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NOT YET RECRUITING
NCT07252856
NA

Transcultural Digital Solutions in Phase III Cardiac Rehabilitation

Sponsor: Fondazione Don Carlo Gnocchi Onlus

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

306

Start Date

2026-04-05

Completion Date

2027-07-31

Last Updated

2026-02-06

Healthy Volunteers

No

Interventions

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.

Locations (5)

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

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