Table 2.
Targeted disease |
Study name/ authors |
Study design | Sample size (RCT no. enrolled, or sys. review studies included) |
Intervention | Outcomes | Findings |
---|---|---|---|---|---|---|
Atherosclerotic disease | Varnfield et al. [32] | RCT | 120 enrolled | Smartphone-based home CR vs.traditional center-based CR | Primary: 6MWT Secondary: CR uptake and completion | mHealth CR and traditional CR both showed improved 6MWT; mHealth improved CR uptake and completion compared with traditional |
HEARTSTRONG [34] | RCT | 1509 enrolled | mHealth-based medication reminders, social support, and lottery incentives vs. usual care in post-Acute Myocardial Infarction patients | Primary: time to first vascular rehospitalization or death Secondary: time to first all-cause rehospitalization, total number of repeated hospitalizations, medication adherence, and total medical costs | No significant improvement in vascular readmissions or medication adherence | |
HONOR [35] | RCT | 200 enrolled | Home-based exercise intervention with wearable activity monitor and telephone coaching compared with usual care for patients with peripheral artery disease | Primary: 6MWT Secondary: pain, functional capacity, social satisfaction scores | Home-based mHealth exercise intervention failed to demonstrate improvement in 6MWT or other secondary outcomes | |
Wongvibulsin et al. [33] | Systematic review | 31 studies | mHealth-based CR strategies | Exercise capacity, rehospitalizations, lipid profile, weight, nutrition, program, adherence, satisfaction, psychosocial wellbeing | mHealth-based CR as effective as traditional CR in improving outcomes, whether as adjunct or alternative, with potential to increase access and participation in CR | |
MiCORE (ongoing) [36] | Non-RCT with propensity matched control | 200 enrolled | Corrie Health App-based home CR with integrated smart BP monitor and apple watch vs. traditional CR | Primary: readmissions within 30 days Secondary: death, ED visits, and hospital observations within 30 days of discharge, med adherence, attendance at followup, program engagement, satisfaction, cost-effectiveness | Study ongoing | |
Heart failure | CardioMEMS [37] | RCT | 550 enrolled | Daily wireless PAP monitoring and standard of care vs. standard of care alone in NYHA symptom class III heart failure (HF) patients with implanted wireless hemodynamic monitor | Primary: HF-related hospitalizations at 6 months Secondary: days alive outside hospital at 6 months, change in baseline PAP, functional capacity score | Wireless monitoring was associated with significant reduction in hospitalizations as well as mean PAP, more days alive outside hospital, and better quality of life compared with control |
Cajita et al. [38] | Systematic review | 10 studies | mHealth-based management strategies in HF | Mortality, hospitalizations, length of stay, functional capacity, quality of life, self-care | Inconsistent results failed to demonstrate significant benefit | |
Allida et al. [39] | Systematic review (Cochrane) | 5 studies | mHealth education interventions in HF | HF knowledge, hospitalization rates, quality of life, self-efficacy, and self-care | Very low quality of evidence with inconsistent results across all outcomes | |
Arrhythmia | Apple Heart Study [42] | Large-scale siteless study | Up to 500,000 | Detection of AF in patients using Apple Watch Series 4 or later | Primary: detection of AF Secondary: self-reporting to clinicians, concordant AF with app notification | Achieved primary outcome with FDA approval of the Apple Watch for AF detection |
Heartline Study (ongoing, clinical trial NCT04276441) | Observational prospective cohort | Actively enrolling as of 2020 | Apple Watch-based AF detection | Primary: early detection of AF, days on anticoagulation Secondary: time to major adverse cardiac event, AMI, stroke, and thromboembolic events | Study ongoing |
6MWT, 6-min walk test; AF, atrial fibrillation; AMI, acute myocardial infarction; CR, cardiac rehab; ED, emergency department; FDA, Food and Drug Administration; HF, heart failure; mHealth, mobile health technologies; NYHA, New York Heart Association; PAP, pulmonary artery pressure; RCT, randomized controlled trial.