Transcultural Digital Solutions in Phase III Cardiac Rehabilitation
COMPASS
CrOss-cultural Model for Postdischarge Assistance and Sustainable Digital Solutions in Phase III Cardiac Rehabilitation: a Randomized Controlled Trial
1 other identifier
interventional
306
4 countries
5
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Apr 2026
Shorter than P25 for not_applicable heart-failure
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2025
CompletedFirst Posted
Study publicly available on registry
November 28, 2025
CompletedStudy Start
First participant enrolled
April 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
February 6, 2026
October 1, 2025
1.2 years
November 19, 2025
February 4, 2026
Conditions
Outcome Measures
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).
6-month change
Secondary Outcomes (18)
Individual LE8 sub-scores
6-month change
Major adverse cardiovascular event (MACE)
6 months
Major adverse cardiovascular event (MACE)
1 year
GAD 7
Changes between baseline and 6-month follow-up
PHQ 9
Changes between baseline and 6-month follow-up
- +13 more secondary outcomes
Study Arms (2)
DEEPER
EXPERIMENTALAs "Standard Care" plus every 15 days in the first month and at least once a month chat with healthcare professional that will keep posted with the patient and the staff (nurse, physiotherapist, cardiologist) for all the issues raised by the patients. chat with answer within 72 hours. Graphical medicine to increase patients' awareness.
Standard of care
NO INTERVENTIONDischarge after phase II, LC9 evaluation, discharge indications, website indication for every country language support (from the European Society of Preventive Cardiology). FU contact by phone at 3 months, clinical visit at 6 months \[6 month LE9 assessment (primary endpoint)\] and contact by phone at 1 year for MACE evaluation.
Interventions
A transcultural scientific digital platform (Rehab companion, Inselspital, University Hospital of Bern) for content delivery, feedback and digital biomarker monitoring will be made available.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
KU Leuven, Kaatje Goetschalckx, KU Leuven
Leuven, Belgium
Carlo Cattaneo - LIUC University
Castellanza, Italy
Istituti Clinici Scientifici Maugeri SpA - Società Benefit, IRCCS, Lumezzane
Lumezzane, Italy
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
Centre for Rehabilitation & Sports Medicine, Inselspital, University Hospital of Bern, Bern Switzerland
Bern, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nuccia Morici, MD
IRCCS Fondazione Don Gnocchi
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2025
First Posted
November 28, 2025
Study Start
April 5, 2026
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
February 6, 2026
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- After the study completion
- Access Criteria
- Data anonymization process
COMPASS research outputs will be primarily disseminated through the Zenodo repository to guarantee persistent access. To enhance discoverability, we will implement a FAIR Data Point following the official FDP specification, initially through a self-hosted solution during the active project phase. As the ecosystem evolves, we plan to migrate this functionality to established platforms like FAIR sharing, contingent on their ability to fully support our metadata requirements for cardiac rehabilitation data.