Patient-centered Personalized Cardiac Rehabilitation in Post Acute Coronary Syndrome (BREAK-trial)

Institut d'Investigació Biomèdica de Bellvitge

Status: Enrolling

Conditions: Cardiac Rehabilitation; Acute Coronary Syndromes (ACS); Women; Frailty; Women's Health

Treatments: Behavioral: Personalised treatment; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07038265

IDIBELL- 202309 10

202309 10 (Other Grant/Funding Number)

Details and patient eligibility

About

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)

Full description

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.

Enrollment: 202 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient aged ≥ 18 years
2. Patients discharged within the last 30 days after an admission for ACS or in the discharge planning process for an admission for ACS.
3. The patient is able to fully communicate with the research team and comply with all study procedures.
4. The patient voluntarily signs and dates the informed consent form approved by the ethics committee

Exclusion criteria

1. Age <18 years
2. Participation in another clinical trial
3. Moderate or severe cognitive impairment in the absence of a competent caregiver
4. Absence of social support
5. Institutionalized patient
6. Life expectancy <1 year
7. Candidates for end-of-life care
8. Severe psychiatric illness
9. Planned cardiac surgery including transplant or circulatory support implant
10. Death before hospital discharge in patients included in the hospital discharge planning phase
11. Carrier of heart transplant.
12. Patient unable or refusing to give written informed consent to participate
13. Patients who, in the opinion of the investigator, are unsuitable candidates for the study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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202 participants in 2 patient groups

Standard of care

Active Comparator group

Description:

Usual cardiac rehabilitation program

Treatment:

Other: Usual Care

Personalized intervention program

Experimental group

Description:

BREAK intervention group with more alternatives of aerobic and strength exercises and also offering remote options for fragile patients

Treatment:

Behavioral: Personalised treatment