Effects of a patient-centered digital health intervention in patients referred to cardiac rehabilitation: the Smart HEART clinical trial.

BACKGROUND: Cardiac rehabilitation (CR) improves outcomes in heart disease yet remains vastly underutilized. Remote CR enhanced with a digital health intervention (DHI) may offer higher access and improved patient-centered outcomes over non-technology approaches. We sought to pragmatically determine whether offering a DHI improves CR access, cardiac risk profile, and patient-reported outcome measures. METHODS: Adults referred to CR at a tertiary VA medical center between October 2017 and December 2021 were offered enrollment into a DHI alongside other CR modalities using shared decision-making. The DHI consisted of remote CR with a structured, 3-month home exercise program enhanced with multi-component coaching, a commercial smartphone app, and wearable activity tracker. We measured completion rates among DHI participants and evaluated changes in 6-min walk distance, cardiovascular risk factors, and patient-reported outcomes from pre- to post-intervention. RESULTS: Among 1,643 patients referred to CR, 258 (16%) consented to the DHI where the mean age was 60 ± 9 years, 93% were male, and 48% were black. A majority (90%) of the DHI group completed the program. Over 3-months, significant improvements were seen in 6MWT (mean difference [MD] -29 m; 95% CI, 10 to 49; P < 0.01) and low-density lipoprotein cholesterol (MD -11 mg/dL; 95% CI, -17 to -5; P < 0.01), and the absolute proportion of patients who reported smoking decreased (10% vs 15%; MD, -5%; 95% CI, -8% to -2%; P < 0.01) among DHI participants with available data. No adverse events were reported. CONCLUSIONS: The addition of a DHI-enhanced remote CR program was delivered in 16% of referred veterans and associated with improved CR access, markers of cardiovascular risk, and healthy behaviors in this real-world study. These findings support the continued implementation of DHIs for remote CR in real-world clinical settings. TRIAL REGISTRATION: This trial was registered on ClinicalTrials.gov: NCT02791685 (07/06/2016).

Feasibility of a Smartphone-enabled Cardiac Rehabilitation Program in Male Veterans With Previous Clinical Evidence of Coronary Heart Disease.

Cardiac rehabilitation (CR) is recommended for patients with coronary heart disease, however, participation among veterans remains poor. Smartphones may facilitate data transfer and communication between patients and providers, among other benefits. We evaluated the feasibility of a smartphone-enabled CR program in a population of veterans. Qualifying veterans were prospectively enrolled in a single-arm, nonrandomized feasibility study of a smartphone-enabled, home-based CR program, featuring an app with daily reminders to exercise, log vitals, and review educational materials. A coach remotely monitored patients through an online dashboard and scheduled telephone visits. Clinical end points were assessed as an exploratory aim. After 21 veterans provided informed consent, 18 were enrolled and successfully completed at least 30days of the program; 13 completed the entire 12-week intervention. Mean (standard deviation) age was 62 (7) years and 96% were male. Program completers logged a mean (standard deviation) of 3.5 (1.4) exercise sessions and 150 (86) exercise minutes per week. The majority (84%) of program completers reported being satisfied overall with the program. Mean functional capacity improved by 1.0 metabolic equivalents (5.3 to 6.3, 95% confidence interval 0.3 to 1.7; p = 0.008) and mean systolic blood pressure at rest improved by 9.6mm Hg (mean difference 9.6, 95% confidence interval -19.0 to -0.7; p = 0.049) among completers. Smartphone-enabled, home-based CR is feasible in veterans with heart disease and is associated with moderate to high levels of engagement and patient satisfaction.