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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
DEEPER
BehavioralA transcultural scientific digital platform (Rehab companion, Inselspital, University Hospital of Bern) for content delivery, feedback and digital biomarker monitoring will be made available.
Treatment groups
306 Participants
are divided into 2 treatment groupsGroup A: DEEPERExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
6-month change in composite Life's Essential 9 (LE9)
LC9 is defined by the American Heart Association's Life's Essential 8 (LE8), complemented by the Patient Health Questionnaire (PHQ-9), collectively referred to as "LC9 \[blood pressure, non-high-density lipoprotein cholesterol (HDL), diet questionnaire, physical activity, smoking habits, sleep health, body mass index (BMI), hemoglobin A1c (HbA1c, %), PHQ9 from questionnaire).
Time frame
6-month changeSecondary outcomes
1
Individual LE8 sub-scores
Reported as differences in the absolute value among the two groups (median and (IQR)
Time frame
6-month change2
Major adverse cardiovascular event (MACE)
defined as a composite of death of any cause, myocardial infarction, unplanned revascularization, rehospitalization for any cause, stroke, considered in a hierarchical way and as single endpoint
Time frame
6 months3
Major adverse cardiovascular event (MACE)
defined as a composite of death of any cause, myocardial infarction, unplanned revascularization, rehospitalization for any cause, stroke, considered in a hierarchical way and as single endpoint
Time frame
1 year4
GAD 7
anxiety score; Seven-item questionnaire that assesses the severity of anxiety symptoms over the past two weeks, with a total score ranging from 0 to 21
Time frame
Changes between baseline and 6-month follow-upSponsors and contacts
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Source ClinicalTrials.gov