Why digital health trials can fail: Lessons learned from a randomized trial of health coaching and virtual cardiac rehabilitation.

ABSTRACT:

Background

We performed a trial to evaluate the efficacy of a blended intervention with personalized health coaching and virtual cardiac rehabilitation to improve medication adherence and risk factors. The trial was terminated early. Here, we describe findings from a root cause analysis and lessons learned.

Methods

SmartGUIDE was an open-label, single-center trial that randomized participants with coronary artery disease who were prescribed a statin and/or P2Y12 inhibitor 1:1 to either usual care or the added use of a mobile app with components of cardiac rehabilitation paired with personal virtual coaching. The primary outcome was medication adherence: proportion of days covered (PDC). The planned sample size was 132. We performed a root cause analysis to evaluate processes

SUBMITTER: Olivier CB 

PROVIDER: S-EPMC8890340 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature