Yang Weiling, Sun Li, Hao Lili, Zhang Xiaonan, Lv Qingyun, Xu Xueying, Wang Yaqi, Li Yanting, Zhou Lihui, Zhao Yue, Zang Xiaoying, Wang Yaogang
School of Public Health, Tianjin Medical University, Tianjin, China.
School of Nursing, Tianjin Medical University, Tianjin, China.
EClinicalMedicine. 2024 Feb 12;69:102481. doi: 10.1016/j.eclinm.2024.102481. eCollection 2024 Mar.
Living with heart failure can severely affect the physical and mental health of patients with heart failure and their caregivers. Available dyadic self-care interventions for heart failure are scarce, especially in China. We aimed to develop and test the family FOCUS programme.
This single-blind, randomised, controlled study was conducted at four hospitals in Tianjin, China. Patients with heart failure (aged at least 18 years) and their caregiver (dyads) were randomly assigned to either the intervention (n = 71) or control (n = 71) group in a 1:1 ratio. The primary outcomes of this study were patient self-care, with three specific dimensions (self-care maintenance, symptom perception, and self-care management), and caregiver contribution to self-care, mirroring these three dimensions. The outcomes were assessed at baseline (T0) and 4 (T1), 12 (T2), and 24 (T3) weeks post-discharge, respectively. This work is registered on ChiCTR, ChiCTR2100053168.
Between May 20, 2022, and September 30, 2022, 142 dyads with heart failure were enrolled. The intervention group exhibited dropout rates of 6%, 8.5%, and 18.3% at 4, 12, and 24 weeks after discharge, while the control group showed 9.9%, 12.3%, and 25.4%. Compared with the control group, patients in the intervention group reported improved self-care maintenance (β: 8.5, 95% CI: 0.7, 16.4) and management (β: 7.2, 95% CI: 0.1, 14.3) at T1, as well as improved symptom perception at both T1 (β: 9.7, 95% CI: 1.5, 17.9) and T2 (β: 9.6, 95% CI: 0.6, 18.6). Furthermore, caregiver contributions to self-care maintenance, self-care management, and symptom perception (excluding T3) exhibited significant improvements at all timepoints.
Although the significant improvements in patients' self-care were not long-lasting, this study suggested that the family FOCUS programme consistently enhanced caregivers' contributions to self-care. Future work could explore the effect of the family FOCUS programme on families with multiple chronic conditions.
The National Natural Science Foundation of China.
心力衰竭患者及其照顾者的生活深受疾病影响，身心健康均受严重波及。目前针对心力衰竭的二元自我护理干预措施稀缺，在中国尤其如此。我们旨在开发并测试家庭聚焦项目。
本单盲、随机对照研究在中国天津的四家医院开展。心力衰竭患者（年龄至少18岁）及其照顾者（二元组）按1:1比例随机分配至干预组（n = 71）或对照组（n = 71）。本研究的主要结局为患者自我护理，包括三个具体维度（自我护理维持、症状感知和自我护理管理），以及照顾者对自我护理的贡献，与这三个维度相对应。分别在基线（T0）、出院后4周（T1）、12周（T2）和24周（T3）评估结局。本研究已在中国临床试验注册中心注册，注册号为ChiCTR2100053168。
在2022年5月20日至2022年9月30日期间，共纳入142个心力衰竭二元组。干预组出院后4周、12周和24周的失访率分别为6%、8.5%和18.3%，而对照组分别为9.9%、12.3%和25.4%。与对照组相比，干预组患者在T1时自我护理维持（β：8.5，95%置信区间：0.7，16.4）和管理（β：7.2，95%置信区间：0.1，14.3）有所改善，在T1（β：9.7，95%置信区间：1.5，17.9）和T2（β：9.6，95%置信区间：0.6，18.6）时症状感知也有所改善。此外，照顾者在自我护理维持、自我护理管理和症状感知（不包括T3）方面的贡献在所有时间点均有显著改善。
尽管患者自我护理的显著改善并不持久，但本研究表明家庭聚焦项目持续增强了照顾者对自我护理的贡献。未来的研究可以探索家庭聚焦项目对患有多种慢性病的家庭的影响。
中国国家自然科学基金。
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