Effects of home-based digital-assisted dyadic Tai Chi training in Chinese chronic heart failure patients and family caregivers: a randomised controlled trial protocol.
Lack of exercise or sustained low engagement in exercise represents a significant risk factor for adverse health outcomes among chronic heart failure (CHF) patients. Concurrently, family caregivers of patients with CHF often endure considerable caring burdens, leading to low quality of life (QoL) and diminished health status. Substantial evidence supports that Tai Chi has beneficial effects on cardiac function and heart failure prognosis. However, conventional Tai Chi interventions are often constrained by limitations such as site dependency and overlook the roles and needs of caregivers. Therefore, we developed a home-based, digital-assisted dyadic Tai Chi training programme aimed at improving health outcomes for both patients with CHF and their family caregivers.
This is a two-arm parallel, single-blinded randomised controlled trial. Patients with CHF and their family caregivers will be randomly assigned to (1) intervention group, participate in usual care plus a 12-week home-based digital-assisted dyadic Tai Chi training programme, comprising a 30-min online educational seminar, 1-hour online nurse-led dyadic coaching session, 1-hour preliminary Tai Chi training session and subsequent 12-week supervised dyadic Tai Chi practice; or (2) control group, only receive usual care. Outcome assessments encompass three perspectives: patients with CHF, caregivers and dyads. The primary outcome is functional capacity and cardiac function in patients with CHF. Secondary outcomes include: exercise self-efficacy of patients with CHF, sedentary behaviour, fear of activity, hospital admission and health-related QoL; care burden and QoL of caregivers; and mutuality, depression, anxiety and stress for both patients with CHF and their caregivers. Process evaluation will be implemented by assessing participation adherence and attrition. Adverse events will be recorded for safety assessment. Data will be collected at baseline (T0), 4 weeks (T1) and 12 weeks (T2) after initiation of the intervention. Intention-to-treat and sensitivity analysis (including per-protocol and subgroup analysis) will be performed using generalised estimating equations models. The minimal clinically important difference for primary outcomes will also be explored using the χ2 test.
This study has been approved by the Hong Kong Polytechnic University (HSEARS20240904005) and the Affiliated Hospital of Qingdao University. The results will be published in an international peer-reviewed journal and disseminated through conference presentation to provide a novel paradigm for optimising dyadic well-being in patients with CHF and their caregivers.
NCT06876441.
This is a two-arm parallel, single-blinded randomised controlled trial. Patients with CHF and their family caregivers will be randomly assigned to (1) intervention group, participate in usual care plus a 12-week home-based digital-assisted dyadic Tai Chi training programme, comprising a 30-min online educational seminar, 1-hour online nurse-led dyadic coaching session, 1-hour preliminary Tai Chi training session and subsequent 12-week supervised dyadic Tai Chi practice; or (2) control group, only receive usual care. Outcome assessments encompass three perspectives: patients with CHF, caregivers and dyads. The primary outcome is functional capacity and cardiac function in patients with CHF. Secondary outcomes include: exercise self-efficacy of patients with CHF, sedentary behaviour, fear of activity, hospital admission and health-related QoL; care burden and QoL of caregivers; and mutuality, depression, anxiety and stress for both patients with CHF and their caregivers. Process evaluation will be implemented by assessing participation adherence and attrition. Adverse events will be recorded for safety assessment. Data will be collected at baseline (T0), 4 weeks (T1) and 12 weeks (T2) after initiation of the intervention. Intention-to-treat and sensitivity analysis (including per-protocol and subgroup analysis) will be performed using generalised estimating equations models. The minimal clinically important difference for primary outcomes will also be explored using the χ2 test.
This study has been approved by the Hong Kong Polytechnic University (HSEARS20240904005) and the Affiliated Hospital of Qingdao University. The results will be published in an international peer-reviewed journal and disseminated through conference presentation to provide a novel paradigm for optimising dyadic well-being in patients with CHF and their caregivers.
NCT06876441.