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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DTx-guided HBCR group | Experimental |
| |
| Usual care group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTx-guided HBCR | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 6 months post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 3 months postrandomization |
| Change in conventional CVD risk factors at 3, 6 months post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of major adverse cardiovascular events (MACEs) at 1 year post randomization | MACEs, defined as the composite of cardiac death (namely, all deaths with a clear cardiovascular or unknown cause will be classified as cardiac, non-cardiac deaths is only due to a documented non-cardiac cause (e.g., cancer)), nonfatal myocardial infarction, nonfatal stroke, and target vessel revascularization. | At 1 year post randomization |
Inclusion Criteria:
To be eligible to participate in this study, a participant must meet all of the following criteria:
A. Clinical features: age ≥ 65 years, female sex, troponin positive acute coronary syndrome, established vascular disease (prior myocardial infarction, coronary revascularization or peripheral arterial disease) , diabetes mellitus requiring medication and chronic kidney disease (estimated glomerular filtration rate < 60 ml/min/1.73 m2 or creatinine clearance < 60 cc/min) .
B. Angiographic features: multivessel coronary artery disease, total stent length > 30 mm, thrombotic target lesion, bifurcation lesion requiring two stents, obstructive left main or proximal left anterior descending lesion and calcified target lesion requiring atherectomy.
Exclusion Criteria:
A potential participant who meets any of the following criteria will be excluded from participation in this study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital | Chengdu | Sichuan | 610041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40735550 | Derived | Ma S, Chen Z, Zhang J, Liu J, Xu L, Huang B, Zhou M, Wang H, Chen Y, Wang M, Li C, He Y; DTx-HBCR trial investigators. Evaluation of the efficacy of integrating digital therapeutics with home-based cardiac rehabilitation on cardiovascular health in high-risk post-PCI patients (DTx-HBCR): Study protocol for a randomized controlled trial. Digit Health. 2025 Jul 25;11:20552076251360885. doi: 10.1177/20552076251360885. eCollection 2025 Jan-Dec. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
Changes in conventional CVD risk factors, such as lipid profile, glycosylated hemoglobin, BMI, BP, and smoking habits. |
| 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. | 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. | 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. | 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. | At 3, 6 months post randomization |
| User satisfaction | User satisfaction as assessed the System Usability Scale modified for the Huaxiaoxin program. | At 6 months post randomization |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |