Rationale and Design of the mTECH-Rehab Randomized Controlled Trial: Impact of a Mobile Technology Enabled Corrie Cardiac Rehabilitation Program on Functional Status and Cardiovascular Health.

BACKGROUND: Cardiac rehabilitation (CR) is an evidence-based, guideline-recommended intervention for patients recovering from a cardiac event, surgery or procedure that improves morbidity, mortality, and functional status. CR is traditionally provided in-center, which limits access and engagement, most notably among underrepresented racial and ethnic groups due to barriers including cost, scheduling, and transportation access. This study is designed to evaluate the Corrie Hybrid CR, a technology-based, multicomponent health equity-focused intervention as an alternative to traditional in-center CR among patients recovering from a cardiac event, surgery, or procedure compared with usual care alone. METHODS: The mTECH-Rehab (Impact of a Mobile Technology Enabled Corrie CR Program) trial will randomize 200 patients who either have diagnosis of myocardial infarction or who undergo coronary artery bypass grafting surgery, percutaneous coronary intervention, heart valve repair, or replacement presenting to 4 hospitals in a large academic health system in Maryland, United States, to the Corrie Hybrid CR program combined with usual care CR (intervention group) or usual care CR alone (control group) in a parallel arm, randomized controlled trial. The Corrie Hybrid CR program leverages 5 components: (1) a patient-facing mobile application that encourages behavior change, patient empowerment, and engagement with guideline-directed therapy; (2) Food and Drug Administration-approved smart devices that collect health metrics; (3) 2 upfront in-center CR sessions to facilitate personalization, self-efficacy, and evaluation for the safety of home exercise, followed by a combination of in-center and home-based sessions per participant preference; (4) a clinician dashboard to track health data; and (5) weekly virtual coaching sessions delivered over 12 weeks for education, encouragement, and risk factor modification. The primary outcome is the mean difference between the intervention versus control groups in distance walked on the 6-minute walk test (ie, functional capacity) at 12 weeks post randomization. Key secondary and exploratory outcomes include improvement in a composite cardiovascular health metric, CR engagement, quality of life, health factors (including low-density lipoprotein-cholesterol, hemoglobin A1c, weight, diet, smoking cessation, blood pressure), and psychosocial factors. Approval for the study was granted by the local institutional review board. Results of the trial will be published once data collection and analysis have been completed. CONCLUSIONS: The Corrie Hybrid CR program has the potential to improve functional status, cardiovascular health, and CR engagement and advance equity in access to cardiac rehabilitation. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05238103.

The Virtual Inclusive Digital Health Intervention Design to Promote Health Equity (iDesign) Framework for Atrial Fibrillation: Co-design and Development Study.

BACKGROUND: Smartphone ownership and mobile app use are steadily increasing in individuals of diverse racial and ethnic backgrounds living in the United States. Growing adoption of technology creates a perfect opportunity for digital health interventions to increase access to health care. To successfully implement digital health interventions and engage users, intervention development should be guided by user input, which is best achieved by the process of co-design. Digital health interventions co-designed with the active engagement of users have the potential to increase the uptake of guideline recommendations, which can reduce morbidity and mortality and advance health equity. OBJECTIVE: We aimed to co-design a digital health intervention for patients with atrial fibrillation, the most common cardiac arrhythmia, with patient, caregiver, and clinician feedback and to describe our approach to human-centered design for building digital health interventions. METHODS: We conducted virtual meetings with patients with atrial fibrillation (n=8), their caregivers, and clinicians (n=8). We used the following 7 steps in our co-design process: step 1, a virtual meeting focused on defining challenges and empathizing with problems that are faced in daily life by individuals with atrial fibrillation and clinicians; step 2, a virtual meeting focused on ideation and brainstorming the top challenges identified during the first meeting; step 3, individualized onboarding of patients with an existing minimally viable version of the atrial fibrillation app; step 4, virtual prototyping of the top 3 ideas generated during ideation; step 5, further ranking by the study investigators and engineers of the ideas that were generated during ideation but were not chosen as top-3 solutions to be prototyped in step 4; step 6, ongoing engineering work to incorporate top-priority features in the app; and step 7, obtaining further feedback from patients and testing the atrial fibrillation digital health intervention in a pilot clinical study. RESULTS: The top challenges identified by patients and caregivers included addressing risk factor modification, medication adherence, and guidance during atrial fibrillation episodes. Challenges identified by clinicians were complementary and included patient education, addressing modifiable atrial fibrillation risk factors, and remote atrial fibrillation episode management. Patients brainstormed more than 30 ideas to address the top challenges, and the clinicians generated more than 20 ideas. Ranking of the ideas informed several novel or modified features aligned with the Theory of Health Behavior Change, features that were geared toward risk factor modification; patient education; rhythm, symptom, and trigger correlation for remote atrial fibrillation management; and social support. CONCLUSIONS: We co-designed an atrial fibrillation digital health intervention in partnership with patients, caregivers, and clinicians by virtually engaging in collaborative creation through the design process. We summarize our experience and describe a flexible approach to human-centered design for digital health intervention development that can guide innovative clinical investigators.

Secular Trends in Risk Profiles Among Adults With Cardiovascular Disease in the United States.

BACKGROUND: Documenting trends in risk factors among individuals with cardiovascular disease (CVD) may inform policy and secondary prevention initiatives. OBJECTIVES: This study aimed to examine 20-year trends in risk profiles among U.S. adults with CVD and any racial/ethnic disparities. METHODS: In this serial cross-sectional analysis of 6,335 adults with self-reported CVD participating in the National Health and Nutrition Examination Survey from 1999 through 2018, we calculated age- and sex-adjusted proportions with ideal risk factor attainment. RESULTS: The proportions with ideal hemoglobin A1c (<7% if diabetes or <5.7% if not) and body mass index (<25 kg/m2) worsened from 58.7% (95% CI: 55.2%-62.1%) to 52.4% (95% CI: 48.2%-56.6%) and 23.9% (95% CI: 21.5%-26.4%) to 18.2% (95% CI: 15.6%-21.2%) from 1999-2002 to 2015-2018, respectively. After initial improvement, the proportion with blood pressure <130/80 mm Hg declined from 52.1% (95% CI: 48.9%-55.4%) in 2007-2010 to 48.6% (95% CI: 44.2%-52.7%) in 2015-2018. The proportion with non-high-density lipoprotein cholesterol levels <100 mg/dL increased from 7.3% (95% CI: 5.6%-9.5%) in 1999-2002 to 30.3% (95% CI: 25.7%-35.5%) in 2015-2018. The proportions with ideal smoking, physical activity, and diet profiles were unchanged over time, and in 2015-2018 were 77.8% (95% CI: 73.6%-81.4%), 22.4% (95% CI: 19.3%-25.9%), and 1.3% (95% CI: 0.7%-2.6%). Worsening trends were observed in Hispanic adults for cholesterol, and in Black adults for smoking (both P < 0.05 for nonlinear and linear trends). Persistently lower ideal risk factor attainment was observed for blood pressure in Black adults and for hemoglobin A1c levels in Asian adults compared with White adults (all P < 0.05 for differences). CONCLUSIONS: Trends in cardiovascular risk factor profiles in U.S. adults with CVD were suboptimal from 1999 through 2018, with persistent racial/ethnic disparities.

Trends in user ratings and reviews of a popular yet inaccurate blood pressure-measuring smartphone app.

Objective: To understand whether user reviews of Instant Blood Pressure (IBP), an inaccurate, unregulated BP-measuring app reflected IBP's inaccuracy, to understand drivers for high and low ratings, and to understand if disclaimers prevented medical use. Materials and Methods: All iTunes app reviews for IBP v1.2.3 were downloaded and assessed for themes by two reviewers. Summary statistics for themes were tabulated with their associated star ratings. Results: Common themes included perceived accuracy (42% of all reviews, star rating mean 4.8, median 5), inaccuracy (10%, 2.0, 1), and convenience (34%, 4.7, 5). Nine percent documented IBP use in medical conditions (4.6, 5), and 2% mentioned IBP's disclaimer (2.7, 3). Discussion: User reviews and ratings of a popular, inaccurate BP-measuring app were positive and uncommonly commented on its inaccuracy. Disclaimers attempting to prevent medical use of the app were ineffective. These findings support the need for more rigorous regulatory review of apps prior to their release.

User experience of instant blood pressure: exploring reasons for the popularity of an inaccurate mobile health app.

Instant blood pressure (IBP) is a top-selling yet inaccurate blood pressure (BP)-measuring app that underreports elevated BP. Its iTunes app store user ratings and reviews were generally positive. Whether underreporting of elevated BP improves user experience is unknown. Participants enrolled at five clinics estimated their BP, measured their BP with IBP, then completed a user experience survey. Participants were grouped based on how their IBP BP measurements compared to their estimated BP (IBP Lower, IBP Similar, or IBP Higher). Logistic regressions compared odds of rating "agree" or "strongly agree" on survey questions by group. Most participants enjoyed using the app. In the adjusted model, IBP Higher had significantly lower proportions reporting enjoyment and motivation to check BP in the future than IBP Similar. All three groups were comparable in perceived accuracy of IBP and most participants perceived it to be accurate. However, user enjoyment and likelihood of future BP monitoring were negatively associated with higher-than-expected reported systolic BP. These data suggest reassuring app results from an inaccurate BP-measuring app may have improved user experience, which may have led to more positive user reviews and greater sales. Systematic underreporting of elevated BPs may have been a contributor to the app's success. Further studies are needed to confirm whether falsely reassuring output from other mobile health apps improve user experience and drives uptake.