Effectiveness of a smartphone-enabled dyadic self-care programme (SDSCP) for stroke survivors and caregivers: study protocol for a randomised controlled trial

Introduction: 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. Aim: 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. Methods and analysis: 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. Ethics and dissemination: 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. Trial registration number: The study was registered with the Chinese Clinical Trial Registry and the registration number is ChiCTR2100053591.