Randomized Trial of Digital Support in Phase III Cardiac Rehabilitation for Adults with Heart Disease

What this Trial Is About

This trial studies patients with atherosclerotic cardiovascular disease ASCVD, including those who have experienced acute or chronic coronary syndrome and ischemic heart failure. It focuses on those who have completed phase II cardiac rehabilitation CR and evaluates the effectiveness of a digitally-enhanced program during phase III CR compared to standard care. The study is a multicenter, prospective, controlled, randomized, open-label trial examining prevention strategies to support ongoing rehabilitation. Participants are randomized to either standard phase III care or standard care plus the Digitally-Enhanced Extended PrEvention & Rehabilitation DEEPER package. The DEEPER intervention includes informative digital modules chosen by the patient, delivered biweekly via a secure platform or booklet if offline, monthly motivational messages, a peer-support forum with leaderboards, and wearable device monitoring of steps and sleep. All participants receive a Fitbit smartwatch to encourage engagement and collect study data. During the study, participants will be monitored through digital communications and clinical visits, with assessments including the composite Lifes Essential 9 LE9 score at 6 months as the primary outcome. Other evaluations include mental health questionnaires, physical fitness tests, cardiovascular events, and social and economic impacts. Follow-up contacts include phone calls at 3 months and 1 year, with the total study duration extending up to one year after enrollment.

Transcultural Digital Solutions in Phase III Cardiac Rehabilitation