School of Nursing, Tianjin Medical University, Tianjin, China.
Institute of Health and Disease, Binzhou Medical University - Yantai Campus, Yantai, China.
BMJ Open. 2022 Jul 27;12(7):e061405. doi: 10.1136/bmjopen-2022-061405.
Living with heart failure (HF), is a shared journey and arduous work for patients and their informal family caregivers. Given the key role and limited evidence of dyad illness management in improving dyad health in the context of HF, we developed a customisable, relationship focused, family online dynamic disease management programme-FOCUS programme-to improve dyad health for HF patients and their informal caregivers in China.
Based on the Theory of Dyadic Illness Management and the Systemic Transactional Model of Stress and Coping, the family customised online FOCUS programme has five modules: (1) family participatory; (2) open communication; (3) coping effectiveness; (4) uncertainty reduction and 5) shared dyad life stories. HF family dyads will be recruited in the cardiology wards of four university-affiliated hospitals in China. The dyads (N=142) will be randomly allocated to the intervention group that will receive the family customised online FOCUS programme, and the attention control group that will not receive elements of the FOCUS programme. Dyadic coping, HF somatic perception, self-care, anxiety and depression for patients and family caregivers and all-cause mortality and hospital admission for patients will be measured at baseline, 4 weeks (after the discharge, T1), 12 weeks (after the discharge, T2) and 24 weeks (after the discharge, T3). Statistical analysis will be performed using SPSS V. 22.0 software.
The study protocol was approved by the ethics committees of Tianjin Medical University (Reference number TMUHEC2019002) that covers all the centres enrolled in this study. The findings of this study will be published in scientific journals and will be presented at scientific conferences.
ChiCTR2100053168.
心力衰竭（HF）患者的生活是一个共同的旅程，对患者及其非正规家庭照顾者来说是一项艰巨的工作。鉴于在 HF 背景下，双元疾病管理对改善双元健康的关键作用和有限证据，我们开发了一个可定制的、以关系为中心的、家庭在线动态疾病管理方案——FOCUS 方案，以改善中国 HF 患者及其非正规照顾者的双元健康。
基于双元疾病管理理论和应激与应对的系统交易模型，家庭定制的在线 FOCUS 方案有五个模块：（1）家庭参与；（2）开放沟通；（3）应对有效性；（4）减少不确定性和（5）共享双元生活故事。HF 家庭双元将在中国的四家大学附属医院的心脏病病房招募。双元（N=142）将被随机分配到干预组，该组将接受家庭定制的在线 FOCUS 方案，而对照组则不会接受 FOCUS 方案的元素。在基线、4 周（出院后，T1）、12 周（出院后，T2）和 24 周（出院后，T3）时，将测量患者和家庭照顾者的双元应对、HF 躯体感知、自我护理、焦虑和抑郁以及患者的全因死亡率和住院率。统计分析将使用 SPSS V. 22.0 软件进行。
该研究方案已获得天津医科大学伦理委员会的批准（编号 TMUHEC2019002），涵盖了本研究纳入的所有中心。本研究的结果将发表在科学期刊上，并将在科学会议上展示。
ChiCTR2100053168。
