A cross-cultural randomized controlled trial is set to evaluate the effectiveness of a new post-discharge digital solution for patients undergoing Phase III cardiac rehabilitation. Titled the “CrOss-cultural Model for Postdischarge Assistance and Sustainable Digital Solutions in Phase III Cardiac Rehabilitation,” this study aims to improve patient outcomes through behavioral interventions under the DEEPER program. Sponsored by Fondazione Don Carlo Gnocchi Onlus, this clinical trial addresses critical conditions such as heart failure and myocardial infarction. Enrollment for the trial is anticipated to begin soon, with the research team recently seeking participants.
In this article
Why is this trial important?
Cardiac rehabilitation is critical for enhancing health outcomes post-myocardial infarction and in managing chronic heart failure. However, the continuity of care post-discharge remains a key challenge globally. This trial seeks to bridge that gap by introducing a cross-cultural approach to digital solutions, ensuring inclusivity and accessibility across diverse patient populations. Leveraging behavioral interventions, the study may offer new strategies to sustain patient adherence and engagement in Phase III cardiac rehabilitation programs.
What is the DEEPER intervention?
DEEPER, the digital intervention at the heart of this study, focuses on behavioral strategies to empower patients in their recovery journey. While specific details of the intervention remain under research protocols, it is expected to include components that provide educational, motivational, and health tracking support. Digital tools hold the potential to address disparities in patient access to post-discharge resources by reaching broader demographics and fostering a sense of self-management in recovery and condition monitoring. DEEPER aligns with global trends advocating for connected health models and personalized care interventions in cardiology.
What are the next steps?
With enrollment yet to begin, the research team at Fondazione Don Carlo Gnocchi Onlus is anticipated to outline the participant selection criteria soon. Clinical trial professionals, as well as regional and global regulatory bodies, will be closely watching this study for its potential to provide replicable and sustainable solutions in cardiac rehabilitation. Once the trial is underway, patient-reported outcomes, adherence rates, and clinical progress will likely be key areas of focus.
FAQs
- What conditions does this study focus on?
The trial focuses on heart failure and myocardial infarction, with targeted interventions designed to improve cardiac rehabilitation outcomes post-discharge. - What is the primary intervention being studied?
The intervention under examination is called DEEPER, a digital behavioral tool aimed at supporting post-discharge recovery in a sustainable and culturally-sensitive manner. - When will enrollment begin?
The study is currently marked as “Not yet recruiting.” Further details are expected to be announced by the sponsoring organization.
Conclusion
This upcoming trial presents a key opportunity to advance cardiac rehabilitation by leveraging digital and behavioral health innovations. Stakeholders in the healthcare and medical device sectors should monitor its progress to gain insights into the potential applications of connected care models in cardiovascular treatment pathways. Further updates on the study will provide vital information for both clinical and regulatory communities alike.
Disclaimer
This article is intended for informational purposes for clinical, quality, and regulatory teams. It does not constitute legal or clinical advice.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07252856?term=medical+device