@Article{info:doi/10.2196/24501, author="Lu{\vs}trek, Mitja and Bohanec, Marko and Cavero Barca, Carlos and Ciancarelli, Costanza Maria and Clays, Els and Dawodu, Adeyemo Amos and Derboven, Jan and De Smedt, Delphine and Dovgan, Erik and Lampe, Jure and Marino, Flavia and Mlakar, Miha and Pioggia, Giovanni and Puddu, Emilio Paolo and Rodr{\'i}guez, Mario Juan and Schiariti, Michele and Slapni{\v c}ar, Ga{\vs}per and Slegers, Karin and Tartarisco, Gennaro and Vali{\v c}, Jakob and Vodopija, Aljo{\vs}a", title="A Personal Health System for Self-Management of Congestive Heart Failure (HeartMan): Development, Technical Evaluation, and Proof-of-Concept Randomized Controlled Trial", journal="JMIR Med Inform", year="2021", month="Mar", day="5", volume="9", number="3", pages="e24501", keywords="congestive heart failure", keywords="personal health system", keywords="mobile application", keywords="mobile phone", keywords="wearable electronic devices", keywords="decision support techniques", keywords="psychological support", keywords="human centered design", abstract="Background: Congestive heart failure (CHF) is a disease that requires complex management involving multiple medications, exercise, and lifestyle changes. It mainly affects older patients with depression and anxiety, who commonly find management difficult. Existing mobile apps supporting the self-management of CHF have limited features and are inadequately validated. Objective: The HeartMan project aims to develop a personal health system that would comprehensively address CHF self-management by using sensing devices and artificial intelligence methods. This paper presents the design of the system and reports on the accuracy of its patient-monitoring methods, overall effectiveness, and patient perceptions. Methods: A mobile app was developed as the core of the HeartMan system, and the app was connected to a custom wristband and cloud services. The system features machine learning methods for patient monitoring: continuous blood pressure (BP) estimation, physical activity monitoring, and psychological profile recognition. These methods feed a decision support system that provides recommendations on physical health and psychological support. The system was designed using a human-centered methodology involving the patients throughout development. It was evaluated in a proof-of-concept trial with 56 patients. Results: Fairly high accuracy of the patient-monitoring methods was observed. The mean absolute error of BP estimation was 9.0 mm Hg for systolic BP and 7.0 mm Hg for diastolic BP. The accuracy of psychological profile detection was 88.6\%. The F-measure for physical activity recognition was 71\%. The proof-of-concept clinical trial in 56 patients showed that the HeartMan system significantly improved self-care behavior (P=.02), whereas depression and anxiety rates were significantly reduced (P<.001), as were perceived sexual problems (P=.01). According to the Unified Theory of Acceptance and Use of Technology questionnaire, a positive attitude toward HeartMan was seen among end users, resulting in increased awareness, self-monitoring, and empowerment. Conclusions: The HeartMan project combined a range of advanced technologies with human-centered design to develop a complex system that was shown to help patients with CHF. More psychological than physical benefits were observed. Trial Registration: ClinicalTrials.gov NCT03497871; https://clinicaltrials.gov/ct2/history/NCT03497871. International Registered Report Identifier (IRRID): RR2-10.1186/s12872-018-0921-2 ", doi="10.2196/24501", url="https://medinform.jmir.org/2021/3/e24501", url="http://www.ncbi.nlm.nih.gov/pubmed/33666562" } @Article{info:doi/10.2196/26516, author="Jiang, Xinchan and Yao, Jiaqi and You, Hoi-Sze Joyce", title="Cost-effectiveness of a Telemonitoring Program for Patients With Heart Failure During the COVID-19 Pandemic in Hong Kong: Model Development and Data Analysis", journal="J Med Internet Res", year="2021", month="Mar", day="3", volume="23", number="3", pages="e26516", keywords="telemonitoring", keywords="mobile health", keywords="smartphone", keywords="heart failure", keywords="COVID-19", keywords="health care avoidance", keywords="cost-effectiveness", abstract="Background: The COVID-19 pandemic has caused patients to avoid seeking medical care. Provision of telemonitoring programs in addition to usual care has demonstrated improved effectiveness in managing patients with heart failure (HF). Objective: We aimed to examine the potential clinical and health economic outcomes of a telemonitoring program for management of patients with HF during the COVID-19 pandemic from the perspective of health care providers in Hong Kong. Methods: A Markov model was designed to compare the outcomes of a care under COVID-19 (CUC) group and a telemonitoring plus CUC group (telemonitoring group) in a hypothetical cohort of older patients with HF in Hong Kong. The model outcome measures were direct medical cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio. Sensitivity analyses were performed to examine the model assumptions and the robustness of the base-case results. Results: In the base-case analysis, the telemonitoring group showed a higher QALY gain (1.9007) at a higher cost (US \$15,888) compared to the CUC group (1.8345 QALYs at US \$15,603). Adopting US \$48,937/QALY (1 {\texttimes} the gross domestic product per capita of Hong Kong) as the willingness-to-pay threshold, telemonitoring was accepted as a highly cost-effective strategy, with an incremental cost-effective ratio of US \$4292/QALY. No threshold value was identified in the deterministic sensitivity analysis. In the probabilistic sensitivity analysis, telemonitoring was accepted as cost-effective in 99.22\% of 10,000 Monte Carlo simulations. Conclusions: Compared to the current outpatient care alone under the COVID-19 pandemic, the addition of telemonitoring-mediated management to the current care for patients with HF appears to be a highly cost-effective strategy from the perspective of health care providers in Hong Kong. ", doi="10.2196/26516", url="https://www.jmir.org/2021/3/e26516", url="http://www.ncbi.nlm.nih.gov/pubmed/33656440" } @Article{info:doi/10.2196/19465, author="Wei, S. Kevin and Ibrahim, E. Nasrien and Kumar, A. Ashok and Jena, Sidhant and Chew, Veronica and Depa, Michal and Mayanil, Namrata and Kvedar, C. Joseph and Gaggin, K. Hanna", title="Habits Heart App for Patient Engagement in Heart Failure Management: Pilot Feasibility Randomized Trial", journal="JMIR Mhealth Uhealth", year="2021", month="Jan", day="20", volume="9", number="1", pages="e19465", keywords="heart failure", keywords="smartphone application", keywords="heart failure management", abstract="Background: Due to the complexity and chronicity of heart failure, engaging yet simple patient self-management tools are needed. Objective: This study aimed to assess the feasibility and patient engagement with a smartphone app designed for heart failure. Methods: Patients with heart failure were randomized to intervention (smartphone with the Habits Heart App installed and Bluetooth-linked scale) or control (paper education material) groups. All intervention group patients were interviewed and monitored closely for app feasibility while receiving standard of care heart failure management by cardiologists. The Atlanta Heart Failure Knowledge Test, a quality of life survey (Kansas City Cardiomyopathy Questionnaire), and weight were assessed at baseline and final visits. Results: Patients (N=28 patients; intervention: n=15; control: n=13) with heart failure (with reduced ejection fraction: 15/28, 54\%; male: 20/28, 71\%, female: 8/28, 29\%; median age 63 years) were enrolled, and 82\% of patients (N=23; intervention: 12/15, 80\%; control: 11/13, 85\%) completed both baseline and final visits (median follow up 60 days). In the intervention group, 2 out of the 12 patients who completed the study did not use the app after study onboarding due to illnesses and hospitalizations. Of the remaining 10 patients who used the app, 5 patients logged ?1 interaction with the app per day on average, and 2 patients logged an interaction with the app every other day on average. The intervention group averaged 403 screen views (per patient) in 56 distinct sessions, 5-minute session durations, and 22 weight entries per patient. There was a direct correlation between duration of app use and improvement in heart failure knowledge (Atlanta Heart Failure Knowledge Test score; $\rho$=0.59, P=.04) and quality of life (Kansas City Cardiomyopathy Questionnaire score; $\rho$=0.63, P=.03). The correlation between app use and weight change was $\rho$=--0.40 (P=.19). Only 1 out of 11 patients in the control group retained education material by the follow-up visit. Conclusions: The Habits Heart App with a Bluetooth-linked scale is a feasible way to engage patients in heart failure management, and barriers to app engagement were identified. A larger multicenter study may be warranted to evaluate the effectiveness of the app. Trial Registration: ClinicalTrials.gov NCT03238729; http://clinicaltrials.gov/ct2/show/NCT03238729 ", doi="10.2196/19465", url="http://mhealth.jmir.org/2021/1/e19465/", url="http://www.ncbi.nlm.nih.gov/pubmed/33470941" } @Article{info:doi/10.2196/18496, author="Cartledge, Susie and Maddison, Ralph and Vogrin, Sara and Falls, Roman and Tumur, Odgerel and Hopper, Ingrid and Neil, Christopher", title="The Utility of Predicting Hospitalizations Among Patients With Heart Failure Using mHealth: Observational Study", journal="JMIR Mhealth Uhealth", year="2020", month="Dec", day="22", volume="8", number="12", pages="e18496", keywords="cardiac failure", keywords="heart failure", keywords="readmission", keywords="hospitalization", keywords="risk prediction", keywords="mHealth", abstract="Background: Heart failure decompensation is a major driver of hospitalizations and represents a significant burden to the health care system. Identifying those at greatest risk of admission can allow for targeted interventions to reduce this risk. Objective: This paper aims to compare the predictive value of objective and subjective heart failure respiratory symptoms on imminent heart failure decompensation and subsequent hospitalization within a 30-day period. Methods: A prospective observational pilot study was conducted. People living at home with heart failure were recruited from a single-center heart failure outpatient clinic. Objective (blood pressure, heart rate, weight, B-type natriuretic peptide) and subjective (4 heart failure respiratory symptoms scored for severity on a 5-point Likert scale) data were collected twice weekly for a 30-day period. Results: A total of 29 participants (median age 79 years; 18/29, 62\% men) completed the study. During the study period, 10 of the 29 participants (34\%) were hospitalized as a result of heart failure. For objective data, only heart rate exhibited a between-group difference. However, it was nonsignificant for variability (P=.71). Subjective symptom scores provided better prediction. Specifically, the highest precision of heart failure hospitalization was observed when patients with heart failure experienced severe dyspnea, orthopnea, and bendopnea on any given day (area under the curve of 0.77; sensitivity of 83\%; specificity of 73\%). Conclusions: The use of subjective respiratory symptom reporting on a 5-point Likert scale may facilitate a simple and low-cost method of predicting heart failure decompensation and imminent hospitalization. Serial collection of symptom data could be augmented using ecological momentary assessment of self-reported symptoms within a mobile health monitoring strategy for patients at high risk for heart failure decompensation. ", doi="10.2196/18496", url="http://mhealth.jmir.org/2020/12/e18496/", url="http://www.ncbi.nlm.nih.gov/pubmed/33350962" } @Article{info:doi/10.2196/20776, author="Gade, Dam Josefine and Spindler, Helle and Hollingdal, Malene and Refsgaard, Jens and Dittmann, Lars and Frost, Lars and Mahboubi, Kiomars and Dinesen, Birthe", title="Predictors of Walking Activity in Patients With Systolic Heart Failure Equipped With a Step Counter: Randomized Controlled Trial", journal="JMIR Biomed Eng", year="2020", month="Nov", day="30", volume="5", number="1", pages="e20776", keywords="heart failure", keywords="cardiovascular rehabilitation", keywords="step counters", keywords="physical activity", keywords="telerehabilitation", abstract="Background: Physical activity has been shown to decrease cardiovascular mortality and morbidity. Walking, a simple physical activity which is an integral part of daily life, is a feasible and safe activity for patients with heart failure (HF). A step counter, measuring daily walking activity, might be a motivational factor for increased activity. Objective: The aim of this study was to examine the association between walking activity and demographical and clinical data of patients with HF, and whether these associations could be used as predictors of walking activity. Methods: A total of 65 patients with HF from the Future Patient Telerehabilitation (FPT) program were included in this study. The patients monitored their daily activity using a Fitbit step counter for 1 year. This monitoring allowed for continuous and safe data transmission of self-monitored activity data. Results: A higher walking activity was associated with younger age, lower New York Heart Association (NYHA) classification, and higher ejection fraction (EF). There was a statistically significant correlation between the number of daily steps and NYHA classification at baseline (P=.01), between the increase in daily steps and EF at baseline (P<.001), and between the increase in daily steps and improvement in EF (P=.005). The patients' demographic, clinical, and activity data could predict 81\% of the variation in daily steps. Conclusions: This study demonstrated an association between demographic, clinical, and activity data for patients with HF that could predict daily steps. A step counter can thus be a useful tool to help patients monitor their own physical activity. Trial Registration: ClinicalTrials.gov NCT03388918; https://clinicaltrials.gov/ct2/show/NCT03388918 International Registered Report Identifier (IRRID): RR2-10.2196/14517 ", doi="10.2196/20776", url="http://biomedeng.jmir.org/2020/1/e20776/" } @Article{info:doi/10.2196/20571, author="Herkert, Cyrille and Kraal, Johannes Jos and Spee, Ferdinand Rudolph and Serier, Anouk and Graat-Verboom, Lidwien and Kemps, Clemens Hareld Marijn", title="Quality Assessment of an Integrated Care Pathway Using Telemonitoring in Patients with Chronic Heart Failure and Chronic Obstructive Pulmonary Disease: Protocol for a Quasi-Experimental Study", journal="JMIR Res Protoc", year="2020", month="Nov", day="19", volume="9", number="11", pages="e20571", keywords="chronic heart failure", keywords="chronic obstructive pulmonary disease", keywords="integrated care pathway", keywords="telemonitoring", abstract="Background: Chronic heart failure (CHF) and chronic obstructive pulmonary disease (COPD) often coexist and are associated with a high morbidity and reduced quality of life (QoL). Although these diseases share similarities in symptoms and clinical course, and exacerbations of both diseases often overlap, care pathways for both conditions are usually not integrated. This results in frequent outpatient consultations and suboptimal treatment during exacerbations, leading to frequent hospital admissions. Therefore, we propose an integrated care pathway for both diseases, using telemonitoring to detect deterioration at an early stage and a single case manager for both diseases. Objective: This study aims to investigate whether an integrated care pathway using telemonitoring in patients with combined CHF and COPD results in a higher general health-related QoL (HRQoL) as compared with the traditional care pathways. Secondary end points include disease-specific HRQoL, level of self-management, patient satisfaction, compliance to the program, and cost-effectiveness. Methods: This is a monocenter, prospective study using a quasi-experimental interrupted time series design. Thirty patients with combined CHF and COPD are included. The study period of 2.5 years per patient is divided into a preintervention phase (6 months) and a postintervention phase (2 years) in which end points are assessed. The intervention consists of an on-demand treatment strategy based on monitoring symptoms related to CHF/COPD and vital parameters (weight, blood pressure, heart rate, oxygen saturation, temperature), which are uploaded on a digital platform. The monitoring frequency and the limit values of the measurements to detect abnormalities are determined individually. Monitoring is performed by a case manager, who has the opportunity for a daily multidisciplinary meeting with both the cardiologist and the pulmonologist. Routine appointments at the outpatient clinic are cancelled and replaced by telemonitoring-guided treatment. Results: Following ethical approval of the study protocol, the first patient was included in May 2018. Inclusion is expected to be complete in May 2021. Conclusions: This study is the first to evaluate the effects of a novel integrated care pathway using telemonitoring for patients with combined CHF and COPD. Unique to this study is the concept of remote on-demand disease management by a single case manager for both diseases, combined with multidisciplinary meetings. Moreover, modern telemonitoring technology is used instead of, rather than as an addition to, regular care. Trial Registration: Netherlands Trial Register NL6741; https://www.trialregister.nl/trial/6741 International Registered Report Identifier (IRRID): DERR1-10.2196/20571 ", doi="10.2196/20571", url="https://www.researchprotocols.org/2020/11/e20571", url="http://www.ncbi.nlm.nih.gov/pubmed/33211017" } @Article{info:doi/10.2196/20032, author="Ding, Hang and Chen, Huey Sheau and Edwards, Iain and Jayasena, Rajiv and Doecke, James and Layland, Jamie and Yang, A. Ian and Maiorana, Andrew", title="Effects of Different Telemonitoring Strategies on Chronic Heart Failure Care: Systematic Review and Subgroup Meta-Analysis", journal="J Med Internet Res", year="2020", month="Nov", day="13", volume="22", number="11", pages="e20032", keywords="telehealth", keywords="telemonitoring", keywords="mobile health", keywords="chronic heart failure", keywords="systematic review", keywords="meta-analysis", abstract="Background: Telemonitoring studies in chronic heart failure are characterized by mixed mortality and hospitalization outcomes, which have deterred the uptake of telemonitoring in clinical practice. These mixed outcomes may reflect the diverse range of patient management strategies incorporated in telemonitoring. To address this, we compared the effects of different telemonitoring strategies on clinical outcomes. Objective: The aim of this systematic review and subgroup meta-analysis was to identify noninvasive telemonitoring strategies attributing to improvements in all-cause mortality or hospitalization outcomes for patients with chronic heart failure. Methods: We reviewed and analyzed telemonitoring strategies from randomized controlled trials (RCTs) comparing telemonitoring intervention with usual care. For each strategy, we examined whether RCTs that applied the strategy in the telemonitoring intervention (subgroup 1) resulted in a significantly lower risk ratio (RR) of all-cause mortality or incidence rate ratio (IRR) of all-cause hospitalization compared with RCTs that did not apply this strategy (subgroup 2). Results: We included 26 RCTs (N=11,450) incorporating 18 different telemonitoring strategies. RCTs that provided medication support were found to be associated with a significantly lower IRR value than RCTs that did not provide this type of support (P=.01; subgroup 1 IRR=0.83, 95\% CI 0.72-0.95 vs subgroup 2 IRR=1.02, 95\% CI 0.93-1.12). RCTs that applied mobile health were associated with a significantly lower IRR (P=.03; IRR=0.79, 95\% CI 0.64-0.96 vs IRR=1.00, 95\% CI 0.94-1.06) and RR (P=.01; RR=0.67, 95\% CI 0.53-0.85 vs RR=0.95, 95\% CI 0.84-1.07). Conclusions: Telemonitoring strategies involving medication support and mobile health were associated with improvements in all-cause mortality or hospitalization outcomes. These strategies should be prioritized in telemonitoring interventions for the management of patients with chronic heart failure. ", doi="10.2196/20032", url="http://www.jmir.org/2020/11/e20032/", url="http://www.ncbi.nlm.nih.gov/pubmed/33185554" } @Article{info:doi/10.2196/15885, author="Wali, Sahr and Keshavjee, Karim and Nguyen, Linda and Mbuagbaw, Lawrence and Demers, Catherine", title="Using an Electronic App to Promote Home-Based Self-Care in Older Patients With Heart Failure: Qualitative Study on Patient and Informal Caregiver Challenges", journal="JMIR Cardio", year="2020", month="Nov", day="9", volume="4", number="1", pages="e15885", keywords="mobile health", keywords="mobile apps", keywords="heart failure", keywords="self-care", keywords="mobile phone", abstract="Background: Heart failure (HF) affects many older individuals in North America, with recurrent hospitalizations despite postdischarge strategies to prevent readmission. Proper HF self-care can potentially lead to better clinical outcomes, yet many older patients find self-care challenging. Mobile health (mHealth) apps can provide support to patients with respect to HF self-care. However, many mHealth apps are not designed to consider potential patient barriers, such as literacy, numeracy, and cognitive impairment, leading to challenges for older patients. We previously demonstrated that a paper-based standardized diuretic decision support tool (SDDST) with daily weights and adjustment of diuretic dose led to improved self-care. Objective: The aim of this study is to better understand the self-care challenges that older patients with HF and their informal care providers (CPs) face on a daily basis, leading to the conversion of the SDDST into a user-centered mHealth app. Methods: We recruited 14 patients (male: 8/14, 57\%) with a confirmed diagnosis of HF, aged ?60 years, and 7 CPs from the HF clinic and the cardiology ward at the Hamilton General Hospital. Patients were categorized into 3 groups based on the self-care heart failure index: patients with adequate self-care, patients with inadequate self-care without a CP, or patients with inadequate self-care with a CP. We conducted semistructured interviews with patients and their CPs using persona-scenarios. Interviews were transcribed verbatim and analyzed for emerging themes using an inductive approach. Results: Six themes were identified: usability of technology, communication, app customization, complexity of self-care, usefulness of HF-related information, and long-term use and cost. Many of the challenges patients and CPs reported involved their unfamiliarity with technology and the lack of incentive for its use. However, participants were supportive and more likely to actively use the HF app when informed of the intervention's inclusion of volunteer and nurse assistance. Conclusions: Patients with varying self-care adequacy levels were willing to use an mHealth app if it was simple in its functionality and user interface. To promote the adoption and usability of these tools, patients confirmed the need for researchers to engage with end users before developing an app. Findings from this study can be used to help inform the design of an mHealth app to ensure that it is adapted for the needs of older individuals with HF. ", doi="10.2196/15885", url="http://cardio.jmir.org/2020/1/e15885/", url="http://www.ncbi.nlm.nih.gov/pubmed/33164901" } @Article{info:doi/10.2196/21962, author="Artanian, Veronica and Ross, J. Heather and Rac, E. Valeria and O'Sullivan, Mary and Brahmbhatt, H. Darshan and Seto, Emily", title="Impact of Remote Titration Combined With Telemonitoring on the Optimization of Guideline-Directed Medical Therapy for Patients With Heart Failure: Internal Pilot of a Randomized Controlled Trial", journal="JMIR Cardio", year="2020", month="Nov", day="3", volume="4", number="1", pages="e21962", keywords="telemonitoring", keywords="remote", keywords="titration", keywords="monitoring", keywords="mHealth", keywords="heart failure", abstract="Background: To improve health outcomes in patients with heart failure, guideline-directed medical therapy (GDMT) should be optimized to target doses. However, GDMT remains underutilized, with less than?25\% of patients receiving target doses in clinical practice. Telemonitoring could provide reliable and real-time physiological data for clinical decision support to facilitate remote GDMT titration. Objective: This paper aims to present findings from an internal pilot study regarding the effectiveness of remote titration facilitated by telemonitoring. Methods: A 2-arm randomized controlled pilot trial comparing remote titration versus standard care in a heart function clinic was conducted. Patients were randomized to undergo remote medication titration facilitated by data from a smartphone-based telemonitoring system or standard titration performed during clinic visits. Results: A total of 42 patients with new-onset (10/42, 24\%) and existing (32/42, 76\%) heart failure and a mean age of 55.29 (SD 11.28) years were randomized between January and June 2019. Within 6 months of enrollment, 86\% (18/21) of patients in the intervention group achieved optimal doses versus 48\% (10/21) of patients in the control group. The median time to dose optimization was 11.0 weeks for the intervention group versus 18.8 weeks for the control group. The number of in-person visits in the intervention group was 54.5\% lower than in the control group. Conclusions: The results of this pilot study suggest that remote titration facilitated by telemonitoring has the potential to increase the proportion of patients who achieve optimal GDMT doses, decrease time to dose optimization, and reduce the number of clinic visits. Remote titration may facilitate optimal and efficient titration of patients with heart failure while reducing the burden for patients to attend in-person clinic visits. Trial Registration: ClinicalTrials.gov NCT04205513; https://clinicaltrials.gov/ct2/show/NCT04205513 International Registered Report Identifier (IRRID): RR2-10.2196/preprints.19705 ", doi="10.2196/21962", url="http://cardio.jmir.org/2020/1/e21962/", url="http://www.ncbi.nlm.nih.gov/pubmed/33141094" } @Article{info:doi/10.2196/20747, author="Davoudi, Mahboube and Najafi Ghezeljeh, Tahereh and Vakilian Aghouee, Farveh", title="Effect of a Smartphone-Based App on the Quality of Life of Patients With Heart Failure: Randomized Controlled Trial", journal="JMIR Nursing", year="2020", month="Nov", day="2", volume="3", number="1", pages="e20747", keywords="heart failure", keywords="mobile app", keywords="quality of life", keywords="mobile phone", abstract="Background: Patients with heart failure have low quality of life because of physical impairments and advanced clinical symptoms. One of the main goals of caring for patients with heart failure is to improve their quality of life. Objective: The aim of this study was to investigate the effect of the use of a smartphone-based app on the quality of life of patients with heart failure. Methods: This randomized controlled clinical trial with a control group was conducted from June to October 2018 in an urban hospital. In this study, 120 patients with heart failure hospitalized in cardiac care units were randomly allocated to control and intervention groups. Besides routine care, patients in the intervention group received a smartphone-based app and used it every day for 3 months. Both the groups completed the Minnesota Living with Heart Failure Questionnaire before entering the study and at 3 months after entering the study. Data were analyzed using the SPSS software V.16. Results: The groups showed statistically significant differences in the mean scores of quality of life and its dimensions after the intervention, thereby indicating a better quality of life in the intervention group (P<.001). The effect size of the intervention on the quality of life was 1.85 (95\% CI 1.41-2.3). Moreover, the groups showed statistically significant differences in the changes in the quality of life scores and its dimensions (P<.001). Conclusions: Use of a smartphone-based app can improve the quality of life in patients with heart failure. The results of our study recommend that digital apps be used for improving the management of patients with heart failure. Trial Registration: Iranian Registry of Clinical Trials IRCT2017061934647N1; https://www.irct.ir/trial/26434 ", doi="10.2196/20747", url="https://nursing.jmir.org/2020/1/e20747" } @Article{info:doi/10.2196/19705, author="Artanian, Veronica and Rac, E. Valeria and Ross, J. Heather and Seto, Emily", title="Impact of Remote Titration Combined With Telemonitoring on the Optimization of Guideline-Directed Medical Therapy for Patients With Heart Failure: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2020", month="Oct", day="13", volume="9", number="10", pages="e19705", keywords="telemonitoring", keywords="telemedicine", keywords="remote titration", keywords="mHealth", keywords="heart failure", abstract="Background: Guideline-directed medical therapy (GDMT), optimized to maximum tolerated doses, has been shown to improve clinical outcomes in patients with heart failure (HF). Timely use and optimization of GDMT can improve HF symptoms, reduce the burden of hospitalization, and increase survival rates, whereas GDMT deferral may worsen the progression of HF, decrease survival rates, and predispose patients to poor outcomes. However, studies indicate that GDMT remains underused, with less than?25\% of patients receiving target doses in clinical practice. Telemonitoring is a potential component in the management of HF that can provide reliable and real-time physiological data for clinical decision support and facilitate remote titration of medication. Objective: The primary objective of this study is to evaluate the impact of remote titration facilitated by telemonitoring on health care outcomes, with a primary outcome measure being the proportion of patients achieving target doses. The secondary objective is to identify the barriers and facilitators that can affect the implementation and effectiveness of the intervention. Methods: A mixed methods study of a smartphone-based telemonitoring system is being conducted at the Peter Munk Cardiac Centre (PMCC), University Health Network, Toronto. The study is based on an effectiveness-implementation hybrid design and incorporates process evaluations alongside the assessment of clinical outcomes. The effectiveness research component is assessed by a two-arm randomized controlled trial (RCT) aiming to enroll 108 patients. The RCT compares a remote titration strategy that uses data from a smartphone-based telemonitoring system with a standard titration program consisting of in-office visits. The implementation research component consists of a qualitative study based on semistructured interviews with a purposive sample of clinicians and patients. Results: Patient recruitment began in January 2019 at PMCC, with a total of 76 participants recruited by February 24, 2020 (39 in the intervention group and 37 in the control group). The final analysis is expected to be completed by the winter of 2021. Conclusions: This study will be among the first to provide evidence on the implementation of remote titration facilitated by telemonitoring and its impact on patient health outcomes. The successful use of telemonitoring for this purpose has the potential to alter the existing approach to titration of HF medication and support the development of a care delivery model that combines clinic visits with virtual follow-ups. Trial Registration: ClinicalTrials.gov NCT04205513; https://clinicaltrials.gov/ct2/show/NCT04205513 International Registered Report Identifier (IRRID): DERR1-10.2196/19705 ", doi="10.2196/19705", url="https://www.researchprotocols.org/2020/10/e19705", url="http://www.ncbi.nlm.nih.gov/pubmed/33048057" } @Article{info:doi/10.2196/18917, author="Boodoo, Chris and Zhang, Qi and Ross, J. Heather and Alba, Carolina Ana and Laporte, Audrey and Seto, Emily", title="Evaluation of a Heart Failure Telemonitoring Program Through a Microsimulation Model: Cost-Utility Analysis", journal="J Med Internet Res", year="2020", month="Oct", day="6", volume="22", number="10", pages="e18917", keywords="cost utility analysis", keywords="cost effectiveness", keywords="telemedicine", keywords="heart failure", keywords="microsimulation", keywords="mobile phone", abstract="Background: Heart failure (HF) is a major public health issue in Canada that is associated with high prevalence, morbidity, and mortality rates and high financial and social burdens. Telemonitoring (TM) has been shown to improve all-cause mortality and hospitalization rates in patients with HF. The Medly program is a TM intervention integrated as standard of care at a large Canadian academic hospital for ambulatory patients with HF that has been found to improve patient outcomes. However, the cost-effectiveness of the Medly program is yet to be determined. Objective: This study aims to conduct a cost-utility analysis of the Medly program compared with the standard of care for HF in Ontario, Canada, from the perspective of the public health care payer. Methods: Using a microsimulation model, individual patient data were simulated over a 25-year time horizon to compare the costs and quality-adjusted life years (QALYs) between the Medly program and standard care for patients with HF treated in the ambulatory care setting. Data were sourced from a Medly Program Evaluation study and literature to inform model parameters, such as Medly's effectiveness in reducing mortality and hospitalizations, health care and intervention costs, and model transition probabilities. Scenario analyses were conducted in relation to HF severity and TM deployment models. One-way deterministic effectiveness analysis and probabilistic sensitivity analysis were performed to explore the impact on the results of uncertainty in model parameters. Results: The Medly program was associated with an average total cost of Can \$102,508 (US \$77,626) per patient and total QALYs of 5.51 per patient compared with the average cost of Can \$97,497 (US \$73,831) and QALYs of 4.95 per patient in the Standard Care Group. This led to an incremental cost of Can \$5011 (US \$3794) and incremental QALY of 0.566, resulting in an incremental cost-effectiveness ratio of Can \$8850 (US \$6701)/QALY. Cost-effectiveness improved in relation to patients with advanced HF and with deployment models in which patients used their own equipment. Baseline and alternative scenarios consistently showed probabilities of cost-effectiveness greater than 85\% at a willingness-to-pay threshold of Can \$50,000 (US \$37,718). Although the results showed some sensitivity to assumptions about effectiveness parameters, the intervention was found to remain cost-effective. Conclusions: The Medly program for patients with HF is cost-effective compared with standard care using commonly reported willingness-to-pay thresholds. This study provides evidence for decision makers on the use of TM for HF, supports the use of a nurse-led model of TM that embeds clinically validated algorithms, and informs the use of economic modeling for future evaluations of early-stage health informatics technology. ", doi="10.2196/18917", url="https://www.jmir.org/2020/10/e18917", url="http://www.ncbi.nlm.nih.gov/pubmed/33021485" } @Article{info:doi/10.2196/22118, author="Gordon, Kayleigh and Dainty, N. Katie and Steele Gray, Carolyn and DeLacy, Jane and Shah, Amika and Resnick, Myles and Seto, Emily", title="Experiences of Complex Patients With Telemonitoring in a Nurse-Led Model of Care: Multimethod Feasibility Study", journal="JMIR Nursing", year="2020", month="Sep", day="29", volume="3", number="1", pages="e22118", keywords="telemonitoring", keywords="adherence", keywords="patient experience", keywords="complex patients", keywords="normalization process theory", keywords="implementation", keywords="mobile phone", abstract="Background: Telemonitoring (TM) interventions have been designed to support care delivery and engage patients in their care at home, but little research exists on TM of complex chronic conditions (CCCs). Given the growing prevalence of complex patients, an evaluation of multi-condition TM is needed to expand TM interventions and tailor opportunities to manage complex chronic care needs. Objective: This study aims to evaluate the feasibility and patients' perceived usefulness of a multi-condition TM platform in a nurse-led model of care. Methods: A pragmatic, multimethod feasibility study was conducted with patients with heart failure (HF), hypertension (HTN), and/or diabetes. Patients were asked to take physiological readings at home via a smartphone-based TM app for 6 months. The recommended frequency of taking readings was dependent on the condition, and adherence data were obtained through the TM system database. Patient questionnaires were administered, and patient interviews were conducted at the end of the study. An inductive analysis was performed, and codes were then mapped to the normalization process theory and Implementation Outcomes constructs by Proctor. Results: In total, 26 participants were recruited, 17 of whom used the TM app for 6 months. Qualitative interviews were conducted with 14 patients, and 8 patients were interviewed with their informal caregiver present. Patient adherence was high, with patients with HF taking readings on average 76.6\% (141/184) of the days they were asked to use the system and patients with diabetes taking readings on average 72\% (19/26) of the days. The HTN adherence rate was 55\% (29/52) of the days they were asked to use the system. The qualitative findings of the patient experience can be grouped into 4 main themes and 13 subthemes. The main themes were (1) making sense of the purpose of TM, (2) engaging and investing in TM, (3) implementing and adopting TM, and (4) perceived usefulness and the perceived benefits of TM in CCCs. Conclusions: Multi-condition TM in nurse-led care was found to be feasible and was perceived as useful. Patients accepted and adopted the technology by demonstrating a moderate to high level of adherence across conditions. These results demonstrate how TM can address the needs of patients with CCCs through virtual TM assessments in a nurse-led care model by supporting patient self-care and keeping patients connected to their clinical team. ", doi="10.2196/22118", url="https://nursing.jmir.org/2020/1/e22118/" } @Article{info:doi/10.2196/20645, author="Li, Rui and Yin, Changchang and Yang, Samuel and Qian, Buyue and Zhang, Ping", title="Marrying Medical Domain Knowledge With Deep Learning on Electronic Health Records: A Deep Visual Analytics Approach", journal="J Med Internet Res", year="2020", month="Sep", day="28", volume="22", number="9", pages="e20645", keywords="electronic health records", keywords="interpretable deep learning", keywords="knowledge graph", keywords="visual analytics", abstract="Background: Deep learning models have attracted significant interest from health care researchers during the last few decades. There have been many studies that apply deep learning to medical applications and achieve promising results. However, there are three limitations to the existing models: (1) most clinicians are unable to interpret the results from the existing models, (2) existing models cannot incorporate complicated medical domain knowledge (eg, a disease causes another disease), and (3) most existing models lack visual exploration and interaction. Both the electronic health record (EHR) data set and the deep model results are complex and abstract, which impedes clinicians from exploring and communicating with the model directly. Objective: The objective of this study is to develop an interpretable and accurate risk prediction model as well as an interactive clinical prediction system to support EHR data exploration, knowledge graph demonstration, and model interpretation. Methods: A domain-knowledge--guided recurrent neural network (DG-RNN) model is proposed to predict clinical risks. The model takes medical event sequences as input and incorporates medical domain knowledge by attending to a subgraph of the whole medical knowledge graph. A global pooling operation and a fully connected layer are used to output the clinical outcomes. The middle results and the parameters of the fully connected layer are helpful in identifying which medical events cause clinical risks. DG-Viz is also designed to support EHR data exploration, knowledge graph demonstration, and model interpretation. Results: We conducted both risk prediction experiments and a case study on a real-world data set. A total of 554 patients with heart failure and 1662 control patients without heart failure were selected from the data set. The experimental results show that the proposed DG-RNN outperforms the state-of-the-art approaches by approximately 1.5\%. The case study demonstrates how our medical physician collaborator can effectively explore the data and interpret the prediction results using DG-Viz. Conclusions: In this study, we present DG-Viz, an interactive clinical prediction system, which brings together the power of deep learning (ie, a DG-RNN--based model) and visual analytics to predict clinical risks and visually interpret the EHR prediction results. Experimental results and a case study on heart failure risk prediction tasks demonstrate the effectiveness and usefulness of the DG-Viz system. This study will pave the way for interactive, interpretable, and accurate clinical risk predictions. ", doi="10.2196/20645", url="http://www.jmir.org/2020/9/e20645/", url="http://www.ncbi.nlm.nih.gov/pubmed/32985996" } @Article{info:doi/10.2196/18101, author="Portz, Dickman Jennifer and Ford, Lynett Kelsey and Elsbernd, Kira and Knoepke, E. Christopher and Flint, Kelsey and Bekelman, B. David and Boxer, S. Rebecca and Bull, Sheana", title="``I Like the Idea of It\ldotsBut Probably Wouldn't Use It'' - Health Care Provider Perspectives on Heart Failure mHealth: Qualitative Study", journal="JMIR Cardio", year="2020", month="Sep", day="4", volume="4", number="1", pages="e18101", keywords="heart failure", keywords="information technology", keywords="informatics", keywords="telemedicine", keywords="mHealth", abstract="Background: Many mobile health (mHealth) technologies exist for patients with heart failure (HF). However, HF mhealth lacks evidence of efficacy, caregiver involvement, and clinically useful real-time data. Objective: We aim to capture health care providers' perceived value of HF mHealth, particularly for pairing patient--caregiver-generated data with clinical intervention to inform the design of future HF mHealth. Methods: This study is a subanalysis of a larger qualitative study based on interviewing patients with HF, their caregivers, and health care providers. This analysis included interviews with health care providers (N=20), focusing on their perceived usefulness of HF mHealth tools and interventions. Results: A total of 5 themes emerged: (1) bio-psychosocial-spiritual monitoring, (2) use of sensors, (3) interoperability, (4) data sharing, and (5) usefulness of patient-reported outcomes in practice. Providers remain interested in mHealth technologies for HF patients and their caregivers. However, providers report being unconvinced of the clinical usefulness of robust real-time patient-reported outcomes. Conclusions: The use of assessments, sensors, and real-time data collection could provide value in patient care. Future research must continually explore how to maximize the utility of mHealth for HF patients, their caregivers, and health care providers. ", doi="10.2196/18101", url="http://cardio.jmir.org/2020/1/e18101/", url="http://www.ncbi.nlm.nih.gov/pubmed/32885785" } @Article{info:doi/10.2196/19892, author="Essay, Patrick and Balkan, Baran and Subbian, Vignesh", title="Decompensation in Critical Care: Early Prediction of Acute Heart Failure Onset", journal="JMIR Med Inform", year="2020", month="Aug", day="7", volume="8", number="8", pages="e19892", keywords="critical care", keywords="heart failure", keywords="intensive care units", keywords="machine learning", keywords="time series", keywords="heart", keywords="cardiology", keywords="prediction", keywords="chronic disease", keywords="ICU", keywords="intensive care unit", abstract="Background: Heart failure is a leading cause of mortality and morbidity worldwide. Acute heart failure, broadly defined as rapid onset of new or worsening signs and symptoms of heart failure, often requires hospitalization and admission to the intensive care unit (ICU). This acute condition is highly heterogeneous and less well-understood as compared to chronic heart failure. The ICU, through detailed and continuously monitored patient data, provides an opportunity to retrospectively analyze decompensation and heart failure to evaluate physiological states and patient outcomes. Objective: The goal of this study is to examine the prevalence of cardiovascular risk factors among those admitted to ICUs and to evaluate combinations of clinical features that are predictive of decompensation events, such as the onset of acute heart failure, using machine learning techniques. To accomplish this objective, we leveraged tele-ICU data from over 200 hospitals across the United States. Methods: We evaluated the feasibility of predicting decompensation soon after ICU admission for 26,534 patients admitted without a history of heart failure with specific heart failure risk factors (ie, coronary artery disease, hypertension, and myocardial infarction) and 96,350 patients admitted without risk factors using remotely monitored laboratory, vital signs, and discrete physiological measurements. Multivariate logistic regression and random forest models were applied to predict decompensation and highlight important features from combinations of model inputs from dissimilar data. Results: The most prevalent risk factor in our data set was hypertension, although most patients diagnosed with heart failure were admitted to the ICU without a risk factor. The highest heart failure prediction accuracy was 0.951, and the highest area under the receiver operating characteristic curve was 0.9503 with random forest and combined vital signs, laboratory values, and discrete physiological measurements. Random forest feature importance also highlighted combinations of several discrete physiological features and laboratory measures as most indicative of decompensation. Timeline analysis of aggregate vital signs revealed a point of diminishing returns where additional vital signs data did not continue to improve results. Conclusions: Heart failure risk factors are common in tele-ICU data, although most patients that are diagnosed with heart failure later in an ICU stay presented without risk factors making a prediction of decompensation critical. Decompensation was predicted with reasonable accuracy using tele-ICU data, and optimal data extraction for time series vital signs data was identified near a 200-minute window size. Overall, results suggest combinations of laboratory measurements and vital signs are viable for early and continuous prediction of patient decompensation. ", doi="10.2196/19892", url="http://medinform.jmir.org/2020/8/e19892/", url="http://www.ncbi.nlm.nih.gov/pubmed/32663162" } @Article{info:doi/10.2196/17703, author="Cornet, Philip Victor and Toscos, Tammy and Bolchini, Davide and Rohani Ghahari, Romisa and Ahmed, Ryan and Daley, Carly and Mirro, J. Michael and Holden, J. Richard", title="Untold Stories in User-Centered Design of Mobile Health: Practical Challenges and Strategies Learned From the Design and Evaluation of an App for Older Adults With Heart Failure", journal="JMIR Mhealth Uhealth", year="2020", month="Jul", day="21", volume="8", number="7", pages="e17703", keywords="user-centered design", keywords="research methods", keywords="mobile health", keywords="digital health", keywords="mobile apps", keywords="usability", keywords="technology", keywords="evaluation", keywords="human-computer interaction", keywords="mobile phone", abstract="Background: User-centered design (UCD) is a powerful framework for creating useful, easy-to-use, and satisfying mobile health (mHealth) apps. However, the literature seldom reports the practical challenges of implementing UCD, particularly in the field of mHealth. Objective: This study aims to characterize the practical challenges encountered and propose strategies when implementing UCD for mHealth. Methods: Our multidisciplinary team implemented a UCD process to design and evaluate a mobile app for older adults with heart failure. During and after this process, we documented the challenges the team encountered and the strategies they used or considered using to address those challenges. Results: We identified 12 challenges, 3 about UCD as a whole and 9 across the UCD stages of formative research, design, and evaluation. Challenges included the timing of stakeholder involvement, overcoming designers' assumptions, adapting methods to end users, and managing heterogeneity among stakeholders. To address these challenges, practical recommendations are provided to UCD researchers and practitioners. Conclusions: UCD is a gold standard approach that is increasingly adopted for mHealth projects. Although UCD methods are well-described and easily accessible, practical challenges and strategies for implementing them are underreported. To improve the implementation of UCD for mHealth, we must tell and learn from these traditionally untold stories. ", doi="10.2196/17703", url="http://mhealth.jmir.org/2020/7/e17703/", url="http://www.ncbi.nlm.nih.gov/pubmed/32706745" } @Article{info:doi/10.2196/17559, author="Ding, Hang and Jayasena, Rajiv and Chen, Huey Sheau and Maiorana, Andrew and Dowling, Alison and Layland, Jamie and Good, Norm and Karunanithi, Mohanraj and Edwards, Iain", title="The Effects of Telemonitoring on Patient Compliance With Self-Management Recommendations and Outcomes of the Innovative Telemonitoring Enhanced Care Program for Chronic Heart Failure: Randomized Controlled Trial", journal="J Med Internet Res", year="2020", month="Jul", day="8", volume="22", number="7", pages="e17559", keywords="heart failure", keywords="digital health", keywords="telemonitoring", keywords="remote monitoring", keywords="patient compliance", keywords="randomized controlled trial", abstract="Background: Telemonitoring enables care providers to remotely support outpatients in self-managing chronic heart failure (CHF), but the objective assessment of patient compliance with self-management recommendations has seldom been studied. Objective: This study aimed to evaluate patient compliance with self-management recommendations of an innovative telemonitoring enhanced care program for CHF (ITEC-CHF). Methods: We conducted a multicenter randomized controlled trial with a 6-month follow-up. The ITEC-CHF program comprised the provision of Bluetooth-enabled scales linked to a call center and nurse care services to assist participants with weight monitoring compliance. Compliance was defined a priori as weighing at least 4 days per week, analyzed objectively from weight recordings on the scales. The intention-to-treat principle was used to perform the analysis. Results: A total of 184 participants (141/184, 76.6\% male), with a mean age of 70.1 (SD 12.3) years, were randomized to receive either ITEC-CHF (n=91) or usual care (control; n=93), of which 67 ITEC-CHF and 81 control participants completed the intervention. For the compliance criterion of weighing at least 4 days per week, the proportion of compliant participants in the ITEC-CHF group was not significantly higher than that in the control group (ITEC-CHF: 67/91, 74\% vs control: 56/91, 60\%; P=.06). However, the proportion of ITEC-CHF participants achieving the stricter compliance standard of at least 6 days a week was significantly higher than that in the control group (ITEC-CHF: 41/91, 45\% vs control: 23/93, 25\%; P=.005). Conclusions: ITEC-CHF improved participant compliance with weight monitoring, although the withdrawal rate was high. Telemonitoring is a promising method for supporting both patients and clinicians in the management of CHF. However, further refinements are required to optimize this model of care. Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12614000916640; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366691 ", doi="10.2196/17559", url="https://www.jmir.org/2020/7/e17559", url="http://www.ncbi.nlm.nih.gov/pubmed/32673222" } @Article{info:doi/10.2196/17846, author="Jiang, Xinchan and Yao, Jiaqi and You, HS Joyce", title="Telemonitoring Versus Usual Care for Elderly Patients With Heart Failure Discharged From the Hospital in the United States: Cost-Effectiveness Analysis", journal="JMIR Mhealth Uhealth", year="2020", month="Jul", day="6", volume="8", number="7", pages="e17846", keywords="telemedicine", keywords="heart failure", keywords="hospitalization", keywords="cost", keywords="quality-adjusted life year", keywords="cost-effectiveness analysis", abstract="Background: Telemonitoring-guided interventional management reduces the need for hospitalization and mortality of patients with chronic heart failure (CHF). Objective: This study aimed to analyze the cost-effectiveness of usual care with and without telemonitoring-guided management in patients with CHF discharged from the hospital, from the perspective of US health care providers. Methods: A lifelong Markov model was designed to estimate outcomes of (1) usual care alone for all postdischarge patients with CHF (New York Heart Association [NYHA] class I-IV), (2) usual care and telemonitoring for all postdischarge patients with CHF, (3) usual care for all postdischarge patients with CHF and telemonitoring for patients with NYHA class III to IV, and (4) usual care for all postdischarge patients with CHF plus telemonitoring for patients with NYHA class II to IV. Model inputs were derived from the literature and public data. Sensitivity analyses were conducted to assess the robustness of model. The primary outcomes were total direct medical cost, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER). Results: In the base case analysis, universal telemonitoring group gained the highest QALYs (6.2967 QALYs), followed by the telemonitoring for NYHA class II to IV group (6.2960 QALYs), the telemonitoring for NYHA class III to IV group (6.2450 QALYs), and the universal usual care group (6.1530 QALYs). ICERs of the telemonitoring for NYHA class III to IV group (US \$35,393 per QALY) and the telemonitoring for NYHA class II to IV group (US \$38,261 per QALY) were lower than the ICER of the universal telemonitoring group (US \$100,458 per QALY). One-way sensitivity analysis identified five critical parameters: odds ratio of hospitalization for telemonitoring versus usual care, hazard ratio of all-cause mortality for telemonitoring versus usual care, CHF hospitalization cost and monthly outpatient costs for NYHA class I, and CHF hospitalization cost for NYHA class II. In probabilistic sensitivity analysis, probabilities of the universal telemonitoring, telemonitoring for NYHA class II to IV, telemonitoring for NYHA class III to IV, and universal usual care groups to be accepted as cost-effective at US \$50,000 per QALY were 2.76\%, 76.31\%, 18.6\%, and 2.33\%, respectively. Conclusions: Usual care for all discharged patients with CHF plus telemonitoring-guided management for NYHA class II to IV patients appears to be the preferred cost-effective strategy. ", doi="10.2196/17846", url="https://mhealth.jmir.org/2020/7/e17846", url="http://www.ncbi.nlm.nih.gov/pubmed/32407288" } @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/10.2196/18378, author="Shaw, E. Sara and Seuren, Martinus Lucas and Wherton, Joseph and Cameron, Deborah and A'Court, Christine and Vijayaraghavan, Shanti and Morris, Joanne and Bhattacharya, Satyajit and Greenhalgh, Trisha", title="Video Consultations Between Patients and Clinicians in Diabetes, Cancer, and Heart Failure Services: Linguistic Ethnographic Study of Video-Mediated Interaction", journal="J Med Internet Res", year="2020", month="May", day="11", volume="22", number="5", pages="e18378", keywords="delivery of health care", keywords="physical examination", keywords="remote consultation", keywords="telemedicine", keywords="health communication", keywords="language", keywords="nonverbal communication", keywords="mobile phone", abstract="Background: Video-mediated clinical consultations offer potential benefits over conventional face-to-face in terms of access, convenience, and sometimes cost. The improved technical quality and dependability of video-mediated consultations has opened up the possibility for more widespread use. However, questions remain regarding clinical quality and safety. Video-mediated consultations are sometimes criticized for being not as good as face-to-face, but there has been little previous in-depth research on their interactional dynamics, and no agreement on what a good video consultation looks like. Objective: Using conversation analysis, this study aimed to identify and analyze the communication strategies through which video-mediated consultations are accomplished and to produce recommendations for patients and clinicians to improve the communicative quality of such consultations. Methods: We conducted an in-depth analysis of the clinician-patient interaction in a sample of video-mediated consultations and a comparison sample of face-to-face consultations drawn from 4 clinical settings across 2 trusts (1 community and 1 acute care) in the UK National Health Service. The video dataset consisted of 37 recordings of video-mediated consultations (with diabetes, antenatal diabetes, cancer, and heart failure patients), 28 matched audio recordings of face-to-face consultations, and fieldnotes from before and after each consultation. We also conducted 37 interviews with staff and 26 interviews with patients. Using linguistic ethnography (combining analysis of communication with an appreciation of the context in which it takes place), we examined in detail how video interaction was mediated by 2 software platforms (Skype and FaceTime). Results: Patients had been selected by their clinician as appropriate for video-mediated consultation. Most consultations in our sample were technically and clinically unproblematic. However, we identified 3 interactional challenges: (1) opening the video consultation, (2) dealing with disruption to conversational flow (eg, technical issues with audio and/or video), and (3) conducting an examination. Operational and technological issues were the exception rather than the norm. In all but 1 case, both clinicians and patients (deliberately or intuitively) used established communication strategies to successfully negotiate these challenges. Remote physical examinations required the patient (and, in some cases, a relative) to simultaneously follow instructions and manipulate technology (eg, camera) to make it possible for the clinician to see and hear adequately. Conclusions: A remote video link alters how patients and clinicians interact and may adversely affect the flow of conversation. However, our data suggest that when such problems occur, clinicians and patients can work collaboratively to find ways to overcome them. There is potential for a limited physical examination to be undertaken remotely with some patients and in some conditions, but this appears to need complex interactional work by the patient and/or their relatives. We offer preliminary guidance for patients and clinicians on what is and is not feasible when consulting via a video link. International Registered Report Identifier (IRRID): RR2-10.2196/10913 ", doi="10.2196/18378", url="http://www.jmir.org/2020/5/e18378/", url="http://www.ncbi.nlm.nih.gov/pubmed/32391799" } @Article{info:doi/10.2196/17142, author="Heiney, P. Sue and Donevant, B. Sara and Arp Adams, Swann and Parker, D. Pearman and Chen, Hongtu and Levkoff, Sue", title="A Smartphone App for Self-Management of Heart Failure in Older African Americans: Feasibility and Usability Study", journal="JMIR Aging", year="2020", month="Apr", day="3", volume="3", number="1", pages="e17142", keywords="heart failure", keywords="mobile health app", keywords="self-management", abstract="Background: Mobile health (mHealth) apps are dramatically changing how patients and providers manage and monitor chronic health conditions, especially in the area of self-monitoring. African Americans have higher mortality rates from heart failure than other racial groups in the United States. Therefore, self-management of heart failure may improve health outcomes for African American patients. Objective: The aim of the present study was to determine the feasibility of using an mHealth app, and explore the outcomes of quality of life, including self-care maintenance, management, and confidence, among African American patients managing their condition after discharge with a diagnosis of heart failure. Methods: Prior to development of the app, we conducted qualitative interviews with 7 African American patients diagnosed with heart failure, 3 African American patients diagnosed with cardiovascular disease, and 6 health care providers (cardiologists, nurse practitioners, and a geriatrician) who worked with heart failure patients. In addition, we asked 6 hospital chaplains to provide positive spiritual messages for the patients, since spirituality is an important coping method for many African Americans. These formative data were then used for creating a prototype of the app, named Healthy Heart. Specifically, the Healthy Heart app incorporated the following evidence-based features to promote self-management: one-way messages, journaling (ie, weight and symptoms), graphical display of data, and customized feedback (ie, clinical decision support) based on daily or weekly weight. The educational messages about heart failure self-management were derived from the teaching materials provided to the patients diagnosed with heart failure, and included information on diet, sleep, stress, and medication adherence. The information was condensed and simplified to be appropriate for text messages and to meet health literacy standards. Other messages were derived from interviews conducted during the formative stage of app development, including interviews with African American chaplains. Usability testing was conducted over a series of meetings between nurses, social workers, and computer engineers. A pilot one-group pretest-posttest design was employed with participants using the mHealth app for 4 weeks. Descriptive statistics were computed for each of the demographic variables, overall and subscales for Health Related Quality of Life Scale 14 (HQOL14) and subscales for the Self-Care of Heart Failure Index (SCHFI) Version 6 using frequencies for categorical measures and means with standard deviations for continuous measures. Baseline and postintervention comparisons were computed using the Fisher exact test for overall health and paired t tests for HQOL14 and SCHFI questionnaire subscales. Results: A total of 12 African American participants (7 men, 5 women; aged 51-69 years) diagnosed with heart failure were recruited for the study. There was no significant increase in quality of life (P=.15), but clinically relevant changes in self-care maintenance, management, and confidence were observed. Conclusions: An mHealth app to assist with the self-management of heart failure is feasible in patients with low literacy, low health literacy, and limited smartphone experience. Based on the clinically relevant changes observed in this feasibility study of the Healthy Heart app, further research should explore effectiveness in this vulnerable population. ", doi="10.2196/17142", url="http://aging.jmir.org/2020/1/e17142/", url="http://www.ncbi.nlm.nih.gov/pubmed/32242822" } @Article{info:doi/10.2196/12141, author="Smeets, P. Christophe J. and Lee, Seulki and Groenendaal, Willemijn and Squillace, Gabriel and Vranken, Julie and De Canni{\`e}re, H{\'e}l{\`e}ne and Van Hoof, Chris and Grieten, Lars and Mullens, Wilfried and Nijst, Petra and Vandervoort, M. Pieter", title="The Added Value of In-Hospital Tracking of the Efficacy of Decongestion Therapy and Prognostic Value of a Wearable Thoracic Impedance Sensor in Acutely Decompensated Heart Failure With Volume Overload: Prospective Cohort Study", journal="JMIR Cardio", year="2020", month="Mar", day="18", volume="4", number="1", pages="e12141", keywords="congestive heart failure", keywords="electric impedance", keywords="prognosis", abstract="Background: Incomplete relief of congestion in acute decompensated heart failure (HF) is related to poor outcomes. However, congestion can be difficult to evaluate, stressing the urgent need for new objective approaches. Due to its inverse correlation with tissue hydration, continuous bioimpedance monitoring might be an effective method for serial fluid status assessments. Objective: This study aimed to determine whether in-hospital bioimpedance monitoring can be used to track fluid changes (ie, the efficacy of decongestion therapy) and the relationships between bioimpedance changes and HF hospitalization and all-cause mortality. Methods: A wearable bioimpedance monitoring device was used for thoracic impedance measurements. Thirty-six patients with signs of acute decompensated HF and volume overload were included. Changes in the resistance at 80 kHz (R80kHz) were analyzed, with fluid balance (fluid in/out) used as a reference. Patients were divided into two groups depending on the change in R80kHz during hospitalization: increase in R80kHz or decrease in R80kHz. Clinical outcomes in terms of HF rehospitalization and all-cause mortality were studied at 30 days and 1 year of follow-up. Results: During hospitalization, R80kHz increased for 24 patients, and decreased for 12 patients. For the total study sample, a moderate negative correlation was found between changes in fluid balance (in/out) and relative changes in R80kHz during hospitalization (rs=-0.51, P<.001). Clinical outcomes at both 30 days and 1 year of follow-up were significantly better for patients with an increase in R80kHz. At 1 year of follow-up, 88\% (21/24) of patients with an increase in R80kHz were free from all-cause mortality, compared with 50\% (6/12) of patients with a decrease in R80kHz (P=.01); 75\% (18/24) and 25\% (3/12) were free from all-cause mortality and HF hospitalization, respectively (P=.01). A decrease in R80kHz resulted in a significant hazard ratio of 4.96 (95\% CI 1.82-14.37, P=.003) on the composite endpoint. Conclusions: The wearable bioimpedance device was able to track changes in fluid status during hospitalization and is a convenient method to assess the efficacy of decongestion therapy during hospitalization. Patients who do not show an improvement in thoracic impedance tend to have worse clinical outcomes, indicating the potential use of thoracic impedance as a prognostic parameter. ", doi="10.2196/12141", url="https://cardio.jmir.org/2020/1/e12141", url="http://www.ncbi.nlm.nih.gov/pubmed/32186520" } @Article{info:doi/10.2196/16694, author="Seuren, Martinus Lucas and Wherton, Joseph and Greenhalgh, Trisha and Cameron, Deborah and A'Court, Christine and Shaw, E. Sara", title="Physical Examinations via Video for Patients With Heart Failure: Qualitative Study Using Conversation Analysis", journal="J Med Internet Res", year="2020", month="Feb", day="20", volume="22", number="2", pages="e16694", keywords="remote consultation", keywords="telemedicine", keywords="videoconferencing", keywords="communication", keywords="language", keywords="linguistics", keywords="gestures", keywords="physical examination", abstract="Background: Video consultations are increasingly seen as a possible replacement for face-to-face consultations. Direct physical examination of the patient is impossible; however, a limited examination may be undertaken via video (eg, using visual signals or asking a patient to press their lower legs and assess fluid retention). Little is currently known about what such video examinations involve. Objective: This study aimed to explore the opportunities and challenges of remote physical examination of patients with heart failure using video-mediated communication technology. Methods: We conducted a microanalysis of video examinations using conversation analysis (CA), an established approach for studying the details of communication and interaction. In all, seven video consultations (using FaceTime) between patients with heart failure and their community-based specialist nurses were video recorded with consent. We used CA to identify the challenges of remote physical examination over video and the verbal and nonverbal communication strategies used to address them. Results: Apart from a general visual overview, remote physical examination in patients with heart failure was restricted to assessing fluid retention (by the patient or relative feeling for leg edema), blood pressure with pulse rate and rhythm (using a self-inflating blood pressure monitor incorporating an irregular heartbeat indicator and put on by the patient or relative), and oxygen saturation (using a finger clip device). In all seven cases, one or more of these examinations were accomplished via video, generating accurate biometric data for assessment by the clinician. However, video examinations proved challenging for all involved. Participants (patients, clinicians, and, sometimes, relatives) needed to collaboratively negotiate three recurrent challenges: (1) adequate design of instructions to guide video examinations (with nurses required to explain tasks using lay language and to check instructions were followed), (2) accommodation of the patient's desire for autonomy (on the part of nurses and relatives) in light of opportunities for involvement in their own physical assessment, and (3) doing the physical examination while simultaneously making it visible to the nurse (with patients and relatives needing adequate technological knowledge to operate a device and make the examination visible to the nurse as well as basic biomedical knowledge to follow nurses' instructions). Nurses remained responsible for making a clinical judgment of the adequacy of the examination and the trustworthiness of the data. In sum, despite significant challenges, selected participants in heart failure consultations managed to successfully complete video examinations. Conclusions: Video examinations are possible in the context of heart failure services. However, they are limited, time consuming, and challenging for all involved. Guidance and training are needed to support rollout of this new service model, along with research to understand if the challenges identified are relevant to different patients and conditions and how they can be successfully negotiated. ", doi="10.2196/16694", url="https://www.jmir.org/2020/2/e16694", url="http://www.ncbi.nlm.nih.gov/pubmed/32130133" } @Article{info:doi/10.2196/13513, author="Johansson, Marcia and Athilingam, Ponrathi", title="A Dual-Pronged Approach to Improving Heart Failure Outcomes: A Quality Improvement Project", journal="JMIR Aging", year="2020", month="Feb", day="10", volume="3", number="1", pages="e13513", keywords="heart failure", keywords="mobile messaging", keywords="structured telephone support", keywords="self-care management", keywords="medication adherence", keywords="quality improvement", abstract="Background: Presently, 6.5 million Americans are living with heart failure (HF). These patients are expected to follow a complex self-management regimen at home. Several demographic and psychosocial factors limit patients with HF in following the prescribed self-management recommendations at home. Poor self-care is associated with increased hospital readmissions. Under the Affordable Care Act, there are financial implications related to hospital readmissions for hospitals and programs such as the Program of All-Inclusive Care for the Elderly (PACE) in Pinellas County, Florida. Previous studies and systematic reviews demonstrated improvement in self-management and quality of life (QoL) in patients with HF with structured telephone support (STS) and SMS text messaging. Objective: This study aimed to evaluate the effects of STS and SMS on self-care, knowledge, medication adherence, and QoL of patients with HF. Methods: A prospective quality improvement project using a pre-post design was implemented. Data were collected at baseline, 30 days, and 3 months from 51 patients with HF who were enrolled in PACE in Pinellas County, Florida. All participants received STS and SMS for 30 days. The feasibility and sustained benefit of using STS and SMS was assessed at a 3-month follow-up. Results: A paired t test was used to compare the mean difference in HF outcomes at the baseline and 30-day follow-up, which demonstrated improved HF self-care maintenance (t49=0.66; P=.01), HF knowledge (t49=0.71; P=.01), medication adherence (t49=0.92; P=.01), and physical and mental health measured using Short-Form-12 (SF-12; t49=0.81; P=.01). The results also demonstrated the sustained benefit with improved HF self-care maintenance, self-care management, self-care confidence, knowledge, medication adherence, and physical and mental health (SF-12) at 3 months with P<.05 for all outcomes. Living status and social support had a strong correlation with HF outcomes. Younger participants (aged less than 65 years) performed extremely well compared with older adults. Conclusions: STS and SMS were feasible to use among PACE participants with sustained benefits at 3 months. Implementing STS and SMS may serve as viable options to improve HF outcomes. Improving outcomes with HF affects hospital systems and the agencies that monitor and provide care for outpatients and those in independent or assisted-living facilities. Investigating viable options and support for implementation will improve outcomes. ", doi="10.2196/13513", url="https://aging.jmir.org/2020/1/e13513" } @Article{info:doi/10.2196/16538, author="Ware, Patrick and Ross, J. Heather and Cafazzo, A. Joseph and Boodoo, Chris and Munnery, Mikayla and Seto, Emily", title="Outcomes of a Heart Failure Telemonitoring Program Implemented as the Standard of Care in an Outpatient Heart Function Clinic: Pretest-Posttest Pragmatic Study", journal="J Med Internet Res", year="2020", month="Feb", day="6", volume="22", number="2", pages="e16538", keywords="telemonitoring", keywords="telemedicine", keywords="virtual care", keywords="mHealth", keywords="heart failure", abstract="Background: Telemonitoring (TM) can improve heart failure (HF) outcomes by facilitating patient self-care and clinical decisions. The Medly program enables patients to use a mobile phone to record daily HF readings and receive personalized self-care messages generated by a clinically validated algorithm. The TM system also generates alerts, which are immediately acted upon by the patients' existing care team. This program has been operating for 3 years as part of the standard of care in an outpatient heart function clinic in Toronto, Canada. Objective: This study aimed to evaluate the 6-month impact of this TM program on health service utilization, clinical outcomes, quality of life (QoL), and patient self-care. Methods: This pragmatic quality improvement study employed a pretest-posttest design to compare 6-month outcome measures with those at program enrollment. The primary outcome was the number of HF-related hospitalizations. Secondary outcomes included all-cause hospitalizations, emergency department visits (HF related and all cause), length of stay (HF related and all cause), and visits to the outpatient clinic. Clinical outcomes included bloodwork (B-type natriuretic peptide [BNP], creatinine, and sodium), left ventricular ejection fraction, and predicted survival score using the Seattle Heart Failure Model. QoL was measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the 5-level EuroQol 5-dimensional questionnaire. Self-care was measured using the Self-Care of Heart Failure Index (SCHFI). The difference in outcome scores was analyzed using negative binomial distribution and Poisson regressions for the health service utilization outcomes and linear regressions for all other outcomes to control for key demographic and clinical variables. Results: Available data for 315 patients enrolled in the TM program between August 2016 and January 2019 were analyzed. A 50\% decrease in HF-related hospitalizations (incidence rate ratio [IRR]=0.50; P<.001) and a 24\% decrease in the number of all-cause hospitalizations (IRR=0.76; P=.02) were found when comparing the number of events 6 months after program enrollment with the number of events 6 months before enrollment. With regard to clinical outcomes at 6 months, a 59\% decrease in BNP values was found after adjusting for control variables. Moreover, 6-month MLHFQ total scores were 9.8 points lower than baseline scores (P<.001), representing a clinically meaningful improvement in HF-related QoL. Similarly, the MLHFQ physical and emotional subscales showed a decrease of 5.4 points (P<.001) and 1.5 points (P=.04), respectively. Finally, patient self-care after 6 months improved as demonstrated by a 7.8-point (P<.001) and 8.5-point (P=.01) increase in the SCHFI maintenance and management scores, respectively. No significant changes were observed in the remaining secondary outcomes. Conclusions: This study suggests that an HF TM program, which provides patients with self-care support and active monitoring by their existing care team, can reduce health service utilization and improve clinical, QoL, and patient self-care outcomes. ", doi="10.2196/16538", url="https://www.jmir.org/2020/2/e16538" } @Article{info:doi/10.2196/15445, author="Aamodt, Thon Ina and Lycholip, Edita and Celutkiene, Jelena and von Lueder, Thomas and Atar, Dan and Falk, S{\o}rum Ragnhild and Helles{\o}, Ragnhild and Jaarsma, Tiny and Str{\"o}mberg, Anna and Lie, Irene", title="Self-Care Monitoring of Heart Failure Symptoms and Lung Impedance at Home Following Hospital Discharge: Longitudinal Study", journal="J Med Internet Res", year="2020", month="Jan", day="7", volume="22", number="1", pages="e15445", keywords="heart failure", keywords="telemedicine", keywords="lung impedance", keywords="diary", keywords="self-care", keywords="prospective study", abstract="Background: Self-care is key to the daily management of chronic heart failure (HF). After discharge from hospital, patients may struggle to recognize and respond to worsening HF symptoms. Failure to monitor and respond to HF symptoms may lead to unnecessary hospitalizations. Objective: This study aimed to (1) determine the feasibility of lung impedance measurements and a symptom diary to monitor HF symptoms daily at home for 30 days following hospital discharge and (2) determine daily changes in HF symptoms of pulmonary edema, lung impedance measurements, and if self-care behavior improves over time when patients use these self-care monitoring tools. Methods: This study used a prospective longitudinal design including patients from cardiology wards in 2 university hospitals---one in Norway and one in Lithuania. Data on HF symptoms and pulmonary edema were collected from 10 participants (mean age 64.5 years; 90\% (9/10) male) with severe HF (New York Heart Association classes III and IV) who were discharged home after being hospitalized for an HF condition. HF symptoms were self-reported using the Memorial Symptom Assessment Scale for Heart Failure. Pulmonary edema was measured by participants using a noninvasive lung impedance monitor, the CardioSet Edema Guard Monitor. Informal caregivers aided the participants with the noninvasive measurements. Results: The prevalence and burden of shortness of breath varied from participants experiencing them daily to never, whereas lung impedance measurements varied for individual participants and the group participants, as a whole. Self-care behavior score improved significantly (P=.007) from a median of 56 (IQR range 22-75) at discharge to a median of 81 (IQR range 72-98) 30 days later. Conclusions: Noninvasive measurement of lung impedance daily and the use of a symptom diary were feasible at home for 30 days in HF patients. Self-care behavior significantly improved after 30 days of using a symptom diary and measuring lung impedance at home. Further research is needed to determine if daily self-care monitoring of HF signs and symptoms, combined with daily lung impedance measurements, may reduce hospital readmissions. ", doi="10.2196/15445", url="https://www.jmir.org/2020/1/e15445", url="http://www.ncbi.nlm.nih.gov/pubmed/31909717" } @Article{info:doi/10.2196/15045, author="Herkert, Cyrille and Kraal, Johannes Jos and van Loon, Agnes Eline Maria and van Hooff, Martijn and Kemps, Clemens Hareld Marijn", title="Usefulness of Modern Activity Trackers for Monitoring Exercise Behavior in Chronic Cardiac Patients: Validation Study", journal="JMIR Mhealth Uhealth", year="2019", month="Dec", day="19", volume="7", number="12", pages="e15045", keywords="cardiac diseases", keywords="activity trackers", keywords="energy metabolism", keywords="physical activity", keywords="validation studies", abstract="Background: Improving physical activity (PA) is a core component of secondary prevention and cardiac (tele)rehabilitation. Commercially available activity trackers are frequently used to monitor and promote PA in cardiac patients. However, studies on the validity of these devices in cardiac patients are scarce. As cardiac patients are being advised and treated based on PA parameters measured by these devices, it is highly important to evaluate the accuracy of these parameters in this specific population. Objective: The aim of this study was to determine the accuracy and responsiveness of 2 wrist-worn activity trackers, Fitbit Charge 2 (FC2) and Mio Slice (MS), for the assessment of energy expenditure (EE) in cardiac patients. Methods: EE assessed by the activity trackers was compared with indirect calorimetry (Oxycon Mobile [OM]) during a laboratory activity protocol. Two groups were assessed: patients with stable coronary artery disease (CAD) with preserved left ventricular ejection fraction (LVEF) and patients with heart failure with reduced ejection fraction (HFrEF). Results: A total of 38 patients were included: 19 with CAD and 19 with HFrEF (LVEF 31.8\%, SD 7.6\%). The CAD group showed no significant difference in total EE between FC2 and OM (47.5 kcal, SD 112 kcal; P=.09), in contrast to a significant difference between MS and OM (88 kcal, SD 108 kcal; P=.003). The HFrEF group showed significant differences in EE between FC2 and OM (38 kcal, SD 57 kcal; P=.01), as well as between MS and OM (106 kcal, SD 167 kcal; P=.02). Agreement of the activity trackers was low in both groups (CAD: intraclass correlation coefficient [ICC] FC2=0.10, ICC MS=0.12; HFrEF: ICC FC2=0.42, ICC MS=0.11). The responsiveness of FC2 was poor, whereas MS was able to detect changes in cycling loads only. Conclusions: Both activity trackers demonstrated low accuracy in estimating EE in cardiac patients and poor performance to detect within-patient changes in the low-to-moderate exercise intensity domain. Although the use of activity trackers in cardiac patients is promising and could enhance daily exercise behavior, these findings highlight the need for population-specific devices and algorithms. ", doi="10.2196/15045", url="http://mhealth.jmir.org/2019/12/e15045/", url="http://www.ncbi.nlm.nih.gov/pubmed/31855191" } @Article{info:doi/10.2196/13229, author="Guo, Xiaorong and Gu, Xiang and Jiang, Jiang and Li, Hongxiao and Duan, Ruoyu and Zhang, Yi and Sun, Lei and Bao, Zhengyu and Shen, Jianhua and Chen, Fukun", title="A Hospital-Community-Family--Based Telehealth Program for Patients With Chronic Heart Failure: Single-Arm, Prospective Feasibility Study", journal="JMIR Mhealth Uhealth", year="2019", month="Dec", day="13", volume="7", number="12", pages="e13229", keywords="telehealth", keywords="chronic heart failure", keywords="feasibility studies", keywords="precise follow-up", keywords="self-management", abstract="Background: An increasing number of patients with chronic heart failure (CHF) are demanding more convenient and efficient modern health care systems, especially in remote areas away from central cities. Telehealth is receiving increasing attention, which may be useful to patients with CHF. Objective: This study aimed to evaluate the feasibility of a hospital-community-family (HCF)--based telehealth program, which was designed to implement remote hierarchical management in patients with CHF. Methods: This was a single-arm prospective study in which 70 patients with CHF participated in the HCF-based telehealth program for remote intervention for at least 4 months. The participants were recruited from the clinic and educated on the use of smart health tracking devices and mobile apps to collect and manually upload comprehensive data elements related to the risk of CHF self-care management. They were also instructed on how to use the remote platform and mobile app to send text messages, check notifications, and open video channels. The general practitioners viewed the index of each participant on the mobile app and provided primary care periodically, and cardiologists in the regional central hospital offered remote guidance, if necessary. The assessed outcomes included accomplishments of the program, usability and satisfaction, engagement with the intervention, and changes of heart failure--related health behaviors. Results: As of February 2018, a total of 66 individuals, aged 40-79 years, completed the 4-month study. Throughout the study period, 294 electronic medical records were formed on the remote monitoring service platform. In addition, a total of 89 remote consultations and 196 remote ward rounds were conducted. Participants indicated that they were generally satisfied with the intervention for its ease of use and usefulness. More than 91\% (21/23) of physicians believed the program was effective, and 87\% (20/23) of physicians stated that their professional knowledge could always be refreshed and enhanced through a library hosted on the platform and remote consultation. More than 60\% (40/66) of participants showed good adherence to the care plan in the study period, and 79\% (52/66) of patients maintained a consistent pattern of reporting and viewing their data over the course of the 4-month follow-up period. The program showed a positive effect on self-management for patients (healthy diet: P=.046, more fruit and vegetable intake: P=.02, weight monitoring: P=.002, blood pressure: P<.001, correct time: P=.049, and daily dosages of medicine taken: P=.006). Conclusions: The HCF-based telehealth program is feasible and provided researchers with evidence of remote hierarchical management for patients with CHF, which can enhance participants' and their families' access and motivation to engage in self-management. Further prospective studies with a larger sample size are necessary to confirm the program's effectiveness. ", doi="10.2196/13229", url="https://mhealth.jmir.org/2019/12/e13229", url="http://www.ncbi.nlm.nih.gov/pubmed/31833835" } @Article{info:doi/10.2196/13353, author="Park, Christopher and Otobo, Emamuzo and Ullman, Jennifer and Rogers, Jason and Fasihuddin, Farah and Garg, Shashank and Kakkar, Sarthak and Goldstein, Marni and Chandrasekhar, Vishudhi Sai and Pinney, Sean and Atreja, Ashish", title="Impact on Readmission Reduction Among Heart Failure Patients Using Digital Health Monitoring: Feasibility and Adoptability Study", journal="JMIR Med Inform", year="2019", month="Nov", day="15", volume="7", number="4", pages="e13353", keywords="heart failure", keywords="blood pressure", keywords="body weight", keywords="mHealth", keywords="remote consultation", keywords="patient care management", keywords="patient readmission", keywords="cell phone", keywords="mobile phone", keywords="blood pressure monitors", keywords="mobile apps", abstract="Background: Heart failure (HF) is a condition that affects approximately 6.2 million people in the United States and has a 5-year mortality rate of approximately 42\%. With the prevalence expected to exceed 8 million cases by 2030, projections estimate that total annual HF costs will increase to nearly US \$70 billion. Recently, the advent of remote monitoring technology has significantly broadened the scope of the physician's reach in chronic disease management. Objective: The goal of our program, named the Heart Health Program, was to examine the feasibility of using digital health monitoring in real-world home settings, ascertain patient adoption, and evaluate impact on 30-day readmission rate. Methods: A digital medicine software platform developed at Mount Sinai Health System, called RxUniverse, was used to prescribe a digital care pathway including the HealthPROMISE digital therapeutic and iHealth mobile apps to patients' personal smartphones. Vital sign data, including blood pressure (BP) and weight, were collected through an ambulatory remote monitoring system that comprised a mobile app and complementary consumer-grade Bluetooth-connected smart devices (BP cuff and digital scale) that send data to the provider care teams. Care teams were alerted via a Web-based dashboard of abnormal patient BP and weight change readings, and further action was taken at the clinicians' discretion. We used statistical analyses to determine risk factors associated with 30-day all-cause readmission. Results: Overall, the Heart Health Program included 58 patients admitted to the Mount Sinai Hospital for HF. The 30-day hospital readmission rate was 10\% (6/58), compared with the national readmission rates of approximately 25\% and the Mount Sinai Hospital's average of approximately 23\%. Single marital status (P=.06) and history of percutaneous coronary intervention (P=.08) were associated with readmission. Readmitted patients were also less likely to have been previously prescribed angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers (P=.02). Notably, readmitted patients utilized the BP and weight monitors less than nonreadmitted patients, and patients aged younger than 70 years used the monitors more frequently on average than those aged over 70 years, though these trends did not reach statistical significance. The percentage of the 58 patients using the monitors at least once dropped from 83\% (42/58) in the first week after discharge to 46\% (23/58) in the fourth week. Conclusions: Given the increasing burden of HF, there is a need for an effective and sustainable remote monitoring system for HF patients following hospital discharge. We identified clinical and social factors as well as remote monitoring usage trends that identify targetable patient populations that could benefit most from integration of daily remote monitoring. In addition, we demonstrated that interventions driven by real-time vital sign data may greatly aid in reducing hospital readmissions and costs while improving patient outcomes. ", doi="10.2196/13353", url="https://medinform.jmir.org/2019/4/e13353", url="http://www.ncbi.nlm.nih.gov/pubmed/31730039" } @Article{info:doi/10.2196/13173, author="Wali, Sahr and Demers, Catherine and Shah, Hiba and Wali, Huda and Lim, Delphine and Naik, Nirav and Ghany, Ahmad and Vispute, Ayushi and Wali, Maya and Keshavjee, Karim", title="Evaluation of Heart Failure Apps to Promote Self-Care: Systematic App Search", journal="JMIR Mhealth Uhealth", year="2019", month="Nov", day="11", volume="7", number="11", pages="e13173", keywords="mHealth", keywords="heart failure", keywords="self-care", keywords="mobile phone", abstract="Background: Heart failure (HF) is a chronic disease that affects over 1\% of Canadians and at least 26 million people worldwide. With the continued rise in disease prevalence and an aging population, HF-related costs are expected to create a significant economic burden. Many mobile health (mHealth) apps have been developed to help support patients' self-care in the home setting, but it is unclear if they are suited to the needs or capabilities of older adults. Objective: This study aimed to identify HF apps and evaluate whether they met the criteria for optimal HF self-care. Methods: We conducted a systematic search of all apps available exclusively for HF self-care across Google Play and the App Store. We then evaluated the apps according to a list of 25 major functions pivotal to promoting HF self-care for older adults. Results: A total of 74 apps for HF self-care were identified, but only 21 apps were listed as being both HF and self-care specific. None of the apps had all 25 of the listed features for an adequate HF self-care app, and only 41\% (31/74) apps had the key weight management feature present. HF Storylines received the highest functionality score (18/25, 72\%). Conclusions: Our findings suggest that currently available apps are not adequate for use by older adults with HF. This highlights the need for mHealth apps to refine their development process so that user needs and capabilities are identified during the design stage to ensure the usability of the app. ", doi="10.2196/13173", url="https://mhealth.jmir.org/2019/11/e13173", url="http://www.ncbi.nlm.nih.gov/pubmed/31710298" } @Article{info:doi/10.2196/14332, author="Sohn, Albert and Speier, William and Lan, Esther and Aoki, Kymberly and Fonarow, Gregg and Ong, Michael and Arnold, Corey", title="Assessment of Heart Failure Patients' Interest in Mobile Health Apps for Self-Care: Survey Study", journal="JMIR Cardio", year="2019", month="Oct", day="29", volume="3", number="2", pages="e14332", keywords="mHealth", keywords="patient-reported outcome", keywords="heart failure", keywords="self-care", keywords="patient monitoring", abstract="Background: Heart failure is a serious public health concern that afflicts millions of individuals in the United States. Development of behaviors that promote heart failure self-care may be imperative to reduce complications and avoid hospital re-admissions. Mobile health solutions, such as activity trackers and smartphone apps, could potentially help to promote self-care through remote tracking and issuing reminders. Objective: The objective of this study was to ascertain heart failure patients' interest in a smartphone app to assist them in managing their treatment and symptoms and to determine factors that influence their interest in such an app. Methods: In the clinic waiting room on the day of their outpatient clinic appointments, 50 heart failure patients participated in a self-administered survey. The survey comprised 139 questions from previously published, institutional review board--approved questionnaires. The survey measured patients' interest in and experience using technology as well as their function, heart failure symptoms, and heart failure self-care behaviors. The Minnesota Living with Heart Failure Questionnaire (MLHFQ) was among the 11 questionnaires and was used to measure the heart failure patients' health-related quality of life through patient-reported outcomes. Results: Participants were aged 64.5 years on average, 32\% (16/50) of the participants were women, and 91\% (41/45) of the participants were determined to be New York Heart Association Class II or higher. More than 60\% (30/50) of the survey participants expressed interest in several potential features of a smartphone app designed for heart failure patients. Participant age correlated negatively with interest in tracking, tips, and reminders in multivariate regression analysis (P<.05). In contrast, MLHFQ scores (worse health status) produced positive correlations with these interests (P<.05). Conclusions: The majority of heart failure patients showed interest in activity tracking, heart failure symptom management tips, and reminder features of a smartphone app. Desirable features and an understanding of factors that influence patient interest in a smartphone app for heart failure self-care may allow researchers to address common concerns and to develop apps that demonstrate the potential benefits of mobile technology. ", doi="10.2196/14332", url="https://cardio.jmir.org/2019/2/e14332", url="http://www.ncbi.nlm.nih.gov/pubmed/31758788" } @Article{info:doi/10.2196/14633, author="Woods, Leanna and Duff, Jed and Roehrer, Erin and Walker, Kim and Cummings, Elizabeth", title="Design of a Consumer Mobile Health App for Heart Failure: Findings From the Nurse-Led Co-Design of Care4myHeart", journal="JMIR Nursing", year="2019", month="Sep", day="23", volume="2", number="1", pages="e14633", keywords="heart failure", keywords="mobile health (mHealth)", keywords="mobile apps", keywords="self-management", keywords="mobile phone", keywords="patient involvement", abstract="Background: Consumer health care technology shows potential to improve outcomes for community-dwelling persons with chronic conditions, yet health app quality varies considerably. In partnership with patients and family caregivers, hospital clinicians developed Care4myHeart, a mobile health (mHealth) app for heart failure (HF) self-management. Objective: The aim of this paper was to report the outcomes of the nurse-led design process in the form of the features and functions of the developed app, Care4myHeart. Methods: Seven patients, four family caregivers, and seven multidisciplinary hospital clinicians collaborated in a design thinking process of innovation. The co-design process, involving interviews, design workshops, and prototype feedback sessions, incorporated the lived experience of stakeholders and evidence-based literature in a design that would be relevant and developed with rigor. Results: The home screen displays the priority HF self-management components with a reminder summary, general information on the condition, and a settings tab. The health management section allows patients to list health care team member's contact details, schedule medical appointments, and store documents. The My Plan section contains nine important self-management components with a combination of information and advice pages, graphical representation of patient data, feedback, and more. The greatest strength of the co-design process to achieve the design outcomes was the involvement of local patients, family caregivers, and clinicians. Moreover, incorporating the literature, guidelines, and current practices into the design strengthened the relevance of the app to the health care context. However, the strength of context specificity is also a limitation to portability, and the final design is limited to the stakeholders involved in its development. Conclusions: We recommend health app development teams strategically incorporate relevant stakeholders and literature to design mHealth solutions that are rigorously designed from a solid evidence base and are relevant to those who will use or recommend their use. ", doi="10.2196/14633", url="https://nursing.jmir.org/2019/1/e14633" } @Article{info:doi/10.2196/14517, author="Dinesen, Birthe and Dittmann, Lars and Gade, Dam Josefine and J{\o}rgensen, Klitgaard Cecilia and Hollingdal, Malene and Leth, Soeren and Melholt, Camilla and Spindler, Helle and Refsgaard, Jens", title="``Future Patient'' Telerehabilitation for Patients With Heart Failure: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2019", month="Sep", day="19", volume="8", number="9", pages="e14517", keywords="heart failure", keywords="telerehabilitation", keywords="research design", keywords="quality of life", keywords="patient education", keywords="user-driven innovation", abstract="Background: Cardiovascular disease is the leading cause of mortality worldwide, accounting for 13\%-15\% of all deaths. Cardiac rehabilitation has poor compliance and adherence. Telerehabilitation has been introduced to increase patients' participation, access, and adherence with the help of digital technologies. The target group is patients with heart failure. A telerehabilitation program called ``Future Patient'' has been developed and consists of three phases: (1) titration of medicine (0-3 months), (2) implementation of the telerehabilitation protocols (3 months), and (3) follow-up with rehabilitation in everyday life (6 months). Patients in the Future Patient program measure their blood pressure, pulse, weight, number of steps taken, sleep, and respiration and answer questions online regarding their well-being. All data are transmitted and accessed in the HeartPortal by patients and health care professionals. Objective: The aim of this paper is to describe the research design, outcome measures, and data collection techniques in the clinical test of the Future Patient Telerehabilitation Program for patients with heart failure. Methods: A randomized controlled study will be performed. The intervention group will follow the Future Patient Telerehabilitation program, and the control group will follow the traditional cardiac rehabilitation program. The primary outcome is quality of life measured by the Kansas City Cardiomyopathy Questionnaire. Secondary outcomes are development of clinical data; illness perception; motivation; anxiety and depression; health and electronic health literacy; qualitative exploration of patients', spouses', and health care professionals' experiences of participating in the telerehabilitation program; and a health economy evaluation of the program. Outcomes were assessed using questionnaires and through the data generated by digital technologies. Results: Data collection began in December 2016 and will be completed in October 2019. The study results will be published in peer-reviewed journals and presented at international conferences. Results from the Future Patient Telerehabilitation program are expected to be published by the spring of 2020. Conclusions: The expected outcomes are increased quality of life, increased motivation and illness perception, reduced anxiety and depressions, improved electronic health literacy, and health economics benefits. We expect the study to have a clinical impact for future telerehabilitation of patients with heart failure. Trial Registration: ClinicalTrials.gov NCT03388918; https://clinicaltrials.gov/ct2/show/NCT03388918 International Registered Report Identifier (IRRID): DERR1-10.2196/14517 ", doi="10.2196/14517", url="https://www.researchprotocols.org/2019/9/e14517", url="http://www.ncbi.nlm.nih.gov/pubmed/31538944" } @Article{info:doi/10.2196/12483, author="Meeker, Daniella and Goldberg, Jordan and Kim, K. Katherine and Peneva, Desi and Campos, Oliveira Hugo De and Maclean, Ross and Selby, Van and Doctor, N. Jason", title="Patient Commitment to Health (PACT-Health) in the Heart Failure Population: A Focus Group Study of an Active Communication Framework for Patient-Centered Health Behavior Change", journal="J Med Internet Res", year="2019", month="Aug", day="06", volume="21", number="8", pages="e12483", keywords="heart failure", keywords="behavioral economics", keywords="motivational interviewing", abstract="Background: Over 6 million Americans have heart failure, and 1 in 8 deaths included heart failure as a contributing cause in 2016. Lifestyle changes and adherence to diet and exercise regimens are important in limiting disease progression. Health coaching and public commitment are two interactive communication strategies that may improve self-management of heart failure. Objective: This study aimed to conduct patient focus groups to gain insight into how best to implement health coaching and public commitment strategies within the heart failure population. Methods: Focus groups were conducted in two locations. We studied 2 patients in Oakland, California, and 5 patients in Los Angeles, California. Patients were referred by local cardiologists and had to have a diagnosis of chronic heart failure. We used a semistructured interview tool to explore several patient-centered themes including medication adherence, exercise habits, dietary habits, goals, accountability, and rewards. We coded focus group data using the a priori coding criteria for these domains. Results: Medication adherence barriers included regimen complexity, forgetfulness, and difficulty coping with side effects. Participants reported that they receive little instruction from care providers on appropriate exercise and dietary habits. They also reported personal and social obstacles to achieving these objectives. Participants were in favor of structured goal setting, use of online social networks, and financial rewards as a means of promoting health lifestyles. Peers were viewed as better motivating agents than family members. Conclusions: An active communication framework involving dissemination of diet- and exercise-related health information, structured goal setting, peer accountability, and financial rewards appears promising in the management of heart failure. ", doi="10.2196/12483", url="http://www.jmir.org/2019/8/e12483/", url="http://www.ncbi.nlm.nih.gov/pubmed/31389339" } @Article{info:doi/10.2196/14142, author="Bogyi, Peter and Vamos, Mate and Bari, Zsolt and Polgar, Balazs and Muk, Balazs and Nyolczas, Noemi and Kiss, Gabor Robert and Duray, Zoltan Gabor", title="Association of Remote Monitoring With Survival in Heart Failure Patients Undergoing Cardiac Resynchronization Therapy: Retrospective Observational Study", journal="J Med Internet Res", year="2019", month="Jul", day="26", volume="21", number="7", pages="e14142", keywords="survival", keywords="CRT-D", keywords="remote monitoring", keywords="telemedicine", keywords="heart failure", abstract="Background: Remote monitoring is an established, guideline-recommended technology with unequivocal clinical benefits; however, its ability to improve survival is contradictory. Objective: The aim of our study was to investigate the effects of remote monitoring on mortality in an optimally treated heart failure patient population undergoing cardiac resynchronization defibrillator therapy (CRT-D) implantation in a large-volume tertiary referral center. Methods: The population of this single-center, retrospective, observational study included 231 consecutive patients receiving CRT-D devices in the Medical Centre of the Hungarian Defence Forces (Budapest, Hungary) from January 2011 to June 2016. Clinical outcomes were compared between patients on remote monitoring and conventional follow-up. Results: The mean follow-up time was 28.4 (SD 18.1) months. Patients on remote monitoring were more likely to have atrial fibrillation, received heart failure management at our dedicated heart failure outpatient clinic more often, and have a slightly lower functional capacity. Crude all-cause mortality of remote-monitored patients was significantly lower compared with patients followed conventionally (hazard ratio [HR] 0.368, 95\% CI 0.186-0.727, P=.004). The survival benefit remained statistically significant after adjustment for important baseline parameters (adjusted HR 0.361, 95\% CI 0.181-0.722, P=.004). Conclusions: In this single-center, retrospective study of optimally treated heart failure patients undergoing CRT-D implantation, the use of remote monitoring systems was associated with a significantly better survival rate. ", doi="10.2196/14142", url="http://www.jmir.org/2019/7/e14142/", url="http://www.ncbi.nlm.nih.gov/pubmed/31350836" } @Article{info:doi/10.2196/11722, author="Seto, Emily and Morita, Pelegrini Plinio and Tomkun, Jonathan and Lee, M. Theresa and Ross, Heather and Reid-Haughian, Cheryl and Kaboff, Andrew and Mulholland, Deb and Cafazzo, A. Joseph", title="Implementation of a Heart Failure Telemonitoring System in Home Care Nursing: Feasibility Study", journal="JMIR Med Inform", year="2019", month="Jul", day="26", volume="7", number="3", pages="e11722", keywords="patient monitoring", keywords="home care services", keywords="heart failure", keywords="mobile phone", keywords="feasibility studies", abstract="Background: Telemonitoring (TM) of heart failure (HF) patients in a clinic setting has been shown to be effective if properly implemented, but little is known about the feasibility and impact of implementing TM through a home care nursing agency. Objective: This study aimed to determine the feasibility of implementing a mobile phone--based TM system through a home care nursing agency and to explore the feasibility of conducting a future effectiveness trial. Methods: A feasibility study was conducted by recruiting, through community cardiologists and family physicians, 10 to 15 HF patients who would use the TM system for 4 months by taking daily measurements of weight and blood pressure and recording symptoms. Home care nurses responded to alerts generated by the TM system through either a phone call and/or a home visit. Patients and their clinicians were interviewed poststudy to determine their perceptions and experiences of using the TM system. Results: Only one community cardiologist was recruited who was willing to refer patients to this study, even after multiple attempts were made to recruit further physicians, including family physicians. The cardiologist referred only 6 patients over a 6-month period, and half of the patients dropped out of the study. The identified barriers to implementing the TM system in home care nursing were numerous and led to the small recruitment in patients and clinicians and large dropout rate. These barriers included challenges in nurses contacting patients and physicians, issues related to retention, and challenges related to integrating the TM system into a complex home care nursing workflow. However, some potential benefits of TM through a home care nursing agency were indicated, including improved patient education, providing nurses with a better understanding of the patient's health status, and reductions in home visits. Conclusions: Lessons learned included the need to incentivize physicians, to ensure streamlined processes for recruitment and communication, to target appropriate patient populations, and to create a core clinical group. Barriers encountered in this feasibility trial should be considered to determine their applicability when deploying innovations into different service delivery models. ", doi="10.2196/11722", url="http://medinform.jmir.org/2019/3/e11722/", url="http://www.ncbi.nlm.nih.gov/pubmed/31350841" } @Article{info:doi/10.2196/13317, author="Shariatpanahi, Shabnam and Ashghali Farahani, Mansoureh and Rafii, Forough and Rassouli, Maryam and Kavousi, Amir", title="Designing and Testing a Treatment Adherence Model Based on the Roy Adaptation Model in Patients With Heart Failure: Protocol for a Mixed Methods Study", journal="JMIR Res Protoc", year="2019", month="Jul", day="26", volume="8", number="7", pages="e13317", keywords="adaptation", keywords="treatment adherence and compliance", keywords="heart failure", abstract="Background: Adherence to treatment is an important factor to decrease repeated and costly hospitalization owing to heart failure (HF). The explanation and prediction of medication adherence and other lifestyle recommendations in chronic diseases, including HF, are complex. Theories lead to a better understanding of complex situations as well as the process of changing behavior and explain the reasons for the existence of a problem. Objective: The aim of this study is to report a protocol for a mixed methods study setting out to investigate the empirical validity of the Roy Adaptation Model as a conceptual framework for explaining and predicting adherence to treatment in patients with HF in Iran. Methods: This mixed methods study consists of an exploratory sequential design to be conducted in 2 phases. The first phase involves identifying the factors associated with treatment adherence in patients with HF through content analysis of the literature and elucidating the perception of participants in the context of Iranian health care where the model of adherence to treatment is designed based on the Roy Adaptation Model. The second phase addresses the interrelationships among variables in the model through a descriptive study using structural equation modeling. Finally, following the summarization and separate interpretation of the qualitative findings and quantitative results, a decision is made about the extent to and ways in which the results of the quantitative stage can be generalized or tested for the qualitative findings. Results: Content analysis of the literature in part 1 of the first phase was completed in 2017. Collection and analysis of qualitative data in part 2 of the first phase will be completed soon. The results are expected to be submitted for publication in 2019. Then, the second phase---the quantitative study---will be conducted. Conclusions: The results of this study will provide valuable information about the empirical validity of the Roy Adaptation Model as a conceptual framework for explaining and predicting adherence to treatment in patients with HF, which, to date, have received little attention. The results can be used as a guide for nursing practice and care provision to patients with HF and also to design and implement effective interventions to improve treatment adherence in these patients. International Registered Report Identifier (IRRID): DERR1-10.2196/13317 ", doi="10.2196/13317", url="https://www.researchprotocols.org/2019/7/e13317/", url="http://www.ncbi.nlm.nih.gov/pubmed/31350842" } @Article{info:doi/10.2196/13521, author="Allemann, Hanna and Thyl{\'e}n, Ingela and {\AA}gren, Susanna and Liljeroos, Maria and Str{\"o}mberg, Anna", title="Perceptions of Information and Communication Technology as Support for Family Members of Persons With Heart Failure: Qualitative Study", journal="J Med Internet Res", year="2019", month="Jul", day="16", volume="21", number="7", pages="e13521", keywords="family", keywords="caregivers", keywords="telemedicine", keywords="perception", keywords="heart failure", keywords="social support", keywords="focus groups", keywords="qualitative research", abstract="Background: Heart failure (HF) affects not only the person diagnosed with the syndrome but also family members, who often have the role of informal carers. The needs of these carers are not always met, and information and communications technology (ICT) could have the potential to support them in their everyday life. However, knowledge is lacking about how family members perceive ICT and see opportunities for this technology to support them. Objective: The aim of this study was to explore the perceptions of ICT solutions as supportive aids among family members of persons with HF. Methods: A qualitative design was applied. A total of 8 focus groups, comprising 23 family members of persons affected by HF, were conducted between March 2015 and January 2017. Participants were recruited from 1 hospital in Sweden. A purposeful sampling strategy was used to find family members of persons with symptomatic HF from diverse backgrounds. Data were analyzed using qualitative content analysis. Results: The analysis revealed 4 categories and 9 subcategories. The first category, about how ICT could provide relevant support, included descriptions of how ICT could be used for communication with health care personnel, for information and communication retrieval, plus opportunities to interact with persons in similar life situations and to share support with peers and extended family. The second category, about how ICT could provide access, entailed how ICT could offer solutions not bound by time or place and how it could be both timely and adaptable to different life situations. ICT could also provide an arena for family members to which they might not otherwise have had access. The third category concerned how ICT could be too impersonal and how it could entail limited personal interaction and individualization, which could lead to concerns about usability. It was emphasized that ICT could not replace physical meetings. The fourth category considered how ICT could be out of scope, reflecting the fact that some family members were generally uninterested in ICT and had difficulties envisioning how it could be used for support. It was also discussed as more of a solution for the future. Conclusions: Family members described multiple uses for ICT and agreed that ICT could provide access to relevant sources of information from which family members could potentially exchange support. ICT was also considered to have its limitations and was out of scope for some but with expected use in the future. Even though some family members seemed hesitant about ICT solutions in general, this might not mean they are unreceptive to suggestions about their usage in, for example, health care. Thus, a variety of factors should be considered to facilitate future implementations of ICT tools in clinical practice. ", doi="10.2196/13521", url="http://www.jmir.org/2019/7/e13521/", url="http://www.ncbi.nlm.nih.gov/pubmed/31313662" } @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/10.2196/13502, author="Zhang, Lingling and Babu, V. Sabarish and Jindal, Meenu and Williams, E. Joel and Gimbel, W. Ronald", title="A Patient-Centered Mobile Phone App (iHeartU) With a Virtual Human Assistant for Self-Management of Heart Failure: Protocol for a Usability Assessment Study", journal="JMIR Res Protoc", year="2019", month="May", day="23", volume="8", number="5", pages="e13502", keywords="heart failure", keywords="mobile health", keywords="self-management", keywords="patient engagement", keywords="virtual human", abstract="Background: Heart failure (HF) causes significant economic and humanistic burden for patients and their families, especially those with a low income, partly due to high hospital readmission rates. Optimal self-care is considered an important nonpharmacological aspect of HF management that can improve health outcomes. Emerging evidence suggests that self-management assisted by smartphone apps may reduce rehospitalization rates and improve the quality of life of patients. We developed a virtual human--assisted, patient-centered mobile health app (iHeartU) for patients with HF to enhance their engagement in self-management and improve their communication with health care providers and family caregivers. iHeartU may help patients with HF in self-management to reduce the technical knowledge and usability barrier while maintaining a low cost and natural, effective social interaction with the user. Objective: With a standardized systematic usability assessment, this study had two objectives: (1) to determine the obstacles to effective and efficient use of iHeartU in patients with HF and (2) to evaluate of HF patients' adoption, satisfaction, and engagement with regard to the of iHeartU app. Methods: The basic methodology to develop iHeartU systems consists of a user-centric design, development, and mixed methods formative evaluation. The iterative design and evaluation are based on the guidelines of the American College of Cardiology Foundation and American Heart Association for the management of heart failure and the validated ``Information, Motivation, and Behavioral skills'' behavior change model. Our hypothesis is that this method of a user-centric design will generate a more usable, useful, and easy-to-use mobile health system for patients, caregivers, and practitioners. Results: The prototype of iHeartU has been developed. It is currently undergoing usability testing. As of September 2018, the first round of usability testing data have been collected. The final data collection and analysis are expected to be completed by the end of 2019. Conclusions: The main contribution of this project is the development of a patient-centered self-management system, which may support HF patients' self-care at home and aid in the communication between patients and their health care providers in a more effective and efficient way. Widely available mobile phones serve as care coordination and ``no-cost'' continuum of care. For low-income patients with HF, a mobile self-management tool will expand their accessibility to care and reduce the cost incurred due to emergency visits or readmissions. The user-centered design will improve the level of engagement of patients and ultimately lead to better health outcomes. Developing and testing a novel mobile system for patients with HF that incorporates chronic disease management is critical for advancing research and clinical practice of care for them. This research fills in the gap in user-centric design and lays the groundwork for a large-scale population study in the next phase. International Registered Report Identifier (IRRID): DERR1-10.2196/13502 ", doi="10.2196/13502", url="http://www.researchprotocols.org/2019/5/e13502/", url="http://www.ncbi.nlm.nih.gov/pubmed/31124472" } @Article{info:doi/10.2196/12122, author="Baril, Jonathan-F and Bromberg, Simon and Moayedi, Yasbanoo and Taati, Babak and Manlhiot, Cedric and Ross, Joan Heather and Cafazzo, Joseph", title="Use of Free-Living Step Count Monitoring for Heart Failure Functional Classification: Validation Study", journal="JMIR Cardio", year="2019", month="May", day="17", volume="3", number="1", pages="e12122", keywords="exercise physiology", keywords="heart rate tracker", keywords="wrist worn devices", keywords="Fitbit", keywords="heart failure", keywords="steps", keywords="cardiopulmonary exercise test", keywords="ambulatory monitoring", abstract="Background: The New York Heart Association (NYHA) functional classification system has poor inter-rater reproducibility. A previously published pilot study showed a statistically significant difference between the daily step counts of heart failure (with reduced ejection fraction) patients classified as NYHA functional class II and III as measured by wrist-worn activity monitors. However, the study's small sample size severely limits scientific confidence in the generalizability of this finding to a larger heart failure (HF) population. Objective: This study aimed to validate the pilot study on a larger sample of patients with HF with reduced ejection fraction (HFrEF) and attempt to characterize the step count distribution to gain insight into a more objective method of assessing NYHA functional class. Methods: We repeated the analysis performed during the pilot study on an independently recorded dataset comprising a total of 50 patients with HFrEF (35 NYHA II and 15 NYHA III) patients. Participants were monitored for step count with a Fitbit Flex for a period of 2 weeks in a free-living environment. Results: Comparing group medians, patients exhibiting NYHA class III symptoms had significantly lower recorded 2-week mean daily total step count (3541 vs 5729 [steps], P=.04), lower 2-week maximum daily total step count (10,792 vs 5904 [steps], P=.03), lower 2-week recorded mean daily mean step count (4.0 vs 2.5 [steps/minute], P=.04,), and lower 2-week mean and 2-week maximum daily per minute step count maximums (88.1 vs 96.1 and 111.0 vs 123.0 [steps/minute]; P=.02 and .004, respectively). Conclusions: Patients with NYHA II and III symptoms differed significantly by various aggregate measures of free-living step count including the (1) mean and (2) maximum daily total step count as well as by the (3) mean of daily mean step count and by the (4) mean and (5) maximum of the daily per minute step count maximum. These findings affirm that the degree of exercise intolerance of NYHA II and III patients as a group is quantifiable in a replicable manner. This is a novel and promising finding that suggests the existence of a possible, completely objective measure of assessing HF functional class, something which would be a great boon in the continuing quest to improve patient outcomes for this burdensome and costly disease. ", doi="10.2196/12122", url="http://cardio.jmir.org/2019/1/e12122/", url="http://www.ncbi.nlm.nih.gov/pubmed/31758777" } @Article{info:doi/10.2196/13009, author="Woods, Sarah Leanna and Duff, Jed and Roehrer, Erin and Walker, Kim and Cummings, Elizabeth", title="Patients' Experiences of Using a Consumer mHealth App for Self-Management of Heart Failure: Mixed-Methods Study", journal="JMIR Hum Factors", year="2019", month="May", day="02", volume="6", number="2", pages="e13009", keywords="heart failure", keywords="mobile health (mHealth)", keywords="mobile apps", keywords="usability study", keywords="Mobile Application Rating Scale", keywords="patient experience", keywords="self-management", keywords="mobile phone", abstract="Background: To support the self-management of heart failure, a team of hospital clinicians, patients, and family caregivers have co-designed the consumer mobile health app, Care4myHeart. Objective: This research aimed to determine patient experiences of using the app to self-manage heart failure. Methods: Patients with heart failure used the app for 14 days on their own smart device in a home setting, following which a mixed-methods evaluation was performed. Eight patients were recruited, of whom six completed the Mobile Application Rating Scale and attended an interview. Results: The overall app quality score was ``acceptable'' with 3.53 of 5 points, with the aesthetics (3.83/5) and information (3.78/5) subscales scoring the highest. The lowest mean score was in the app-specific subscale representing the perceived impact on health behavior change (2.53/5). Frequently used features were weight and fluid restriction tracking, with graphical representation of data particularly beneficial for improved self-awareness and ongoing learning. The use of technology for self-management will fundamentally differ from current practices and require a change in daily routines. However, app use was correlated with potential utility for daily management of illness with benefits of accurate recording and review of personal health data and as a communication tool for doctors to assist with care planning, as all medical information is available in one place. Technical considerations included participants' attitudes toward technology, functionality and data entry issues, and relatively minor suggested changes. Conclusions: The findings from this usability study suggest that a significant barrier to adoption is the lack of integration of technology into everyday life in the context of already established disease self-management routines. Future studies should explore the barriers to adoption and sustainability of consumer mobile health interventions for chronic conditions, particularly whether introducing such apps is more beneficial at the commencement of a self-management regimen. ", doi="10.2196/13009", url="http://humanfactors.jmir.org/2019/2/e13009/", url="http://www.ncbi.nlm.nih.gov/pubmed/31045504" } @Article{info:doi/10.2196/12134, author="Athilingam, Ponrathi and Jenkins, Bradlee and Redding, A. Barbara", title="Reading Level and Suitability of Congestive Heart Failure (CHF) Education in a Mobile App (CHF Info App): Descriptive Design Study", journal="JMIR Aging", year="2019", month="Apr", day="25", volume="2", number="1", pages="e12134", keywords="health literacy", keywords="reading level", keywords="patient education", keywords="heart failure", keywords="mobile app", abstract="Background: Education at the time of diagnosis or at discharge after an index illness is a vital component of improving outcomes in congestive heart failure (CHF). About 90 million Americans have limited health literacy and have a readability level at or below a 5th-grade level, which could affect their understanding of education provided at the time of diagnosis or discharge from hospital. Objective: The aim of this paper was to assess the suitability and readability level of a mobile phone app, the CHF Info App. Methods: A descriptive design was used to assess the reading level and suitability of patient educational materials included in the CHF Info App. The suitability assessment of patient educational materials included in the CHF Info App was independently assessed by two of the authors using the 26-item Suitability Assessment of Materials (SAM) tool. The reading grade level for each of the 10 CHF educational modules included in the CHF Info App was assessed using the comprehensive online Text Readability Consensus Calculator based on the seven most-common readability formulas: the Flesch Reading Ease Formula, the Gunning Fog Index, the Flesch-Kincaid Grade Level Formula, the Coleman-Liau Index, the Simplified Measure of Gobbledygook Index, the Automated Readability Index, and the Linsear Write Formula. The reading level included the text-scale score, the ease-of-reading score, and the corresponding grade level. Results: The educational materials included in the CHF Info App ranged from a 5th-grade to an 8th-grade reading level, with a mean of a 6th-grade level, which is recommended by the American Medical Association. The SAM tool result demonstrated adequate-to-superior levels in all four components assessed, including content, appearance, visuals, and layout and design, with a total score of 77\%, indicating superior suitability. Conclusions: The authors conclude that the CHF Info App will be suitable and meet the recommended health literacy level for American adult learners. Further testing of the CHF Info App in a longitudinal study is warranted to determine improvement in CHF knowledge. ", doi="10.2196/12134", url="http://aging.jmir.org/2019/1/e12134/", url="http://www.ncbi.nlm.nih.gov/pubmed/31518265" } @Article{info:doi/10.2196/cardio.9894, author="Treskes, Willem Roderick and Maan, C. Arie and Verwey, Florence Harriette and Schot, Robert and Beeres, Anna Saskia Lambertha Maria and Tops, F. Laurens and Van Der Velde, Tjeerd Enno and Schalij, Jan Martin and Slats, Margaretha Annelies", title="Mobile Health for Central Sleep Apnea Screening Among Patients With Stable Heart Failure: Single-Cohort, Open, Prospective Trial", journal="JMIR Cardio", year="2019", month="Mar", day="19", volume="3", number="1", pages="e9894", keywords="mobile health", keywords="central sleep apnea", keywords="heart failure", keywords="prevention", keywords="screening", keywords="mobile phone", abstract="Background: Polysomnography is the gold standard for detection of central sleep apnea in patients with stable heart failure. However, this procedure is costly, time consuming, and a burden to the patient and therefore unsuitable as a screening method. An electronic health (eHealth) app to measure overnight oximetry may be an acceptable screening alternative, as it can be automatically analyzed and is less burdensome to patients. Objective: This study aimed to assess whether overnight pulse oximetry using a smartphone-compatible oximeter can be used to detect central sleep apnea in a population with stable heart failure. Methods: A total of 26 patients with stable heart failure underwent one night of both a polygraph examination and overnight saturation using a smartphone-compatible oximeter. The primary endpoint was agreement between the oxygen desaturation index (ODI) above or below 15 on the smartphone-compatible oximeter and the diagnosis of the polygraph. Results: The median age of patients was 66.4 (interquartile range, 62-71) years and 92\% were men. The median body mass index was 27.1 (interquartile range, 24.4-30.8) kg/m2. Two patients were excluded due to incomplete data, and two other patients were excluded because they could not use a smartphone. Seven patients had central sleep apnea, and 6 patients had obstructive sleep apnea. Of the 7 (of 22, 32\%) patients with central sleep apnea that were included in the analysis, 3 (13\%) had an ODI?15. Of all patients without central sleep apnea, 8 (36\%) had an ODI<15. The McNemar test yielded a P value of .55. Conclusions: Oxygen desaturation measured by this smartphone-compatible oximeter is a weak predictor of central sleep apnea in patients with stable heart failure. ", doi="10.2196/cardio.9894", url="http://cardio.jmir.org/2019/1/e9894/", url="http://www.ncbi.nlm.nih.gov/pubmed/31758786" } @Article{info:doi/10.2196/13259, author="Ware, Patrick and Dorai, Mala and Ross, J. Heather and Cafazzo, A. Joseph and Laporte, Audrey and Boodoo, Chris and Seto, Emily", title="Patient Adherence to a Mobile Phone--Based Heart Failure Telemonitoring Program: A Longitudinal Mixed-Methods Study", journal="JMIR Mhealth Uhealth", year="2019", month="Feb", day="26", volume="7", number="2", pages="e13259", keywords="telemonitoring", keywords="mHealth", keywords="adherence", keywords="heart failure", abstract="Background: Telemonitoring (TM) can improve heart failure (HF) outcomes by facilitating patient self-care and clinical decision support. However, these outcomes are only possible if patients consistently adhere to taking prescribed home readings. Objective: The objectives of this study were to (1) quantify the degree to which patients adhered to taking prescribed home readings in the context of a mobile phone--based TM program and (2) explain longitudinal adherence rates based on the duration of program enrollment, patient characteristics, and patient perceptions of the TM program. Methods: A mixed-methods explanatory sequential design was used to meet the 2 research objectives, and all explanatory methods were guided by the unified theory of acceptance and use of technology 2 (UTAUT2). Overall adherence rates were calculated as the proportion of days patients took weight, blood pressure, heart rate, and symptom readings over the total number of days they were enrolled in the program up to 1 year. Monthly adherence rates were also calculated as the proportion of days patients took the same 4 readings over each 30-day period following program enrollment. Next, simple and multivariate regressions were performed to determine the influence of time, age, sex, and disease severity on adherence rates. Additional explanatory methods included questionnaires at 6 and 12 months probing patients on the perceived benefits and ease of use of the TM program, an analysis of reasons for patients leaving the program, and semistructured interviews conducted with a purposeful sampling of patients (n=24) with a range of adherence rates and demographics. Results: Overall average adherence was 73.6\% (SD 25.0) with average adherence rates declining over time at a rate of 1.4\% per month (P<.001). The multivariate regressions found no significant effect of sex and disease severity on adherence rates. When grouping patients' ages by decade, age was a significant predictor (P=.04) whereby older patients had higher adherence rates over time. Adherence rates were further explained by patients' perceptions with regard to the themes of (1) performance expectancy (improvements in HF management and peace of mind), (2) effort expectancy (ease of use and technical issues), (3) facilitating conditions (availability of technical support and automated adherence calls), (4) social influence (support from family, friends, and trusted clinicians), and (5) habit (degree to which taking readings became automatic). Conclusions: The decline in adherence rates over time is consistent with findings from other studies. However, this study also found adherence to be the highest and most consistent over time in older age groups and progressively lower over time for younger age groups. These findings can inform the design and implementation of TM interventions that maximize patient adherence, which will enable a more accurate evaluation of impact and optimization of resources. International Registered Report Identifier (IRRID): RR2-10.2196/resprot.9911 ", doi="10.2196/13259", url="http://mhealth.jmir.org/2019/2/e13259/", url="http://www.ncbi.nlm.nih.gov/pubmed/30806625" } @Article{info:doi/10.2196/10362, author="Aamodt, Thon Ina and Lycholip, Edita and Celutkiene, Jelena and Str{\"o}mberg, Anna and Atar, Dan and Falk, S{\o}rum Ragnhild and von Lueder, Thomas and Helles{\o}, Ragnhild and Jaarsma, Tiny and Lie, Irene", title="Health Care Professionals' Perceptions of Home Telemonitoring in Heart Failure Care: Cross-Sectional Survey", journal="J Med Internet Res", year="2019", month="Feb", day="06", volume="21", number="2", pages="e10362", keywords="nurses", keywords="physicians", keywords="perception", keywords="telemedicine", keywords="heart failure", keywords="self-care", abstract="Background: Noninvasive telemonitoring (TM) can be used in heart failure (HF) patients to perform early detection of decompensation at home, prevent unnecessary health care utilization, and decrease health care costs. However, the evidence is not sufficient to be part of HF guidelines for follow-up care, and we have no knowledge of how TM is used in the Nordic Baltic region. Objective: The aim of this study was to describe health care professionals' (HCPs) perception of and presumed experience with noninvasive TM in daily HF patient care, perspectives of the relevance of and reasons for applying noninvasive TM, and barriers to the use of noninvasive TM. Methods: A cross-sectional survey was performed between September and December 2016 in Norway and Lithuania with physicians and nurses treating HF patients at either a hospital ward or an outpatient clinic. A total of 784 questionnaires were sent nationwide by postal mail to 107 hospitals. The questionnaire consisted of 43 items with close- and open-ended questions. In Norway, the response rate was 68.7\% (226/329), with 57 of 60 hospitals participating, whereas the response rate was 68.1\% (310/455) in Lithuania, with 41 of 47 hospitals participating. Responses to the closed questions were analyzed using descriptive statistics, and the open-ended questions were analyzed using summative content analysis. Results: This study showed that noninvasive TM is not part of the current daily clinical practice in Norway or Lithuania. A minority of HCPs responded to be familiar with noninvasive TM in HF care in Norway (48/226, 21.2\%) and Lithuania (64/310, 20.6\%). Approximately half of the HCPs in both countries perceived noninvasive TM to be relevant in follow-up of HF patients in Norway (131/226, 58.0\%) and Lithuania (172/310, 55.5\%). For physicians in both countries and nurses in Norway, the 3 most mentioned reasons for introducing noninvasive TM were to improve self-care, to reduce hospitalizations, and to provide high-quality care, whereas the Lithuanian nurses described ability to treat more patients and to reduce their workload as reasons for introducing noninvasive TM. The main barriers to implement noninvasive TM were lack of funding from health care authorities or the Territorial Patient Fund. Moreover, HCPs perceive that HF patients themselves could represent barriers because of their physical or mental condition in addition to a lack of internet access. Conclusions: HCPs in Norway and Lithuania are currently nonusers of TM in daily HF care. However, they perceive a future with TM to improve the quality of care for HF patients. Financial barriers and HF patients' condition may have an impact on the use of TM, whereas sufficient funding from health care authorities and improved knowledge may encourage the more widespread use of TM in the Nordic Baltic region and beyond. ", doi="10.2196/10362", url="http://www.jmir.org/2019/2/e10362/", url="http://www.ncbi.nlm.nih.gov/pubmed/30724744" } @Article{info:doi/10.2196/12419, author="Conn, J. Nicholas and Schwarz, Q. Karl and Borkholder, A. David", title="In-Home Cardiovascular Monitoring System for Heart Failure: Comparative Study", journal="JMIR Mhealth Uhealth", year="2019", month="Jan", day="18", volume="7", number="1", pages="e12419", keywords="ballistocardiogram", keywords="BCG", keywords="blood pressure", keywords="ECG", keywords="electrocardiogram", keywords="heart failure", keywords="Internet of Things", keywords="IoT", keywords="photoplethysmogram", keywords="PPG", keywords="remote monitoring", keywords="SpO2", keywords="stroke volume", abstract="Background: There is a pressing need to reduce the hospitalization rate of heart failure patients to limit rising health care costs and improve outcomes. Tracking physiologic changes to detect early deterioration in the home has the potential to reduce hospitalization rates through early intervention. However, classical approaches to in-home monitoring have had limited success, with patient adherence cited as a major barrier. This work presents a toilet seat--based cardiovascular monitoring system that has the potential to address low patient adherence as it does not require any change in habit or behavior. Objective: The objective of this work was to demonstrate that a toilet seat--based cardiovascular monitoring system with an integrated electrocardiogram, ballistocardiogram, and photoplethysmogram is capable of clinical-grade measurements of systolic and diastolic blood pressure, stroke volume, and peripheral blood oxygenation. Methods: The toilet seat--based estimates of blood pressure and peripheral blood oxygenation were compared to a hospital-grade vital signs monitor for 18 subjects over an 8-week period. The estimated stroke volume was validated on 38 normative subjects and 111 subjects undergoing a standard echocardiogram at a hospital clinic for any underlying condition, including heart failure. Results: Clinical grade accuracy was achieved for all of the seat measurements when compared to their respective gold standards. The accuracy of diastolic blood pressure and systolic blood pressure is 1.2 (SD 6.0) mm Hg (N=112) and --2.7 (SD 6.6) mm Hg (N=89), respectively. Stroke volume has an accuracy of --2.5 (SD 15.5) mL (N=149) compared to an echocardiogram gold standard. Peripheral blood oxygenation had an RMS error of 2.3\% (N=91). Conclusions: A toilet seat--based cardiovascular monitoring system has been successfully demonstrated with blood pressure, stroke volume, and blood oxygenation accuracy consistent with gold standard measures. This system will be uniquely positioned to capture trend data in the home that has been previously unattainable. Demonstration of the clinical benefit of the technology requires additional algorithm development and future clinical trials, including those targeting a reduction in heart failure hospitalizations. ", doi="10.2196/12419", url="http://mhealth.jmir.org/2019/1/e12419/", url="http://www.ncbi.nlm.nih.gov/pubmed/30664492" } @Article{info:doi/10.2196/10319, author="Isaranuwatchai, Wanrudee and Redwood, Olwen and Schauer, Adrian and Van Meer, Tim and Vall{\'e}e, Jonathan and Clifford, Patrick", title="A Remote Patient Monitoring Intervention for Patients With Chronic Obstructive Pulmonary Disease and Chronic Heart Failure: Pre-Post Economic Analysis of the Smart Program", journal="JMIR Cardio", year="2018", month="Dec", day="20", volume="2", number="2", pages="e10319", keywords="chronic heart failure", keywords="chronic obstructive pulmonary disease", keywords="costs", keywords="economic analysis", keywords="emergency department visits", keywords="hospitalizations", keywords="health service utilization", keywords="remote patient monitoring", abstract="Background: Exacerbation of chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) are associated with high health care costs owing to increased emergency room (ER) visits and hospitalizations. Remote patient monitoring (RPM) interventions aim to improve the monitoring of symptoms to detect early deterioration and provide self-management strategies. As a result, RPM aims to reduce health resource utilization. To date, studies have inconsistently reported the benefits of RPM in chronic illnesses. The Smart Program is an RPM intervention that aims to provide clinical benefit to patients and economic benefit to health care payers. Objective: This study aims to economically evaluate the potential benefits of the Smart Program in terms of hospitalizations and ER visits and, thus, associated health care costs from the perspective of the public health care system. Methods: Seventy-four patients diagnosed with COPD or CHF from one hospital site were included in this one-group, pre-post study. The study involved a secondary data analysis of deidentified data collected during the study period -- from 3 months before program initiation (baseline), during the program, to 3 months after program completion (follow-up). Descriptive analysis was conducted for the study population characteristics at baseline, the clinical frailty score at baseline and 3-month follow-up, client satisfaction at 3-month follow-up, and number and costs of ER visits and hospitalizations throughout the study period. Furthermore, the cost of the Smart Program over a 3-month period was calculated from the perspective of the potential implementer. Results: The baseline characteristics of the study population (N=74) showed that the majority of patients had COPD (50/74, 68\%), were female (42/74, 57\%), and had an average age of 72 (SD 12) years. Using the Wilcoxon signed-rank test, the number of ER visits and hospitalizations, including their associated costs, were significantly reduced between baseline and 3-month follow-up (P<.001). The intervention showed a potential 68\% and 35\% reduction in ER visits and hospitalizations, respectively, between the 3-month pre- and 3-month postintervention period. The average cost of ER visits reduced from Can \$243 at baseline to Can \$67 during the 3-month follow-up, and reduced from Can \$3842 to Can \$1399 for hospitalizations. Conclusions: In this study, the number and cost of ER visits and hospitalizations appeared to be markedly reduced for patients with COPD or CHF when comparing data before and after the Smart Program implementation. Recognizing the limitations of the one-group, pre-post study design, RPM requires an upfront investment, but it has the potential to reduce health care costs to the system over time. This study represents another piece of evidence to support the potential value of RPM among patients with COPD or CHF. ", doi="10.2196/10319", url="http://cardio.jmir.org/2018/2/e10319/", url="http://www.ncbi.nlm.nih.gov/pubmed/31758770" } @Article{info:doi/10.2196/11466, author="Ware, Patrick and Ross, J. Heather and Cafazzo, A. Joseph and Laporte, Audrey and Gordon, Kayleigh and Seto, Emily", title="User-Centered Adaptation of an Existing Heart Failure Telemonitoring Program to Ensure Sustainability and Scalability: Qualitative Study", journal="JMIR Cardio", year="2018", month="Dec", day="06", volume="2", number="2", pages="e11466", keywords="telemonitoring", keywords="mHealth", keywords="diffusion of innovation", keywords="heart failure", abstract="Background: Telemonitoring interventions for the management of heart failure have seen limited adoption in Canadian health systems, but isolated examples of telemonitoring programs do exist. An example of such a program was launched in a specialty heart failure clinic in Toronto, Canada, and a recent implementation evaluation concluded that reducing the cost of delivering the program is necessary to ensure its sustainability and scalability. Objective: The objectives of this study were to (1) understand which components of the telemonitoring program could be modified to reduce costs and adapted to other contexts while maintaining program fidelity and (2) describe the changes made to the telemonitoring program to enable its sustainability within the initial implementation site and scalability to other health organizations. Methods: Semistructured interviews probed the experiences of patients (n=23) and clinicians (n=8) involved in the telemonitoring program to identify opportunities for cost reduction and resource optimization. Ideas for adapting the program were informed by the interview results and prioritized based on (1) potential impact for sustainability and scalability, (2) feasibility, and (3) perceived risks to negatively impacting the program's ability to yield desired health outcomes. Results: A total of 5 themes representing opportunities for cost reduction were discussed, including (1) Bring Your Own Device (BYOD), (2) technical support, (3) clinician role, (4) duration of enrollment, and (5) intensity of monitoring. The hardware used for the telemonitoring system and the modalities of providing technical support were found to be highly adaptable, which supported the decision to implement a BYOD model, whereby patients used their own smartphone, weight scale, and blood pressure cuff. Changes also included the development of a website aimed at reducing the burden on a technical support telehealth analyst. In addition, the interviews suggested that although it is important to have a clinician who is part of a patient's circle of care monitoring telemonitoring alerts, the skill level and experience were moderately adaptable. Thus, a registered nurse was determined to be more cost-effective and was hired to replace the existing nurse practitioners in the frontline management of telemonitoring alerts and take over the technical support role from a telehealth analyst. Conclusions: This study provides a user-centered example of how necessary cost-reduction actions can be taken to ensure the sustainability and scalability of telemonitoring programs. In addition, the findings offer insights into what components of a telemonitoring program can be safely adapted to ensure its integration in various clinical settings. ", doi="10.2196/11466", url="http://cardio.jmir.org/2018/2/e11466/", url="http://www.ncbi.nlm.nih.gov/pubmed/31758774" } @Article{info:doi/10.2196/12178, author="Lefler, L. Leanne and Rhoads, J. Sarah and Harris, Melodee and Funderburg, E. Ashley and Lubin, A. Sandra and Martel, D. Isis and Faulkner, L. Jennifer and Rooker, L. Janet and Bell, K. Deborah and Marshall, Heather and Beverly, J. Claudia", title="Evaluating the Use of Mobile Health Technology in Older Adults With Heart Failure: Mixed-Methods Study", journal="JMIR Aging", year="2018", month="Dec", day="04", volume="1", number="2", pages="e12178", keywords="heart failure", keywords="remote monitoring", keywords="mHealth", keywords="older adults", keywords="feasibility", keywords="self-management", abstract="Background: Heart failure (HF) is associated with high rates of hospitalizations, morbidity, mortality, and costs. Remote patient monitoring (mobile health, mHealth) shows promise in improving self-care and HF management, thus increasing quality of care while reducing hospitalizations and costs; however, limited information exists regarding perceptions of older adults with HF about mHealth use. Objective: This study aimed to compare perspectives of older adults with HF who were randomized to either (1) mHealth equipment connected to a 24-hour call center, (2) digital home equipment, or (3) standard care, with regard to ease and satisfaction with equipment, provider communication and engagement, and ability to self-monitor and manage their disease. Methods: We performed a pilot study using a mixed-methods descriptive design with pre- and postsurveys, following participants for 12 weeks. We augmented these data with semistructured qualitative interviews to learn more about feasibility, satisfaction, communication, and self-management. Results: We enrolled 28 patients with HF aged 55 years and above, with 57\% (16/28) male, 79\% (22/28) non-Hispanic white, and with multiple comorbid conditions. At baseline, 50\% (14/28) rated their health fair or poor and 36\% (10/28) and 25\% (7/28) were very often/always frustrated and discouraged by their health. At baseline, 46\% (13/28) did not monitor their weight, 29\% (8/28) did not monitor their blood pressure, and 68\% (19/28) did not monitor for symptoms. Post intervention, 100\% of the equipment groups home monitored daily. For technology anxiety, 36\% (10/28) indicated technology made them nervous, and 32\% (9/28) reported fear of technology, without significant changes post intervention. Technology usability post intervention scored high (91/100), reflecting ease of use. A majority indicated that a health care provider should be managing their health, and 71\% reported that one should trust and not question the provider. Moreover, 57\% (16/28) believed it was better to seek professional help than caring for oneself. Post intervention, mHealth users relied more on themselves, which was not mirrored in the home equipment or standard care groups. Participants were satisfied with communication and engagement with providers, yet many described access problems. Distressing symptoms were unpredictable and prevailed over the 12 weeks with 79 provider visits and 7 visits to emergency departments. The nurse call center received 872 readings, and we completed 289 telephone calls with participants. Narrative data revealed the following main themes: (1) traditional communication and engagement with providers prevailed, delaying access to care; (2) home monitoring with technology was described as useful, and mHealth users felt secure knowing that someone was observing them; (3) equipment groups felt more confident in self-monitoring and managing; and finally, (4) uncertainty and frustration with persistent health problems. Conclusions: mHealth equipment is feasible with potential to improve patient-centered outcomes and increase self-management in older adults with HF. ", doi="10.2196/12178", url="http://aging.jmir.org/2018/2/e12178/", url="http://www.ncbi.nlm.nih.gov/pubmed/31518257" } @Article{info:doi/10.2196/10771, author="Bashi, Nazli and Fatehi, Farhad and Fallah, Mina and Walters, Darren and Karunanithi, Mohanraj", title="Self-Management Education Through mHealth: Review of Strategies and Structures", journal="JMIR Mhealth Uhealth", year="2018", month="Oct", day="19", volume="6", number="10", pages="e10771", keywords="health education", keywords="mHealth", keywords="mobile apps", keywords="mobile phone", keywords="patient education", keywords="self-management education", abstract="Background: Despite the plethora of evidence on mHealth interventions for patient education, there is a lack of information regarding their structures and delivery strategies. Objective: This review aimed to investigate the structures and strategies of patient education programs delivered through smartphone apps for people with diverse conditions and illnesses. We also examined the aim of educational interventions in terms of health promotion, disease prevention, and illness management. Methods: We searched PubMed, Cumulative Index to Nursing and Allied Health Literature, Embase, and PsycINFO for peer-reviewed papers that reported patient educational interventions using mobile apps and published from 2006 to 2016. We explored various determinants of educational interventions, including the content, mode of delivery, interactivity with health care providers, theoretical basis, duration, and follow-up. The reporting quality of studies was evaluated according to the mHealth evidence and reporting assessment criteria. Results: In this study, 15 papers met the inclusion criteria and were reviewed. The studies mainly focused on the use of mHealth educational interventions for chronic disease management, and the main format for delivering interventions was text. Of the 15 studies, 6 were randomized controlled trials (RCTs), which have shown statistically significant effects on patients' health outcomes, including patients' engagement level, hemoglobin A1c, weight loss, and depression. Although the results of RCTs were mostly positive, we were unable to identify any specific effective structure and strategy for mHealth educational interventions owing to the poor reporting quality and heterogeneity of the interventions. Conclusions: Evidence on mHealth interventions for patient education published in peer-reviewed journals demonstrates that current reporting on essential mHealth criteria is insufficient for assessing, understanding, and replicating mHealth interventions. There is a lack of theory or conceptual framework for the development of mHealth interventions for patient education. Therefore, further research is required to determine the optimal structure, strategies, and delivery methods of mHealth educational interventions. ", doi="10.2196/10771", url="https://mhealth.jmir.org/2018/10/e10771/", url="http://www.ncbi.nlm.nih.gov/pubmed/30341042" } @Article{info:doi/10.2196/10302, author="Lundgren, Johan and Johansson, Peter and Jaarsma, Tiny and Andersson, Gerhard and K{\"a}rner K{\"o}hler, Anita", title="Patient Experiences of Web-Based Cognitive Behavioral Therapy for Heart Failure and Depression: Qualitative Study", journal="J Med Internet Res", year="2018", month="Sep", day="05", volume="20", number="9", pages="e10302", keywords="cognitive therapy", keywords="content analysis", keywords="depression", keywords="heart failure", keywords="internet", keywords="patient experience", keywords="telehealth", abstract="Background: Web-based cognitive behavioral therapy (wCBT) has been proposed as a possible treatment for patients with heart failure and depressive symptoms. Depressive symptoms are common in patients with heart failure and such symptoms are known to significantly worsen their health. Although there are promising results on the effect of wCBT, there is a knowledge gap regarding how persons with chronic heart failure and depressive symptoms experience wCBT. Objective: The aim of this study was to explore and describe the experiences of participating and receiving health care through a wCBT intervention among persons with heart failure and depressive symptoms. Methods: In this qualitative, inductive, exploratory, and descriptive study, participants with experiences of a wCBT program were interviewed. The participants were included through purposeful sampling among participants previously included in a quantitative study on wCBT. Overall, 13 participants consented to take part in this study and were interviewed via telephone using an interview guide. Verbatim transcripts from the interviews were qualitatively analyzed following the recommendations discussed by Patton in Qualitative Research \& Evaluation Methods: Integrating Theory and Practice. After coding each interview, codes were formed into categories. Results: Overall, six categories were identified during the analysis process. They were as follows: ``Something other than usual health care,'' ``Relevance and recognition,'' ``Flexible, understandable, and safe,'' ``Technical problems,'' ``Improvements by real-time contact,'' and ``Managing my life better.'' One central and common pattern in the findings was that participants experienced the wCBT program as something they did themselves and many participants described the program as a form of self-care. Conclusions: Persons with heart failure and depressive symptoms described wCBT as challenging. This was due to participants balancing the urge for real-time contact with perceived anonymity and not postponing the work with the program. wCBT appears to be a valuable tool for managing depressive symptoms. ", doi="10.2196/10302", url="http://www.jmir.org/2018/9/e10302/", url="http://www.ncbi.nlm.nih.gov/pubmed/30185405" } @Article{info:doi/10.2196/resprot.9911, author="Ware, Patrick and Ross, J. Heather and Cafazzo, A. Joseph and Laporte, Audrey and Seto, Emily", title="Implementation and Evaluation of a Smartphone-Based Telemonitoring Program for Patients With Heart Failure: Mixed-Methods Study Protocol", journal="JMIR Res Protoc", year="2018", month="May", day="03", volume="7", number="5", pages="e121", keywords="heart failure", keywords="telemedicine", keywords="self-management", keywords="health services research", keywords="costs and cost analysis", abstract="Background: Meta-analyses of telemonitoring for patients with heart failure conclude that it can lower the utilization of health services and improve health outcomes compared with the standard of care. A smartphone-based telemonitoring program is being implemented as part of the standard of care at a specialty care clinic for patients with heart failure in Toronto, Canada. Objective: The objectives of this study are to (1) evaluate the impact of the telemonitoring program on health service utilization, patient health outcomes, and their ability to self-care; (2) identify the contextual barriers and facilitators of implementation at the physician, clinic, and institutional level; (3) describe patient usage patterns to determine adherence and other behaviors in the telemonitoring program; and (4) evaluate the costs associated with implementation of the telemonitoring program from the perspective of the health care system (ie, public payer), hospital, and patient. Methods: The evaluation will use a mixed-methods approach. The quantitative component will include a pragmatic pre- and posttest study design for the impact and cost analyses, which will make use of clinical data and questionnaires administered to at least 108 patients at baseline and 6 months. Furthermore, outcome data will be collected at 1, 12, and 24 months to explore the longitudinal impact of the program. In addition, quantitative data related to implementation outcomes and patient usage patterns of the telemonitoring system will be reported. The qualitative component involves an embedded single case study design to identify the contextual factors that influenced the implementation. The implementation evaluation will be completed using semistructured interviews with clinicians, and other program staff at baseline, 4 months, and 12 months after the program start date. Interviews conducted with patients will be triangulated with usage data to explain usage patterns and adherence to the system. Results: The telemonitoring program was launched in August 2016 and patient enrollment is ongoing. Conclusions: The methods described provide an example for conducting comprehensive evaluations of telemonitoring programs. The combination of impact, implementation, and cost evaluations will inform the quality improvement of the existing program and will yield insights into the sustainability of smartphone-based telemonitoring programs for patients with heart failure within a specialty care setting. International Registered Report Identifier (IRRID): RR1-10.2196/resprot.9911 ", doi="10.2196/resprot.9911", url="http://www.researchprotocols.org/2018/5/e121/", url="http://www.ncbi.nlm.nih.gov/pubmed/29724704" } @Article{info:doi/10.2196/10057, author="Athilingam, Ponrathi and Jenkins, Bradlee", title="Mobile Phone Apps to Support Heart Failure Self-Care Management: Integrative Review", journal="JMIR Cardio", year="2018", month="May", day="02", volume="2", number="1", pages="e10057", keywords="heart failure", keywords="self-care management", keywords="mobile health", abstract="Background: With an explosive growth in mobile health, an estimated 500 million patients are potentially using mHealth apps for supporting health and self-care of chronic diseases. Therefore, this review focused on mHealth apps for use among patients with heart failure. Objective: The aim of this integrative review was to identify and assess the functionalities of mHealth apps that provided usability and efficacy data and apps that are commercially available without supporting data, all of which are to support heart failure self-care management and thus impact heart failure outcomes. Methods: A search of published, peer-reviewed literature was conducted for studies of technology-based interventions that used mHealth apps specific for heart failure. The initial database search yielded 8597 citations. After filters for English language and heart failure, the final 487 abstracts was reviewed. After removing duplicates, a total of 18 articles that tested usability and efficacy of mobile apps for heart failure self-management were included for review. Google Play and Apple App Store were searched with specified criteria to identify mHealth apps for heart failure. A total of 26 commercially available apps specific for heart failure were identified and rated using the validated Mobile Application Rating Scale. Results: The review included studies with low-quality design and sample sizes ranging from 7 to 165 with a total sample size of 847 participants from all 18 studies. Nine studies assessed usability of the newly developed mobile health system. Six of the studies included are randomized controlled trials, and 4 studies are pilot randomized controlled trials with sample sizes of fewer than 40. There were inconsistencies in the self-care components tested, increasing bias. Thus, risk of bias was assessed using the Cochrane Collaboration's tool for risk of selection, performance, detection, attrition, and reporting biases. Most studies included in this review are underpowered and had high risk of bias across all categories. Three studies failed to provide enough information to allow for a complete assessment of bias, and thus had unknown or unclear risk of bias. This review on the commercially available apps demonstrated many incomplete apps, many apps with bugs, and several apps with low quality. Conclusions: The heterogeneity of study design, sample size, intervention components, and outcomes measured precluded the performance of a systematic review or meta-analysis, thus introducing bias of this review. Although the heart failure--related outcomes reported in this review vary, they demonstrated trends toward making an impact and offer a potentially cost-effective solution with 24/7 access to symptom monitoring as a point of care solution, promoting patient engagement in their own home care. ", doi="10.2196/10057", url="http://cardio.jmir.org/2018/1/e10057/", url="http://www.ncbi.nlm.nih.gov/pubmed/31758762" } @Article{info:doi/10.2196/resprot.8865, author="Woessner, N. Mary and Levinger, Itamar and Neil, Christopher and Smith, Cassandra and Allen, D. Jason", title="Effects of Dietary Inorganic Nitrate Supplementation on Exercise Performance in Patients With Heart Failure: Protocol for a Randomized, Placebo-Controlled, Cross-Over Trial", journal="JMIR Res Protoc", year="2018", month="Apr", day="06", volume="7", number="4", pages="e86", keywords="cardiovascular disease", keywords="nitric oxide", keywords="exercise tolerance", abstract="Background: Chronic heart failure is characterized by an inability of the heart to pump enough blood to meet the demands of the body, resulting in the hallmark symptom of exercise intolerance. Chronic underperfusion of the peripheral tissues and impaired nitric oxide bioavailability have been implicated as contributors to the decrease in exercise capacity in these patients. nitric oxide bioavailability has been identified as an important mediator of exercise tolerance in healthy individuals, but there are limited studies examining the effects in patients with chronic heart failure. Objective: The proposed trial is designed to determine the effects of chronic inorganic nitrate supplementation on exercise tolerance in both patients with heart failure preserved ejection fraction (HFpEF) and heart failure reduced ejection fraction (HFrEF) and to determine whether there are any differential responses between the 2 cohorts. A secondary objective is to provide mechanistic insights into the 2 heart failure groups' exercise responses to the nitrate supplementation. Methods: Patients with chronic heart failure (15=HFpEF and 15=HFrEF) aged 40 to 85 years will be recruited. Following an initial screen cardiopulmonary exercise test, participants will be randomly allocated in a double-blind fashion to consume either a nitrate-rich beetroot juice (16 mmol nitrate/day) or a nitrate-depleted placebo (for 5 days). Participants will continue daily dosing until the completion of the 4 testing visits (maximal cardiopulmonary exercise test, submaximal exercise test with echocardiography, vascular function assessment, and vastus lateralis muscle biopsy). There will then be a 2-week washout period after which the participants will cross over to the other treatment and complete the same 4 testing visits. Results: This study is funded by National Heart Foundation of Australia and Victoria University. Enrolment has commenced and the data collection is expected to be completed in mid 2018. The initial results are expected to be submitted for publication by the end of 2018. Conclusions: If inorganic nitrate supplementation can improve exercise tolerance in patients with chronic heart failure, it has the potential to aid in further refining the treatment of patients in this population. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12615000906550; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368912 (Archived by WebCite at http://www.webcitation.org/6xymLMiFK) ", doi="10.2196/resprot.8865", url="http://www.researchprotocols.org/2018/4/e86/", url="http://www.ncbi.nlm.nih.gov/pubmed/29625952" } @Article{info:doi/10.2196/cardio.9153, author="Smeets, JP Christophe and Storms, Valerie and Vandervoort, M. Pieter and Dreesen, Pauline and Vranken, Julie and Houbrechts, Marita and Goris, Hanne and Grieten, Lars and Dendale, Paul", title="A Novel Intelligent Two-Way Communication System for Remote Heart Failure Medication Uptitration (the CardioCoach Study): Randomized Controlled Feasibility Trial", journal="JMIR Cardio", year="2018", month="Apr", day="04", volume="2", number="1", pages="e8", keywords="heart failure", keywords="telemedicine", keywords="clinical decision support", keywords="drug monitoring", keywords="drug utilization", keywords="call centers", abstract="Background: European Society of Cardiology guidelines for the treatment of heart failure (HF) prescribe uptitration of angiotensin-converting enzyme inhibitors (ACE-I) and $\beta$-blockers to the maximum-tolerated, evidence-based dose. Although HF prognosis can drastically improve when correctly implementing these guidelines, studies have shown that they are insufficiently implemented in clinical practice. Objective: The aim of this study was to verify whether supplementing the usual care with the CardioCoach follow-up tool is feasible and safe, and whether the tool is more efficient in implementing the guideline recommendations for $\beta$-blocker and ACE-I. Methods: A total of 25 HF patients were randomly assigned to either the usual care control group (n=10) or CardioCoach intervention group (n=15), and observed for 6 months. The CardioCoach follow-up tool is a two-way communication platform with decision support algorithms for semiautomatic remote medication uptitration. Remote monitoring sensors automatically transmit patient's blood pressure, heart rate, and weight on a daily basis. Results: Patients' satisfaction and adherence for medication intake (10,018/10,825, 92.55\%) and vital sign measurements (4504/4758, 94.66\%) were excellent. However, the number of technical issues that arose was large, with 831 phone contacts (median 41, IQR 32-65) in total. The semiautomatic remote uptitration was safe, as there were no adverse events and no false positive uptitration proposals. Although no significant differences were found between both groups, a higher number of patients were on guideline-recommended medication dose in both groups compared with previous reports. Conclusions: The CardioCoach follow-up tool for remote uptitration is feasible and safe and was found to be efficient in facilitating information exchange between care providers, with high patient satisfaction and adherence. Trial Registration: ClinicalTrials.gov NCT03294811; https://clinicaltrials.gov/ct2/show/NCT03294811 (Archived by WebCite at http://www.webcitation.org/6xLiWVsgM) ", doi="10.2196/cardio.9153", url="http://cardio.jmir.org/2018/1/e8/", url="http://www.ncbi.nlm.nih.gov/pubmed/31758773" } @Article{info:doi/10.2196/jmir.7873, author="Farnia, Troskah and Jaulent, Marie-Christine and Steichen, Olivier", title="Evaluation Criteria of Noninvasive Telemonitoring for Patients With Heart Failure: Systematic Review", journal="J Med Internet Res", year="2018", month="Jan", day="16", volume="20", number="1", pages="e16", keywords="telemedicine", keywords="outcome and process assessment (health care)", keywords="program evaluation", keywords="heart failure", abstract="Background: Telemonitoring can improve heart failure (HF) management, but there is no standardized evaluation framework to comprehensively evaluate its impact. Objective: Our objectives were to list the criteria used in published evaluations of noninvasive HF telemonitoring projects, describe how they are used in the evaluation studies, and organize them into a consistent scheme. Methods: Articles published from January 1990 to August 2015 were obtained through MEDLINE, Web of Science, and EMBASE. Articles were eligible if they were original reports of a noninvasive HF telemonitoring evaluation study in the English language. Studies of implantable telemonitoring devices were excluded. Each selected article was screened to extract the description of the telemonitoring project and the evaluation process and criteria. A qualitative synthesis was performed. Results: We identified and reviewed 128 articles leading to 52 evaluation criteria classified into 6 dimensions: clinical, economic, user perspective, educational, organizational, and technical. The clinical and economic impacts were evaluated in more than 70\% of studies, whereas the educational, organizational, and technical impacts were studied in fewer than 15\%. User perspective was the most frequently covered dimension in the development phase of telemonitoring projects, whereas clinical and economic impacts were the focus of later phases. Conclusions: Telemonitoring evaluation frameworks should cover all 6 dimensions appropriately distributed along the telemonitoring project lifecycle. Our next goal is to build such a comprehensive evaluation framework for telemonitoring and test it on an ongoing noninvasive HF telemonitoring project. ", doi="10.2196/jmir.7873", url="http://www.jmir.org/2018/1/e16/", url="http://www.ncbi.nlm.nih.gov/pubmed/29339348" } @Article{info:doi/10.2196/cardio.8301, author="Moayedi, Yasbanoo and Abdulmajeed, Raghad and Duero Posada, Juan and Foroutan, Farid and Alba, Carolina Ana and Cafazzo, Joseph and Ross, Joan Heather", title="Assessing the Use of Wrist-Worn Devices in Patients With Heart Failure: Feasibility Study", journal="JMIR Cardio", year="2017", month="Dec", day="19", volume="1", number="2", pages="e8", keywords="MeSH: exercise physiology", keywords="heart rate tracker", keywords="wrist worn devices", keywords="Fitbit", keywords="Apple watch", keywords="heart failure", keywords="steps", abstract="Background: Exercise capacity and raised heart rate (HR) are important prognostic markers in patients with heart failure (HF). There has been significant interest in wrist-worn devices that track activity and HR. Objective: We aimed to assess the feasibility and accuracy of HR and activity tracking of the Fitbit and Apple Watch. Methods: We conducted a two-phase study assessing the accuracy of HR by Apple Watch and Fitbit in healthy participants. In Phase 1, 10 healthy individuals wore a Fitbit, an Apple Watch, and a GE SEER Light 5-electrode Holter monitor while exercising on a cycle ergometer with a 10-watt step ramp protocol from 0-100 watts. In Phase 2, 10 patients with HF and New York Heart Association (NYHA) Class II-III symptoms wore wrist devices for 14 days to capture overall step count/exercise levels. Results: Recorded HR by both wrist-worn devices had the best agreement with Holter readings at a workload of 60-100 watts when the rate of change of HR is less dynamic. Fitbit recorded a mean 8866 steps/day for NYHA II patients versus 4845 steps/day for NYHA III patients (P=.04). In contrast, Apple Watch recorded a mean 7027 steps/day for NYHA II patients and 4187 steps/day for NYHA III patients (P=.08). Conclusions: Both wrist-based devices are best suited for static HR rate measurements. In an outpatient setting, these devices may be adequate for average HR in patients with HF. When assessing exercise capacity, the Fitbit better differentiated patients with NYHA II versus NYHA III by the total number of steps recorded. This exploratory study indicates that these wrist-worn devices show promise in prognostication of HF in the continuous monitoring of outpatients. ", doi="10.2196/cardio.8301", url="http://cardio.jmir.org/2017/2/e8/", url="http://www.ncbi.nlm.nih.gov/pubmed/31758789" } @Article{info:doi/10.2196/cardio.7848, author="Athilingam, Ponrathi and Jenkins, Bradlee and Johansson, Marcia and Labrador, Miguel", title="A Mobile Health Intervention to Improve Self-Care in Patients With Heart Failure: Pilot Randomized Control Trial", journal="JMIR Cardio", year="2017", month="Aug", day="11", volume="1", number="2", pages="e3", keywords="heart failure", keywords="mobile applications", keywords="self-care", keywords="quality of life", abstract="Background: Heart failure (HF) is a progressive chronic disease affecting 6.5 million Americans and over 15 million individuals globally. Patients with HF are required to engage in complex self-care behaviors. Although the advancements in medicine have enabled people with HF to live longer, they often have poor health-related quality of life and experience severe and frequent symptoms that limit several aspects of their lives. Mobile phone apps have not only created new and interactive ways of communication between patients and health care providers but also provide a platform to enhance adherence to self-care management. Objective: The aim of this pilot study was to test the feasibility of a newly developed mobile app (HeartMapp) in improving self-care behaviors and quality of life of patients with HF and to calculate effect sizes for sample size calculation for a larger study. Methods: This was a pilot feasibility randomized controlled trial. Participants were enrolled in the hospital before discharge and followed at home for 30 days. The intervention group used HeartMapp (n=9), whereas the control group (n=9) received HF education. These apps were downloaded onto their mobile phones for daily use. Results: A total of 72\% (13/18) participants completed the study; the mean age of the participants was 53 (SD 4.02) years, 56\% (10/18) were females, 61\% (11/18) lived alone, 33\% (6/18) were African Americans, and 61\% (11/18) used mobile phone to get health information. The mean engagement with HeartMapp was 78\%. Results were promising with a trend that participants in the HeartMapp group had a significant mean score change on self-care management (8.7 vs 2.3; t3.38=11, P=.01), self-care confidence (6.7 vs 1.8; t2.53=11, P=.28), and HF knowledge (3 vs ?0.66; t2.37=11, P=.04. Depression improved among both groups, more so in the control group (?1.14 vs ?5.17; t1.97=11, P=.07). Quality of life declined among both groups, more so in the control group (2.14 vs 9.0; t?1.43=11, P=.18). Conclusions: The trends demonstrated in this pilot feasibility study warrant further exploration on the use of HeartMapp to improve HF outcomes. Trial Registration: Pilot study, no funding from National agencies, hence not registered. ", doi="10.2196/cardio.7848", url="http://cardio.jmir.org/2017/2/e3/", url="http://www.ncbi.nlm.nih.gov/pubmed/31758759" } @Article{info:doi/10.2196/jmir.6931, author="Hargreaves, Sarah and Hawley, S. Mark and Haywood, Annette and Enderby, M. Pamela", title="Informing the Design of ``Lifestyle Monitoring'' Technology for the Detection of Health Deterioration in Long-Term Conditions: A Qualitative Study of People Living With Heart Failure", journal="J Med Internet Res", year="2017", month="Jun", day="28", volume="19", number="6", pages="e231", keywords="independent living", keywords="human activities", keywords="heart failure", keywords="biomedical technology", abstract="Background: Health technologies are being developed to help people living at home manage long-term conditions. One such technology is ``lifestyle monitoring'' (LM), a telecare technology based on the idea that home activities may be monitored unobtrusively via sensors to give an indication of changes in health-state. However, questions remain about LM technology: how home activities change when participants experience differing health-states; and how sensors might capture clinically important changes to inform timely interventions. Objective: The objective of this paper was to report the findings of a study aimed at identifying changes in activity indicative of important changes in health in people with long-term conditions, particularly changes indicative of exacerbation, by exploring the relationship between home activities and health among people with heart failure (HF). We aimed to add to the knowledge base informing the development of home monitoring technologies designed to detect health deterioration in order to facilitate early intervention and avoid hospital admissions. Methods: This qualitative study utilized semistructured interviews to explore everyday activities undertaken during the three health-states of HF: normal days, bad days, and exacerbations. Potential recruits were identified by specialist nurses and attendees at an HF support group. The sample was purposively selected to include a range of experience of living with HF. Results: The sample comprised a total of 20 people with HF aged 50 years and above, and 11 spouses or partners of the individuals with HF. All resided in Northern England. Participant accounts revealed that home activities are in part shaped by the degree of intrusion from HF symptoms. During an exacerbation, participants undertook activities specifically to ease symptoms, and detailed activity changes were identified. Everyday activity was also influenced by a range of factors other than health. Conclusions: The study highlights the importance of careful development of LM technology to identify changes in activities that occur during clinically important changes in health. These detailed activity changes need to be considered by developers of LM sensors, platforms, and algorithms intended to detect early signs of deterioration. Results suggest that for LM to move forward, sensor set-up should be personalized to individual circumstances and targeted at individual health conditions. LM needs to take account of the uncertainties that arise from placing technology within the home, in order to inform sensor set-up and data interpretation. This targeted approach is likely to yield more clinically meaningful data and address some of the ethical issues of remote monitoring. ", doi="10.2196/jmir.6931", url="http://www.jmir.org/2017/6/e231/", url="http://www.ncbi.nlm.nih.gov/pubmed/28659253" } @Article{info:doi/10.2196/resprot.7110, author="Pedersen, S. Susanne and Schmidt, Thomas and Skovbakke, Jensen S{\o}ren and Wiil, Kock Uffe and Egstrup, Kenneth and Smolderen, G. Kim and Spertus, A. John", title="A Personalized and Interactive Web-Based Health Care Innovation to Advance the Quality of Life and Care of Patients With Heart Failure (ACQUIRE-HF): A Mixed Methods Feasibility Study", journal="JMIR Res Protoc", year="2017", month="May", day="23", volume="6", number="5", pages="e96", keywords="feasibility", keywords="heart failure", keywords="patient-centered tools", keywords="mixed methods", keywords="Internet", abstract="Background: Heart failure (HF) is a progressive, debilitating, and complex disease, and due to an increasing incidence and prevalence, it represents a global health and economic problem. Hence, there is an urgent need to evaluate alternative care modalities to current practice to safeguard a high level of care for this growing population. Objective: Our goal was to examine the feasibility of engaging patients to use patient-centered and personalized tools coupled with a Web-based, shared care and interactive platform in order to empower and enable them to live a better life with their disease. Methods: We used a mixed methods, single-center, pre-post design. Patients with HF and reduced left ventricular ejection fraction (n=26) were recruited from the outpatient HF clinic at Odense University Hospital (Svendborg Hospital), Denmark, between October 2015 and March 2016. Patients were asked to monitor their health status via the platform using the standardized, disease-specific measure, the Kansas City Cardiomyopathy Questionnaire (KCCQ), and to register their weight. A subset of patients and nursing staff were interviewed after 3-month follow-up about their experiences with the platform. Results: Overall, patients experienced improvement in patient-reported health status but deterioration in self-care behavior between baseline and 3-month follow-up. The mean score reflecting patient expectations toward use prior to start of the study was lower (16 [SD 5]) than their actual experiences with use of the platform (21 [SD 5]) after 3-month follow-up. Of all patients, 19 completed both a baseline and follow-up KCCQ. A total of 9 experienced deterioration in their health status (range from 3-34 points), while 10 experienced an improvement (range from 1-23 points). The qualitative data indicated that the majority of patients found the registration and monitoring on the platform useful. Both nursing staff and patients indicated that such monitoring could be a useful tool to engage and empower patients, in particular when patients are just diagnosed with HF. Conclusions: The use of patient tracking and monitoring of health status in HF using a standardized and validated measure seems feasible and may lead to insights that will help educate, empower, and engage patients more in their own disease management, although it is not suitable for all patients. Nursing staff found the patient-centered tool beneficial as a communication tool with patients but were more reticent with respect to using it as a replacement for the personal contact in the outpatient clinic. ", doi="10.2196/resprot.7110", url="http://www.researchprotocols.org/2017/5/e96/", url="http://www.ncbi.nlm.nih.gov/pubmed/28536092" } @Article{info:doi/10.2196/mhealth.7141, author="Kim, YB Ben and Lee, Joon", title="Smart Devices for Older Adults Managing Chronic Disease: A Scoping Review", journal="JMIR Mhealth Uhealth", year="2017", month="May", day="23", volume="5", number="5", pages="e69", keywords="mobile health", keywords="mHealth", keywords="smartphone", keywords="mobile phone", keywords="tablet", keywords="older adults", keywords="seniors", keywords="chronic disease", keywords="chronic disease management", keywords="scoping review", abstract="Background: The emergence of smartphones and tablets featuring vastly advancing functionalities (eg, sensors, computing power, interactivity) has transformed the way mHealth interventions support chronic disease management for older adults. Baby boomers have begun to widely adopt smart devices and have expressed their desire to incorporate technologies into their chronic care. Although smart devices are actively used in research, little is known about the extent, characteristics, and range of smart device-based interventions. Objective: We conducted a scoping review to (1) understand the nature, extent, and range of smart device-based research activities, (2) identify the limitations of the current research and knowledge gap, and (3) recommend future research directions. Methods: We used the Arksey and O'Malley framework to conduct a scoping review. We identified relevant studies from MEDLINE, Embase, CINAHL, and Web of Science databases using search terms related to mobile health, chronic disease, and older adults. Selected studies used smart devices, sampled older adults, and were published in 2010 or after. The exclusion criteria were sole reliance on text messaging (short message service, SMS) or interactive voice response, validation of an electronic version of a questionnaire, postoperative monitoring, and evaluation of usability. We reviewed references. We charted quantitative data and analyzed qualitative studies using thematic synthesis. To collate and summarize the data, we used the chronic care model. Results: A total of 51 articles met the eligibility criteria. Research activity increased steeply in 2014 (17/51, 33\%) and preexperimental design predominated (16/50, 32\%). Diabetes (16/46, 35\%) and heart failure management (9/46, 20\%) were most frequently studied. We identified diversity and heterogeneity in the collection of biometrics and patient-reported outcome measures within and between chronic diseases. Across studies, we found 8 self-management supporting strategies and 4 distinct communication channels for supporting the decision-making process. In particular, self-monitoring (38/40, 95\%), automated feedback (15/40, 38\%), and patient education (13/40, 38\%) were commonly used as self-management support strategies. Of the 23 studies that implemented decision support strategies, clinical decision making was delegated to patients in 10 studies (43\%). The impact on patient outcomes was consistent with studies that used cellular phones. Patients with heart failure and asthma reported improved quality of life. Qualitative analysis yielded 2 themes of facilitating technology adoption for older adults and 3 themes of barriers. Conclusions: Limitations of current research included a lack of gerontological focus, dominance of preexperimental design, narrow research scope, inadequate support for participants, and insufficient evidence for clinical outcome. Recommendations for future research include generating evidence for smart device-based programs, using patient-generated data for advanced data mining techniques, validating patient decision support systems, and expanding mHealth practice through innovative technologies. ", doi="10.2196/mhealth.7141", url="http://mhealth.jmir.org/2017/5/e69/", url="http://www.ncbi.nlm.nih.gov/pubmed/28536089" } @Article{info:doi/10.2196/jmir.6688, author="Hanlon, Peter and Daines, Luke and Campbell, Christine and McKinstry, Brian and Weller, David and Pinnock, Hilary", title="Telehealth Interventions to Support Self-Management of Long-Term Conditions: A Systematic Metareview of Diabetes, Heart Failure, Asthma, Chronic Obstructive Pulmonary Disease, and Cancer", journal="J Med Internet Res", year="2017", month="May", day="17", volume="19", number="5", pages="e172", keywords="telehealth", keywords="telemonitoring", keywords="self-management", keywords="chronic disease", keywords="diabetes", keywords="heart failure", keywords="asthma", keywords="COPD", keywords="pulmonary disease, chronic obstructive", keywords="cancer", abstract="Background: Self-management support is one mechanism by which telehealth interventions have been proposed to facilitate management of long-term conditions. Objective: The objectives of this metareview were to (1) assess the impact of telehealth interventions to support self-management on disease control and health care utilization, and (2) identify components of telehealth support and their impact on disease control and the process of self-management. Our goal was to synthesise evidence for telehealth-supported self-management of diabetes (types 1 and 2), heart failure, asthma, chronic obstructive pulmonary disease (COPD) and cancer to identify components of effective self-management support. Methods: We performed a metareview (a systematic review of systematic reviews) of randomized controlled trials (RCTs) of telehealth interventions to support self-management in 6 exemplar long-term conditions. We searched 7 databases for reviews published from January 2000 to May 2016 and screened identified studies against eligibility criteria. We weighted reviews by quality (revised A Measurement Tool to Assess Systematic Reviews), size, and relevance. We then combined our results in a narrative synthesis and using harvest plots. Results: We included 53 systematic reviews, comprising 232 unique RCTs. Reviews concerned diabetes (type 1: n=6; type 2, n=11; mixed, n=19), heart failure (n=9), asthma (n=8), COPD (n=8), and cancer (n=3). Findings varied between and within disease areas. The highest-weighted reviews showed that blood glucose telemonitoring with feedback and some educational and lifestyle interventions improved glycemic control in type 2, but not type 1, diabetes, and that telemonitoring and telephone interventions reduced mortality and hospital admissions in heart failure, but these findings were not consistent in all reviews. Results for the other conditions were mixed, although no reviews showed evidence of harm. Analysis of the mediating role of self-management, and of components of successful interventions, was limited and inconclusive. More intensive and multifaceted interventions were associated with greater improvements in diabetes, heart failure, and asthma. Conclusions: While telehealth-mediated self-management was not consistently superior to usual care, none of the reviews reported any negative effects, suggesting that telehealth is a safe option for delivery of self-management support, particularly in conditions such as heart failure and type 2 diabetes, where the evidence base is more developed. Larger-scale trials of telehealth-supported self-management, based on explicit self-management theory, are needed before the extent to which telehealth technologies may be harnessed to support self-management can be established. ", doi="10.2196/jmir.6688", url="http://www.jmir.org/2017/5/e172/", url="http://www.ncbi.nlm.nih.gov/pubmed/28526671" } @Article{info:doi/10.2196/jmir.6571, author="Bashi, Nazli and Karunanithi, Mohanraj and Fatehi, Farhad and Ding, Hang and Walters, Darren", title="Remote Monitoring of Patients With Heart Failure: An Overview of Systematic Reviews", journal="J Med Internet Res", year="2017", month="Jan", day="20", volume="19", number="1", pages="e18", keywords="systematic review", keywords="patient monitoring", keywords="mobile phone", keywords="telemedicine", keywords="heart failure", abstract="Background: Many systematic reviews exist on the use of remote patient monitoring (RPM) interventions to improve clinical outcomes and psychological well-being of patients with heart failure. However, research is broadly distributed from simple telephone-based to complex technology-based interventions. The scope and focus of such evidence also vary widely, creating challenges for clinicians who seek information on the effect of RPM interventions. Objective: The aim of this study was to investigate the effects of RPM interventions on the health outcomes of patients with heart failure by synthesizing review-level evidence. Methods: We searched PubMed, EMBASE, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and the Cochrane Library from 2005 to 2015. We screened reviews based on relevance to RPM interventions using criteria developed for this overview. Independent authors screened, selected, and extracted information from systematic reviews. AMSTAR (Assessment of Multiple Systematic Reviews) was used to assess the methodological quality of individual reviews. We used standardized language to summarize results across reviews and to provide final statements about intervention effectiveness. Results: A total of 19 systematic reviews met our inclusion criteria. Reviews consisted of RPM with diverse interventions such as telemonitoring, home telehealth, mobile phone--based monitoring, and videoconferencing. All-cause mortality and heart failure mortality were the most frequently reported outcomes, but others such as quality of life, rehospitalization, emergency department visits, and length of stay were also reported. Self-care and knowledge were less commonly identified. Conclusions: Telemonitoring and home telehealth appear generally effective in reducing heart failure rehospitalization and mortality. Other interventions, including the use of mobile phone--based monitoring and videoconferencing, require further investigation. ", doi="10.2196/jmir.6571", url="http://www.jmir.org/2017/1/e18/", url="http://www.ncbi.nlm.nih.gov/pubmed/28108430" } @Article{info:doi/10.2196/mhealth.5882, author="Masterson Creber, M. Ruth and Maurer, S. Mathew and Reading, Meghan and Hiraldo, Grenny and Hickey, T. Kathleen and Iribarren, Sarah", title="Review and Analysis of Existing Mobile Phone Apps to Support Heart Failure Symptom Monitoring and Self-Care Management Using the Mobile Application Rating Scale (MARS)", journal="JMIR Mhealth Uhealth", year="2016", month="Jun", day="14", volume="4", number="2", pages="e74", keywords="mobile apps", keywords="mobile health", keywords="heart failure", keywords="self-care", keywords="self-management", keywords="review", keywords="symptom assessment", keywords="nursing informatics", abstract="Background: Heart failure is the most common cause of hospital readmissions among Medicare beneficiaries and these hospitalizations are often driven by exacerbations in common heart failure symptoms. Patient collaboration with health care providers and decision making is a core component of increasing symptom monitoring and decreasing hospital use. Mobile phone apps offer a potentially cost-effective solution for symptom monitoring and self-care management at the point of need. Objective: The purpose of this review of commercially available apps was to identify and assess the functionalities of patient-facing mobile health apps targeted toward supporting heart failure symptom monitoring and self-care management. Methods: We searched 3 Web-based mobile app stores using multiple terms and combinations (eg, ``heart failure,'' ``cardiology,'' ``heart failure and self-management''). Apps meeting inclusion criteria were evaluated using the Mobile Application Rating Scale (MARS), IMS Institute for Healthcare Informatics functionality scores, and Heart Failure Society of America (HFSA) guidelines for nonpharmacologic management. Apps were downloaded and assessed independently by 2-4 reviewers, interclass correlations between reviewers were calculated, and consensus was met by discussion. Results: Of 3636 potentially relevant apps searched, 34 met inclusion criteria. Most apps were excluded because they were unrelated to heart failure, not in English or Spanish, or were games. Interrater reliability between reviewers was high. AskMD app had the highest average MARS total (4.9/5). More than half of the apps (23/34, 68\%) had acceptable MARS scores (>3.0). Heart Failure Health Storylines (4.6) and AskMD (4.5) had the highest scores for behavior change. Factoring MARS, functionality, and HFSA guideline scores, the highest performing apps included Heart Failure Health Storylines, Symple, ContinuousCare Health App, WebMD, and AskMD. Peer-reviewed publications were identified for only 3 of the 34 apps. Conclusions: This review suggests that few apps meet prespecified criteria for quality, content, or functionality, highlighting the need for further refinement and mapping to evidence-based guidelines and room for overall quality improvement in heart failure symptom monitoring and self-care related apps. ", doi="10.2196/mhealth.5882", url="http://mhealth.jmir.org/2016/2/e74/", url="http://www.ncbi.nlm.nih.gov/pubmed/27302310" } @Article{info:doi/10.2196/jmir.4417, author="Agboola, Stephen and Jethwani, Kamal and Khateeb, Kholoud and Moore, Stephanie and Kvedar, Joseph", title="Heart Failure Remote Monitoring: Evidence From the Retrospective Evaluation of a Real-World Remote Monitoring Program", journal="J Med Internet Res", year="2015", month="Apr", day="22", volume="17", number="4", pages="e101", keywords="heart failure", keywords="telemonitoring", keywords="remote monitoring", keywords="self-management", keywords="hospitalizations", keywords="mortality", abstract="Background: Given the magnitude of increasing heart failure mortality, multidisciplinary approaches, in the form of disease management programs and other integrative models of care, are recommended to optimize treatment outcomes. Remote monitoring, either as structured telephone support or telemonitoring or a combination of both, is fast becoming an integral part of many disease management programs. However, studies reporting on the evaluation of real-world heart failure remote monitoring programs are scarce. Objective: This study aims to evaluate the effect of a heart failure telemonitoring program, Connected Cardiac Care Program (CCCP), on hospitalization and mortality in a retrospective database review of medical records of patients with heart failure receiving care at the Massachusetts General Hospital. Methods: Patients enrolled in the CCCP heart failure monitoring program at the Massachusetts General Hospital were matched 1:1 with usual care patients. Control patients received care from similar clinical settings as CCCP patients and were identified from a large clinical data registry. The primary endpoint was all-cause mortality and hospitalizations assessed during the 4-month program duration. Secondary outcomes included hospitalization and mortality rates (obtained by following up on patients over an additional 8 months after program completion for a total duration of 1 year), risk for multiple hospitalizations and length of stay. The Cox proportional hazard model, stratified on the matched pairs, was used to assess primary outcomes. Results: A total of 348 patients were included in the time-to-event analyses. The baseline rates of hospitalizations prior to program enrollment did not differ significantly by group. Compared with controls, hospitalization rates decreased within the first 30 days of program enrollment: hazard ratio (HR)=0.52, 95\% CI 0.31-0.86, P=.01). The differential effect on hospitalization rates remained consistent until the end of the 4-month program (HR=0.74, 95\% CI 0.54-1.02, P=.06). The program was also associated with lower mortality rates at the end of the 4-month program: relative risk (RR)=0.33, 95\% 0.11-0.97, P=.04). Additional 8-months follow-up following program completion did not show residual beneficial effects of the CCCP program on mortality (HR=0.64, 95\% 0.34-1.21, P=.17) or hospitalizations (HR=1.12, 95\% 0.90-1.41, P=.31). Conclusions: CCCP was associated with significantly lower hospitalization rates up to 90 days and significantly lower mortality rates over 120 days of the program. However, these effects did not persist beyond the 120-day program duration. ", doi="10.2196/jmir.4417", url="http://www.jmir.org/2015/4/e101/", url="http://www.ncbi.nlm.nih.gov/pubmed/25903278" } @Article{info:doi/10.2196/mhealth.3789, author="Zan, Shiyi and Agboola, Stephen and Moore, A. Stephanie and Parks, A. Kimberly and Kvedar, C. Joseph and Jethwani, Kamal", title="Patient Engagement With a Mobile Web-Based Telemonitoring System for Heart Failure Self-Management: A Pilot Study", journal="JMIR mHealth uHealth", year="2015", month="Apr", day="01", volume="3", number="2", pages="e33", keywords="heart failure", keywords="disease self-management", keywords="remote monitoring", keywords="telemonitoring", keywords="interactive voice response system", keywords="mobile health", keywords="Web portal", keywords="patient engagement", keywords="quality of life", abstract="Background: Intensive remote monitoring programs for congestive heart failure have been successful in reducing costly readmissions, but may not be appropriate for all patients. There is an opportunity to leverage the increasing accessibility of mobile technologies and consumer-facing digital devices to empower patients in monitoring their own health outside of the hospital setting. The iGetBetter system, a secure Web- and telephone-based heart failure remote monitoring program, which leverages mobile technology and portable digital devices, offers a creative solution at lower cost. Objective: The objective of this pilot study was to evaluate the feasibility of using the iGetBetter system for disease self-management in patients with heart failure. Methods: This was a single-arm prospective study in which 21 ambulatory, adult heart failure patients used the intervention for heart failure self-management over a 90-day study period. Patients were instructed to take their weight, blood pressure, and heart rate measurements each morning using a WS-30 bluetooth weight scale, a self-inflating blood pressure cuff (Withings LLC, Issy les Moulineaux, France), and an iPad Mini tablet computer (Apple Inc, Cupertino, CA, USA) equipped with cellular Internet connectivity to view their measurements on the Internet. Outcomes assessed included usability and satisfaction, engagement with the intervention, hospital resource utilization, and heart failure-related quality of life. Descriptive statistics were used to summarize data, and matched controls identified from the electronic medical record were used as comparison for evaluating hospitalizations. Results: There were 20 participants (mean age 53 years) that completed the study. Almost all participants (19/20, 95\%) reported feeling more connected to their health care team and more confident in performing care plan activities, and 18/20 (90\%) felt better prepared to start discussions about their health with their doctor. Although heart failure-related quality of life improved from baseline, it was not statistically significant (P=.55). Over half of the participants had greater than 80\% (72/90 days) weekly and overall engagement with the program, and 15\% (3/20) used the interactive voice response telephone system exclusively for managing their care plan. Hospital utilization did not differ in the intervention group compared to the control group (planned hospitalizations P=.23, and unplanned hospitalizations P=.99). Intervention participants recorded shorter average length of hospital stay, but no significant differences were observed between intervention and control groups (P=.30). Conclusions: This pilot study demonstrated the feasibility of a low-intensive remote monitoring program leveraging commonly used mobile and portable consumer devices in augmenting care for a fairly young population of ambulatory patients with heart failure. Further prospective studies with a larger sample size and within more diverse patient populations is necessary to determine the effect of mobile-based remote monitoring programs such as the iGetBetter system on clinical outcomes in heart failure. ", doi="10.2196/mhealth.3789", url="http://mhealth.jmir.org/2015/2/e33/", url="http://www.ncbi.nlm.nih.gov/pubmed/25842282" } @Article{info:doi/10.2196/resprot.3411, author="Stut, Wim and Deighan, Carolyn and Armitage, Wendy and Clark, Michelle and Cleland, G. John and Jaarsma, Tiny", title="Design and Usage of the HeartCycle Education and Coaching Program for Patients With Heart Failure", journal="JMIR Res Protoc", year="2014", month="Dec", day="11", volume="3", number="4", pages="e72", keywords="e-counseling", keywords="heart failure", keywords="lifestyle", keywords="patient adherence", keywords="self-care", keywords="telehealth", abstract="Background: Heart failure (HF) is common, and it is associated with high rates of hospital readmission and mortality. It is generally assumed that appropriate self-care can improve outcomes in patients with HF, but patient adherence to many self-care behaviors is poor. Objective: The objective of our study was to develop and test an intervention to increase self-care in patients with HF using a novel, online, automated education and coaching program. Methods: The online automated program was developed using a well-established, face-to-face, home-based cardiac rehabilitation approach. Education is tailored to the behaviors and knowledge of the individual patient, and the system supports patients in adopting self-care behaviors. Patients are guided through a goal-setting process that they conduct at their own pace through the support of the system, and they record their progress in an electronic diary such that the system can provide appropriate feedback. Only in challenging situations do HF nurses intervene to offer help. The program was evaluated in the HeartCycle study, a multicenter, observational trial with randomized components in which researchers investigated the ability of a third-generation telehealth system to enhance the management of patients with HF who had a recent (<60 days) admission to the hospital for symptoms or signs of HF (either new onset or recurrent) or were outpatients with persistent New York Heart Association (NYHA) functional class III/IV symptoms despite treatment with diuretic agents. The patients were enrolled from January 2012 through February 2013 at 3 hospital sites within the United Kingdom, Germany, and Spain. Results: Of 123 patients enrolled (mean age 66 years (SD 12), 66\% NYHA III, 79\% men), 50 patients (41\%) reported that they were not physically active, 56 patients (46\%) did not follow a low-salt diet, 6 patients (5\%) did not restrict their fluid intake, and 6 patients (5\%) did not take their medication as prescribed. About 80\% of the patients who started the coaching program for physical activity and low-salt diet became adherent by achieving their personal goals for 2 consecutive weeks. After becoming adherent, 61\% continued physical activity coaching, but only 36\% continued low-salt diet coaching. Conclusions: The HeartCycle education and coaching program helped most nonadherent patients with HF to adopt recommended self-care behaviors. Automated coaching worked well for most patients who started the coaching program, and many patients who achieved their goals continued to use the program. For many patients who did not engage in the automated coaching program, their choice was appropriate rather than a failure of the program. ", doi="10.2196/resprot.3411", url="http://www.researchprotocols.org/2014/4/e72/", url="http://www.ncbi.nlm.nih.gov/pubmed/25499976" } @Article{info:doi/10.2196/jmir.3651, author="Vuorinen, Anna-Leena and Lepp{\"a}nen, Juha and Kaijanranta, Hannu and Kulju, Minna and Heli{\"o}, Tiina and van Gils, Mark and L{\"a}hteenm{\"a}ki, Jaakko", title="Use of Home Telemonitoring to Support Multidisciplinary Care of Heart Failure Patients in Finland: Randomized Controlled Trial", journal="J Med Internet Res", year="2014", month="Dec", day="11", volume="16", number="12", pages="e282", keywords="heart failure", keywords="telemonitoring", keywords="hospitalization", keywords="user experience", keywords="clinical outcomes", keywords="EHFSBS", keywords="health care resources", abstract="Background: Heart failure (HF) patients suffer from frequent and repeated hospitalizations, causing a substantial economic burden on society. Hospitalizations can be reduced considerably by better compliance with self-care. Home telemonitoring has the potential to boost patients' compliance with self-care, although the results are still contradictory. Objective: A randomized controlled trial was conducted in order to study whether the multidisciplinary care of heart failure patients promoted with telemonitoring leads to decreased HF-related hospitalization. Methods: HF patients were eligible whose left ventricular ejection fraction was lower than 35\%, NYHA functional class ?2, and who needed regular follow-up. Patients in the telemonitoring group (n=47) measured their body weight, blood pressure, and pulse and answered symptom-related questions on a weekly basis, reporting their values to the heart failure nurse using a mobile phone app. The heart failure nurse followed the status of patients weekly and if necessary contacted the patient. The primary outcome was the number of HF-related hospital days. Control patients (n=47) received multidisciplinary treatment according to standard practices. Patients' clinical status, use of health care resources, adherence, and user experience from the patients' and the health care professionals' perspective were studied. Results: Adherence, calculated as a proportion of weekly submitted self-measurements, was close to 90\%. No difference was found in the number of HF-related hospital days (incidence rate ratio [IRR]=0.812, P=.351), which was the primary outcome. The intervention group used more health care resources: they paid an increased number of visits to the nurse (IRR=1.73, P<.001), spent more time at the nurse reception (mean difference of 48.7 minutes, P<.001), and there was a greater number of telephone contacts between the nurse and intervention patients (IRR=3.82, P<.001 for nurse-induced contacts and IRR=1.63, P=.049 for patient-induced contacts). There were no statistically significant differences in patients' clinical health status or in their self-care behavior. The technology received excellent feedback from the patient and professional side with a high adherence rate throughout the study. Conclusions: Home telemonitoring did not reduce the number of patients' HF-related hospital days and did not improve the patients' clinical condition. Patients in the telemonitoring group contacted the Cardiology Outpatient Clinic more frequently, and on this way increased the use of health care resources. Trial Registration: Clinicaltrials.gov NCT01759368; http://clinicaltrials.gov/show/NCT01759368 (Archived by WebCite at http://www.webcitation.org/6UFxiCk8Z). ", doi="10.2196/jmir.3651", url="http://www.jmir.org/2014/12/e282/", url="http://www.ncbi.nlm.nih.gov/pubmed/25498992" } @Article{info:doi/10.2196/jmir.2587, author="Zanaboni, Paolo and Landolina, Maurizio and Marzegalli, Maurizio and Lunati, Maurizio and Perego, B. Giovanni and Guenzati, Giuseppe and Curnis, Antonio and Valsecchi, Sergio and Borghetti, Francesca and Borghi, Gabriella and Masella, Cristina", title="Cost-Utility Analysis of the EVOLVO Study on Remote Monitoring for Heart Failure Patients With Implantable Defibrillators: Randomized Controlled Trial", journal="J Med Internet Res", year="2013", month="May", day="30", volume="15", number="5", pages="e106", keywords="telemedicine", keywords="heart failure", keywords="implantable defibrillators", keywords="cost-effectiveness", abstract="Background: Heart failure patients with implantable defibrillators place a significant burden on health care systems. Remote monitoring allows assessment of device function and heart failure parameters, and may represent a safe, effective, and cost-saving method compared to conventional in-office follow-up. Objective: We hypothesized that remote device monitoring represents a cost-effective approach. This paper summarizes the economic evaluation of the Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators (EVOLVO) study, a multicenter clinical trial aimed at measuring the benefits of remote monitoring for heart failure patients with implantable defibrillators. Methods: Two hundred patients implanted with a wireless transmission--enabled implantable defibrillator were randomized to receive either remote monitoring or the conventional method of in-person evaluations. Patients were followed for 16 months with a protocol of scheduled in-office and remote follow-ups. The economic evaluation of the intervention was conducted from the perspectives of the health care system and the patient. A cost-utility analysis was performed to measure whether the intervention was cost-effective in terms of cost per quality-adjusted life year (QALY) gained. Results: Overall, remote monitoring did not show significant annual cost savings for the health care system ({\texteuro}1962.78 versus {\texteuro}2130.01; P=.80). There was a significant reduction of the annual cost for the patients in the remote arm in comparison to the standard arm ({\texteuro}291.36 versus {\texteuro}381.34; P=.01). Cost-utility analysis was performed for 180 patients for whom QALYs were available. The patients in the remote arm gained 0.065 QALYs more than those in the standard arm over 16 months, with a cost savings of {\texteuro}888.10 per patient. Results from the cost-utility analysis of the EVOLVO study show that remote monitoring is a cost-effective and dominant solution. Conclusions: Remote management of heart failure patients with implantable defibrillators appears to be cost-effective compared to the conventional method of in-person evaluations. Trial Registration: ClinicalTrials.gov NCT00873899; http://clinicaltrials.gov/show/NCT00873899 (Archived by WebCite at http://www.webcitation.org/6H0BOA29f). ", doi="10.2196/jmir.2587", url="http://www.jmir.org/2013/5/e106/", url="http://www.ncbi.nlm.nih.gov/pubmed/23722666" } @Article{info:doi/10.2196/jmir.1912, author="Seto, Emily and Leonard, J. Kevin and Cafazzo, A. Joseph and Barnsley, Jan and Masino, Caterina and Ross, J. Heather", title="Perceptions and Experiences of Heart Failure Patients and Clinicians on the Use of Mobile Phone-Based Telemonitoring", journal="J Med Internet Res", year="2012", month="Feb", day="10", volume="14", number="1", pages="e25", keywords="heart failure", keywords="telemonitoring", keywords="mobile phone", keywords="patient monitoring", keywords="self-care", keywords="qualitative research", abstract="Background: Previous trials of heart failure telemonitoring systems have produced inconsistent findings, largely due to diverse interventions and study designs. Objectives: The objectives of this study are (1) to provide in-depth insight into the effects of telemonitoring on self-care and clinical management, and (2) to determine the features that enable successful heart failure telemonitoring. Methods: Semi-structured interviews were conducted with 22 heart failure patients attending a heart function clinic who had used a mobile phone-based telemonitoring system for 6 months. The telemonitoring system required the patients to take daily weight and blood pressure readings, weekly single-lead ECGs, and to answer daily symptom questions on a mobile phone. Instructions were sent to the patient's mobile phone based on their physiological values. Alerts were also sent to a cardiologist's mobile phone, as required. All clinicians involved in the study were also interviewed post-trial (N = 5). The interviews were recorded, transcribed, and then analyzed using a conventional content analysis approach. Results: The telemonitoring system improved patient self-care by instructing the patients in real-time how to appropriately modify their lifestyle behaviors. Patients felt more aware of their heart failure condition, less anxiety, and more empowered. Many were willing to partially fund the use of the system. The clinicians were able to manage their patients' heart failure conditions more effectively, because they had physiological data reported to them frequently to help in their decision-making (eg, for medication titration) and were alerted at the earliest sign of decompensation. Essential characteristics of the telemonitoring system that contributed to improved heart failure management included immediate self-care and clinical feedback (ie, teachable moments), how the system was easy and quick to use, and how the patients and clinicians perceived tangible benefits from telemonitoring. Some clinical concerns included ongoing costs of the telemonitoring system and increased clinical workload. A few patients did not want to be watched long-term while some were concerned they might become dependent on the system. Conclusions: The success of a telemonitoring system is highly dependent on its features and design. The essential system characteristics identified in this study should be considered when developing telemonitoring solutions. Key Words: ", doi="10.2196/jmir.1912", url="http://www.jmir.org/2012/1/e25/", url="http://www.ncbi.nlm.nih.gov/pubmed/22328237" }