Digital enhancements to Phase III cardiac rehabilitation for ASCVD patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this multicenter, open-label trial, adults with ASCVD who completed Phase II CR are randomized to standard Phase III care or standard care plus the DEEPER package, delivered through a digital platform with optional offline access. The DEEPER package includes choice of modules (graphic medicine, video, or interactive messaging), monthly motivational messages, a moderated peer-support forum, and remote wearable data with personalized feedback. Outcomes focus on a 6-month change in the Life’s Crucial 9 composite score (LE8+PHQ-9). All participants are encouraged to use their own device, and a smartwatch is provided to collect outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• KU Leuven, Kaatje Goetschalckx, KU Leuven
  Leuven, Belgium Recruiting
• Istituti Clinici Scientifici Maugeri SpA - Società Benefit, IRCCS, Lumezzane
  Lumezzane, Italy Recruiting
• IRCCS Dongnocchi
  Milan, Italy Recruiting
• 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 Recruiting
• Centre for Rehabilitation & Sports Medicine, Inselspital, University Hospital of Bern, Bern Switzerland
  Bern, Switzerland Recruiting
• Carlo Cattaneo - LIUC University
  Castellanza, Italy Not yet recruiting

Study contacts

• Principal investigator: Nuccia Morici, MD — IRCCS Fondazione Don Gnocchi
• Study coordinator: Nuccia Morici, MD
• Email: nmorici@dongnocchi.it
• Phone: 00390240308519

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.