Home-Based, Digitally Assisted Dyadic Tai Chi Intervention for Patients With Chronic Heart Failure and Their Caregivers: Development of an Intervention and Pilot Randomized Controlled Trial

Background Chronic heart failure (CHF) imposes a dual and dynamically interrelated burden on patients and family caregivers, whose health and illness management behaviors are interdependent. Exercise interventions that actively engage the patient-caregiver dyad as the unit of rehabilitation in the home setting remain underdeveloped. Objective This study aimed to develop a home-based, digitally assisted, dyadic tai chi (HDTC) intervention and evaluate its feasibility, acceptability, safety, and preliminary effects among dyads of patients with CHF and their caregivers. Methods This sequential, multiphase study comprised intervention development followed by a single-center, assessor-blinded, parallel-group pilot randomized controlled trial. Phase 1 integrated literature review, theoretical frameworks, and stakeholder focus group interviews to develop and refine the HDTC intervention. In phase 2, eligible adults with CHF (aged 18-75 years; New York Heart Association class I-III) and their primary caregivers were recruited from a tertiary medical center in Qingdao, China, from October 14 to November 12, 2024, and followed for 12 weeks. Forty dyads were allocated 1:1 to the 12-week HDTC intervention plus usual care or usual care alone (n=20 per group). Outcome assessors and the data analyst were blinded to group allocation. Feasibility, acceptability, and safety were the primary focus of the pilot trial. Patient, caregiver, and dyadic health outcomes were preliminarily explored at baseline and 4 and 12 weeks. All 40 randomized dyads were included in the intention-to-treat analyses. Results The HDTC intervention comprised an online educational seminar, nurse-led dyadic coaching, preliminary face-to-face tai chi training, and supervised HDTC practice. The recruitment rate was 83.3% (40/48), mean session attendance was 73.7% (SD 8.6%), and 70% (14/20) of participants achieved high adherence rate (≥75% attendance). All intervention dyads rated the intervention as acceptable. No intervention-related adverse events were identified. Exploratory generalized estimating equation analyses suggested greater improvements from baseline to 12 weeks in the intervention group than in the control group in functional capacity (β=38.858; P=.001), together with greater reductions in Minnesota Living With Heart Failure Questionnaire scores (β=−1.850; P=.002), sedentary time (β=−1.025; P=.01), and fear of activity (β=−6.550; P=.01). Caregiver burden also decreased (β=−4.350; P<.001), while mutuality improved more for both patients (β=10.508; P<.001) and caregivers (β=6.450; P<.001). Conclusions The HDTC intervention was feasible and acceptable, with preliminary improvements across patient, caregiver, and dyadic outcomes. By integrating shared patient-caregiver participation with digitally supported home-based tai chi, the HDTC intervention extends patient-centered rehabilitation toward a dyad-oriented model. If confirmed in a fully powered trial, this approach may offer a practical strategy for expanding home-based cardiac rehabilitation. Trial Registration ClinicalTrials.gov NCT06876441; https://clinicaltrials.gov/study/NCT06876441