Efficacy of the Integration of Digital Therapeutics and Home-based Cardiac Rehabilitation in High-Risk Post-PCI Patients on Cardiovascular Health
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- Change in 6-minute walk distance (i.e., functional capacity) at 6 months post randomization
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible to participate in this study, a participant must meet all of the following criteria:
- •Women or men, the ages of 18 and 75 years.
- •Have sufficient reading and writing language skills in Chinese.
- •Be willing to participate the study and sign informed consent.
- •Patients must have at least one clinical feature and one angiographic feature:
- •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.
排除标准
- •A potential participant who meets any of the following criteria will be excluded from participation in this study:
- •Contraindications to exercise rehabilitation (e.g., untreated ventricular tachycardia, severe heart failure (New York Heart Association class III or IV heart failure, or ejection fraction < 40%), uncontrolled hypertension or hypotension, active hemorrhage, severe liver failure, significant exercise limitations).
- •Vision, hearing, cognition-related or mental impairment leading to inability to cooperate.
- •Patients with established planned Phase II PCI.
- •Having pre-existing comorbid disease with a life expectancy of < 1 year.
- •Poor compliance and unable to complete the expected follow-up.
- •Unable to access WeChat via a smartphone after training.
结局指标
主要结局
Change in 6-minute walk distance (i.e., functional capacity) at 6 months post randomization
时间窗: 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.
次要结局
- Change in psychological status at 3, 6 months post randomization(At 3, 6 months post randomization)
- Change in functional capacity at 3 months postrandomization(At 3 months postrandomization)
- Change in conventional CVD risk factors at 3, 6 months post randomization(At 3, 6 months post randomization)
- Change in quality of life at 3, 6 months post randomization(At 3, 6 months post randomization)
- Change in physical activity levels at 3, 6 months post randomization(At 3, 6 months post randomization)
- Change in medication adherence at 3, 6 months post randomization(At 3, 6 months post randomization)