Transcultural Digital Solutions in Phase III Cardiac Rehabilitation
Recruiting · NCT07252856 · Interventional (participants receive a specific treatment) · Lead sponsor: Fondazione Don Carlo Gnocchi ETS
View the official record on ClinicalTrials.gov →Interventions studied
DEEPER
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Where it is running
6 locations listed.
- Centre for Rehabilitation & Sports Medicine, Inselspital, University Hospital of Bern, Bern Switzerland - Bern, Switzerland
- Carlo Cattaneo - LIUC University - Castellanza, Italy
- KU Leuven, Kaatje Goetschalckx, KU Leuven - Leuven, Belgium
- 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
- Istituti Clinici Scientifici Maugeri SpA - Società Benefit, IRCCS, Lumezzane - Lumezzane, Italy
- IRCCS Dongnocchi - Milan, Italy