NCT07252856

Transcultural Digital Solutions in Phase III Cardiac Rehabilitation

CrOss-cultural Model for Postdischarge Assistance and Sustainable Digital Solutions in Phase III Cardiac Rehabilitation: a Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 306 (estimated)
• Sponsor: Fondazione Don Carlo Gnocchi Onlus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicenter Prospective Controlled Randomized Trial, open-label, in patients with atherosclerotic cardiovascular disease (ASCVD) (acute coronary syndrome or chronic coronary syndrome and ischemic heart failure) and an approved indication for cardiac rehabilitation (CR). Patients completing phase II CR will be randomized 1:1 to usual Phase-III care (standard care) versus standard care plus the Digitally-Enhanced Extended PrEvention \& Rehabilitation (DEEPER) package (intervention). Primary outcome is 6-month change in composite Life's Crucial 9 (LC9) (LE8 + PHQ-9).

Detailed description

Multicenter Prospective Controlled Randomized Trial, open-label, in patients with atherosclerotic cardiovascular disease (ASCVD) (acute coronary syndrome or chronic coronary syndrome and ischemic heart failure) and an approved indication for cardiac rehabilitation (CR). Patients completing phase II CR will be randomized 1:1 to usual Phase-III care (standard care) versus standard care plus the Digitally-Enhanced Extended PrEvention \& Rehabilitation (DEEPER) package (intervention). Primary outcome is 6-month change in composite Life's Crucial 9 (LE9) (LE8 + PHQ-9). Intervention (DEEPER) will include informative modules (patient will choose among graphic medicine, video or interactive messaging) that will be delivered every two weeks via secure digital platform (or booklet if offline); monthly motivational messages; moderated peer-support forum with leaderboard; remote wearable step/sleep upload with personalized content assignment and feedback, linked to the hospital interactive digital platform (Rehab companion). Patients will be encouraged to have their own device to be adopted as lifelong maintenance. Nevertheless, centres will provide a smartwatch (fitbit) to all the patients enrolled in the trial as incentive for study participation and to uniformly collect study outcomes.

Conditions

• Heart Failure
• Myocardial Infarction

Interventions

Type	Name	Description
BEHAVIORAL	DEEPER	A transcultural scientific digital platform (Rehab companion, Inselspital, University Hospital of Bern) for content delivery, feedback and digital biomarker monitoring will be made available.

Timeline

• Start date: 2026-04-05
• Primary completion: 2027-06-30
• Completion: 2027-07-31
• First posted: 2025-11-28
• Last updated: 2026-02-06

Locations

5 sites across 4 countries: Belgium, Italy, Portugal, Switzerland