Patient-centered Personalized Cardiac Rehabilitation in Post Acute Coronary Syndrome (BREAK-trial)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Personalised treatment, Usual Care.
- Who it may be relevant to
- Registry conditions: Acute Coronary Syndromes (ACS), Cardiac Rehabilitation, Frailty, Women. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Patient-centered Cardiac rehaBilitation pRogramE in Post Acute Coronary Syndrome:Identification of Key Barriers and Evaluation of Personalized Intervention (BREAK-trial)
Overview
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)
Detailed 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.
Interventions
- Behavioral Personalised treatment
Patients going through a personalized intervention program - Other Usual Care
Usual cardiac rehabilitation program
Primary outcome measures
- Improvement in functional capacity [Time frame: First visit and 3 months after hospital discharge (after completing rehabilitation program)]
Secondary outcome measures (12)
- Physical Activity. IPAQ [Time frame: First visit; 3 months (after completing rehabilitation program) and 6 months after hospital discharge]
- Physical Activity. Podometer [Time frame: First visit; 3 months (after completing rehabilitation program) and 6 months after hospital dischargeFirst visit and 6 months after hospital discharge]
- Psychological status [Time frame: First visit; 3 months (after completing rehabilitation program) and 6 months after hospital dischargeFirst Visit and 6 months after hospital discharge]
- Dietary Changes [Time frame: In-hospital evaluation and 6 months after hospital discharge]
- Body composition [Time frame: First visit and 3 months after hospital discharge (after completing rehabilitation program)]
- Sarcopenia [Time frame: First visit; 3 months (after completing rehabilitation program) and 6 months after hospital discharge]
- Frailty [Time frame: First visit; 3 months (after completing rehabilitation program) and 6 months after hospital discharge]
- Patient reported quality of life [Time frame: First visit and 3 months after hospital discharge (after completing rehabilitation program)]
- Sleep quality [Time frame: First visit; 3 months (after completing rehabilitation program) and 6 months after hospital discharge]
- Sexual dysfunction [Time frame: First visit; 3 months (after completing rehabilitation program) and 6 months after hospital discharge]
- Readmission and mortality rates [Time frame: First visit; 3 months (after completing rehabilitation program) and 6 months after hospital discharge]
- Adherence to program [Time frame: First visit; 3 months after discharge (after completing rehabilitation program)]
Eligibility criteria
Inclusion criteria
- Patient aged ≥ 18 years
- Patients discharged within the last 30 days after an admission for ACS or in the discharge planning process for an admission for ACS.
- The patient is able to fully communicate with the research team and comply with all study procedures.
- The patient voluntarily signs and dates the informed consent form approved by the ethics committee
Exclusion criteria
- Age <18 years
- Participation in another clinical trial
- Moderate or severe cognitive impairment in the absence of a competent caregiver
- Absence of social support
- Institutionalized patient
- Life expectancy <1 year
- Candidates for end-of-life care
- Severe psychiatric illness
- Planned cardiac surgery including transplant or circulatory support implant
- Death before hospital discharge in patients included in the hospital discharge planning phase
- Carrier of heart transplant.
- Patient unable or refusing to give written informed consent to participate
- Patients who, in the opinion of the investigator, are unsuitable candidates for the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Spain · 1 center
- Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat
Identifiers
NCT: NCT07038265 · IDIBELL- 202309 10 · 202309 10