@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" } @Article{info:doi/10.2196/21986, author="Kapoor, Alok and Andrade, Andreza and Hayes, Anna and Mazor, Kathleen and Possidente, Carl and Nolen, Kim and Hegeman-Dingle, Rozelle and McManus, David", title="Usability, Perceived Usefulness, and Shared Decision-Making Features of the AFib 2gether Mobile App: Protocol for a Single-Arm Intervention Study", journal="JMIR Res Protoc", year="2021", month="Feb", day="24", volume="10", number="2", pages="e21986", keywords="shared decision making", keywords="mobile health", keywords="stroke risk", keywords="anticoagulation risk", keywords="anticoagulation education", keywords="atrial fibrillation", keywords="anticoagulation therapy", keywords="anticoagulation", keywords="atrial flutter", keywords="mobile phone", abstract="Background: The Centers for Disease Control and Prevention has estimated that atrial fibrillation (AF) affects between 2.7 million and 6.1 million people in the United States. Those who have AF tend to have a much higher stroke risk than others. Although most individuals with AF benefit from anticoagulation (AC) therapy, a significant majority are hesitant to start it. To add, providers often struggle in helping patients negotiate the decision to start AC therapy. To assist in the communication between patients and providers regarding preferences and knowledge about AC therapy, different strategies are being used to try and solve this problem. In this research study, we will have patients and providers utilize the AFib 2gether app with hopes that it will create a platform for shared decision making regarding the prevention of stroke in patients with AF receiving AC therapy. Objective: The aim of our study is to measure several outcomes related to encounters between patients and their cardiology providers where AFib 2gether is used. These outcomes include usability and perceived usefulness of the app from the perspective of patients and providers. In addition, we will assess the extent and nature of shared decision making. Methods: Eligible patients and providers will evaluate the AFib 2gether mobile app for usability and perceived usefulness in facilitating shared decision making regarding understanding the patient's risk of stroke and whether or not to start AC therapy. Both patients and providers will review the app and complete multiple questionnaires about the usability and perceived usefulness of the mobile app in a clinical setting. We will also audio-record a subset of encounters to assess for evidence of shared decision making. Results: Enrollment in the AFib 2gether shared decision-making study is still ongoing for both patients and providers. The first participant enrolled on November 22, 2019. Analysis and publishing of results are expected to be completed in spring 2021. Conclusions: The AFib 2gether app emerged from a desire to increase the ability of patients and providers to engage in shared decision making around understanding the risk of stroke and AC therapy. We anticipate that the AFib 2gether mobile app will facilitate patient discussion with their cardiologist and other providers. Additionally, we hope the study will help us identify barriers that providers face when placing patients on AC therapy. We aim to demonstrate the usability and perceived usefulness of the app with a future goal of testing the value of our approach in a larger sample of patients and providers at multiple medical centers across the country. Trial Registration: ClinicalTrials.gov NCT04118270; https://clinicaltrials.gov/ct2/show/NCT04118270 International Registered Report Identifier (IRRID): DERR1-10.2196/21986 ", doi="10.2196/21986", url="https://www.researchprotocols.org/2021/2/e21986", url="http://www.ncbi.nlm.nih.gov/pubmed/33625361" } @Article{info:doi/10.2196/18834, author="Spaulding, M. Erin and Marvel, A. Francoise and Piasecki, J. Rebecca and Martin, S. Seth and Allen, K. Jerilyn", title="User Engagement With Smartphone Apps and Cardiovascular Disease Risk Factor Outcomes: Systematic Review", journal="JMIR Cardio", year="2021", month="Feb", day="3", volume="5", number="1", pages="e18834", keywords="mHealth", keywords="smartphone", keywords="mobile phone", keywords="engagement", keywords="cardiovascular disease", keywords="health behaviors", keywords="risk factors", abstract="Background: The use of mobile health (mHealth) interventions, including smartphone apps, for the prevention of cardiovascular disease (CVD) has demonstrated mixed results for obesity, hypercholesterolemia, diabetes, and hypertension management. A major factor attributing to the variation in mHealth study results may be mHealth user engagement. Objective: This systematic review aims to determine if user engagement with smartphone apps for the prevention and management of CVD is associated with improved CVD health behavior change and risk factor outcomes. Methods: We conducted a comprehensive search of PubMed, CINAHL, and Embase databases from 2007 to 2020. Studies were eligible if they assessed whether user engagement with a smartphone app used by an individual to manage his or her CVD risk factors was associated with the CVD health behavior change or risk factor outcomes. For eligible studies, data were extracted on study and sample characteristics, intervention description, app user engagement measures, and the relationship between app user engagement and the CVD risk factor outcomes. App user engagement was operationalized as general usage (eg, number of log-ins or usage days per week) or self-monitoring within the app (eg, total number of entries made in the app). The quality of the studies was assessed. Results: Of the 24 included studies, 17 used a randomized controlled trial design, 4 used a retrospective analysis, and 3 used a single-arm pre- and posttest design. Sample sizes ranged from 55 to 324,649 adults, with 19 studies recruiting participants from a community setting. Most of the studies assessed weight loss interventions, with 6 addressing additional CVD risk factors, including diabetes, sleep, stress, and alcohol consumption. Most of the studies that assessed the relationship between user engagement and reduction in weight (9/13, 69\%), BMI (3/4, 75\%), body fat percentage (1/2, 50\%), waist circumference (2/3, 67\%), and hemoglobin A1c (3/5, 60\%) found statistically significant results, indicating that greater app user engagement was associated with better outcomes. Of 5 studies, 3 (60\%) found a statistically significant relationship between higher user engagement and an increase in objectively measured physical activity. The studies assessing the relationship between user engagement and dietary and diabetes self-care behaviors, blood pressure, and lipid panel components did not find statistically significant results. Conclusions: Increased app user engagement for prevention and management of CVD may be associated with improved weight and BMI; however, only a few studies assessed other outcomes, limiting the evidence beyond this. Additional studies are needed to assess user engagement with smartphone apps targeting other important CVD risk factors, including dietary behaviors, hypercholesterolemia, diabetes, and hypertension. Further research is needed to assess mHealth user engagement in both inpatient and outpatient settings to determine the effect of integrating mHealth interventions into the existing clinical workflow and on CVD outcomes. ", doi="10.2196/18834", url="http://cardio.jmir.org/2021/1/e18834/", url="http://www.ncbi.nlm.nih.gov/pubmed/33533730" } @Article{info:doi/10.2196/26155, author="Lokker, Cynthia and Jezrawi, Rita and Gabizon, Itzhak and Varughese, Jobin and Brown, Michael and Trottier, Dan and Alvarez, Elizabeth and Schwalm, Jon-David and McGillion, Michael and Ma, Jinhui and Bhagirath, Vinai", title="Feasibility of a Web-Based Platform (Trial My App) to Efficiently Conduct Randomized Controlled Trials of mHealth Apps For Patients With Cardiovascular Risk Factors: Protocol For Evaluating an mHealth App for Hypertension", journal="JMIR Res Protoc", year="2021", month="Feb", day="1", volume="10", number="2", pages="e26155", keywords="mHealth", keywords="mobile health", keywords="hypertension", keywords="app", keywords="patient-oriented", keywords="feasibility", keywords="cardiovascular disease", keywords="internet-administered", keywords="randomized controlled trial", abstract="Background: Mobile health (mHealth) interventions can improve health by improving cardiovascular risk factors, but their adoption in care by physicians and patients is untapped. Few mHealth apps have been evaluated in clinical trials, and due to the fast pace of technological development, those previously evaluated are often outdated by the time trial results are available. Given the rapid pace of change in this field, it is not feasible to rigorously evaluate mHealth apps with current methodologies. Objective: The overall aim of this pilot study was to test the feasibility of using a web research platform called Trial My App to conduct efficient and rigorous web-based randomized controlled trials (RCTs) of mHealth apps relevant to patients with cardiovascular risk factors by evaluating an app that targets hypertension. Methods: For this study, 200 participants with suboptimally controlled hypertension will be recruited through advertisements in newsletters, media, and the internet, as well as through referrals from their health care providers. Screening, consent, randomization, and collection of patient-important health confidence and self-management ability outcomes will be conducted online through the Trial My App research platform. Participants will be randomized into 2 groups: 100 that will use an mHealth app for tracking hypertension and 100 that will be considered as an educational control. All participants will complete questionnaires at 0, 1, 3 and 6 months after enrolment. A substudy to validate the method of blood pressure readings and the consistency of data entered through Trial My App will be conducted with 40 participants. Results: The development of the Trial My App web platform has been completed. The creation of survey instruments has been completed in collaboration with our patient partners and advisory board. Recruitment is expected to begin in the first quarter of 2021; data collection and analysis are expected to be completed approximately 1 year after study commencement. Results will be disseminated through conferences and publications. The primary outcomes of this study include the feasibility of conducting an RCT using the Trial My App platform by reporting recruitment, retention, and completion statistics. We will validate app-entered data with a standard 7-day home blood pressure measurement method. Lastly, the pilot, nonblinded RCT will assess the effectiveness of the mHealth app in improving the control of hypertension compared with the control of hypertension in the educational control group. Conclusions: This study will determine if it is feasible to use the Trial My App web-based platform to evaluate the effectiveness of mHealth apps for patients with cardiovascular risk factors. As more mHealth apps are evaluated in RCTs, patients will be able to select apps that meet their needs and physicians will be able to make evidence-based recommendations to their patients for apps aimed at improving cardiovascular health. Trial Registration: ClinicalTrials.gov NCT04528654; https://clinicaltrials.gov/ct2/show/NCT04528654 International Registered Report Identifier (IRRID): PRR1-10.2196/26155 ", doi="10.2196/26155", url="https://www.researchprotocols.org/2021/2/e26155", url="http://www.ncbi.nlm.nih.gov/pubmed/33522978" } @Article{info:doi/10.2196/25424, author="Lakshminarayan, Kamakshi and Murray, A. Thomas and Westberg, M. Sarah and Connett, John and Overton, Val and Nyman, A. John and Culhane-Pera, A. Kathleen and Pergament, L. Shannon and Drawz, Paul and Vollbrecht, Emily and Xiong, Txia and Everson-Rose, A. Susan", title="Mobile Health Intervention to Close the Guidelines-To-Practice Gap in Hypertension Treatment: Protocol for the mGlide Randomized Controlled Trial", journal="JMIR Res Protoc", year="2021", month="Jan", day="25", volume="10", number="1", pages="e25424", keywords="hypertension", keywords="mobile health technology", keywords="health disparities", keywords="randomized controlled trial", abstract="Background: Suboptimal treatment of hypertension remains a widespread problem, particularly among minorities and socioeconomically disadvantaged groups. We present a health system--based intervention with diverse patient populations using readily available smartphone technology. This intervention is designed to empower patients and create partnerships between patients and their provider team to promote hypertension control. Objective: The mGlide randomized controlled trial is a National Institutes of Health--funded study, evaluating whether a mobile health (mHealth)-based intervention that is an active partnership between interprofessional health care teams and patients results in better hypertension control rates than a state-of-clinical care comparison. Methods: We are recruiting 450 participants including stroke survivors and primary care patients with elevated cardiovascular disease risk from diverse health systems. These systems include an acute stroke service (n=100), an academic medical center (n=150), and community medical centers including Federally Qualified Health Centers serving low-income and minority (Latino, Hmong, African American, Somali) patients (n=200). The primary aim tests the clinical effectiveness of the 6-month mHealth intervention versus standard of care. Secondary aims evaluate sustained hypertension control rates at 12 months; describe provider experiences of system usability and satisfaction; examine patient experiences, including medication adherence and medication use self-efficacy, self-rated health and quality of life, and adverse event rates; and complete a cost-effectiveness analysis. Results: To date, we have randomized 107 participants (54 intervention, 53 control). Conclusions: This study will provide evidence for whether a readily available mHealth care model is better than state-of-clinical care for bridging the guideline-to-practice gap in hypertension treatment in health systems serving diverse patient populations. Trial Registration: Clinicaltrials.gov NCT03612271; https://clinicaltrials.gov/ct2/show/NCT03612271 International Registered Report Identifier (IRRID): DERR1-10.2196/25424 ", doi="10.2196/25424", url="http://www.researchprotocols.org/2021/1/e25424/", url="http://www.ncbi.nlm.nih.gov/pubmed/33492231" } @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/10.2196/16114, author="M{\"u}ller, Dueholm Sune and Lauridsen, Glerup Kasper and Palic, Hadrovic Amra and Frederiksen, Nygaard Lotte and Mathiasen, Morten and L{\o}fgren, Bo", title="Mobile App Support for Cardiopulmonary Resuscitation: Development and Usability Study", journal="JMIR Mhealth Uhealth", year="2021", month="Jan", day="5", volume="9", number="1", pages="e16114", keywords="the Kano model", keywords="cardiopulmonary resuscitation", keywords="healthcare", keywords="smartphone apps", keywords="public health", keywords="ALS CPR algorithm", keywords="app evaluation", keywords="mobile phone", abstract="Background: The user requirements for in-hospital cardiopulmonary resuscitation (CPR) support apps are understudied. To study usability, functionality, and design based on user requirements, we applied a mixed methods research design using interviews, observations, and a Kano questionnaire to survey perspectives of both physicians and nurses. Objective: This study aims to identify what an in-hospital CPR support app should include to meet the requirements and expectations of health care professionals by evaluating the CprPrototype app. Methods: We used a mixed methods research design. The qualitative methods consisted of semistructured interviews and observations from an advanced life support (ALS) course; both provided input to the subsequent questionnaire development. The quantitative method is a questionnaire based on the Kano model classifying user requirements as must-be, one-dimensional (attributes causing satisfaction when present and dissatisfaction when absent), attractive, indifferent, and reverse (attributes causing dissatisfaction when present and satisfaction when absent). The questionnaire was supplemented with comment fields. All respondents were physicians and nurses providing ALS at hospitals in the Central Denmark Region. Results: A total of 83 physicians and nurses responded to the questionnaire, 15 physicians and nurses were observed during ALS training, and 5 physicians were interviewed. On the basis of the Kano questionnaire, 53\% (9/17) of requirements were classified as indifferent, 29\% (5/17) as attractive, and 18\% (3/17) as one-dimensional. The comments revealed 7 different categories of user requirements with noticeable differences between those of physicians and nurses: technological challenges, keep track of time, documentation and history, disturbing element, improvement areas: functions, improvement areas: design, and better guidance. Conclusions: The study provides recommendations to developers on the user requirements that need to be addressed when developing CPR support apps. Three features (one-dimensional attributes) must be incorporated in an in-hospital CPR support app: reminder of rhythm check, reminder of resuscitation drugs, and differentiate between adults and children. In addition, 5 features (attractive attributes) would result in higher user satisfaction: all functions on one side, access to the patient journal in the app, automatic time recording when cardiac arrest is called, sound to guide the chest compression rate (metronome), and send CPR history to the DANARREST(Danish in-hospital cardiac arrest registry) database. ", doi="10.2196/16114", url="https://mhealth.jmir.org/2021/1/e16114", url="http://www.ncbi.nlm.nih.gov/pubmed/33399539" } @Article{info:doi/10.2196/19065, author="Gomis-Pastor, Mar and Mirabet, Sonia and Roig, Eulalia and Lopez, Laura and Brossa, Vicens and Galvez-Tugas, Elisabeth and Rodriguez-Murphy, Esther and Feliu, Anna and Ontiveros, Gerardo and Garcia-Cuy{\`a}s, Francesc and Salazar, Albert and Mangues, Antonia M.", title="Interdisciplinary Mobile Health Model to Improve Clinical Care After Heart Transplantation: Implementation Strategy Study", journal="JMIR Cardio", year="2020", month="Nov", day="24", volume="4", number="1", pages="e19065", keywords="cardiology", keywords="heart transplantation", keywords="implementation strategy", keywords="health care model", keywords="integrated health care systems", keywords="interdisciplinary health team", keywords="medication therapy management", keywords="health care technology", keywords="mHealth", keywords="eHealth", abstract="Background: Solid organ transplantation could be the only life-saving treatment for end-stage heart failure. Nevertheless, multimorbidity and polypharmacy remain major problems after heart transplant. A technology-based behavioral intervention model was established to improve clinical practice in a heart transplant outpatient setting. To support the new strategy, the mHeart app, a mobile health (mHealth) tool, was developed for use by patients and providers. Objective: The primary objective of this study was to describe the implementation of the mHeart model and to outline the main facilitators identified when conceiving an mHealth approach. The secondary objectives were to evaluate the barriers, benefits, and willingness to use mHealth services reported by heart transplant recipients and cardiology providers. Methods: This was an implementation strategy study directed by a multidisciplinary cardiology team conducted in four stages: design of the model and the software, development of the mHeart tool, interoperability among systems, and quality and security requirements. A mixed methods study design was applied combining a literature review, several surveys, interviews, and focus groups. The approach involved merging engineering and behavioral theory science. Participants were chronic-stage heart transplant recipients, patient associations, health providers, stakeholders, and diverse experts from the legal, data protection, and interoperability fields. Results: An interdisciplinary and patient-centered process was applied to obtain a comprehensive care model. The heart transplant recipients (N=135) included in the study confirmed they had access to smartphones (132/135, 97.7\%) and were willing to use the mHeart system (132/135, 97.7\%). Based on stakeholder agreement (>75\%, N=26), the major priorities identified of the mHealth approach were to improve therapy management, patient empowerment, and patient-provider interactions. Stakeholder agreement on the barriers to implementing the system was weak (<75\%). Establishing the new model posed several challenges to the multidisciplinary team in charge. The main factors that needed to be overcome were ensuring data confidentiality, reducing workload, minimizing the digital divide, and increasing interoperability. Experts from various fields, scientific societies, and patient associations were essential to meet the quality requirements and the model scalability. Conclusions: The mHeart model will be applicable in distinct clinical and research contexts, and may inspire other cardiology health providers to create innovative ways to deal with therapeutic complexity and multimorbidity through health care systems. Professionals and patients are willing to use such innovative mHealth programs. The facilitators and key strategies described were needed for success in the implementation of the new holistic theory--based mHealth strategy. ", doi="10.2196/19065", url="http://cardio.jmir.org/2020/1/e19065/", url="http://www.ncbi.nlm.nih.gov/pubmed/33231557" } @Article{info:doi/10.2196/19070, author="Corazza, Francesco and Snijders, Deborah and Arpone, Marta and Stritoni, Valentina and Martinolli, Francesco and Daverio, Marco and Losi, Giulia Maria and Soldi, Luca and Tesauri, Francesco and Da Dalt, Liviana and Bressan, Silvia", title="Development and Usability of a Novel Interactive Tablet App (PediAppRREST) to Support the Management of Pediatric Cardiac Arrest: Pilot High-Fidelity Simulation-Based Study", journal="JMIR Mhealth Uhealth", year="2020", month="Oct", day="1", volume="8", number="10", pages="e19070", keywords="cardiac arrest", keywords="resuscitation", keywords="mobile app", keywords="high-fidelity simulation training", keywords="cognitive aid", keywords="pediatrics", keywords="emergency medicine", abstract="Background: Pediatric cardiac arrest (PCA), although rare, is associated with high mortality. Deviations from international management guidelines are frequent and associated with poorer outcomes. Different strategies/devices have been developed to improve the management of cardiac arrest, including cognitive aids. However, there is very limited experience on the usefulness of interactive cognitive aids in the format of an app in PCA. No app has so far been tested for its usability and effectiveness in guiding the management of PCA. Objective: To develop a new audiovisual interactive app for tablets, named PediAppRREST, to support the management of PCA and to test its usability in a high-fidelity simulation-based setting. Methods: A research team at the University of Padova (Italy) and human--machine interface designers, as well as app developers, from an Italian company (RE:Lab S.r.l.) developed the app between March and October 2019, by applying an iterative design approach (ie, design--prototyping--evaluation iterative loops). In October--November 2019, a single-center nonrandomized controlled simulation--based pilot study was conducted including 48 pediatric residents divided into teams of 3. The same nonshockable PCA scenario was managed by 11 teams with and 5 without the app. The app user's experience and interaction patterns were documented through video recording of scenarios, debriefing sessions, and questionnaires. App usability was evaluated with the User Experience Questionnaire (UEQ) (scores range from --3 to +3 for each scale) and open-ended questions, whereas participants' workload was measured using the NASA Raw-Task Load Index (NASA RTLX). Results: Users' difficulties in interacting with the app during the simulations were identified using a structured framework. The app usability, in terms of mean UEQ scores, was as follows: attractiveness 1.71 (SD 1.43), perspicuity 1.75 (SD 0.88), efficiency 1.93 (SD 0.93), dependability 1.57 (SD 1.10), stimulation 1.60 (SD 1.33), and novelty 2.21 (SD 0.74). Team leaders' perceived workload was comparable (P=.57) between the 2 groups; median NASA RTLX score was 67.5 (interquartile range [IQR] 65.0-81.7) for the control group and 66.7 (IQR 54.2-76.7) for the intervention group. A preliminary evaluation of the effectiveness of the app in reducing deviations from guidelines showed that median time to epinephrine administration was significantly longer in the group that used the app compared with the control group (254 seconds versus 165 seconds; P=.015). Conclusions: The PediAppRREST app received a good usability evaluation and did not appear to increase team leaders' workload. Based on the feedback collected from the participants and the preliminary results of the evaluation of its effects on the management of the simulated scenario, the app has been further refined. The effectiveness of the new version of the app in reducing deviations from guidelines recommendations in the management of PCA and its impact on time to critical actions will be evaluated in an upcoming multicenter simulation-based randomized controlled trial. ", doi="10.2196/19070", url="https://mhealth.jmir.org/2020/10/e19070", url="http://www.ncbi.nlm.nih.gov/pubmed/32788142" } @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/10.2196/16695, 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/10.2196/13756, author="Salvi, Dario and Poffley, Emma and Orchard, Elizabeth and Tarassenko, Lionel", title="The Mobile-Based 6-Minute Walk Test: Usability Study and Algorithm Development and Validation", journal="JMIR Mhealth Uhealth", year="2020", month="Jan", day="3", volume="8", number="1", pages="e13756", keywords="cardiology", keywords="exercise test", keywords="pulmonary hypertension", keywords="mobile apps", keywords="digital signal processing", keywords="global positioning system", abstract="Background: The 6-min walk test (6MWT) is a convenient method for assessing functional capacity in patients with cardiopulmonary conditions. It is usually performed in the context of a hospital clinic and thus requires the involvement of hospital staff and facilities, with their associated costs. Objective: This study aimed to develop a mobile phone--based system that allows patients to perform the 6MWT in the community. Methods: We developed 2 algorithms to compute the distance walked during a 6MWT using sensors embedded in a mobile phone. One algorithm makes use of the global positioning system to track the location of the phone when outdoors and hence computes the distance travelled. The other algorithm is meant to be used indoors and exploits the inertial sensors built into the phone to detect U-turns when patients walk back and forth along a corridor of fixed length. We included these algorithms in a mobile phone app, integrated with wireless pulse oximeters and a back-end server. We performed Bland-Altman analysis of the difference between the distances estimated by the phone and by a reference trundle wheel on 49 indoor tests and 30 outdoor tests, with 11 different mobile phones (both Apple iOS and Google Android operating systems). We also assessed usability aspects related to the app in a discussion group with patients and clinicians using a technology acceptance model to guide discussion. Results: The mean difference between the mobile phone-estimated distances and the reference values was ?2.013 m (SD 7.84 m) for the indoor algorithm and ?0.80 m (SD 18.56 m) for the outdoor algorithm. The absolute maximum difference was, in both cases, below the clinically significant threshold. A total of 2 pulmonary hypertension patients, 1 cardiologist, 2 physiologists, and 1 nurse took part in the discussion group, where issues arising from the use of the 6MWT in hospital were identified. The app was demonstrated to be usable, and the 2 patients were keen to use it in the long term. Conclusions: The system described in this paper allows patients to perform the 6MWT at a place of their convenience. In addition, the use of pulse oximetry allows more information to be generated about the patient's health status and, possibly, be more relevant to the real-life impact of their condition. Preliminary assessment has shown that the developed 6MWT app is highly accurate and well accepted by its users. Further tests are needed to assess its clinical value. ", doi="10.2196/13756", url="https://mhealth.jmir.org/2020/1/e13756", url="http://www.ncbi.nlm.nih.gov/pubmed/31899457" } @Article{info:doi/10.2196/14909, author="Zhang, Hui and Zhang, Jie and Li, Hong-Bao and Chen, Yi-Xin and Yang, Bin and Guo, Yu-Tao and Chen, Yun-Dai", title="Validation of Single Centre Pre-Mobile Atrial Fibrillation Apps for Continuous Monitoring of Atrial Fibrillation in a Real-World Setting: Pilot Cohort Study", journal="J Med Internet Res", year="2019", month="Dec", day="3", volume="21", number="12", pages="e14909", keywords="atrial fibrillation", keywords="photoplethysmography", keywords="continuous detection", keywords="accuracy", keywords="smartphone", keywords="smart band", keywords="algorithm", abstract="Background: Atrial fibrillation is the most common recurrent arrhythmia in clinical practice, with most clinical events occurring outside the hospital. Low detection and nonadherence to guidelines are the primary obstacles to atrial fibrillation management. Photoplethysmography is a novel technology developed for atrial fibrillation screening. However, there has been limited validation of photoplethysmography-based smart devices for the detection of atrial fibrillation and its underlying clinical factors impacting detection. Objective: This study aimed to explore the feasibility of photoplethysmography-based smart devices for the detection of atrial fibrillation in real-world settings. Methods: Subjects aged ?18 years (n=361) were recruited from September 14 to October 16, 2018, for screening of atrial fibrillation with active measurement, initiated by the users, using photoplethysmography-based smart wearable devices (ie, a smart band or smart watches). Of these, 200 subjects were also automatically and periodically monitored for 14 days with a smart band. The baseline diagnosis of ``suspected'' atrial fibrillation was confirmed by electrocardiogram and physical examination. The sensitivity and accuracy of photoplethysmography-based smart devices for monitoring atrial fibrillation were evaluated. Results: A total of 2353 active measurement signals and 23,864 periodic measurement signals were recorded. Eleven subjects were confirmed to have persistent atrial fibrillation, and 20 were confirmed to have paroxysmal atrial fibrillation. Smart devices demonstrated >91\% predictive ability for atrial fibrillation. The sensitivity and specificity of devices in detecting atrial fibrillation among active recording of the 361 subjects were 100\% and about 99\%, respectively. For subjects with persistent atrial fibrillation, 127 (97.0\%) active measurements and 2240 (99.2\%) periodic measurements were identified as atrial fibrillation by the algorithm. For subjects with paroxysmal atrial fibrillation, 36 (17\%) active measurements and 717 (19.8\%) periodic measurements were identified as atrial fibrillation by the algorithm. All persistent atrial fibrillation cases could be detected as ``atrial fibrillation episodes'' by the photoplethysmography algorithm on the first monitoring day, while 14 (70\%) patients with paroxysmal atrial fibrillation demonstrated ``atrial fibrillation episodes'' within the first 6 days. The average time to detect paroxysmal atrial fibrillation was 2 days (interquartile range: 1.25-5.75) by active measurement and 1 day (interquartile range: 1.00-2.00) by periodic measurement (P=.10). The first detection time of atrial fibrillation burden of <50\% per 24 hours was 4 days by active measurement and 2 days by periodic measurementThe first detection time of atrial fibrillation burden of >50\% per 24 hours was 1 day for both active and periodic measurements (active measurement: P=.02, periodic measurement: P=.03). Conclusions: Photoplethysmography-based smart devices demonstrated good atrial fibrillation predictive ability in both active and periodic measurements. However, atrial fibrillation type could impact detection, resulting in increased monitoring time. Trial Registration: Chinese Clinical Trial Registry of the International Clinical Trials Registry Platform of the World Health Organization ChiCTR-OOC-17014138; http://www.chictr.org.cn/showprojen.aspx?proj=24191. ", doi="10.2196/14909", url="https://www.jmir.org/2019/12/e14909", url="http://www.ncbi.nlm.nih.gov/pubmed/31793887" } @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/10.2196/13651, author="Pald{\'a}n, Katrin and Simanovski, Jan and Ullrich, Greta and Steinmetz, Martin and Rammos, Christos and J{\'a}nosi, Alexander Rolf and Moebus, Susanne and Rassaf, Tienush and Lortz, Julia", title="Feasibility and Clinical Relevance of a Mobile Intervention Using TrackPAD to Support Supervised Exercise Therapy in Patients With Peripheral Arterial Disease: Study Protocol for a Randomized Controlled Pilot Trial", journal="JMIR Res Protoc", year="2019", month="Jun", day="26", volume="8", number="6", pages="e13651", keywords="peripheral arterial disease", keywords="telemedicine", keywords="patient participation", keywords="patient compliance", keywords="primary health care", abstract="Background: Peripheral arterial disease (PAD) is a common and severe disease with a highly increased cardiovascular morbidity and mortality. Through the circulatory disorder and the linked undersupply of oxygen carriers in the lower limbs, the ongoing decrease of the pain-free walking distance occurs with a significant reduction in patients' quality of life. Studies including activity monitoring for patients with PAD are rare and digital support to increase activity via mobile health technologies is mainly targeted at patients with cardiovascular disease in general. The special requirement of patients with PAD is the need to reach a certain pain level to improve the pain-free walking distance. Unfortunately, both poor adherence and availability of institutional resources are major problems in patient-centered care. Objective: The objective of this trackPAD pilot study is to evaluate the feasibility of a mobile phone--based self tracking app to promote physical activity and supervised exercise therapy (SET) in particular. We also aim for a subsequent patient centered adjustment of the app prototype based on the results of the app evaluation and process evaluation. Methods: This study was designed as a closed user group trial, with assessors blinded, and parallel group study with face-to-face components for assessment with a follow-up of 3 months. Patients with symptomatic PAD (Fontaine stage IIa or IIb) and possession of a mobile phone were eligible. Eligible participants were randomly assigned into study and control group, stratified by their distance covered in the 6-min walk test, using the software TENALEA. Participants randomized to the study group received usual care and the mobile intervention (trackPAD) for the follow-up period of 3 months, whereas participants randomized to the control group received only usual care. TrackPAD records the frequency and duration of training sessions and pain level using manual user input. Clinical outcome data were collected at the baseline and after 3 months via validated tools (6-min walk test, ankle-brachial index, and duplex ultrasound at the lower arteries) and self-reported quality of life. Usability and quality of the app was determined using the user version of the Mobile Application Rating Scale. Results: The study enrolled 45 participants with symptomatic PAD (44\% male). Of these participants, 21 (47\%) were randomized to the study group and 24 (53\%) were randomized to the control group. The distance walked in the 6-min walk test was comparable in both groups at baseline (study group: mean 368.1m [SD 77.6] vs control group: mean 394.6m [SD 100.6]). Conclusions: This is the first trial to test a mobile intervention called trackPAD that was designed especially for patients with PAD. Its results will provide important insights in terms of feasibility, effectiveness, and patient preferences of an app-based mobile intervention supporting SET for the conservative treatment of PAD. International Registered Report Identifier (IRRID): DERR1-10.2196/13651 ", doi="10.2196/13651", url="http://www.researchprotocols.org/2019/6/e13651/", url="http://www.ncbi.nlm.nih.gov/pubmed/31244477" } @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/10.2196/10755, author="Choi, G. Brian and Dhawan, Tania and Metzger, Kelli and Marshall, Lorraine and Akbar, Awdah and Jain, Tushina and Young, A. Heather and Katz, J. Richard", title="Image-Based Mobile System for Dietary Management in an American Cardiology Population: Pilot Randomized Controlled Trial to Assess the Efficacy of Dietary Coaching Delivered via a Smartphone App Versus Traditional Counseling", journal="JMIR Mhealth Uhealth", year="2019", month="Apr", day="23", volume="7", number="4", pages="e10755", keywords="Mediterranean diet", keywords="telemedicine", keywords="cardiovascular disease", keywords="randomized controlled trial", abstract="Background: Randomized controlled trials conducted in Mediterranean countries have shown that the Mediterranean diet lowers adverse cardiovascular events. In the American population, diet remains the biggest uncontrolled risk factor for cardiovascular disease. Objective: This study aimed to test the hypothesis that asynchronous dietary counseling supplied through a custom smartphone app results in better adherence to a Mediterranean diet in a non-Mediterranean population than traditional standard-of-care (SOC) counseling. Methods: In total, 100 patients presenting to the cardiology clinic of an academic medical center were randomized to either the SOC or smartphone app-based experimental (EXP) Mediterranean diet intervention after informed consent and 1 hour of individual face-to-face dietary counseling with a registered dietitian. Participants in EXP received a custom smartphone app that reinforced the Mediterranean diet, whereas participants in SOC received 2 additional sessions of in-person dietary counseling with the registered dietitian---30 min at 1 month and 30 min at 3 months. Preexisting knowledge of a Mediterranean diet was measured by the validated Mediterranean Diet Score (MDS) instrument. Baseline height, weight, blood pressure (BP), and laboratory biomarkers were collected. At 1, 3, and 6 months, participants presented for a follow-up appointment to assess compliance to the Mediterranean diet using the MDS as well as a patient satisfaction survey, BP, and weight. Repeat laboratory biomarkers were performed at 3 and 6 months. Results: Enrolled participants had a mean age with SE of 56.6 (SD 1.7) for SOC and 57.2 (SD 1.8) for EXP; 65.3\% of SOC and 56.9\% of EXP were male, and 20.4\% of SOC and 35.3\% of EXP had coronary artery disease. There were no significant differences between EXP and SOC with regard to BP, lipid parameters, hemoglobin A1c, or C-reactive protein (CRP). Participants in EXP achieved a significantly greater weight loss on average of 3.3 pounds versus 3.1 pounds for participants in SOC, P=.04. Adherence to the Mediterranean diet increased significantly over time for both groups (P<.001), but there was no significant difference between groups (P=.69). Similarly, there was no significant difference in diet satisfaction between EXP and SOC, although diet satisfaction increased significantly over time for both groups. The proportion of participants with high Mediterranean diet compliance (defined as the MDS ?9) increased significantly over time (P<.001)---from 18.4\% to 57.1\% for SOC and 27.5\% to 64.7\% for EXP; however, there was no significant difference between the groups. Conclusions: Both traditional SOC counseling and smartphone-based counseling were effective in getting participants to adhere to a Mediterranean diet, and these dietary changes persisted even after counseling had ended. However, neither method was more effective than the other. This pilot study demonstrates that patients can change to and maintain a Mediterranean diet with either traditional or smartphone app-based nutrition counseling. Trial Registration: ClinicalTrials.gov NCT03897426;https://clinicaltrials.gov/ct2/show/NCT03897426 ", doi="10.2196/10755", url="https://mhealth.jmir.org/2019/4/e10755/", url="http://www.ncbi.nlm.nih.gov/pubmed/31012860" } @Article{info:doi/10.2196/10809, author="Leong, Y. Amanda and Makowsky, J. Mark", title="Quality of Blood Pressure Tracking Apps for the iPhone: Content Analysis and Evaluation of Adherence With Home Blood Pressure Measurement Best Practices", journal="JMIR Mhealth Uhealth", year="2019", month="Apr", day="12", volume="7", number="4", pages="e10809", keywords="hypertension", keywords="mobile apps", keywords="self-management", keywords="blood pressure monitoring, ambulatory", keywords="cross-sectional studies", abstract="Background: Blood pressure (BP) tracking apps may aid in hypertension (HTN) self-management, but app quality may be problematic. Objective: This study aimed to develop a content-dependent rating system for BP tracking apps and systematically evaluate BP tracking features, content-independent quality, functional characteristics, and educational comprehensiveness of English language iPhone apps developed with the primary purpose of tracking a consumer's BP measurements. Methods: We created a 28-item checklist reflecting overall app quality and a simplified 2-item checklist to assess adherence with home BP monitoring best practices. Apps with educational information were evaluated for comprehensiveness on a 7-point scale and for consistency with evidence-based guidelines. Higher scores represent better quality and comprehensiveness. We searched the Canadian App Store on June 28, 2016, using the keywords hypertension and blood pressure. A total of 2 reviewers independently assessed apps according to the standardized template. We determined if paid apps, educational apps, or those rated ?4 stars were of higher quality. Results: Of the 948 apps screened, 62 met the inclusion criteria. The mean overall quality score was 12.2 (SD 4.6, out of 28) and 6 apps (10\%, 6/62) met the home BP monitoring best practice criteria. In all, 12 apps contained educational content (mean comprehensiveness 2.4, SD 1.6 out of 14), most commonly, background information on HTN. Apps with educational content (mean 15.1, SD 3.8 vs 11.8, SD 4.8; P=.03) or a ?4 star rating (median 19, interquartile range [IQR] 15-20, vs 12, IQR 9-15; P=.02) had higher overall quality. Conclusions: The BP tracking apps reviewed had variable quality and few met the home BP monitoring best practice criteria. When deciding to recommend a specific BP tracking app, we suggest clinicians should evaluate whether the app allows input of duplicate BP readings in the morning and evening for at least seven days and presents the mean BP value for user-specified dates. Greater attention to home BP measurement best practices is required during app development. ", doi="10.2196/10809", url="https://mhealth.jmir.org/2019/4/e10809/", url="http://www.ncbi.nlm.nih.gov/pubmed/30977739" } @Article{info:doi/10.2196/10874, author="Sankaran, Supraja and Dendale, Paul and Coninx, Karin", title="Evaluating the Impact of the HeartHab App on Motivation, Physical Activity, Quality of Life, and Risk Factors of Coronary Artery Disease Patients: Multidisciplinary Crossover Study", journal="JMIR Mhealth Uhealth", year="2019", month="Apr", day="04", volume="7", number="4", pages="e10874", keywords="heart diseases", keywords="cardiac rehabilitation", keywords="human factors engineering", keywords="evaluation studies", keywords="telerehabilitation", keywords="mobile app", keywords="multidisciplinary research", abstract="Background: Telerehabilitation approaches have been successful in supporting coronary artery disease (CAD) patients to rehabilitate at home after hospital-based rehabilitation. However, on completing a telerehabilitation program, the effects are not sustained beyond the intervention period because of the lack of lifestyle adaptations. Furthermore, decline in patients' motivation lead to recurrence of disease and increased rehospitalization rates. We developed HeartHab, using persuasive design principles and personalization, to enable sustenance of rehabilitation effects beyond the intervention period. HeartHab promotes patients' understanding, motivates them to reach personalized rehabilitation goals, and helps to maintain positive lifestyle adaptations during telerehabilitation. Objective: This study aimed to investigate the impact of the HeartHab app on patients' overall motivation, increasing physical activities, reaching exercise targets, quality of life, and modifiable risk factors in patients with CAD during telerehabilitation. The study also investigated carryover effects to determine the maintenance of effects after the conclusion of the intervention. Methods: A total of 32 CAD patients were randomized on a 1:1 ratio to telerehabilitation or usual care. We conducted a 4-month crossover study with a crossover point at 2 months using a mixed-methods approach for evaluation. We collected qualitative data on users' motivation, user experience, and quality of life using questionnaires, semistructured interviews and context-based sentiment analysis. Quantitative data on health parameters, exercise capacity, and risk factors were gathered from blood tests and ergo-spirometry tests. Data procured during the app usage phase were compared against baseline values to assess the impact of the app on parameters such as motivation, physical activity, quality of life, and risk factors. Carryover effects were used to gather insights on the maintenance of effects. Results: The qualitative data showed that 75\% (21/28) of patients found the HeartHab app motivating and felt encouraged to achieve their rehabilitation targets. 84\% (21/25) of patients either reached or exceeded their prescribed physical activity targets. We found positive significant effects on glycated hemoglobin (P=.01; d=1.03; 95\% CI 0.24-1.82) with a mean decrease of 1.5 mg/dL and high-density lipoprotein (HDL) cholesterol (P=.04; d=0.78; 95\% CI 0.02-1.55) with a mean increase of 0.61 mg/dL after patients used the HeartHab app. We observed significant carryover effects on weight, HDL cholesterol, and maximal oxygen consumption (VO2 max), indicating the maintenance of effects. Conclusions: Persuasive design techniques integrated in HeartHab and tailoring of exercise targets were effective in motivating patients to reach their telerehabilitation targets. This study demonstrated significant effects on glucose and HDL cholesterol and positive carryover effects on weight, HDL cholesterol, and VO2 max. There was also a perceived improvement in quality of life. A longer-term evaluation with more patients could possibly reveal effectiveness on other risk factors and maintenance of the positive health behavior change. Trial Registration: ClinicalTrials.gov NCT03102671; https://clinicaltrials.gov/ct2/show/NCT03102671 (Archived by WebCite at http://www.webcitation.org/76gzI9Pvd) ", doi="10.2196/10874", url="https://mhealth.jmir.org/2019/4/e10874/", url="http://www.ncbi.nlm.nih.gov/pubmed/30946021" } @Article{info:doi/10.2196/12191, author="Ricci-Cabello, Ignacio and Bobrow, Kirsten and Islam, Shariful Sheikh Mohammed and Chow, K. Clara and Maddison, Ralph and Whittaker, Robyn and Farmer, J. Andrew", title="Examining Development Processes for Text Messaging Interventions to Prevent Cardiovascular Disease: Systematic Literature Review", journal="JMIR Mhealth Uhealth", year="2019", month="Mar", day="29", volume="7", number="3", pages="e12191", keywords="systematic review", keywords="cardiovascular disease", keywords="telemedicine", keywords="text messaging", keywords="methods", abstract="Background: Interventions delivered by mobile phones have the potential to prevent cardiovascular disease (CVD) by supporting behavior change toward healthier lifestyles and treatment adherence. To allow replication and adaptation of these interventions across settings, it is important to fully understand how they have been developed. However, the development processes of these interventions have not previously been systematically examined. Objective: This study aimed to systematically describe and compare the development process of text messaging interventions identified in the Text2PreventCVD systematic review. Methods: We extracted data about the development process of the 9 interventions identified in the Text2PreventCVD systematic review. Data extraction, which was guided by frameworks for the development of complex interventions, considered the following development stages: intervention planning, design, development, and pretesting. Following data extraction, we invited the developers of the interventions to contribute to our study by reviewing the accuracy of the extracted data and providing additional data not reported in the available publications. Results: A comprehensive description of the development process was available for 5 interventions. Multiple methodologies were used for the development of each intervention. Intervention planning involved gathering information from stakeholder consultations, literature reviews, examination of relevant theory, and preliminary qualitative research. Intervention design involved the use of behavior change theories and behavior change techniques. Intervention development involved (1) generating message content based on clinical guidelines and expert opinions; (2) conducting literature reviews and primary qualitative research to inform decisions about message frequency, timing, and level of tailoring; and (3) gathering end-user feedback concerning message readability, intervention acceptability, and perceived utility. Intervention pretesting involved pilot studies with samples of 10 to 30 participants receiving messages for a period ranging from 1 to 4 weeks. Conclusions: The development process of the text messaging interventions examined was complex and comprehensive, involving multiple studies to guide decisions about the scope, content, and structure of the interventions. Additional research is needed to establish whether effective messaging systems can be adapted from work already done or whether this level of development is needed for application in other conditions and settings. ", doi="10.2196/12191", url="http://mhealth.jmir.org/2019/3/e12191/", url="http://www.ncbi.nlm.nih.gov/pubmed/30924790" } @Article{info:doi/10.2196/12179, author="Ernsting, Clemens and St{\"u}hmann, Mareike Lena and Dombrowski, U. Stephan and Voigt-Antons, Jan-Niklas and Kuhlmey, Adelheid and Gellert, Paul", title="Associations of Health App Use and Perceived Effectiveness in People With Cardiovascular Diseases and Diabetes: Population-Based Survey", journal="JMIR Mhealth Uhealth", year="2019", month="Mar", day="28", volume="7", number="3", pages="e12179", keywords="mHealth", keywords="eHealth", keywords="smartphone", keywords="telemedicine", keywords="health literacy", keywords="chronic disease", keywords="comorbidity", keywords="multimorbidity", abstract="Background: Mobile health apps can help to change health-related behaviors and manage chronic conditions in patients with cardiovascular diseases (CVDs) and diabetes mellitus, but a certain level of health literacy and electronic health (eHealth) literacy may be needed. Objective: The aim of this study was to identify factors associated with mobile health app use in individuals with CVD or diabetes and detect relations with the perceived effectiveness of health apps among app users. Methods: The study used population-based Web-based survey (N=1500) among Germans, aged 35 years and older, with CVD, diabetes, or both. A total of 3 subgroups were examined: (1) Individuals with CVD (n=1325), (2) Individuals with diabetes (n=681), and (3) Individuals with CVD and diabetes (n=524). Sociodemographics, health behaviors, CVD, diabetes, health and eHealth literacy, characteristics of health app use, and characteristics of apps themselves were assessed by questionnaires. Linear and logistic regression models were applied. Results: Overall, patterns of factors associated with health app use were comparable in individuals with CVD or diabetes or both. Across subgroups, about every fourth patient reported using apps for health-related purposes, with physical activity and weight loss being the most prominent target behaviors. Health app users were younger, more likely to be female (except in those with CVD and diabetes combined), better educated, and reported more physical activity. App users had higher eHealth literacy than nonusers. Those users who perceived the app to have a greater effectiveness on their health behaviors tended to be more health and eHealth literate and rated the app to use more behavior change techniques (BCTs). Conclusions: There are health- and literacy-related disparities in the access to health app use among patients with CVD, diabetes, or both, which are relevant to specific health care professionals such as endocrinologists, dieticians, cardiologists, or general practitioners. Apps containing more BCTs had a higher perceived effect on people's health, and app developers should take the complexity of needs into account. Furthermore, eHealth literacy appears to be a requirement to use health apps successfully, which should be considered in health education strategies to improve health in patients with CVD and diabetes. ", doi="10.2196/12179", url="http://mhealth.jmir.org/2019/3/e12179/", url="http://www.ncbi.nlm.nih.gov/pubmed/30920383" } @Article{info:doi/10.2196/11889, author="Falter, Maarten and Budts, Werner and Goetschalckx, Kaatje and Cornelissen, V{\'e}ronique and Buys, Roselien", title="Accuracy of Apple Watch Measurements for Heart Rate and Energy Expenditure in Patients With Cardiovascular Disease: Cross-Sectional Study", journal="JMIR Mhealth Uhealth", year="2019", month="Mar", day="19", volume="7", number="3", pages="e11889", keywords="mobile health", keywords="heart rate", keywords="energy expenditure", keywords="validation", keywords="Apple Watch", keywords="wrist-worn devices", keywords="cardiovascular rehabilitation", abstract="Background: Wrist-worn tracking devices such as the Apple Watch are becoming more integrated in health care. However, validation studies of these consumer devices remain scarce. Objectives: This study aimed to assess if mobile health technology can be used for monitoring home-based exercise in future cardiac rehabilitation programs. The purpose was to determine the accuracy of the Apple Watch in measuring heart rate (HR) and estimating energy expenditure (EE) during a cardiopulmonary exercise test (CPET) in patients with cardiovascular disease. Methods: Forty patients (mean age 61.9 [SD 15.2] yrs, 80\% male) with cardiovascular disease (70\% ischemic, 22.5\% valvular, 7.5\% other) completed a graded maximal CPET on a cycle ergometer while wearing an Apple Watch. A 12-lead electrocardiogram (ECG) was used to measure HR; indirect calorimetry was used for EE. HR was analyzed at three levels of intensity (seated rest, HR1; moderate intensity, HR2; maximal performance, HR3) for 30 seconds. The EE of the entire test was used. Bias or mean difference (MD), standard deviation of difference (SDD), limits of agreement (LoA), mean absolute error (MAE), mean absolute percentage error (MAPE), and intraclass correlation coefficients (ICCs) were calculated. Bland-Altman plots and scatterplots were constructed. Results: SDD for HR1, HR2, and HR3 was 12.4, 16.2, and 12.0 bpm, respectively. Bias and LoA (lower, upper LoA) were 3.61 (--20.74, 27.96) for HR1, 0.91 (--30.82, 32.63) for HR2, and --1.82 (--25.27, 21.63) for HR3. MAE was 6.34 for HR1, 7.55 for HR2, and 6.90 for HR3. MAPE was 10.69\% for HR1, 9.20\% for HR2, and 6.33\% for HR3. ICC was 0.729 (P<.001) for HR1, 0.828 (P<.001) for HR2, and 0.958 (P<.001) for HR3. Bland-Altman plots and scatterplots showed good correlation without systematic error when comparing Apple Watch with ECG measurements. SDD for EE was 17.5 kcal. Bias and LoA were 30.47 (--3.80, 64.74). MAE was 30.77; MAPE was 114.72\%. ICC for EE was 0.797 (P<.001). The Bland-Altman plot and a scatterplot directly comparing Apple Watch and indirect calorimetry showed systematic bias with an overestimation of EE by the Apple Watch. Conclusions: In patients with cardiovascular disease, the Apple Watch measures HR with clinically acceptable accuracy during exercise. If confirmed, it might be considered safe to incorporate the Apple Watch in HR-guided training programs in the setting of cardiac rehabilitation. At this moment, however, it is too early to recommend the Apple Watch for cardiac rehabilitation. Also, the Apple Watch systematically overestimates EE in this group of patients. Caution might therefore be warranted when using the Apple Watch for measuring EE. ", doi="10.2196/11889", url="http://mhealth.jmir.org/2019/3/e11889/", url="http://www.ncbi.nlm.nih.gov/pubmed/30888332" } @Article{info:doi/10.2196/11108, author="Haldane, Victoria and Tan, Guo Yao and Teo, Qi Krichelle Wei and Koh, Kai Joel Jun and Srivastava, Aastha and Cheng, Xiang Rui and Yap, Cheng Yi and Ong, Pei-Shi and van Dam, M. Rob and Foo, Min Jie and M{\"u}ller-Riemenschneider, Falk and Koh, Choon-Huat Gerald and Perel, Pablo and Legido-Quigley, Helena", title="Perspectives on Acceptance and Use of a Mobile Health Intervention for the Prevention of Atherosclerotic Cardiovascular Disease in Singapore: Mixed-Methods Study", journal="JMIR Mhealth Uhealth", year="2019", month="Mar", day="14", volume="7", number="3", pages="e11108", keywords="atherosclerosis", keywords="mHealth", keywords="eHealth", keywords="patient-centered care", keywords="patient acceptance of health care", keywords="medication adherence", abstract="Background: Cardiovascular disease, including atherosclerotic cardiovascular disease (ASCVD), is a growing public health threat globally and many individuals remain undiagnosed, untreated, and uncontrolled. Simultaneously, mobile health (mHealth) interventions using short messaging service (SMS) have gained popularity globally. There is an opportunity for innovative approaches such as mHealth to encourage and enable adherence to medications for ASCVD and its risk factors. Objective: This study aimed to understand mobile technology acceptance, use, and facilitating conditions among the study population ahead of the design of an mHealth intervention. Methods: Using data from a mixed-methods study conducted in Singapore, we conducted a cross-sectional survey with 100 participants and in-depth, semistructured interviews with 20 patients. All participants were over the age of 40 years with ASCVD or its risk factors. Interviews were conducted in English and Mandarin and if needed translated to English. Nvivo 11 (QSR International) was used for analyses. Results: Participants reported their perspectives on technology use and preferences, including low or sporadic mobile phone use and usability concerns including small screen and text size, among others; the benefit of previous mHealth use in creating a favorable opinion of SMS for health information; trust in both the source of mHealth SMS, as well as in treatment; the formation of habits; and fear of sequelae or death for facilitating intention to use an mHealth intervention and adhere to medication. We also highlighted a case that underscored the importance of the period after diagnosis in habit forming as an opportunity for an mHealth intervention. Conclusions: We explored both technology- and adherence-related factors that influence a patient's intention to use an mHealth intervention for adherence to ASCVD medication in Singapore. We highlighted the importance of identifying the right opportunity to engage with patients and promote an mHealth intervention for adherence, such as immediately following diagnosis when patients are establishing medication-taking habits. ", doi="10.2196/11108", url="http://mhealth.jmir.org/2019/3/e11108/", url="http://www.ncbi.nlm.nih.gov/pubmed/30869651" } @Article{info:doi/10.2196/11606, author="Li, Christien Ka Hou and White, Anne Francesca and Tipoe, Timothy and Liu, Tong and Wong, CS Martin and Jesuthasan, Aaron and Baranchuk, Adrian and Tse, Gary and Yan, P. Bryan", title="The Current State of Mobile Phone Apps for Monitoring Heart Rate, Heart Rate Variability, and Atrial Fibrillation: Narrative Review", journal="JMIR Mhealth Uhealth", year="2019", month="Feb", day="15", volume="7", number="2", pages="e11606", keywords="mobile phone apps", keywords="atrial fibrillation", keywords="heart rate", keywords="arrhythmia", keywords="photoplethysmography", keywords="electrocardiography", keywords="mobile health", abstract="Background: Mobile phone apps capable of monitoring arrhythmias and heart rate (HR) are increasingly used for screening, diagnosis, and monitoring of HR and rhythm disorders such as atrial fibrillation (AF). These apps involve either the use of (1) photoplethysmographic recording or (2) a handheld external electrocardiographic recording device attached to the mobile phone or wristband. Objective: This review seeks to explore the current state of mobile phone apps in cardiac rhythmology while highlighting shortcomings for further research. Methods: We conducted a narrative review of the use of mobile phone devices by searching PubMed and EMBASE from their inception to October 2018. Potentially relevant papers were then compared against a checklist for relevance and reviewed independently for inclusion, with focus on 4 allocated topics of (1) mobile phone monitoring, (2) AF, (3) HR, and (4) HR variability (HRV). Results: The findings of this narrative review suggest that there is a role for mobile phone apps in the diagnosis, monitoring, and screening for arrhythmias and HR. Photoplethysmography and handheld electrocardiograph recorders are the 2 main techniques adopted in monitoring HR, HRV, and AF. Conclusions: A number of studies have demonstrated high accuracy of a number of different mobile devices for the detection of AF. However, further studies are warranted to validate their use for large scale AF screening. ", doi="10.2196/11606", url="http://mhealth.jmir.org/2019/2/e11606/", url="http://www.ncbi.nlm.nih.gov/pubmed/30767904" } @Article{info:doi/10.2196/resprot.9017, author="Woringer, Maria and Dharmayat, I. Kanika and Greenfield, Geva and Bottle, Alex and Ray, K. Kausik", title="American Heart Association's Cholesterol CarePlan as a Smartphone-Delivered Web App for Patients Prescribed Cholesterol-Lowering Medication: Protocol for an Observational Feasibility Study", journal="JMIR Res Protoc", year="2019", month="Jan", day="24", volume="8", number="1", pages="e9017", keywords="behavioral change", keywords="cholesterol", keywords="lifestyle", keywords="mHealth", keywords="medication adherence", abstract="Background: Adoption of healthy lifestyle and compliance with cholesterol-lowering medication reduces the risk of cardiovascular disease (CVD). The use of digital tools and mobile technology may be important for sustaining positive behavioral change. Objective: The primary objective of this study is to evaluate the feasibility and acceptability of administering the Cholesterol CarePlan Web app developed by the American Heart Association aimed at improving lifestyle and medication adherence among patients prescribed cholesterol-lowering medication. The secondary objective is to assess the Web app's efficacy. Methods: A prospective, observational feasibility study will be conducted to demonstrate whether the Web app may be successfully taken up by patients and will be associated with improved clinical and behavioral outcomes. The study will aim to recruit 180 study participants being prescribed cholesterol-lowering medication for at least 30 days across 14 general practices in London, England. Potentially eligible patients will be invited to use the Web app on a smartphone and visit general practice for three 20-minute clinical assessments of blood pressure, height, weight, smoking, and nonfasting cholesterol over 24 weeks. The feasibility of administering the Web app will be judged by recruitment and dropout statistics and the sociodemographic and comorbidity profile of consenting study participants, consenting nonparticipants, and all potentially eligible patients. Acceptability will be assessed using patients' readiness to embrace new technologies, the usability of the Web app, and patient satisfaction. The efficacy of the Web app will be assessed by changes in medication adherence and clinical risk factors by levels of the Web app compliance. Results: This study is currently funded by the American Heart Association. Initial study recruitment will take place between February and July 2018 followed by patient follow-up. Patient level data will be obtained in January 2019. Data analysis will be completed by February 2019. Results will be submitted for publication in March 2019. Conclusions: The potential of an app to improve patients' lifestyle and management of cholesterol may inform the design of a randomized controlled trial and the delivery of more effective CVD prevention programs. International Registered Report Identifier (IRRID): PRR1-10.2196/9017 ", doi="10.2196/resprot.9017", url="https://www.researchprotocols.org/2019/1/e9017/", url="http://www.ncbi.nlm.nih.gov/pubmed/30679150" } @Article{info:doi/10.2196/12008, author="Napa, Sandeep and Moore, Michael and Bardyn, Tania", title="Advancing Cardiac Surgery Case Planning and Case Review Conferences Using Virtual Reality in Medical Libraries: Evaluation of the Usability of Two Virtual Reality Apps", journal="JMIR Hum Factors", year="2019", month="Jan", day="16", volume="6", number="1", pages="e12008", keywords="virtual reality", keywords="cardiac surgery", keywords="usability study", keywords="system usability score", keywords="NASA-Task Load Index", keywords="medical libraries", keywords="case planning", keywords="presurgical planning", abstract="Background: Care providers and surgeons prepare for cardiac surgery using case conferences to review, discuss, and run through the surgical procedure. Surgeons visualize a patient's anatomy to decide the right surgical approach using magnetic resonance imaging and echocardiograms in a presurgical case planning session. Previous studies have shown that surgical errors can be reduced through the effective use of immersive virtual reality (VR) to visualize patient anatomy. However, inconsistent user interfaces, delegation of view control, and insufficient depth information cause user disorientation and interaction difficulties in using VR apps for case planning. Objective: The objective of the study was to evaluate and compare the usability of 2 commercially available VR apps---Bosc (Pyrus Medical systems) and Medical Holodeck (Nooon Web \& IT GmbH)---using the Vive VR headset (HTC Corporation) to evaluate ease of use, physician attitudes toward VR technology, and viability for presurgical case planning. The role of medical libraries in advancing case planning is also explored. Methods: After screening a convenience sample of surgeons, fellows, and residents, ethnographic interviews were conducted to understand physician attitudes and experience with VR. Gaps in current case planning methods were also examined. We ran a usability study, employing a concurrent think-aloud protocol. To evaluate user satisfaction, we used the system usability scale (SUS) and the National Aeronautics and Space Administration-Task Load Index (NASA-TLX). A poststudy questionnaire was used to evaluate the VR experience and explore the role of medical libraries in advancing presurgical case planning. Semistructured interview data were analyzed using content analysis with feedback categorization. Results: Participants were residents, fellows, and surgeons from the University of Washington with a mean age of 41.5 (SD 11.67) years. A total of 8 surgeons participated in the usability study, 3 of whom had prior exposure to VR. Users found Medical Holodeck easier to use than Bosc. Mean adjusted NASA-TLX score for Medical Holodeck was 62.71 (SD 18.25) versus Bosc's 40.87 (SD 13.90). Neither app passed the mean SUS score of 68 for an app to be considered usable, though Medical Holodeck (66.25 [SD 12.87]) scored a higher mean SUS than Bosc (37.19 [SD 22.41]). One user rated the Bosc usable, whereas 3 users rated Medical Holodeck usable. Conclusions: Interviews highlighted the importance of precise anatomical conceptualization in presurgical case planning and teaching, identifying it as the top reason for modifying a surgical procedure. The importance of standardized user interaction features such as labeling is justified. The study also sheds light on the new roles medical librarians can play in curating VR content and promoting interdisciplinary collaboration. ", doi="10.2196/12008", url="http://humanfactors.jmir.org/2019/1/e12008/", url="http://www.ncbi.nlm.nih.gov/pubmed/30664469" } @Article{info:doi/10.2196/11753, author="Albrecht, Urs-Vito and Hasenfu{\ss}, Gerd and von Jan, Ute", title="Description of Cardiological Apps From the German App Store: Semiautomated Retrospective App Store Analysis", journal="JMIR Mhealth Uhealth", year="2018", month="Nov", day="20", volume="6", number="11", pages="e11753", keywords="mHealth", keywords="mobile health", keywords="mobile apps", keywords="retrospective app store analysis", keywords="cardiology", abstract="Background: In the app stores of mobile platforms, consumers are confronted with an enormous number of mobile apps. Over the past few years, considerable research has been undertaken into to identifying, characterizing, and evaluating apps, be it in health-related or other contexts. However, many of these projects are restricted to specific areas of application and offer little flexibility in adapting the applied criteria. Objective: This paper presents an adaptable method for selecting and characterizing mobile apps listed in a mobile App Store (the Apple App Store). The method is based on filtering processes using predefined criteria, through a semiautomated retrospective App Store analysis (SARASA). Methods: To illustrate the SARASA process, keyword-based filtering and metadata-based description, review, and ranking steps were applied to a dataset, more specifically, an April 2018 readout of the Medical category of the German App Store, with the aim of obtaining a list of cardiology-related apps. Results: From the original list of 39,427 apps within the ``Medical'' category of the App Store on April 14, 2018, 34,382 apps with store descriptions in languages other than German were removed. For the remaining 5045 apps, keywords related to cardiology were applied to filter the output, obtaining a final total of 335 subject-specific apps for further analysis and description. Conclusions: SARASA provides an easy to use method for applying filtering processes to identify apps matching predefined, formal criteria from app stores. The criteria can be well adapted to the needs of users. Automatic and manual analyses are easily combined when using SARASA. In the future, additional features, such as algorithmic topic analyses, may supplement the process. Although the area of application is currently limited to Apple's App Store, expansion to other stores is planned. The method stands or falls with the transparency of the app store providers and the manufacturers to make relevant meta-information available. It is up to them to liberalize information and restrict censorship to provide clients, customers, and users truly fair circumstances finding their way around the app market. ", doi="10.2196/11753", url="http://mhealth.jmir.org/2018/11/e11753/", url="http://www.ncbi.nlm.nih.gov/pubmed/30459140" } @Article{info:doi/10.2196/mhealth.9651, author="Metelmann, Bibiana and Metelmann, Camilla and Schuffert, Louisa and Hahnenkamp, Klaus and Brinkrolf, Peter", title="Medical Correctness and User Friendliness of Available Apps for Cardiopulmonary Resuscitation: Systematic Search Combined With Guideline Adherence and Usability Evaluation", journal="JMIR Mhealth Uhealth", year="2018", month="Nov", day="06", volume="6", number="11", pages="e190", keywords="mHealth", keywords="resuscitation", keywords="review", keywords="guidelines", keywords="mobile phones", keywords="health care information systems", keywords="health informatics", abstract="Background: In case of a cardiac arrest, start of cardiopulmonary resuscitation by a bystander before the arrival of the emergency personnel increases the probability of survival. However, the steps of high-quality resuscitation are not known by every bystander or might be forgotten in this complex and time-critical situation. Mobile phone apps offering real-time step-by-step instructions might be a valuable source of information. Objective: The aim of this study was to examine mobile phone apps offering real-time instructions in German or English in case of a cardiac arrest, to evaluate their adherence to current resuscitation guidelines, and to test their usability. Methods: Our 3-step approach combines a systematic review of currently available apps guiding a medical layperson through a resuscitation situation, an adherence testing to medical guidelines, and a usability evaluation of the determined apps. The systematic review followed an adapted preferred reporting items for systematic reviews and meta-analyses flow diagram, the guideline adherence was tested by applying a conformity checklist, and the usability was evaluated by a group of mobile phone frequent users and emergency physicians with the system usability scale (SUS) tool. Results: The structured search in Google Play Store and Apple App Store resulted in 3890 hits. After removing redundant ones, 2640 hits were checked for fulfilling the inclusion criteria. As a result, 34 apps meeting all inclusion criteria were identified. These included apps were analyzed to determine medical accuracy as defined by the European Resuscitation Council's guidelines. Only 5 out of 34 apps (15\%, 5/34) fulfilled all criteria chosen to determine guideline adherence. All other apps provided no or wrong information on at least one relevant topic. The usability of 3 apps was evaluated by 10 mobile phone frequent users and 9 emergency physicians. Of these 3 apps, solely the app ``HELP Notfall'' (median=87.5) was ranked with an SUS score above the published average of 68. This app was rated significantly superior to ``HAMBURG SCHOCKT'' (median=55; asymptotic Wilcoxon test: z=?3.63, P<.01, n=19) and ``Mein DRK'' (median=32.5; asymptotic Wilcoxon test: z=?3.83, P<.01, n=19). Conclusions: Implementing a systematic quality control for health-related apps should be enforced to ensure that all products provide medically accurate content and sufficient usability in complex situations. This is of exceptional importance for apps dealing with the treatment of life-threatening events such as cardiac arrest. ", doi="10.2196/mhealth.9651", url="http://mhealth.jmir.org/2018/11/e190/", url="http://www.ncbi.nlm.nih.gov/pubmed/30401673" } @Article{info:doi/10.2196/10499, author="Gandhi, Sumeet and Morillo, A. Carlos and Schwalm, Jon-David", title="Implantable Cardioverter Defibrillator mHealth App for Physician Referrals and eHealth Education: ICD-TEACH Pilot Study", journal="JMIR Cardio", year="2018", month="Nov", day="05", volume="2", number="2", pages="e10499", keywords="mHealth", keywords="smartphone app", keywords="implantable defibrillator cardioverter", keywords="ICD", keywords="physician decision", keywords="eHealth", keywords="mobile phone", abstract="Background: Mobile health (mHealth) decision tools for implantable cardioverter defibrillator may increase physician knowledge and overall patient care. Objective: The goals of the ICD-TEACH pilot study were to design a smartphone app or mHealth technology with a novel physician decision support algorithm, implement a direct referral mechanism for device implantation from the app, and assess its overall usability and feasibility with physicians involved in the care of patients with an implantable cardioverter defibrillator. Methods: The initial design and development of the mHealth or smartphone app included strategic collaboration from an information technology company and key stakeholders including arrhythmia specialists (electrophysiologists), general cardiologists, and key members of the hospital administrative team. A convenience sampling method was used to recruit general internists or cardiologists that refer to our local tertiary care center. Physicians were asked to incorporate the mHealth app in daily clinical practice and avail the decision support algorithm and direct referral feature to the arrhythmia clinic. Feasibility assessment, in the form of a physician survey, was conducted after initial mHealth app use (within 3 months) addressing the physicians' overall satisfaction with the app, compliance, and reason for noncompliance; usability assessment of the mHealth app was addressed in the physician survey for technical or hardware problems encountered while using the app and suggestions on improvement. Results: A total of 17 physicians agreed to participate in the pilot study with 100\% poststudy survey response rate. Physicians worked in an academic practice, which included both inpatient and ambulatory care. System Usability Scale was applied with an average score of 77 including the 17 participants (>68 points is above average). Regarding the novel physician decision support algorithm for implantable cardioverter defibrillator referral, 11\% (1/9) strongly agreed and 78\% (7/9) agreed that the algorithm for device eligibility was easy to use. Only 1 patient was referred through the direct referral system via the mHealth app during the pilot study of 3 months. Feasibility assessment showed that 46\% (5/11) strongly agreed and 55\% (6/11) agreed that the mHealth app would be utilized if integrated into an electronic medical record (EMR) where data are automatically sent to the referring arrhythmia clinic. Conclusions: The ICD-TEACH pilot study revealed high usability features of a physician decision support algorithm; however, we received only 1 direct referral through our app despite supportive feedback. A specific reason from our physician survey included the lack of integration into an EMR. Future studies should continue to systematically evaluate smartphone apps in cardiology to assess usability, feasibility, and strategies to integrate into daily workflow. ", doi="10.2196/10499", url="http://cardio.jmir.org/2018/2/e10499/", url="http://www.ncbi.nlm.nih.gov/pubmed/31758779" } @Article{info:doi/10.2196/10126, author="Steijlen, SM Annemarijn and Jansen, MB Kaspar and Albayrak, Armagan and Verschure, O. Derk and Van Wijk, F. Diederik", title="A Novel 12-Lead Electrocardiographic System for Home Use: Development and Usability Testing", journal="JMIR Mhealth Uhealth", year="2018", month="Jul", day="30", volume="6", number="7", pages="e10126", keywords="12-lead ECG system", keywords="electrocardiography", keywords="home use", keywords="handheld", keywords="user-centered design", abstract="Background: Cardiovascular diseases (CVD) are the leading cause of morbidity and mortality worldwide. Early diagnosis is of pivotal importance for patients with cardiac arrhythmias and ischemia to minimize the consequences like strokes and myocardial infarctions. The chance of capturing signals of arrhythmias or ischemia is substantially high when a 12-lead electrocardiogram (ECG) can be recorded at the moment when a patient experiences the symptoms. However, until now, available diagnostic systems (Holter monitors and other wearable ECG sensors) have not enabled patients to record a reliable 12-lead ECG at home. Objective: The objective of this project was to develop a user-friendly system that enables persons with cardiac complaints to record a reliable 12-lead ECG at home to improve the diagnostic process and, consequently, reduce the time between the onset of symptoms and adequate treatment. Methods: Using an iterative design approach, ECGraph was developed. The system consists of an ECG measurement system and a mobile app, which were developed with the help of several concept tests. To evaluate the design, a prototype of the final design was built and a final technical performance test and usability test were executed. Results: The ECG measurement system consists of a belt and 4 limb straps. Ten wet Ag/AgCl electrodes are placed in the belt to optimize skin-electrode contact. The product is controlled via an app on the mobile phone of the user. Once a person experiences symptoms, he or she can put on the belt and record ECGs within a few minutes. Short instructions, supported by visualizations, offer guidance during use. ECGs are sent wirelessly to the caregiver, and the designated expert can quickly interpret the results. Usability tests with the final prototype (n=6) showed that the participants were able to put on the product within 8 minutes during first-time use. However, we expect that the placement of the product can be executed faster when the user becomes more familiar with the product. Areas of improvement focus mainly on confidence during product use. In the technical performance test, a 12-lead ECG was made and reproduced 6 times. Conclusions: We developed a new 12-lead ECG system for home use. The product is expected to be more user-friendly than current hospital ECG systems and is designed to record more reliable data than current ECG systems for home use, which makes it suitable for expert interpretation. The system has great potential to be incorporated into an outpatient practice, so that arrhythmias and ischemia can be diagnosed and treated as early as possible. ", doi="10.2196/10126", url="http://mhealth.jmir.org/2018/7/e10126/", url="http://www.ncbi.nlm.nih.gov/pubmed/30061094" } @Article{info:doi/10.2196/10723, author="Alessa, Tourkiah and Abdi, Sarah and Hawley, S. Mark and de Witte, Luc", title="Mobile Apps to Support the Self-Management of Hypertension: Systematic Review of Effectiveness, Usability, and User Satisfaction", journal="JMIR Mhealth Uhealth", year="2018", month="Jul", day="23", volume="6", number="7", pages="e10723", keywords="mobile phone", keywords="mobile application", keywords="mobile app", keywords="self-management", keywords="hypertension", keywords="blood pressure", abstract="Background: Hypertension is a chronic disease that is considered to be a public health problem and requires efforts by patients to manage themselves. The global growth in the use of mobile phones and tablets has been accompanied by the increased use of health apps. Many of these apps support the self-management of hypertension and, therefore, they have the potential benefits of lowering blood pressure. Despite this, there is currently a lack of evidence for their effectiveness, usability, and patient satisfaction with their use. Objective: A systematic review was conducted to assess the effectiveness of apps in lowering blood pressure, as well as their usability and patients' satisfaction with their use. Methods: We conducted searches in the following databases: MEDLINE (OVID), EMBASE (OVID), PsycINFO (OVID), CINAHL, the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), IEEE Xplore ASSIAN, Google Scholar and the main Arabic databases Al Manhal, AskZad, and Mandumah. We looked for studies that used apps in the self-management of hypertension from 2008-2016. We also checked the reference lists of the review papers and all the primary studies for additional references. Results: A total of 21 studies with a total of 3112 participants were included in the review. Of the 14 studies that assessed the effectiveness of the apps in lowering blood pressure, 10 (71.4\%) studies (6 RCTs and 4 nonrandomized studies) reported that using the apps led to significant decreases in blood pressure and seemed to be effective in the self-management of hypertension. Of these 10, only 2 (20\%) RCTs and 3 (30\%) nonrandomized studies had a low--moderate risk of bias. The results of this review are inconclusive regarding which combinations of functionalities would be most effective in lowering blood pressure because of variation in the studies' quality, but the data suggest that apps incorporating more comprehensive functionalities are likely to be more effective. In all the studies that assessed the usability of the apps and users' acceptance of them, all the apps seemed to be accepted and easy to use. Conclusions: Most of the studies reported that apps might be effective in lowering blood pressure and are accepted by users. However, these findings should be interpreted with caution, as most of the studies had a high risk of bias. More well-designed, large-scale studies are required to evaluate the real effect of using apps in lowering blood pressure and to identify the most effective functionality combinations for lowering blood pressure. ", doi="10.2196/10723", url="http://mhealth.jmir.org/2018/7/e10723/", url="http://www.ncbi.nlm.nih.gov/pubmed/30037787" } @Article{info:doi/10.2196/jmir.9751, author="Lunde, Pernille and Nilsson, Blakstad Birgitta and Bergland, Astrid and Kv{\ae}rner, Jorunn Kari and Bye, Asta", title="The Effectiveness of Smartphone Apps for Lifestyle Improvement in Noncommunicable Diseases: Systematic Review and Meta-Analyses", journal="J Med Internet Res", year="2018", month="May", day="04", volume="20", number="5", pages="e162", keywords="smartphone", keywords="telemedicine", keywords="noncommunicable diseases", keywords="lifestyle", keywords="diet", keywords="exercise", abstract="Background: Noncommunicable diseases (NCDs) account for 70\% of all deaths in a year globally. The four main NCDs are cardiovascular diseases, cancers, chronic pulmonary diseases, and diabetes mellitus. Fifty percent of persons with NCD do not adhere to prescribed treatment; in fact, adherence to lifestyle interventions is especially considered as a major challenge. Smartphone apps permit structured monitoring of health parameters, as well as the opportunity to receive feedback. Objective: The aim of this study was to review and assess the effectiveness of app-based interventions, lasting at least 3 months, to promote lifestyle changes in patients with NCDs. Methods: In February 2017, a literature search in five databases (EMBASE, MEDLINE, CINAHL, Academic Research Premier, and Cochrane Reviews and Trials) was conducted. Inclusion criteria was quantitative study designs including randomized and nonrandomized controlled trials that included patients aged 18 years and older diagnosed with any of the four main NCDs. Lifestyle outcomes were physical activity, physical fitness, modification of dietary habits, and quality of life. All included studies were assessed for risk of bias using the Cochrane Collaboration`s risk of bias tool. Meta-analyses were conducted for one of the outcomes (glycated hemoglobin, HbA1c) by using the estimate of effect of mean post treatment with SD or CI. Heterogeneity was tested using the I2 test. All studies included in the meta-analyses were graded. Results: Of the 1588 records examined, 9 met the predefined criteria. Seven studies included diabetes patients only, one study included heart patients only, and another study included both diabetes and heart patients. Statistical significant effect was shown in HbA1c in 5 of 8 studies, as well in body weight in one of 5 studies and in waist circumference in one of 3 studies evaluating these outcomes. Seven of the included studies were included in the meta-analyses and demonstrated significantly overall effect on HbA1c on a short term (3-6 months; P=.02) with low heterogeneity (I2=41\%). In the long term (10-12 months), the overall effect on HbA1c was statistical significant (P=.009) and without heterogeneity (I2=0\%). The quality of evidence according to Grading of Recommendations Assessment, Development and Evaluation was low for short term and moderate for long term. Conclusions: Our review demonstrated limited research of the use of smartphone apps for NCDs other than diabetes with a follow-up of at least 3 months. For diabetes, the use of apps seems to improve lifestyle factors, especially to decrease HbA1c. More research with long-term follow-up should be performed to assess the effect of smartphone apps for NCDs other than diabetes. ", doi="10.2196/jmir.9751", url="http://www.jmir.org/2018/5/e162/", url="http://www.ncbi.nlm.nih.gov/pubmed/29728346" } @Article{info:doi/10.2196/humanfactors.8004, author="Hirschey, Jaclyn and Bane, Sunetra and Mansour, Moussa and Sperber, Jodi and Agboola, Stephen and Kvedar, Joseph and Jethwani, Kamal", title="Evaluating the Usability and Usefulness of a Mobile App for Atrial Fibrillation Using Qualitative Methods: Exploratory Pilot Study", journal="JMIR Hum Factors", year="2018", month="Mar", day="15", volume="5", number="1", pages="e13", keywords="nonvalvular atrial fibrillation", keywords="medication adherence", keywords="patient self-care", keywords="mobile application", keywords="exploratory research", keywords="pilot study", keywords="usability study", keywords="acceptability study", keywords="qualitative methods", abstract="Background: Atrial fibrillation (AFib) is the most common form of heart arrhythmia and a potent risk factor for stroke. Nonvitamin K antagonist oral anticoagulants (NOACs) are routinely prescribed to manage AFib stroke risk; however, nonadherence to treatment is a concern. Additional tools that support self-care and medication adherence may benefit patients with AFib. Objective: The aim of this study was to evaluate the perceived usability and usefulness of a mobile app designed to support self-care and treatment adherence for AFib patients who are prescribed NOACs. Methods: A mobile app to support AFib patients was previously developed based on early stage interview and usability test data from clinicians and patients. An exploratory pilot study consisting of naturalistic app use, surveys, and semistructured interviews was then conducted to examine patients' perceptions and everyday use of the app. Results: A total of 12 individuals with an existing diagnosis of nonvalvular AFib completed the 4-week study. The average age of participants was 59 years. All participants somewhat or strongly agreed that the app was easy to use, and 92\% (11/12) reported being satisfied or very satisfied with the app. Participant feedback identified changes that may improve app usability and usefulness for patients with AFib. Areas of usability improvement were organized by three themes: app navigation, clarity of app instructions and design intent, and software bugs. Perceptions of app usefulness were grouped by three key variables: core needs of the patient segment, patient workflow while managing AFib, and the app's ability to support the patient's evolving needs. Conclusions: The results of this study suggest that mobile tools that target self-care and treatment adherence may be helpful to AFib patients, particularly those who are newly diagnosed. Additionally, participant feedback provided insight into the varied needs and health experiences of AFib patients, which may improve the design and targeting of the intervention. Pilot studies that qualitatively examine patient perceptions of usability and usefulness are a valuable and often underutilized method for assessing the real-world acceptability of an intervention. Additional research evaluating the AFib Connect mobile app over a longer period, and including a larger, more diverse sample of AFib patients, will be helpful for understanding whether the app is perceived more broadly to be useful and effective in supporting patient self-care and medication adherence. ", doi="10.2196/humanfactors.8004", url="http://humanfactors.jmir.org/2018/1/e13/", url="http://www.ncbi.nlm.nih.gov/pubmed/29549073" } @Article{info:doi/10.2196/cardio.8574, author="Abt, Grant and Bray, James and Benson, Clare Amanda", title="Measuring Moderate-Intensity Exercise with the Apple Watch: Validation Study", journal="JMIR Cardio", year="2018", month="Feb", day="28", volume="2", number="1", pages="e6", keywords="smartwatch", keywords="wearables", keywords="technology", keywords="physical activity", keywords="cardiovascular health, Apple Watch", abstract="Background: Moderate fitness levels and habitual exercise have a protective effect for cardiovascular disease, stroke, type 2 diabetes, and all-cause mortality. The Apple Watch displays exercise completed at an intensity of a brisk walk or above using a green ``exercise'' ring. However, it is unknown if the exercise ring accurately represents an exercise intensity comparable to that defined as moderate-intensity. In order for health professionals to prescribe exercise intensity with confidence, consumer wearable devices need to be accurate and precise if they are to be used as part of a personalized medicine approach to disease management. Objective: The aim of this study was to examine the validity and reliability of the Apple Watch for measuring moderate-intensity exercise, as defined as 40-59\% oxygen consumption reserve (VO2R). Methods: Twenty recreationally active participants completed resting oxygen consumption (VO2rest) and maximal oxygen consumption (VO2 max) tests prior to a series of 5-minute bouts of treadmill walking at increasing speed while wearing an Apple Watch on both wrists, and with oxygen consumption measured continuously. Five-minute exercise bouts were added until the Apple Watch advanced the green ``exercise'' ring by 5 minutes (defined as the treadmill inflection speed). Validity was examined using a one-sample t-test, with interdevice and intradevice reliability reported as the standardized typical error and intraclass correlation. Results: The mean \%VO2R at the treadmill inflection speed was 30\% (SD 7) for both Apple Watches. There was a large underestimation of moderate-intensity exercise (left hand: mean difference = -10\% [95\% CI -14 to -7], d=-1.4; right hand: mean difference = -10\% [95\% CI -13 to -7], d=-1.5) when compared to the criterion of 40\% VO2R. Standardized typical errors for \%VO2R at the treadmill inflection speed were small to moderate, with intraclass correlations higher within trials compared to between trials. Conclusions: The Apple Watch threshold for moderate-intensity exercise was lower than the criterion, which would lead to an overestimation of moderate-intensity exercise minutes completed throughout the day. ", doi="10.2196/cardio.8574", url="http://cardio.jmir.org/2018/1/e6/", url="http://www.ncbi.nlm.nih.gov/pubmed/31758766" } @Article{info:doi/10.2196/cardio.8802, author="De Ridder, Benjamin and Van Rompaey, Bart and Kampen, K. Jarl and Haine, Steven and Dilles, Tinne", title="Smartphone Apps Using Photoplethysmography for Heart Rate Monitoring: Meta-Analysis", journal="JMIR Cardio", year="2018", month="Feb", day="27", volume="2", number="1", pages="e4", keywords="mobile applications", keywords="heart rate", keywords="photoplethysmography", keywords="electrocardiography", keywords="oximetry", keywords="meta-analysis", abstract="Background: Smartphone ownership is rising at a stunning rate. Moreover, smartphones prove to be suitable for use in health care due to their availability, portability, user-friendliness, relatively low price, wireless connectivity, far-reaching computing capabilities, and comprehensive memory. To measure vital signs, smartphones are often connected to a mobile sensor or a medical device. However, by using the white light-emitting diode as light source and the phone camera as photodetector, a smartphone could be used to perform photoplethysmography (PPG), enabling the assessment of vital signs. Objective: The objective of this meta-analysis was to evaluate the available evidence on the use of smartphone apps to measure heart rate by performing PPG in comparison with a validated method. Methods: PubMed and ISI Web of Knowledge were searched for relevant studies published between January 1, 2009 and December 7, 2016. The reference lists of included studies were hand-searched to find additional eligible studies. Critical Appraisal Skills Programme (CASP) Diagnostic Test Study checklist and some extra items were used for quality assessment. A fixed effects model of the mean difference and a random effects model of Pearson correlation coefficient were applied to pool the outcomes of the studies. Results: In total, 14 studies were included. The pooled result showed no significant difference between heart rate measurements with a smartphone and a validated method (mean difference ?0.32; 99\% CI ?1.24 to 0.60; P=.37). In adults, the Pearson correlation coefficient of the relation between heart rate measurement with a smartphone and a validated method was always ?.90. In children, the results varied depending on measuring point and heart rate. The pooled result showed a strong correlation that was significant (correlation coefficient .951; 95\% CI 0.906-0.975; P<.001). The reported limits of agreement showed good agreement between a smartphone and a validated method. There was a moderately strong significant negative correlation between the year of publication of the included studies and the mean difference (r=?.69; P<.001). Conclusions: Smartphone apps measuring heart rate by performing PPG appear to agree with a validated method in an adult population during resting sinus rhythm. In a pediatric population, the use of these apps is currently not validated. ", doi="10.2196/cardio.8802", url="http://cardio.jmir.org/2018/1/e4/", url="http://www.ncbi.nlm.nih.gov/pubmed/31758768" } @Article{info:doi/10.2196/cardio.8710, author="Kropp, Caley and Ellis, Jordan and Nekkanti, Rajasekhar and Sears, Samuel", title="Monitoring Patients With Implantable Cardioverter Defibrillators Using Mobile Phone Electrocardiogram: Case Study", journal="JMIR Cardio", year="2018", month="Feb", day="21", volume="2", number="1", pages="e5", keywords="atrial fibrillation", keywords="ICD", keywords="ECG", keywords="mobile phone monitoring", keywords="mobile health", keywords="electrophysiology", abstract="Background: Preventable poor health outcomes associated with atrial fibrillation continue to make early detection a priority. A one-lead mobile electrocardiogram (mECG) device given to patients with an implantable cardioverter defibrillator (ICD) allowed users to receive real-time ECG readings in 30 seconds. Objective: Three cases were selected from an institutional review board-approved clinical trial aimed at assessing mECG device usage and satisfaction, patient engagement, quality of life (QoL), and cardiac anxiety. These three specific cases were selected to examine a variety of possible patient presentations and user experiences. Methods: Three ICD patients with mobile phones who were being seen in an adult device clinic were asked to participate. The participants chosen represented individuals with varying degrees of reported education and patient engagement. Participants were instructed to use the mECG device at least once per day for 30 days. Positive ECGs for atrial fibrillation were evaluated in clinic. At follow-up, information was collected regarding their frequency of use of the mECG device and three psychological outcomes in the domains of patient engagement, QoL, and cardiac anxiety. Results: Each patient used the technology approximately daily or every other day as prescribed. At the 30-day follow-up, usage reports indicated an average of 32 readings per month per participant. At 90-day follow-up, usage reports indicated an average of 34 readings per month per participant. Two of the three participants self-reported a significant improvement in their physical QoL from baseline to completion, while simultaneously self-reporting a significant decrease in their mental QoL. All three participants reported high levels of device acceptance and technology satisfaction. Conclusions: This case study demonstrates that ICD patients with varying degrees of education and patient engagement were relatively active in their use of mECGs. All three participants using the mECG technology reported high technology satisfaction and device acceptance. High sensitivity, specificity, and accuracy of mECG technology may allow routine atrial fibrillation screening at lower costs, in addition to improving patient outcomes. ", doi="10.2196/cardio.8710", url="http://cardio.jmir.org/2018/1/e5/", url="http://www.ncbi.nlm.nih.gov/pubmed/31758776" } @Article{info:doi/10.2196/resprot.8842, author="Brewer, C. LaPrincess and Jenkins, Sarah and Lackore, Kandace and Johnson, Jacqueline and Jones, Clarence and Cooper, A. Lisa and Radecki Breitkopf, Carmen and Hayes, N. Sharonne and Patten, Christi", title="mHealth Intervention Promoting Cardiovascular Health Among African-Americans: Recruitment and Baseline Characteristics of a Pilot Study", journal="JMIR Res Protoc", year="2018", month="Jan", day="31", volume="7", number="1", pages="e31", keywords="mHealth intervention", keywords="community-based participatory research", keywords="cardiovascular disease", keywords="cardiovascular health", keywords="health disparities", keywords="African-Americans", keywords="faith-based intervention", abstract="Background: Mobile health (mHealth) interventions are promising avenues to promote cardiovascular (CV) health among African-Americans (AAs) and culturally tailored technology-based interventions are emerging for this population. Objective: The objectives of this study were to use a community-based participatory research (CBPR) approach to recruit AAs into a pilot intervention study of an innovative mHealth CV health promotion program and to characterize technology use patterns and eHealth literacy (EHL). Methods: Community partners from five predominately AA churches in southeast Minnesota collaborated with our academic institution to recruit AA congregants into the pilot study. Field notes as well as communications between the study team and community partners were used to design the recruitment strategy and its implementation with a goal of enrolling 50 participants. At its core, the recruitment strategy included community kickoff events to detail the state-of-the-art nature of the mHealth intervention components, the utility of CV health assessments (physical examination, laboratory studies and surveys) and the participants' role in advancing our understanding of the efficacy of mHealth interventions among racial/ethnic minority groups. Detailed recruitment data were documented throughout the study. A self-administered, electronic survey measured sociodemographics, technology use and EHL (eHEALS scale). Results: A total of 50 participants (70\% women) from five AA churches were recruited over a one-month period. The majority (>90\%) of participants reported using some form of mobile technology with all utilizing these technologies within their homes. Greater than half (60\% [30/50]) reported being ``very comfortable'' with mobile technologies. Overall, participants had high EHL (84.8\% [39/46] with eHEALS score ?26) with no differences by sex. Conclusions: This study illustrates the feasibility and success of a CBPR approach in recruiting AAs into mHealth intervention research and contributes to the growing body of evidence that AAs have high EHL, are high-users of mobile technologies, and thus are likely to be receptive to mHealth interventions. ", doi="10.2196/resprot.8842", url="http://www.researchprotocols.org/2018/1/e31/", url="http://www.ncbi.nlm.nih.gov/pubmed/29386174" } @Article{info:doi/10.2196/cardio.7586, author="Marvel, Adeline Francoise and Wang, Jane and Martin, Shay Seth", title="Digital Health Innovation: A Toolkit to Navigate From Concept to Clinical Testing", journal="JMIR Cardio", year="2018", month="Jan", day="18", volume="2", number="1", pages="e2", keywords="digital health innovation models", keywords="mHealth", keywords="innovation framework", keywords="development of smartphone applications", keywords="wearable technology", keywords="healthcare transformation", doi="10.2196/cardio.7586", url="http://cardio.jmir.org/2018/1/e2/", url="http://www.ncbi.nlm.nih.gov/pubmed/31758761" } @Article{info:doi/10.2196/mhealth.8873, author="Marcolino, Soriano Milena and Oliveira, Queiroz Jo{\~a}o Antonio and D'Agostino, Marcelo and Ribeiro, Luiz Antonio and Alkmim, Moreira Maria Beatriz and Novillo-Ortiz, David", title="The Impact of mHealth Interventions: Systematic Review of Systematic Reviews", journal="JMIR Mhealth Uhealth", year="2018", month="Jan", day="17", volume="6", number="1", pages="e23", keywords="telemedicine", keywords="medical informatics", keywords="mobile phones", abstract="Background: Mobile phone usage has been rapidly increasing worldwide. mHealth could efficiently deliver high-quality health care, but the evidence supporting its current effectiveness is still mixed. Objective: We performed a systematic review of systematic reviews to assess the impact or effectiveness of mobile health (mHealth) interventions in different health conditions and in the processes of health care service delivery. Methods: We used a common search strategy of five major scientific databases, restricting the search by publication date, language, and parameters in methodology and content. Methodological quality was evaluated using the Measurement Tool to Assess Systematic Reviews (AMSTAR) checklist. Results: The searches resulted in a total of 10,689 articles. Of these, 23 systematic reviews (371 studies; more than 79,665 patients) were included. Seventeen reviews included studies performed in low- and middle-income countries. The studies used diverse mHealth interventions, most frequently text messaging (short message service, SMS) applied to different purposes (reminder, alert, education, motivation, prevention). Ten reviews were rated as low quality (AMSTAR score 0-4), seven were rated as moderate quality (AMSTAR score 5-8), and six were categorized as high quality (AMSTAR score 9-11). A beneficial impact of mHealth was observed in chronic disease management, showing improvement in symptoms and peak flow variability in asthma patients, reducing hospitalizations and improving forced expiratory volume in 1 second; improving chronic pulmonary diseases symptoms; improving heart failure symptoms, reducing deaths and hospitalization; improving glycemic control in diabetes patients; improving blood pressure in hypertensive patients; and reducing weight in overweight and obese patients. Studies also showed a positive impact of SMS reminders in improving attendance rates, with a similar impact to phone call reminders at reduced cost, and improved adherence to tuberculosis and human immunodeficiency virus therapy in some scenarios, with evidence of decrease of viral load. Conclusions: Although mHealth is growing in popularity, the evidence for efficacy is still limited. In general, the methodological quality of the studies included in the systematic reviews is low. For some fields, its impact is not evident, the results are mixed, or no long-term studies exist. Exceptions include the moderate quality evidence of improvement in asthma patients, attendance rates, and increased smoking abstinence rates. Most studies were performed in high-income countries, implying that mHealth is still at an early stage of development in low-income countries. ", doi="10.2196/mhealth.8873", url="http://mhealth.jmir.org/2018/1/e23/", url="http://www.ncbi.nlm.nih.gov/pubmed/29343463" } @Article{info:doi/10.2196/humanfactors.8017, author="Beatty, L. Alexis and Magnusson, L. Sara and Fortney, C. John and Sayre, G. George and Whooley, A. Mary", title="VA FitHeart, a Mobile App for Cardiac Rehabilitation: Usability Study", journal="JMIR Hum Factors", year="2018", month="Jan", day="15", volume="5", number="1", pages="e3", keywords="cardiac rehabilitation", keywords="mobile applications", keywords="exercise therapy", keywords="exercise", keywords="rehabilitation research", keywords="telemedicine", keywords="habits", keywords="qualitative research", abstract="Background: Cardiac rehabilitation (CR) improves outcomes for patients with ischemic heart disease or heart failure but is underused. New strategies to improve access to and engagement in CR are needed. There is considerable interest in technology-facilitated home CR. However, little is known about patient acceptance and use of mobile technology for CR. Objective: The aim of this study was to develop a mobile app for technology-facilitated home CR and seek to determine its usability. Methods: We recruited patients eligible for CR who had access to a mobile phone, tablet, or computer with Internet access. The mobile app includes physical activity goal setting, logs for tracking physical activity and health metrics (eg, weight, blood pressure, and mood), health education, reminders, and feedback. Study staff demonstrated the mobile app to participants in person and then observed participants completing prespecified tasks with the mobile app. Participants completed the System Usability Scale (SUS, 0-100), rated likelihood to use the mobile app (0-100), questionnaires on mobile app use, and participated in a semistructured interview. The Unified Theory of Acceptance and Use of Technology and the Theory of Planned Behavior informed the analysis. On the basis of participant feedback, we made iterative revisions to the mobile app between users. Results: We conducted usability testing in 13 participants. The first version of the mobile app was used by the first 5 participants, and revised versions were used by the final 8 participants. From the first version to revised versions, task completion success rate improved from 44\% (11/25 tasks) to 78\% (31/40 tasks; P=.05), SUS improved from 54 to 76 (P=.04; scale 0-100, with 100 being the best usability), and self-reported likelihood of use remained high at 76 and 87 (P=.30; scale 0-100, with 100 being the highest likelihood). In interviews, patients expressed interest in tracking health measures (``I think it'll be good to track my exercise and to see what I'm doing''), a desire for introductory training (``Initially, training with a technical person, instead of me relying on myself''), and an expectation for sharing data with providers (``It would also be helpful to share with my doctor, it just being a matter of clicking a button and sharing it with my doctor''). Conclusions: With participant feedback and iterative revisions, we significantly improved the usability of a mobile app for CR. Patient expectations for using a mobile app for CR include tracking health metrics, introductory training, and sharing data with providers. Iterative mixed-method evaluation may be useful for improving the usability of health technology. ", doi="10.2196/humanfactors.8017", url="http://humanfactors.jmir.org/2018/1/e3/", url="http://www.ncbi.nlm.nih.gov/pubmed/29335235" } @Article{info:doi/10.2196/mhealth.8458, author="Mazoteras Pardo, Victoria and Losa Iglesias, E. Marta and L{\'o}pez Chicharro, Jos{\'e} and Becerro de Bengoa Vallejo, Ricardo", title="The QardioArm App in the Assessment of Blood Pressure and Heart Rate: Reliability and Validity Study", journal="JMIR Mhealth Uhealth", year="2017", month="Dec", day="15", volume="5", number="12", pages="e198", keywords="blood pressure", keywords="heart rate", keywords="reliability", keywords="validity", keywords="mobile apps", abstract="Background: Self-measurement of blood pressure is a priority strategy for managing blood pressure. Objective: The aim of this study was to evaluate the reliability and validity of blood pressure and heart rate following the European Society of Hypertension's international validation protocol, as measured with the QardioArm, a fully automatic, noninvasive wireless blood pressure monitor and mobile app. Methods: A total of 100 healthy volunteers older than 25 years from the general population of Ciudad Real, Spain, participated in a test-retest validation study with two measurement sessions separated by 5 to 7 days. In each measurement session, seven systolic blood pressure, diastolic blood pressure, and heart rate assessments were taken, alternating between the two devices. The test device was the QardioArm and the previously validated criterion device was the Omron M3. Sessions took place at a single study site with an evaluation room that was maintained at an appropriate temperature and kept free from noises and distractions. Results: The QardioArm displayed very consistent readings both within and across sessions (intraclass correlation coefficients=0.80-0.95, standard errors of measurement=2.5-5.4). The QardioArm measurements corresponded closely to those from the criterion device (r>.96) and mean values for the two devices were nearly identical. The QardioArm easily passed all validation standards set by the European Society of Hypertension International Protocol. Conclusions: The QardioArm mobile app has validity and it can be used free of major measurement error. ", doi="10.2196/mhealth.8458", url="http://mhealth.jmir.org/2017/12/e198/", url="http://www.ncbi.nlm.nih.gov/pubmed/29246880" } @Article{info:doi/10.2196/mhealth.8549, author="Xie, Bo and Su, Zhaohui and Zhang, Wenhui and Cai, Run", title="Chinese Cardiovascular Disease Mobile Apps' Information Types, Information Quality, and Interactive Functions for Self-Management: Systematic Review", journal="JMIR Mhealth Uhealth", year="2017", month="Dec", day="14", volume="5", number="12", pages="e195", keywords="mobile health", keywords="mHealth", keywords="cardiovascular disease", keywords="CVD", keywords="patient preferences", keywords="information quality", keywords="self-management", keywords="mobile applications", keywords="mobile apps", keywords="China", abstract="Background: China has a large population with cardiovascular disease (CVD) that requires extensive self-management. Mobile health (mHealth) apps may be a useful tool for CVD self-management. Little is currently known about the types and quality of health information provided in Chinese CVD mobile apps and whether app functions are conducive to promoting CVD self-management. Objective: We undertook a systematic review to evaluate the types and quality of health information provided in Chinese CVD mobile apps and interactive app functions for promoting CVD self-management. Methods: Mobile apps targeting end users in China with CVD conditions were selected in February 2017 through a multi-stage process. Three frameworks were used to evaluate the selected apps: (1) types of health information offered were assessed using our Health Information Wants framework, which encompasses 7 types of information; (2) quality of information provided in the apps was assessed using the 11 guidelines recommended by the National Library of Medicine of the National Institutes of Health; and (3) types of interactive app functions for CVD self-management were assessed using a 15-item framework adapted from the literature, including our own prior work. Results: Of 578 apps identified, 82 were eligible for final review. Among these, information about self-care (67/82, 82\%) and information specifically regarding CVD (63/82, 77\%) were the most common types of information provided, while information about health care providers (22/82, 27\%) and laboratory tests (5/82, 6\%) were least common. The most common indicators of information quality were the revealing of apps' providers (82/82, 100\%) and purpose (82/82, 100\%), while the least common quality indicators were the revealing of how apps' information was selected (1/82, 1\%) and app sponsorship (0/82, 0\%). The most common interactive functions for CVD self-management were those that enabled user interaction with the app provider (57/82, 70\%) and with health care providers (36/82, 44\%), while the least common interactive functions were those that enabled lifestyle management (13/82, 16\%) and psychological health management (6/82, 7\%). None of the apps covered all 7 types of health information, all 11 indicators of information quality, or all 15 interactive functions for CVD self-management. Conclusions: Chinese CVD apps are insufficient in providing comprehensive health information, high-quality information, and interactive functions to facilitate CVD self-management. End users should exercise caution when using existing apps. Health care professionals and app developers should collaborate to better understand end users' preferences and follow evidence-based guidelines to develop mHealth apps conducive to CVD self-management. ", doi="10.2196/mhealth.8549", url="http://mhealth.jmir.org/2017/12/e195/", url="http://www.ncbi.nlm.nih.gov/pubmed/29242176" } @Article{info:doi/10.2196/cardio.8543, author="Magnani, W. Jared and Schlusser, L. Courtney and Kimani, Everlyne and Rollman, L. Bruce and Paasche-Orlow, K. Michael and Bickmore, W. Timothy", title="The Atrial Fibrillation Health Literacy Information Technology System: Pilot Assessment", journal="JMIR Cardio", year="2017", month="Dec", day="12", volume="1", number="2", pages="e7", keywords="atrial fibrillation", keywords="mHealth", keywords="health-related quality of life", keywords="medication adherence", abstract="Background: Atrial fibrillation (AF) is a highly prevalent heart rhythm condition that has significant associated morbidity and requires chronic treatment. Mobile health (mHealth) technologies have the potential to enhance multiple aspects of AF care, including education, monitoring of symptoms, and encouraging and tracking medication adherence. We have previously implemented and tested relational agents to improve outcomes in chronic disease and sought to develop a smartphone-based relational agent for improving patient-centered outcomes in AF. Objective: The objective of this study was to pilot a smartphone-based relational agent as preparation for a randomized clinical trial, the Atrial Fibrillation Health Literacy Information Technology Trial (AF-LITT). Methods: We developed the relational agent for use by a smartphone consistent with our prior approaches. We programmed the relational agent as a computer-animated agent to simulate a face-to-face conversation and to serve as a health counselor or coach specific to AF. Relational agent's dialogue content, informed by a review of literature, focused on patient-centered domains and qualitative interviews with patients with AF, encompassed AF education, common symptoms, adherence challenges, and patient activation. We established that the content was accessible to individuals with limited health or computer literacy. Relational agent content coordinated with use of the smartphone AliveCor Kardia heart rate and rhythm monitor. Participants (N=31) were recruited as a convenience cohort from ambulatory clinical sites and instructed to use the relational agent and Kardia for 30 days. We collected demographic, social, and clinical characteristics and conducted baseline and 30-day assessments of health-related quality of life (HRQoL) with the Atrial Fibrillation Effect on Quality of life (AFEQT) measure; self-reported medication adherence with the Morisky 8-item Medication Adherence Scale (MMAS-8); and patient activation with the Patient Activation Measure (PAM). Results: Participants (mean age 68 [SD 11]; 39\% [12/31] women) used the relational agent for an average 17.8 (SD 10.0) days. The mean number of independent log-ins was 19.6 (SD 10.7), with a median of 20 times over 30 days. The mean number of Kardia uses was 26.5 (SD 5.9), and participants using Kardia were in AF for 14.3 (SD 11.0) days. AFEQT scores improved significantly from 64.5 (SD 22.9) at baseline to 76.3 (SD 19.4) units at 30 days (P<.01). We observed marginal but statistically significant improvement in self-reported medication adherence (baseline: 7.3 [SD 0.9], 30 days: 7.7 [SD 0.5]; P=.01). Assessments of acceptability identified that most of the participants found the relational agent useful, informative, and trustworthy. Conclusions: We piloted a 30-day smartphone-based intervention that combined a relational agent with dedicated content for AF alongside Kardia heart rate and rhythm monitoring. Pilot participants had favorable improvements in HRQoL and self-reported medication adherence, as well as positive responses to the intervention. These data will guide a larger, enhanced randomized trial implementing the smartphone relational agent and the Kardia monitor system. ", doi="10.2196/cardio.8543", url="http://cardio.jmir.org/2017/2/e7/", url="http://www.ncbi.nlm.nih.gov/pubmed/29473644" } @Article{info:doi/10.2196/mhealth.7254, author="Vandenberk, Thijs and Stans, Jelle and Mortelmans, Christophe and Van Haelst, Ruth and Van Schelvergem, Gertjan and Pelckmans, Caroline and Smeets, JP Christophe and Lanssens, Dorien and De Canni{\`e}re, H{\'e}l{\`e}ne and Storms, Valerie and Thijs, M. Inge and Vaes, Bert and Vandervoort, M. Pieter", title="Clinical Validation of Heart Rate Apps: Mixed-Methods Evaluation Study", journal="JMIR Mhealth Uhealth", year="2017", month="Aug", day="25", volume="5", number="8", pages="e129", keywords="heart rate", keywords="software validation", keywords="remote sensing technology", abstract="Background: Photoplethysmography (PPG) is a proven way to measure heart rate (HR). This technology is already available in smartphones, which allows measuring HR only by using the smartphone. Given the widespread availability of smartphones, this creates a scalable way to enable mobile HR monitoring. An essential precondition is that these technologies are as reliable and accurate as the current clinical (gold) standards. At this moment, there is no consensus on a gold standard method for the validation of HR apps. This results in different validation processes that do not always reflect the veracious outcome of comparison. Objective: The aim of this paper was to investigate and describe the necessary elements in validating and comparing HR apps versus standard technology. Methods: The FibriCheck (Qompium) app was used in two separate prospective nonrandomized studies. In the first study, the HR of the FibriCheck app was consecutively compared with 2 different Food and Drug Administration (FDA)-cleared HR devices: the Nonin oximeter and the AliveCor Mobile ECG. In the second study, a next step in validation was performed by comparing the beat-to-beat intervals of the FibriCheck app to a synchronized ECG recording. Results: In the first study, the HR (BPM, beats per minute) of 88 random subjects consecutively measured with the 3 devices showed a correlation coefficient of .834 between FibriCheck and Nonin, .88 between FibriCheck and AliveCor, and .897 between Nonin and AliveCor. A single way analysis of variance (ANOVA; P=.61 was executed to test the hypothesis that there were no significant differences between the HRs as measured by the 3 devices. In the second study, 20,298 (ms) R-R intervals (RRI)--peak-to-peak intervals (PPI) from 229 subjects were analyzed. This resulted in a positive correlation (rs=.993, root mean square deviation [RMSE]=23.04 ms, and normalized root mean square error [NRMSE]=0.012) between the PPI from FibriCheck and the RRI from the wearable ECG. There was no significant difference (P=.92) between these intervals. Conclusions: Our findings suggest that the most suitable method for the validation of an HR app is a simultaneous measurement of the HR by the smartphone app and an ECG system, compared on the basis of beat-to-beat analysis. This approach could lead to more correct assessments of the accuracy of HR apps. ", doi="10.2196/mhealth.7254", url="http://mhealth.jmir.org/2017/8/e129/" } @Article{info:doi/10.2196/biomedeng.8179, author="Lang, Michael", title="Heart Rate Monitoring Apps: Information for Engineers and Researchers About the New European Medical Devices Regulation 2017/745", journal="JMIR Biomed Eng", year="2017", month="Aug", day="18", volume="2", number="1", pages="e2", keywords="European Medical Device Regulation", keywords="(EU) 2017/745", keywords="MDR", keywords="93/42/EEC", keywords="MDD", keywords="heart rate monitoring", keywords="health apps", keywords="mHealth", abstract="Background: After years in the making, on April 5, 2017, the European Parliament and Council finally adopted Regulation (EU) 2017/745, the new Medical Devices Regulation (MDR), repealing the existing Medical Device Directive (MDD) 93/42/EEC. Though long anticipated, this shift in policy will have strong and lasting effects in the medical devices industry. Objective: This paper focuses specifically on the classification of software as a potential medical device under MDD and MDR and examines whether or not the regulatory framework for health apps has changed substantially and what, if any, impact is to expected. A particular emphasis will be on the issue of classification uncertainty raised by borderline cases such as heart rate monitoring and well-being apps. The paper primarily targets researchers and engineers unfamiliar with regulatory requirements for medical devices and aims to provide a concise, yet accurate, overview of the European regulatory framework. This is of particular relevance as with the exponential growth of fitness and health-related apps, the lines between toys, lifestyle products, and medical devices have increasingly blurred. Methods: The recently published European Medical Device Regulation is analyzed and compared to the preceding MDD. Results: The previous regulatory framework already provided for the possibility of apps to fall under the definition of medical devices, in which case classification rules for active medical devices applied. However, while applicability of the new regulatory framework still hinges on whether the intended purpose is medical or not, the threshold for classifying as a medical device has been considerably lowered due to a broader interpretation of what constitutes a medical purpose. Conclusions: The adoption of the new European regulation on medical devices entails the risk that manufacturers previously unaffected by the medical devices regulatory framework may now unwillingly and unwittingly find themselves in the arena of medical device manufacturing. ", doi="10.2196/biomedeng.8179", url="http://biomedeng.jmir.org/2017/1/e2/" } @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.7782, author="Duff, Mairead Orlaith and Walsh, MJ Deirdre and Furlong, A. Br{\'o}na and O'Connor, E. Noel and Moran, A. Kieran and Woods, B. Catherine", title="Behavior Change Techniques in Physical Activity eHealth Interventions for People With Cardiovascular Disease: Systematic Review", journal="J Med Internet Res", year="2017", month="Aug", day="02", volume="19", number="8", pages="e281", keywords="systematic review", keywords="exercise", keywords="behavior", keywords="telemedicine", keywords="cardiovascular disease", abstract="Background: Cardiovascular disease (CVD) is the leading cause of premature death and disability in Europe, accounting for 4 million deaths per year and costing the European Union economy almost {\texteuro}196 billion annually. There is strong evidence to suggest that exercise-based secondary rehabilitation programs can decrease the mortality risk and improve health among patients with CVD. Theory-informed use of behavior change techniques (BCTs) is important in the design of cardiac rehabilitation programs aimed at changing cardiovascular risk factors. Electronic health (eHealth) is the use of information and communication technologies (ICTs) for health. This emerging area of health care has the ability to enhance self-management of chronic disease by making health care more accessible, affordable, and available to the public. However, evidence-based information on the use of BCTs in eHealth interventions is limited, and particularly so, for individuals living with CVD. Objective: The aim of this systematic review was to assess the application of BCTs in eHealth interventions designed to increase physical activity (PA) in CVD populations. Methods: A total of 7 electronic databases, including EBSCOhost (MEDLINE, PsycINFO, Academic Search Complete, SPORTDiscus with Full Text, and CINAHL Complete), Scopus, and Web of Science (Core Collection) were searched. Two authors independently reviewed references using the software package Covidence (Veritas Health Innovation). The reviewers met to resolve any discrepancies, with a third independent reviewer acting as an arbitrator when required. Following this, data were extracted from the papers that met the inclusion criteria. Bias assessment of the studies was carried out using the Cochrane Collaboration's tool for assessing the risk of bias within Covidence; this was followed by a narrative synthesis. Results: Out of the 987 studies that were identified, 14 were included in the review. An additional 9 studies were added following a hand search of review paper references. The average number of BCTs used across the 23 studies was 7.2 (range 1-19). The top three most frequently used BCTs included information about health consequences (78\%, 18/23), goal setting (behavior; 74\%, 17/23), and joint third, self-monitoring of behavior and social support (practical) were included in 11 studies (48\%, 11/23) each. Conclusions: This systematic review is the first to investigate the use of BCTs in PA eHealth interventions specifically designed for people with CVD. This research will have clear implications for health care policy and research by outlining the BCTs used in eHealth interventions for chronic illnesses, in particular CVD, thereby providing clear foundations for further research and developments in the area. ", doi="10.2196/jmir.7782", url="http://www.jmir.org/2017/8/e281/", url="http://www.ncbi.nlm.nih.gov/pubmed/28768610" } @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/cardio.6057, author="Darling, Eric Chad and Dovancescu, Silviu and Saczynski, S. Jane and Riistama, Jarno and Sert Kuniyoshi, Fatima and Rock, Joseph and Meyer, E. Theo and McManus, D. David", title="Bioimpedance-Based Heart Failure Deterioration Prediction Using a Prototype Fluid Accumulation Vest-Mobile Phone Dyad: An Observational Study", journal="JMIR Cardio", year="2017", month="Mar", day="13", volume="1", number="1", pages="e1", keywords="telemedicine", keywords="outpatient monitoring", keywords="heart failure", keywords="electric impedance", abstract="Background: Recurrent heart failure (HF) events are common in patients discharged after acute decompensated heart failure (ADHF). New patient-centered technologies are needed to aid in detecting HF decompensation. Transthoracic bioimpedance noninvasively measures pulmonary fluid retention. Objective: The objectives of our study were to (1) determine whether transthoracic bioimpedance can be measured daily with a novel, noninvasive, wearable fluid accumulation vest (FAV) and transmitted using a mobile phone and (2) establish whether an automated algorithm analyzing daily thoracic bioimpedance values would predict recurrent HF events. Methods: We prospectively enrolled patients admitted for ADHF. Participants were trained to use a FAV--mobile phone dyad and asked to transmit bioimpedance measurements for 45 consecutive days. We examined the performance of an algorithm analyzing changes in transthoracic bioimpedance as a predictor of HF events (HF readmission, diuretic uptitration) over a 75-day follow-up. Results: We observed 64 HF events (18 HF readmissions and 46 diuretic uptitrations) in the 106 participants (67 years; 63.2\%, 67/106, male; 48.1\%, 51/106, with prior HF) who completed follow-up. History of HF was the only clinical or laboratory factor related to recurrent HF events (P=.04). Among study participants with sufficient FAV data (n=57), an algorithm analyzing thoracic bioimpedance showed 87\% sensitivity (95\% CI 82-92), 70\% specificity (95\% CI 68-72), and 72\% accuracy (95\% CI 70-74) for identifying recurrent HF events. Conclusions: Patients discharged after ADHF can measure and transmit daily transthoracic bioimpedance using a FAV--mobile phone dyad. Algorithms analyzing thoracic bioimpedance may help identify patients at risk for recurrent HF events after hospital discharge. ", doi="10.2196/cardio.6057", url="http://cardio.jmir.org/2017/1/e1/", url="http://www.ncbi.nlm.nih.gov/pubmed/31758769" } @Article{info:doi/10.2196/mhealth.7275, author="Yan, P. Bryan and Chan, KY Christy and Li, KH Christien and To, TL Olivia and Lai, HS William and Tse, Gary and Poh, C. Yukkee and Poh, Ming-Zher", title="Resting and Postexercise Heart Rate Detection From Fingertip and Facial Photoplethysmography Using a Smartphone Camera: A Validation Study", journal="JMIR Mhealth Uhealth", year="2017", month="Mar", day="13", volume="5", number="3", pages="e33", keywords="heart rate", keywords="mobile apps", keywords="photoplethysmography", keywords="smartphone", keywords="mobile phone", abstract="Background: Modern smartphones allow measurement of heart rate (HR) by detecting pulsatile photoplethysmographic (PPG) signals with built-in cameras from the fingertips or the face, without physical contact, by extracting subtle beat-to-beat variations of skin color. Objective: The objective of our study was to evaluate the accuracy of HR measurements at rest and after exercise using a smartphone-based PPG detection app. Methods: A total of 40 healthy participants (20 men; mean age 24.7, SD 5.2 years; von Luschan skin color range 14-27) underwent treadmill exercise using the Bruce protocol. We recorded simultaneous PPG signals for each participant by having them (1) facing the front camera and (2) placing their index fingertip over an iPhone's back camera. We analyzed the PPG signals from the Cardiio-Heart Rate Monitor + 7 Minute Workout (Cardiio) smartphone app for HR measurements compared with a continuous 12-lead electrocardiogram (ECG) as the reference. Recordings of 20 seconds' duration each were acquired at rest, and immediately after moderate- (50\%-70\% maximum HR) and vigorous- (70\%-85\% maximum HR) intensity exercise, and repeated successively until return to resting HR. We used Bland-Altman plots to examine agreement between ECG and PPG-estimated HR. The accuracy criterion was root mean square error (RMSE) ?5 beats/min or ?10\%, whichever was greater, according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation EC-13 standard. Results: We analyzed a total of 631 fingertip and 626 facial PPG measurements. Fingertip PPG-estimated HRs were strongly correlated with resting ECG HR (r=.997, RMSE=1.03 beats/min or 1.40\%), postmoderate-intensity exercise (r=.994, RMSE=2.15 beats/min or 2.53\%), and postvigorous-intensity exercise HR (r=.995, RMSE=2.01 beats/min or 1.93\%). The correlation of facial PPG-estimated HR was stronger with resting ECG HR (r=.997, RMSE=1.02 beats/min or 1.44\%) than with postmoderate-intensity exercise (r=.982, RMSE=3.68 beats/min or 4.11\%) or with postvigorous-intensity exercise (r=.980, RMSE=3.84 beats/min or 3.73\%). Bland-Altman plots showed better agreement between ECG and fingertip PPG-estimated HR than between ECG and facial PPG-estimated HR. Conclusions: We found that HR detection by the Cardiio smartphone app was accurate at rest and after moderate- and vigorous-intensity exercise in a healthy young adult sample. Contact-free facial PPG detection is more convenient but is less accurate than finger PPG due to body motion after exercise. ", doi="10.2196/mhealth.7275", url="http://mhealth.jmir.org/2017/3/e33/", url="http://www.ncbi.nlm.nih.gov/pubmed/28288955" } @Article{info:doi/10.2196/jmir.7005, author="Siebert, N. Johan and Ehrler, Frederic and Combescure, Christophe and Lacroix, Laurence and Haddad, Kevin and Sanchez, Oliver and Gervaix, Alain and Lovis, Christian and Manzano, Sergio", title="A Mobile Device App to Reduce Time to Drug Delivery and Medication Errors During Simulated Pediatric Cardiopulmonary Resuscitation: A Randomized Controlled Trial", journal="J Med Internet Res", year="2017", month="Feb", day="01", volume="19", number="2", pages="e31", keywords="resuscitation", keywords="medication errors", keywords="pharmaceutical preparations", keywords="pediatrics", keywords="biomedical technology", abstract="Background: During pediatric cardiopulmonary resuscitation (CPR), vasoactive drug preparation for continuous infusion is both complex and time-consuming, placing children at higher risk than adults for medication errors. Following an evidence-based ergonomic-driven approach, we developed a mobile device app called Pediatric Accurate Medication in Emergency Situations (PedAMINES), intended to guide caregivers step-by-step from preparation to delivery of drugs requiring continuous infusion. Objective: The aim of our study was to determine whether the use of PedAMINES reduces drug preparation time (TDP) and time to delivery (TDD; primary outcome), as well as medication errors (secondary outcomes) when compared with conventional preparation methods. Methods: The study was a randomized controlled crossover trial with 2 parallel groups comparing PedAMINES with a conventional and internationally used drugs infusion rate table in the preparation of continuous drug infusion. We used a simulation-based pediatric CPR cardiac arrest scenario with a high-fidelity manikin in the shock room of a tertiary care pediatric emergency department. After epinephrine-induced return of spontaneous circulation, pediatric emergency nurses were first asked to prepare a continuous infusion of dopamine, using either PedAMINES (intervention group) or the infusion table (control group), and second, a continuous infusion of norepinephrine by crossing the procedure. The primary outcome was the elapsed time in seconds, in each allocation group, from the oral prescription by the physician to TDD by the nurse. TDD included TDP. The secondary outcome was the medication dosage error rate during the sequence from drug preparation to drug injection. Results: A total of 20 nurses were randomized into 2 groups. During the first study period, mean TDP while using PedAMINES and conventional preparation methods was 128.1 s (95\% CI 102-154) and 308.1 s (95\% CI 216-400), respectively (180 s reduction, P=.002). Mean TDD was 214 s (95\% CI 171-256) and 391 s (95\% CI 298-483), respectively (177.3 s reduction, P=.002). Medication errors were reduced from 70\% to 0\% (P<.001) by using PedAMINES when compared with conventional methods. Conclusions: In this simulation-based study, PedAMINES dramatically reduced TDP, to delivery and the rate of medication errors. ", doi="10.2196/jmir.7005", url="http://www.jmir.org/2017/2/e31/", url="http://www.ncbi.nlm.nih.gov/pubmed/28148473" } @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/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/jmir.2951, author="Kalz, Marco and Lenssen, Niklas and Felzen, Marc and Rossaint, Rolf and Tabuenca, Bernardo and Specht, Marcus and Skorning, Max", title="Smartphone Apps for Cardiopulmonary Resuscitation Training and Real Incident Support: A Mixed-Methods Evaluation Study", journal="J Med Internet Res", year="2014", month="Mar", day="19", volume="16", number="3", pages="e89", keywords="basic life support (BLS)", keywords="cardiopulmonary resuscitation (CPR)", keywords="external chest compression (ECC)", keywords="smartphone apps", keywords="mobile phone", keywords="mobile health", abstract="Background: No systematic evaluation of smartphone/mobile apps for resuscitation training and real incident support is available to date. To provide medical, usability, and additional quality criteria for the development of apps, we conducted a mixed-methods sequential evaluation combining the perspective of medical experts and end-users. Objective: The study aims to assess the quality of current mobile apps for cardiopulmonary resuscitation (CPR) training and real incident support from expert as well as end-user perspective. Methods: Two independent medical experts evaluated the medical content of CPR apps from the Google Play store and the Apple App store. The evaluation was based on pre-defined minimum medical content requirements according to current Basic Life Support (BLS) guidelines. In a second phase, non-medical end-users tested usability and appeal of the apps that had at least met the minimum requirements. Usability was assessed with the System Usability Scale (SUS); appeal was measured with the self-developed ReactionDeck toolkit. Results: Out of 61 apps, 46 were included in the experts' evaluation. A consolidated list of 13 apps resulted for the following layperson evaluation. The interrater reliability was substantial (kappa=.61). Layperson end-users (n=14) had a high interrater reliability (intraclass correlation 1 [ICC1]=.83, P<.001, 95\% CI 0.75-0.882 and ICC2=.79, P<.001, 95\% CI 0.695-0.869). Their evaluation resulted in a list of 5 recommendable apps. Conclusions: Although several apps for resuscitation training and real incident support are available, very few are designed according to current BLS guidelines and offer an acceptable level of usability and hedonic quality for laypersons. The results of this study are intended to optimize the development of CPR mobile apps. The app ranking supports the informed selection of mobile apps for training situations and CPR campaigns as well as for real incident support. ", doi="10.2196/jmir.2951", url="http://www.jmir.org/2014/3/e89/", url="http://www.ncbi.nlm.nih.gov/pubmed/24647361" } @Article{info:doi/10.2196/mhealth.2737, author="Mart{\'i}nez-P{\'e}rez, Borja and de la Torre-D{\'i}ez, Isabel and L{\'o}pez-Coronado, Miguel and Herreros-Gonz{\'a}lez, Jes{\'u}s", title="Mobile Apps in Cardiology: Review", journal="JMIR Mhealth Uhealth", year="2013", month="Jul", day="24", volume="1", number="2", pages="e15", keywords="apps", keywords="cardiology", keywords="heart", keywords="m-health", keywords="mobile applications", abstract="Background: Cardiovascular diseases are the deadliest diseases worldwide, with 17.3 million deaths in 2008 alone. Among them, heart-related deaths are of the utmost relevance; a fact easily proven by the 7.25 million deaths caused by ischemic heart disease alone in that year. The latest advances in smartphones and mHealth have been used in the creation of thousands of medical apps related to cardiology, which can help to reduce these mortality rates. Objective: The aim of this paper is to study the literature on mobile systems and applications currently available, as well as the existing apps related to cardiology from the leading app stores and to then classify the results to see what is available and what is missing, focusing particularly on commercial apps. Methods: Two reviews have been developed. One is a literature review of mobile systems and applications, retrieved from several databases and systems such as Scopus, PubMed, IEEE Xplore, and Web of Knowledge. The other is a review of mobile apps in the leading app stores, Google play for Android and Apple's App Store for iOS. Results: Search queries up to May 2013 located 406 papers and 710 apps related to cardiology and heart disease. The most researched section in the literature associated with cardiology is related to mobile heart (and vital signs) monitoring systems and the methods involved in the classification of heart signs in order to detect abnormal functions. Other systems with a significant number of papers are mobile cardiac rehabilitation systems, blood pressure measurement, and systems for the detection of heart failure. The majority of apps for cardiology are heart monitors and medical calculators. Other categories with a high number of apps are those for ECG education and interpretation, cardiology news and journals, blood pressure tracking, heart rate monitoring using an external device, and CPR instruction. There are very few guides on cardiac rehabilitation and apps for the management of the cardiac condition, and there were no apps that assist people who have undergone a heart transplant. Conclusions: The distribution of work in the field of cardiology apps is considerably disproportionate. Whereas some systems have significant research and apps are available, other important systems lack such research and lack apps, even though the contribution they could provide is significant. ", doi="10.2196/mhealth.2737", url="http://mhealth.jmir.org/2013/2/e15/", url="http://www.ncbi.nlm.nih.gov/pubmed/25098320" } @Article{info:doi/10.2196/jmir.1909, author="Seto, Emily and Leonard, J. Kevin and Cafazzo, A. Joseph and Barnsley, Jan and Masino, Caterina and Ross, J. Heather", title="Mobile Phone-Based Telemonitoring for Heart Failure Management: A Randomized Controlled Trial", journal="J Med Internet Res", year="2012", month="Feb", day="16", volume="14", number="1", pages="e31", keywords="heart failure", keywords="telemedicine", keywords="mobile phone", keywords="patient monitoring", keywords="randomized controlled trial", abstract="Background: Previous trials of telemonitoring for heart failure management have reported inconsistent results, largely due to diverse intervention and study designs. Mobile phones are becoming ubiquitous and economical, but the feasibility and efficacy of a mobile phone-based telemonitoring system have not been determined. Objective: The objective of this trial was to investigate the effects of a mobile phone-based telemonitoring system on heart failure management and outcomes. Methods: One hundred patients were recruited from a heart function clinic and randomized into telemonitoring and control groups. The telemonitoring group (N = 50) took daily weight and blood pressure readings and weekly single-lead ECGs, and answered daily symptom questions on a mobile phone over 6 months. Readings were automatically transmitted wirelessly to the mobile phone and then to data servers. Instructions were sent to the patients' mobile phones and alerts to a cardiologist's mobile phone as required. Results: Baseline questionnaires were completed and returned by 94 patients, and 84 patients returned post-study questionnaires. About 70\% of telemonitoring patients completed at least 80\% of their possible daily readings. The change in quality of life from baseline to post-study, as measured with the Minnesota Living with Heart Failure Questionnaire, was significantly greater for the telemonitoring group compared to the control group (P = .05). A between-group analysis also found greater post-study self-care maintenance (measured with the Self-Care of Heart Failure Index) for the telemonitoring group (P = .03). Brain natriuretic peptide (BNP) levels, self-care management, and left ventricular ejection fraction (LVEF) improved significantly for both groups from baseline to post-study, but did not show a between-group difference. However, a subgroup within-group analysis using the data from the 63 patients who had attended the heart function clinic for more than 6 months revealed the telemonitoring group had significant improvements from baseline to post-study in BNP (decreased by 150 pg/mL, P = .02), LVEF (increased by 7.4\%, P = .005) and self-care maintenance (increased by 7 points, P = .05) and management (increased by 14 points, P = .03), while the control group did not. No differences were found between the telemonitoring and control groups in terms of hospitalization, mortality, or emergency department visits, but the trial was underpowered to detect differences in these metrics. Conclusions: Our findings provide evidence of improved quality of life through improved self-care and clinical management from a mobile phone-based telemonitoring system. The use of the mobile phone-based system had high adherence and was feasible for patients, including the elderly and those with no experience with mobile phones. Trial Registration: ClinicalTrials.gov NCT00778986 ", doi="10.2196/jmir.1909", url="http://www.jmir.org/2012/1/e31/", url="http://www.ncbi.nlm.nih.gov/pubmed/22356799" } @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" }