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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Belgium
KU Leuven, Kaatje Goetschalckx, KU Leuven
RECRUITING
Leuven
Italy
Carlo Cattaneo - LIUC University
NOT_YET_RECRUITING
Castellanza
Istituti Clinici Scientifici Maugeri SpA - Società Benefit, IRCCS, Lumezzane
RECRUITING
Lumezzane
IRCCS Dongnocchi
RECRUITING
Milan
Portugal
Associação para Investigação e Desenvolvimento da Faculdade de Medicina - AIDFM, representing Instituto Medicina Preventiva e Saúde Public (IMPSP) & Instituto de Saúde Ambiental (ISAMB)
RECRUITING
Lisbon
Switzerland
Centre for Rehabilitation & Sports Medicine, Inselspital, University Hospital of Bern, Bern Switzerland
RECRUITING
Bern
Contact Information
Primary
Nuccia Morici, MD
nmorici@dongnocchi.it
00390240308519
Backup
Anastasia Toccafondi
atoccafondi@dongnocchi.it
Time Frame
Start Date: 2026-04-20
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 306
Treatments
Experimental: DEEPER
As Standard Care plus every 15 days in the first month and at least once a month chat with healthcare professional that will keep posted with the patient and the staff (nurse, physiotherapist, cardiologist) for all the issues raised by the patients. chat with answer within 72 hours. Graphical medicine to increase patients' awareness.
No_intervention: Standard of care
Discharge after phase II, LC9 evaluation, discharge indications, website indication for every country language support (from the European Society of Preventive Cardiology). FU contact by phone at 3 months, clinical visit at 6 months \[6 month LE9 assessment (primary endpoint)\] and contact by phone at 1 year for MACE evaluation.
Sponsors
Leads: Fondazione Don Carlo Gnocchi ETS

This content was sourced from clinicaltrials.gov