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Patient-centered Cardiac rehaBilitation pRogramE in Post Acute Coronary Syndrome:Identification of Key Barriers and Evaluation of Personalized Intervention (BREAK-trial)
The primary objective of this study is to compare an integrated, multidisciplinar patient-centered CRP (Cardiac Rehabilitation Program) (intervention group) especially focused on covering the needs for the female and fragile population to the usual care conventional CRP (control group)
The Break-CR study is designed as an unicentric, open, randomized controlled trial, blind end-point evaluation and adjudication, to compare the feasibility, efficacy, and safety of a patient-centered CR-program versus usual care in patients after an acute coronary syndrome (ACS). The project aims to identify these barriers and design a CR-intervention to overcome said barriers and evaluate its usefulness in clinical practice. The first part of this study consists of a qualitative study to specifically determine barriers, difficulties and facilitators that condition the participation of women in the CRPs, the second part of the study is undertaken to address the underrepresentation of women in CRPs and provide a solution to the recognized need to redesign CR programs to respond to the unique physiological and psychosocial needs of women. The aim is to design a groundbreaking intervention model that will respond to this need because it will incorporate all the factors on which a CR programme should be based, from a woman's perspective, from the beginning to the end, while also adressing the needs of the fragile portion ACS survivors. It is hypothesized that the Break-CR program would be able to demonstrate greater improvements in incorporation and adherence of women and fragile patients to CR-programs, enhanced functional benefits, as well as improve patient-satisfaction and quality of life. Finally, the fundamental purpose is to enhance poor health outcomes of women and fragile patients with coronary diseases and to provide a solution that will contribute to bridge the health gap that exists in the field of cardiovascular diseases in health systems.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Start Date
May 26, 2025
Primary Completion Date
November 1, 2027
Completion Date
November 1, 2027
Last Updated
June 26, 2025
202
ESTIMATED participants
Personalised treatment
BEHAVIORAL
Usual Care
OTHER
Lead Sponsor
Institut d'Investigació Biomèdica de Bellvitge
Collaborators
NCT06505109
NCT07469761
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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