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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Myocardial Infarction; Heart Failure
• Intervention / Treatment: Behavioral: DEEPER

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.

• Study Type: Interventional
• Enrollment (Estimated): 306
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nuccia Morici, MD; Phone Number: 00390240308519; Email: nmorici@dongnocchi.it
• Study Contact Backup: Name: Anastasia Toccafondi; Email: atoccafondi@dongnocchi.it

Study Locations

• Belgium
  • Leuven, Belgium
    • KU Leuven, Kaatje Goetschalckx, KU Leuven
    • Contact: Véronique Cornelissen
• Italy
  • Castellanza, Italy
    • Carlo Cattaneo - LIUC University
    • Contact: Emanuela Foglia
  • Lumezzane, Italy
    • Istituti Clinici Scientifici Maugeri SpA - Società Benefit, IRCCS, Lumezzane
    • Contact: Simonetta Scalvini
• Portugal
  • Lisbon, Portugal
    • Associação para Investigação e Desenvolvimento da Faculdade de Medicina - AIDFM, representing Instituto Medicina Preventiva e Saúde Public (IMPSP) & Instituto de Saúde Ambiental (ISAMB)
    • Contact: Ana Abreu
• Switzerland
  • Bern, Switzerland
    • Centre for Rehabilitation & Sports Medicine, Inselspital, University Hospital of Bern, Bern Switzerland
    • Contact: Matthias Wilhelm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DEEPER; As "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.	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.
No Intervention: Standard of care; Discharge 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individual LE8 sub-scores	Reported as differences in the absolute value among the two groups (median and (IQR)	6-month change
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	6 months
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	1 year
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	Changes between baseline and 6-month follow-up
PHQ 9	depression score; The PHQ-9 score ranges from 0 to 27. Scores between 5 and 9 indicate the presence of subthreshold depression.	Changes between baseline and 6-month follow-up
Physical fitness	distance achieved in 6-minute walking test	Changes between baseline and 6-month follow-up
VO2 peak	cardiopulmonary test (CPET)	Changes between baseline and 6-month follow-up
30 second sit-to -stand test	number of times the patient stands in 30 seconds	Changes between baseline and 6-month follow-up
Hand-grip strength	maximum voluntary muscle strength measured by dynamometer	Changes between baseline and 6-month follow-up
Steps per day	amount of steps during the day	Changes between baseline and 6-month follow-up
Waist circumference	Waist circumference in cm	Changes between baseline and 6-month follow-up
counter movement jump test.	Maximum power measured by dynamometer; difference in the absolute value among the two groups	Changes between baseline and 6-month follow-up
Compliance with study treatment	Compliance with study treatment defined as number (percentage) of patients who will attend the sessions provided and will complete the study.	6 months
Economic impact of the CR pathways and financial sustainability: standard care versus stardard care plus the DEEPER package	Direct costs of the two pathways, estimated using Activity Based Costing and financial sustainability measured with a budget impact analysis (BIA). Results reported as mean difference and standard deviation (SD) between groups. Cost per patient and cost-effectiveness ratio will be calculated per group of treatment.	6 months
Assessment of social, ethical and equity dimensions.	Perceptions reported by the patients, measured with a seven item Likert scale structured questionnaire based on the EUnetHTA Core Model dimensions, comparing standard care versus DEEPER package (mean and p-value)	6 months
Social costs	Analysis of the indirect and out of pocket costs as average value in case of standard care and DEEPER package, to define the social costs related to the interventions.	6 months
Safety endpoint	Musculo-skeletal injuries (requiring medical attention) and Arrhythmias (atrial fibrillation, supraventricular tachycardia, ventricular tachycardia) requiring medical attention and an emergency room or ambulatory visit.	6 months
Acceptance of the usual care and the DEEPER package pathway using the Service User Technology Acceptance Questionnaire (SUTAQ) average values	Responses to SUTAQ-based questionnaire administered to patients involved in the study, analyzed through a seven items scale scoring. Results reported as mean, p-value and linear regression models for enhanced care, increased accessibility, privacy and discomfort, care personnel concerns, telerehabilitation as substitution and satisfaction.	6 months

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus
• Investigators: Principal Investigator: Nuccia Morici, MD, IRCCS Fondazione Don Gnocchi

Study record dates

Study Major Dates

• Study Start (Estimated): April 5, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Heart Failure; Myocardial Infarction; AT1G72490 protein, Arabidopsis
• Other Study ID Numbers: COMPASS (CardioDx)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: After the study completion
• IPD Sharing Access Criteria: Data anonymization process
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No