Effects of Home-Based Digital-Assisted Dyadic Tai Chi Training in Chinese Chronic Heart Failure

The study proposes a home-based, digitally supported dyadic Tai Chi program to address both patient and caregiver needs.

• The protocol targets chronic heart failure (CHF) patients and their family caregivers, recognizing that insufficient or waning exercise is a known risk factor for adverse outcomes and that caregiver burden can degrade quality of life.
• Tai Chi is referenced as having potential benefits for cardiac function and heart failure prognosis, while traditional delivery often depends on fixed sites and may neglect caregiver involvement.

Components include a 30-minute online educational seminar, a 1-hour online nurse-led dyadic coaching session, a 1-hour initial Tai Chi training session, and ongoing 12-week supervised dyadic Tai Chi practice.

The minimal clinically important difference for primary outcomes will be explored using the 2 test approach.

• Design: A two-arm, parallel, single-blinded randomized controlled trial.
• Population: CHF patients and their family caregivers, with random allocation to an intervention or control condition.
• Interventions:
• Intervention group: Usual care plus a 12-week home-based, digital-assisted dyadic Tai Chi program.
• Control group: Usual care only.
• Outcomes and measurement framework:
• Primary outcome: Functional capacity and cardiac function in CHF patients.
• Secondary patient outcomes: Exercise self-efficacy, sedentary behavior, fear of activity, hospital admissions, and health-related quality of life.
• Caregiver outcomes: Care burden, quality of life.
• Dyadic outcomes: Mutuality, depression, anxiety, and stress for both patients and caregivers.
• Process measures: Adherence to participation and attrition.
• Safety: Adverse events recorded.
• Timing: Assessments at baseline (T0), 4 weeks (T1), and 12 weeks (T2) after initiation.
• Analysis plan: Intention-to-treat analyses with generalised estimating equations; sensitivity analyses including per-protocol and subgroup analyses.
• Economic/operational considerations: The design implies a home-based delivery model with digital components intended to facilitate adherence and caregiver involvement, though specific economic analyses are not described in depth.

• Ethics approvals obtained from Hong Kong Polytechnic University and the Affiliated Hospital of Qingdao University.
• Dissemination plans include publication in an international peer-reviewed journal and conference presentations, aiming to establish a novel dyadic well-being paradigm in CHF management.

• The protocol document does not provide results, effect sizes, or observed adverse events, as it describes planned methods rather than findings.
• Specific details on the digital platform, patient and caregiver eligibility criteria, sample size, and statistical power calculations are not provided in the summary content.
• It is unclear whether any cost-effectiveness analysis or long-term follow-up beyond 12 weeks is planned.