Patient-centered Personalized Cardiac Rehabilitation in Post Acute Coronary Syndrome (BREAK-trial)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Personalised treatment, Usual Care.
- Кому может быть актуально
- Состояния в реестре: Acute Coronary Syndromes (ACS), Cardiac Rehabilitation, Frailty, Women. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Patient-centered Cardiac rehaBilitation pRogramE in Post Acute Coronary Syndrome:Identification of Key Barriers and Evaluation of Personalized Intervention (BREAK-trial)
Обзор
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)
Подробное описание
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.
Вмешательства
- Поведенческое Personalised treatment
Patients going through a personalized intervention program - Другое Usual Care
Usual cardiac rehabilitation program
Первичные конечные точки
- Improvement in functional capacity [Срок оценки: First visit and 3 months after hospital discharge (after completing rehabilitation program)]
Вторичные конечные точки (12)
- Physical Activity. IPAQ [Срок оценки: First visit; 3 months (after completing rehabilitation program) and 6 months after hospital discharge]
- Physical Activity. Podometer [Срок оценки: First visit; 3 months (after completing rehabilitation program) and 6 months after hospital dischargeFirst visit and 6 months after hospital discharge]
- Psychological status [Срок оценки: First visit; 3 months (after completing rehabilitation program) and 6 months after hospital dischargeFirst Visit and 6 months after hospital discharge]
- Dietary Changes [Срок оценки: In-hospital evaluation and 6 months after hospital discharge]
- Body composition [Срок оценки: First visit and 3 months after hospital discharge (after completing rehabilitation program)]
- Sarcopenia [Срок оценки: First visit; 3 months (after completing rehabilitation program) and 6 months after hospital discharge]
- Frailty [Срок оценки: First visit; 3 months (after completing rehabilitation program) and 6 months after hospital discharge]
- Patient reported quality of life [Срок оценки: First visit and 3 months after hospital discharge (after completing rehabilitation program)]
- Sleep quality [Срок оценки: First visit; 3 months (after completing rehabilitation program) and 6 months after hospital discharge]
- Sexual dysfunction [Срок оценки: First visit; 3 months (after completing rehabilitation program) and 6 months after hospital discharge]
- Readmission and mortality rates [Срок оценки: First visit; 3 months (after completing rehabilitation program) and 6 months after hospital discharge]
- Adherence to program [Срок оценки: First visit; 3 months after discharge (after completing rehabilitation program)]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Испания · 1 центр
- Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat
Идентификаторы
NCT: NCT07038265 · IDIBELL- 202309 10 · 202309 10