The DTx-HBCR trial will randomize 366 high-risk patients who undergo PCI at the West China Hospital of Sichuan University to either the 6-month DTx-guided HBCR group (intervention group) or the 6-months usual care group (control group) in a parallel-arm randomized controlled trial. The primary outcome is the difference between the intervention group and control group in walk distance on the 6-minute walk test (i.e., functional capacity) at 6 months post randomization. The key secondary outcomes include improvements in cardiovascular risk factor control, quality of life, psychological status, physical activity, major adverse cardiovascular events, and medication adherence. This study aims to evaluate the DTx-guided HBCR, a software-driven, multidisciplinary health intervention as an alternative to traditional in-center CR in patients with high-risk patients following percutaneous coronary intervention (PCI) compared with usual care alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
366
The Huaxiaoxin WeChat mini program incorporating the core components of guidelines are divided into two main sections. Section 1 comprises interventions such as exercise training, educational programmes and cardiovascular risk factor management. Section 2 provides a secure platform for individualized feedback, just-in-time two-way communication, remote data transmission, and data repository, allowing patients and healthcare providers to access all relevant files anytime and anywhere throughout the 12-month study period.
West China Hospital
Chengdu, Sichuan, China
Change in 6-minute walk distance (i.e., functional capacity) at 6 months post randomization
Change in distance participants walked (i.e., functional capacity) between the intervention and usual care groups, as measured by the 6MWT at 6 months postrandomization.
Time frame: At 6 months post randomization
Change in functional capacity at 3 months postrandomization
Change in distance participants walked (i.e., functional capacity) between the intervention and usual care groups, as measured by the 6MWT at 3 months postrandomization.
Time frame: At 3 months postrandomization
Change in conventional CVD risk factors at 3, 6 months post randomization
Changes in conventional CVD risk factors, such as lipid profile, glycosylated hemoglobin, BMI, BP, and smoking habits.
Time frame: At 3, 6 months post randomization
Change in quality of life at 3, 6 months post randomization
Quality of life as assessed by the Seattle Angina Questionnaire41 and the EuroQol 5-Dimensions Questionnaire.
Time frame: At 3, 6 months post randomization
Change in psychological status at 3, 6 months post randomization
Depression scores, as assessed by the 9-item Patient Health Questionnaire; anxiety scores, as assessed by the 7-item Generalized Anxiety Disorder questionnaire.
Time frame: At 3, 6 months post randomization
Change in physical activity levels at 3, 6 months post randomization
Qhysical activity levels as assessed by the International Physical Activity Questionnaire.
Time frame: At 3, 6 months post randomization
Change in medication adherence at 3, 6 months post randomization
Medication adherence as assessed by the 8-item Morisky Medication Adherence Scale.
Time frame: At 3, 6 months post randomization
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