← Back to all trials
Recruiting
NCT07252856
Transcultural Digital Solutions in Phase III Cardiac Rehabilitation
Conditions: Heart Failure, Myocardial Infarction
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 306
Sponsor: Fondazione Don Carlo Gnocchi Onlus
Location: KU Leuven, Kaatje Goetschalckx, KU Leuven Leuven
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).
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18, men and women;
* patients with atherosclerotic cardiovascular disease (ASCVD) (acute coronary syndrome or chronic coronary syndrome and ischemic heart failure);
* patients who completed phase II CR and are therefore eligible for CR phase III (maintenance).
Exclusion Criteria:
* Unable to sign the informed consent;
* unable or unwilling to use digital devices due to mental/cognitive issues or without a support person helping them to access the respective technical devices;
* pregnant, lactating or women planning pregnancy during the course of the trial.
Source: ClinicalTrials.gov (NCT07252856). StuddyBuddy aggregates publicly available trial information.