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Transcultural Digital Solutions in Phase III Cardiac Rehabilitation
Sponsor: Fondazione Don Carlo Gnocchi Onlus
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
Conditions
Interventions
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