RecruitingNot ApplicableNCT07252856

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


Sponsor

Fondazione Don Carlo Gnocchi ETS

Enrollment

306 participants

Start Date

Apr 20, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called DEEPER for people with heart failure and myocardial infarction. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALDEEPER

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


Locations(6)

KU Leuven, Kaatje Goetschalckx, KU Leuven

Leuven, Belgium

Carlo Cattaneo - LIUC University

Castellanza, Italy

Istituti Clinici Scientifici Maugeri SpA - Società Benefit, IRCCS, Lumezzane

Lumezzane, Italy

IRCCS Dongnocchi

Milan, Italy

Associação para Investigação e Desenvolvimento da Faculdade de Medicina - AIDFM, representing Instituto Medicina Preventiva e Saúde Public (IMPSP) & Instituto de Saúde Ambiental (ISAMB)

Lisbon, Portugal

Centre for Rehabilitation & Sports Medicine, Inselspital, University Hospital of Bern, Bern Switzerland

Bern, Switzerland

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NCT07252856


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