Transcultural Digital Solutions in Phase III Cardiac Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Don Carlo Gnocchi Onlus
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- DEEPER
Treatment groups
306 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov