Academy of Medical Sciences, Zhengzhou University, Zhengzhou, China.
School of Nursing and Health, Zhengzhou University, Zhengzhou, Henan, China.
BMJ Open. 2023 Sep 4;13(9):e073016. doi: 10.1136/bmjopen-2023-073016.
The promotion of self-care has begun to serve as a central response strategy to the rising burden of stroke. In fact, stroke self-care can be recognised to be a dyad phenomenon having an effect on the health of stroke survivors and their caregivers. While studies have confirmed the effectiveness of smartphone-based interventions in improving self-care among stroke survivors, there remains a lack of evidence specifically regarding dyadic self-care interventions for both patients and caregivers.
The present single-blinded, two-arm, randomised controlled trial aims to verify the effectiveness of a smartphone-enabled dyadic self-care programme (SDSCP) for stroke survivors and their caregivers.
The estimated sample size is 152 stroke survivor-caregiver dyads. The participants will be randomly classified (1:1) into either a control (N=76) or an experimental group (N=76) through block randomisation. The participants classified into the experimental group will be provided with SDSCP, and during the initial home visit, the research team members will provide instructions to all patients and caregivers on how to download and use the smartphone application. While the participants in the control group will be given the existing stroke standard care. The main outcome measures of stroke survivors will consist of the Self-Care of Stroke Inventory and a short version of the Stroke Specific Quality of Life Scale. The outcome measures of stroke caregivers will primarily cover the Caregiver Contribution to Self-Care of Stroke Inventory and Zarit burden interview. The data of this study will be collected at three time points, including baseline, 1 month and 6 months from the baseline.
This study has been approved by the Ethics Committee of Zhengzhou University (ZZUIRB 2021-115) in January 2021. The results achieved in this study will facilitate the clinical practice to improve self-care of stroke survivors and promote dyadic health outcomes for stroke patients and caregivers.
The study was registered with the Chinese Clinical Trial Registry and the registration number is ChiCTR2100053591.
促进自我护理已开始成为应对中风负担增加的核心应对策略。事实上，中风自我护理可以被认为是一种双重现象，对中风幸存者及其照顾者的健康都有影响。虽然研究已经证实基于智能手机的干预措施在改善中风幸存者的自我护理方面的有效性，但专门针对患者和照顾者的双重自我护理干预措施仍缺乏证据。
本单盲、双臂、随机对照试验旨在验证智能手机支持的双重自我护理计划（SDSCP）对中风幸存者及其照顾者的有效性。
预计样本量为 152 对中风幸存者-照顾者二人组。参与者将通过区组随机化（1:1）随机分为对照组（N=76）或实验组（N=76）。被分配到实验组的参与者将获得 SDSCP，在首次家访时，研究团队成员将向所有患者和照顾者说明如何下载和使用智能手机应用程序。而对照组的参与者将接受现有的中风标准护理。中风幸存者的主要结局测量将包括自我护理的中风清单和中风特定生活质量量表的简短版本。中风照顾者的主要结局测量将主要涵盖照顾者对中风自我护理的贡献清单和 Zarit 负担访谈。该研究的数据将在三个时间点收集，包括基线、1 个月和 6 个月。
本研究已于 2021 年 1 月获得郑州大学伦理委员会的批准（ZZUIRB 2021-115）。本研究取得的结果将有助于临床实践，改善中风幸存者的自我护理，并促进中风患者和照顾者的双重健康结果。
该研究在中国临床试验注册中心注册，注册号为 ChiCTR2100053591。
