Firstly, we will conduct a pilot RCT before this full scale RCT to assess the feasibility, acceptability, and preliminary efficacy of the HDTC training program. If the HDTC training program is feasible and acceptable, this full scale will then conducted based on the refined protocol. The full scale RCT aims to assess the effectiveness of the HDTC training program in improving cardiac function and secondary outcomes among sedentary heart failure individuals, while simultaneously reducing care burden and improving other outcomes for their caregivers.
The pilot part is a two-arm parallel, single-blinded randomized controlled trial. 20 HF dyads will be enrolled and attend the 12 weeks intervention. The full scale RCT is a two-arm parallel, single-blinded randomized controlled trial. A total of 118 HF individuals and 118 caregivers will be enrolled and allocated to the HDTC group and the control group in a 1:1 ratio. Participants in the control group will receive usual care. Those in the HDTC group will attend usual care plus the HDTC training program, including a 30-minute educational seminar, a 1-hour dyadic coaching session, and 12-week Tai Chi training. Data on cardiac function, exercise tolerance, exercise self-efficacy, fear of activity, sedentary behavior, hospital admission, health-related quality of life, depression, anxiety, stress, and mutuality for HF individuals, as well as care burden, quality of life, depression, anxiety, stress, and mutuality of caregivers, will be collected at baseline (T0), 4 weeks (T1) and 12 weeks (T2) after the intervention. The intention-to-treat analysis (ITT), modified ITT analysis, and per-protocol analysis will be conducted. The generalized estimating equation (GEE) model will be used to measure changes in outcome variables.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
236
Participants will receive usual care plus HDTC training program, including four parts: (1)30-minute educational seminar via WeChat: provide disease knowledge, propose strategies to replace sedentary behavior, and introduce Tai Chi. (2)1-hour online nurse-lead dyadic coaching session: introduce dyadic Tai Chi, clarify the roles and responsibilities, and establish a shared goal among dyads. (3)1-hour preliminary Tai Chi training session: face-to-face, introduce online Tai Chi learning, demonstrations on using heart rate monitor. (4)12-week Tai Chi training: Dyads learn Tai Chi following Tai Chi master online. The frequency gradually increased from 2 to 3 classes per week and duration extending from 30 to 50 minutes. Subsequently, they will practice Tai Chi with the master once a week and follow instructional videos twice a week, with each session lasting 50 minutes. The finalized contents will be determined based on the pilot RCT.
HF-caregiver dyads in the control group will receive the usual care, including a 30-min online comprehensive education and nurse-led support through telephone consultations in the aspects of symptom management, medication, dietary and exercise suggestions, psychosocial support, and regular monthly follow-up every month.
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
RECRUITINGcardiac function of HF individuals
The primary outcome of this study is the cardiac function, measured by LVEF. LVEF is a crucial parameter for assessing cardiac function. It is an echocardiographic measure that reflects cardiac function by indicating the percentage of blood ejected from the left ventricle with each heartbeat. Three-dimensional echocardiography will be employed to measure LVEF. For the pilot RCT, the primary outcome is the feasibilty and acceptability measuring by recruitment period, recruitment rate, attendance rate and adherence rate of online Tai Chi classes, attrition rate, and dyads opinions about the intervention based on the Theoretical Framework of Acceptability.
Time frame: From enrollment to the end of intervention at 4 weeks and 12 weeks
exercise tolerance of HF individuals
The 6MWT will be used to assess exercise tolerance.
Time frame: From enrollment to the end of intervention at 4 and 12 weeks
sedentary behavior of HF individuals
HF individuals' sedentary behavior will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF).
Time frame: From enrollment to the end of intervention at 4 and 12 weeks
hospital admission of HF individuals
The HF individual's hospital admission status will be presented based on the number of hospital admissions during the intervention period, including emergency visits.
Time frame: From enrollment to the end of intervention at 12 weeks
Health-related QoL of HF individuals
Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a specific and commonly used scale for measuring QoL among HF patients, which will be used to assess QoL.
Time frame: From enrollment to the end of intervention at 4 and12 weeks
care burden of caregivers
The Chinese version of the Zarit Caregiver Burden Interview (ZBI), will be used to measure caregivers' perceived burden of providing care.
Time frame: From enrollment to the end of intervention at 4 and 12 weeks
QoL of caregivers
The Family Caregiver Quality of Life (FAMQOL) is a specific instrument designed by Nauser in 2011 to assess the QoL among caregivers of HF patients.
Time frame: From enrollment to the end of intervention at 4 and 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.