the program had above average usability; however, only 29\% (2/7, no history of mental illness) to 40\% (2/5, history of mental illness) of participants reported that they would like to use the program frequently and would recommend it to other young people. Participants also identified a number of ways in which the program could be improved. Conclusions: This study describes the formative research and process of planning that formed the development of MyHealthPA and the evidence base underpinning the approach. The MyHealthPA program represents an innovative approach to CVD risk reduction among people with mental health problems. MyHealthPA appears to be an acceptable, easy-to-use, and potentially effective mHealth intervention to assist young people with mental illness to monitor risk factors for CVD. However, ways in which the program could be improved for future testing and dissemination were identified and discussed. ", doi="10.2196/10228", url="http://cardio.jmir.org/2018/2/e10228/", url="http://www.ncbi.nlm.nih.gov/pubmed/31758772" } @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/humanfactors.9030, author="DeJonckheere, Melissa and Robinson, H. Claire and Evans, Lindsey and Lowery, Julie and Youles, Bradley and Tremblay, Adam and Kelley, Caitlin and Sussman, B. Jeremy", title="Designing for Clinical Change: Creating an Intervention to Implement New Statin Guidelines in a Primary Care Clinic", journal="JMIR Hum Factors", year="2018", month="Apr", day="24", volume="5", number="2", pages="e19", keywords="cardiovascular disease", keywords="preventative medicine", keywords="clinical decision support", keywords="user-centered design", keywords="qualitative research", keywords="implementation", abstract="Background: Recent clinical practice guidelines from major national organizations, including a joint United States Department of Veterans Affairs (VA) and Department of Defense (DoD) committee, have substantially changed recommendations for the use of the cholesterol-lowering statin medications after years of relative stability. Because statin medications are among the most commonly prescribed treatments in the United States, any change in their use may have significant implications for patients and providers alike. Prior research has shown that effective implementation interventions should be both user centered and specifically chosen to address identified barriers. Objective: The objectives of this study were to identify potential determinants of provider uptake of the new statin guidelines and to use that information to tailor a coordinated and streamlined local quality improvement intervention focused on prescribing appropriate statins. Methods: We employed user-centered design principles to guide the development and testing of a multicomponent guideline implementation intervention to improve statin prescribing. This paper describes the intervention development process whereby semistructured qualitative interviews with providers were conducted to (1) illuminate the knowledge, attitudes, and behaviors of providers and (2) elicit feedback on intervention prototypes developed to align with and support the use of the VA/DoD guidelines. Our aim was to use this information to design a local quality improvement intervention focused on statin prescribing that was tailored to the needs of primary care providers at our facility. Cabana's Clinical Practice Guidelines Framework for Improvement and Nielsen's Usability Heuristics were used to guide the analysis of data obtained in the intervention development process. Results: Semistructured qualitative interviews were conducted with 15 primary care Patient Aligned Care Team professionals (13 physicians and 2 clinical pharmacists) at a single VA medical center. Findings highlight that providers were generally comfortable with the paradigm shift to risk-based guidelines but less clear on the need for the VA/DoD guidelines in specific. Providers preferred a clinical decision support tool that helped them calculate patient risk and guide their care without limiting autonomy. They were less comfortable with risk communication and performance measurement systems that do not account for shared decision making. When possible, we incorporated their recommendations into the intervention. Conclusions: By combining qualitative methods and user-centered design principles, we could inform the design of a multicomponent guideline implementation intervention to better address the needs and preferences of providers, including clear and direct language, logical decision prompts with an option to dismiss a clinical decision support tool, and logical ordering of feedback information. Additionally, this process allowed us to identify future design considerations for quality improvement interventions. ", doi="10.2196/humanfactors.9030", url="http://humanfactors.jmir.org/2018/2/e19/", url="http://www.ncbi.nlm.nih.gov/pubmed/29691206" } @Article{info:doi/10.2196/cardio.8718, author="McKenna, A. Rebecca and Rollo, E. Megan and Skinner, A. Janelle and Burrows, L. Tracy", title="Food Addiction Support: Website Content Analysis", journal="JMIR Cardio", year="2018", month="Apr", day="24", volume="2", number="1", pages="e10", keywords="food addiction", keywords="self-help groups", keywords="social support", abstract="Background: Food addiction has a long history; however, there has been a substantial increase in published literature and public media focus in the past decade. Food addiction has previously demonstrated an overlap with overweight and obesity, a risk for cardiovascular disease. This increased focus has led to the establishment of numerous support options for addictive eating behaviors, yet evidence-based support options are lacking. Objective: This study aimed to evaluate the availability and content of support options, accessible online, for food addiction. Methods: A standardized Web search was conducted using 4 search engines to identify current support availability for food addiction. Through use of a comprehensive data extraction sheet, 2 reviewers independently extracted data related to the program or intervention characteristics, and support fidelity including fundamentals, support modality, social support offered, program or intervention origins, member numbers, and program or intervention evaluation. Results: Of the 800 records retrieved, 13 (1.6\%, 13/800) websites met the inclusion criteria. All 13 websites reported originating in the United States, and 1 website reported member numbers. The use of credentialed health professionals was reported by only 3 websites, and 5 websites charged a fee-for-service. The use of the 12 steps or traditions was evident in 11 websites, and 9 websites described the use of food plans. In total, 6 websites stated obligatory peer support, and 11 websites featured spirituality as a main theme of delivery. Moreover, 12 websites described phone meetings as the main program delivery modality, with 7 websites stating face-to-face delivery and 4 opting for online meetings. Newsletters (n=5), closed social media groups (n=5), and retreat programs (n=5) were the most popular forms of social support. Conclusions: This is the first review to analyze online support options for food addiction. Very few online support options include health professionals, and a strengthening argument is forming for an increase in support options for food addiction. This review forms part of this argument by showing a lack of evidence-based options. By reviewing current support availability, it can provide a guide toward the future development of evidence-based support for food addiction. ", doi="10.2196/cardio.8718", url="http://cardio.jmir.org/2018/1/e10/", url="http://www.ncbi.nlm.nih.gov/pubmed/31758778" } @Article{info:doi/10.2196/resprot.8121, author="Giner-Soriano, Maria and Sotorra Figuerola, Gerard and Cort{\'e}s, Jordi and Pera Pujadas, Helena and Garcia-Sangenis, Ana and Morros, Rosa", title="Impact of Medication Adherence on Mortality and Cardiovascular Morbidity: Protocol for a Population-Based Cohort Study", journal="JMIR Res Protoc", year="2018", month="Mar", day="09", volume="7", number="3", pages="e73", keywords="cardiovascular diseases", keywords="coronary heart disease", keywords="acute coronary syndrome", keywords="adherence", keywords="aspirin", keywords="statins", keywords="beta-blockers", keywords="angiotensin-converting enzyme inhibitors", keywords="angiotensin-receptor blockers", abstract="Background: Cardiovascular disease (CVD) is a group of disorders of the heart and blood vessels, such as coronary heart disease (CHD), cerebrovascular disease, and peripheral artery disease. CVD is the leading threat to global health, whether measured by mortality, morbidity, or economic cost. Long-term administration of aspirin, statins, beta-blockers, and angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers improves survival in patients with stablished coronary heart disease. Nevertheless, adherence to prescribed medication is poor for long-term drug treatment. Objective: We aim to assess the relationship between adherences to the four pharmacological groups recommended for secondary prevention and the clinical outcomes of cardiovascular morbidity and mortality in patients with established CHD according to the level of adherence to these drugs in a population of incident cases of acute coronary syndrome (ACS). Methods: Population-based cohort study of patients with a first episode of ACS during 2006-2015 in the Information System for Research in Primary Care (SIDIAP) database. We will estimate adherence to these drugs. The primary endpoint is a composite of all-cause mortality, ACS, and ischaemic stroke. Bivariate analyses will be performed estimating odds ratios for categorical variables and mean differences for continuous variables. Hazard ratios for adherences will be calculated for outcome events using Cox proportional hazard regression models, and proportionality of hazards assumption will be tested. Results: We expect to estimate adherence to all four study treatments, the incidence of MACE, and to analyze if this incidence is associated with the level of drug adherence. Conclusions: We expect to find that adherent patients have a lower risk of the primary endpoints compared with nonadherent patients. Trial Registration: This study protocol was classified as EPA-OD by the AEMPS (IJG-EST-2017-01-2017-01, 07/04/2017) and registered in the EU PAS register (EUPAS19017, 09/05/2017). ", doi="10.2196/resprot.8121", url="http://www.researchprotocols.org/2018/3/e73/", url="http://www.ncbi.nlm.nih.gov/pubmed/29523501" }