Patient-centered Cardiac rehaBilitation pRogramE in Post Acute Coronary Syndrome:Identification of Key Barriers and Evaluation of Personalized Intervention (BREAK-trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 202
- 试验地点
- 2
- 主要终点
- Improvement in functional capacity
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Improvement in functional capacity
时间窗: First visit and 3 months after hospital discharge (after completing rehabilitation program)
The primary endpoint of the study will be a composite functional capacity score, designed to capture the overall improvement in cardiorespiratory fitness following the rehabilitation intervention. This composite score will integrate the standardized change (from baseline to the end of the intervention) in the following four variables: 1. Peak oxygen uptake (VO₂ peak, in ml/kg/min), measured via cardiopulmonary exercise testing (CPET). 2. Six-minute walk distance (6MWD, in meters), assessed using the six-minute walk test. 3. Maximal metabolic equivalents (METs), achieved during CPET. 4. Exercise test duration (in minutes), defined as the total time sustained during the treadmill or cycle ergometer test under a standardized, symptom-limited protocol. Each of these variables will be converted to z-scores based on the distribution of change scores in the study population. The composite score will be calculated as the mean of the four standardized values
次要结局
- Physical Activity. IPAQ(First visit; 3 months (after completing rehabilitation program) and 6 months after hospital discharge)
- Physical Activity. Podometer(First visit; 3 months (after completing rehabilitation program) and 6 months after hospital dischargeFirst visit and 6 months after hospital discharge)
- Psychological status(First visit; 3 months (after completing rehabilitation program) and 6 months after hospital dischargeFirst Visit and 6 months after hospital discharge)
- Dietary Changes(In-hospital evaluation and 6 months after hospital discharge)
- Body composition(First visit and 3 months after hospital discharge (after completing rehabilitation program))
- Sarcopenia(First visit; 3 months (after completing rehabilitation program) and 6 months after hospital discharge)
- Frailty(First visit; 3 months (after completing rehabilitation program) and 6 months after hospital discharge)
- Patient reported quality of life(First visit and 3 months after hospital discharge (after completing rehabilitation program))
- Sleep quality(First visit; 3 months (after completing rehabilitation program) and 6 months after hospital discharge)
- Sexual dysfunction(First visit; 3 months (after completing rehabilitation program) and 6 months after hospital discharge)
- Readmission and mortality rates(First visit; 3 months (after completing rehabilitation program) and 6 months after hospital discharge)
- Adherence to program(First visit; 3 months after discharge (after completing rehabilitation program))
- Patient experience(First visit; 3 months (after completing rehabilitation program) and 6 months after hospital discharge)
研究者
Cristina Enjuanes Grau
Coordinator of Community Heart Failure Unit, Cardiology Department. MD, PhD
Institut d'Investigació Biomèdica de Bellvitge