Transcultural Digital Solutions in Phase III Cardiac Rehabilitation
NCT ID: NCT07252856
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
306 participants
INTERVENTIONAL
2026-01-05
2026-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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.
Standard of care
Discharge after phase II, LE9 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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Fondazione Don Carlo Gnocchi Onlus
OTHER
Responsible Party
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Principal Investigators
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Nuccia Morici, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Fondazione Don Gnocchi
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Véronique Cornelissen
Role: primary
Emanuela Foglia
Role: primary
Simonetta Scalvini
Role: primary
Ana Abreu
Role: primary
Matthias Wilhelm
Role: primary
Other Identifiers
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COMPASS
Identifier Type: -
Identifier Source: org_study_id
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