Transcultural Digital Solutions in Phase III Cardiac Rehabilitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DEEPER.
- Who it may be relevant to
- Registry conditions: Heart Failure, Myocardial Infarction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Italy, Portugal, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
CrOss-cultural Model for Postdischarge Assistance and Sustainable Digital Solutions in Phase III Cardiac Rehabilitation: a Randomized Controlled Trial
Overview
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).
Detailed description
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 (LE9) (LE8 + PHQ-9). Intervention (DEEPER) will include informative modules (patient will choose among graphic medicine, video or interactive messaging) that will be delivered every two weeks via secure digital platform (or booklet if offline); monthly motivational messages; moderated peer-support forum with leaderboard; remote wearable step/sleep upload with personalized content assignment and feedback, linked to the hospital interactive digital platform (Rehab companion).
Patients will be encouraged to have their own device to be adopted as lifelong maintenance. Nevertheless, centres will provide a smartwatch (fitbit) to all the patients enrolled in the trial as incentive for study participation and to uniformly collect study outcomes.
Interventions
- Behavioral DEEPER
A transcultural scientific digital platform (Rehab companion, Inselspital, University Hospital of Bern) for content delivery, feedback and digital biomarker monitoring will be made available.
Primary outcome measures
- 6-month change in composite Life's Essential 9 (LE9) [Time frame: 6-month change]
Secondary outcome measures (12)
- Individual LE8 sub-scores [Time frame: 6-month change]
- Major adverse cardiovascular event (MACE) [Time frame: 6 months]
- Major adverse cardiovascular event (MACE) [Time frame: 1 year]
- GAD 7 [Time frame: Changes between baseline and 6-month follow-up]
- PHQ 9 [Time frame: Changes between baseline and 6-month follow-up]
- Physical fitness [Time frame: Changes between baseline and 6-month follow-up]
- VO2 peak [Time frame: Changes between baseline and 6-month follow-up]
- 30 second sit-to -stand test [Time frame: Changes between baseline and 6-month follow-up]
- Hand-grip strength [Time frame: Changes between baseline and 6-month follow-up]
- Steps per day [Time frame: Changes between baseline and 6-month follow-up]
- Waist circumference [Time frame: Changes between baseline and 6-month follow-up]
- counter movement jump test. [Time frame: Changes between baseline and 6-month follow-up]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Italy · 3 centers
- Carlo Cattaneo - LIUC University — Castellanza
- Istituti Clinici Scientifici Maugeri SpA - Società Benefit, IRCCS, Lumezzane — Lumezzane
- IRCCS Dongnocchi — Milan
Belgium · 1 center
- KU Leuven, Kaatje Goetschalckx, KU Leuven — Leuven
Portugal · 1 center
- Associação para Investigação e Desenvolvimento da Faculdade de Medicina - AIDFM, represent — Lisbon
Switzerland · 1 center
- Centre for Rehabilitation & Sports Medicine, Inselspital, University Hospital of Bern, Ber — Bern
Identifiers
NCT: NCT07252856 · COMPASS