|

Transcultural Digital Solutions in Phase III Cardiac Rehabilitation

RECRUITINGN/ASponsored by Fondazione Don Carlo Gnocchi ETS
Actively Recruiting
PhaseN/A
SponsorFondazione Don Carlo Gnocchi ETS
Started2026-04-20
Est. completion2027-06-30
Eligibility
Age18 Years+
Healthy vol.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).

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions3

Heart DiseaseHeart FailureMyocardial Infarction

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.