Department of Cardiology, Affiliated Hospital of Jiangnan University, Wuxi, China.
School of Nursing, Soochow University, Suzhou, China.
Trials. 2024 Oct 9;25(1):667. doi: 10.1186/s13063-024-08523-w.
Currently, most elderly chronic heart failure (CHF) patients go home for rehabilitation after certain treatment in hospitals. However, the results of their rehabilitation at home are not satisfactory. According to studies, dyadic treatments can increase the efficiency of home rehabilitation, enhance both partners' quality of life, lessen the caregiver's load of care, and alleviate the strain of medical resources. Thus, the aim of our research is to design a study protocol that included elderly CHF patients and their informal caregivers as an intervention unit and to explore the impact of the protocol on their health and physical outcomes.
This is a prospective randomized controlled trial conducted in a triple-A hospital. In total, 80 elderly CHF patients and informal caregivers (80 dyads) will be recruited with informed consent. Based on the randomized numbers, they are divided into a control group (40 dyads) and an intervention group (40 dyads), subjects in the control group will receive usual care, and subjects in the intervention group will receive a home-based disease management program based on the Theory of Dyadic Illness Management on the basis of the control group. The duration of the intervention is 3 months, and the follow-up is 6 months. Data is collected at enrolment, 3 months after the intervention, and 3 months after the end of the intervention. The primary outcome is patients' quality of life and readmission. Secondary outcomes include patients' self-management behaviors, anxiety, and depression and caregivers' quality of life and care burden.
This study focuses on whether this home-based disease management program can improve the quality of life of elderly patients with CHF, reduce the readmission rate, enhance their self-management capacity, reduce negative emotions, and reduce the burden of informal caregivers. It can provide a new perspective on home management and cardiac rehabilitation of heart failure disease in the elderly, as well as alleviate problems such as the burden of healthcare resources.
Chinese Clinical Trials Registry ChiCRT2300068026. Registered on 3 February 2023, manuscript Version: 1.0, https://www.chictr.org.cn/ .
目前，大多数老年慢性心力衰竭（CHF）患者在医院接受一定治疗后回家康复。然而，他们在家康复的效果并不理想。研究表明，双元治疗可以提高家庭康复的效率，提高伴侣双方的生活质量，减轻照顾者的照顾负担，缓解医疗资源的压力。因此，我们的研究目的是设计一个包括老年 CHF 患者及其非正式照顾者作为干预单位的研究方案，并探讨该方案对他们健康和身体结果的影响。
这是一项在三甲医院进行的前瞻性随机对照试验。共招募 80 名老年 CHF 患者及其非正式照顾者（80 对），并获得知情同意。根据随机数字，将他们分为对照组（40 对）和干预组（40 对），对照组接受常规护理，干预组在对照组的基础上接受基于双元疾病管理理论的家庭疾病管理方案。干预持续 3 个月，随访 6 个月。在入组时、干预 3 个月后和干预结束后 3 个月收集数据。主要结局是患者的生活质量和再入院率。次要结局包括患者的自我管理行为、焦虑和抑郁以及照顾者的生活质量和照顾负担。
本研究重点关注该家庭疾病管理方案是否能提高老年 CHF 患者的生活质量，降低再入院率，增强自我管理能力，减轻负面情绪，减轻非正式照顾者的负担。它可以为心力衰竭疾病的家庭管理和心脏康复提供新的视角，缓解医疗资源负担等问题。
中国临床试验注册中心 ChiCTR2300068026。注册于 2023 年 2 月 3 日，版本号：1.0，网址：https://www.chictr.org.cn/。
