NCT07252856Recruiting
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
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 306 (estimated)
- First submitted
- 19 Nov 2025
- Start date
- 20 Apr 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Diseases
- Heart failure, Coronary artery disease
- NCT number
- NCT07252856
What you commit to
- Study type: Interventional
- Planned participants: 306
- From 20 Apr 2026 to the primary completion date, 30 Jun 2027
- 6 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| KU Leuven, Kaatje Goetschalckx, KU Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Centre for Rehabilitation & Sports Medicine, Inselspital, University Hospital of Bern, Bern Switzerland Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
| Carlo Cattaneo - LIUC University Coordinator of this site? Confirm its status | Castellanza | Italy | Not yet recruiting |
| Istituti Clinici Scientifici Maugeri SpA - Società Benefit, IRCCS, Lumezzane Coordinator of this site? Confirm its status | Lumezzane | Italy | Recruiting |
| IRCCS Dongnocchi Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Associação para Investigação e Desenvolvimento da Faculdade de Medicina - AIDFM, representing Instituto Medicina Preventiva e Saúde Public (IMPSP) & Instituto de Saúde Ambiental (ISAMB) Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.