Abstract 17571: Lessons From Launching a Digital Health Trial for Hybrid Cardiac Rehabilitation

Abstract

BACKGROUND: Despite the well-established benefits of cardiac rehabilitation (CR) for secondary prevention of cardiovascular disease, participation remains low due to limited supply and access barriers. We built a hybrid CR program that combines in-person and home-based CR (with smartphone app (Corrie Health), smartwatch, Bluetooth blood pressure monitor, and health coaching delivered over 12 weeks). We assessed this novel CR program in a pilot study at Johns Hopkins Hospital and applied the lessons learned to launch a randomized controlled trial (mTECH REHAB; NCT05238103) of hybrid versus traditional CR. METHODS: We examined pilot data from Nov 2022 to Feb 2023 for electronic health record (EHR) screening, bedside enrollment, technology onboarding, access to CR, and weekly health coaching. We identified barriers in the enrollment process which we then used to guide trial design and team organization. RESULTS: EHR screening yielded 1,270 candidates, among which 209 (16.5%) were eligible following chart review. Our team approached 106 (50.7%) at bedside and 20 (9.6%) were enrolled into the pilot study. Ten (50.0%) were lost to follow up, with reasons of: loss of interest (3), post-procedural complication (3), frailty requiring acute CR (1), no insurance coverage (1), follow up in external CR (1), and technology challenges (1). These findings informed trial design as follows: 1) pre-specified filters for cardiovascular procedures/surgeries were added to EHR screening; 2) remote enrollment pathway was added; 3) a 2-week run-in period was added to verify insurance and continued interest following hospital discharge; and 4) standardized workflows and specialized teams were developed for patient recruitment, technology onboarding, and health coaching. The mTECH REHAB trial was launched in Apr 2023. In the first 9 weeks, 851 patients were screened, 157 (18.4%) were eligible, 148 (94.2%) were able to be reached at bedside or via telephone, 41 (27.7%; 16 bedside, 25 remote) were enrolled, and 5 (12.2%) were lost to early follow up because of: loss of interest (3), post-procedural complication (1), and patient relocation (1). CONCLUSIONS: A pilot study can inform and improve the enrollment process in a multi-component digital health trial.