Efficacy of the Integration of Digital Therapeutics and Home-based Cardiac Rehabilitation in High-Risk Post-PCI Patients

Not Applicable

• Conditions: Coronary Artery Disease; Myocardial Infarction
• Interventions: Other: DTx-guided HBCR

• Registration Number: NCT06542575
• Lead Sponsor: West China Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-04
• Study First Submitted QC: 2024-08-04
• Study First Posted: 2024-08-07
• Study Start: 2024-12-04
• Last Update Submitted: 2025-01-11
• Last Update Posted: 2025-01-14
• Primary Completion: 2025-11
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 366

Inclusion Criteria

• To be eligible to participate in this study, a participant must meet all of the following criteria:

  1. Women or men, the ages of 18 and 75 years.
  2. Have sufficient reading and writing language skills in Chinese.
  3. Be willing to participate the study and sign informed consent.
  4. 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.

Exclusion Criteria

• A potential participant who meets any of the following criteria will be excluded from participation in this study:

  1. 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).
  2. Vision, hearing, cognition-related or mental impairment leading to inability to cooperate.
  3. Patients with established planned Phase II PCI.
  4. Having pre-existing comorbid disease with a life expectancy of < 1 year.
  5. Poor compliance and unable to complete the expected follow-up.
  6. Unable to access WeChat via a smartphone after training.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DTx-guided HBCR group	DTx-guided HBCR	-

Primary Outcome Measures

Name	Time	Method
Change in 6-minute walk distance (i.e., functional capacity) at 6 months post randomization	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.

Secondary Outcome Measures

Name	Time	Method
Change in psychological status at 3, 6 months post randomization	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.
Change in functional capacity at 3 months postrandomization	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.
Change in conventional CVD risk factors at 3, 6 months post randomization	At 3, 6 months post randomization	Changes in conventional CVD risk factors, such as lipid profile, glycosylated hemoglobin, BMI, BP, and smoking habits.
Change in quality of life at 3, 6 months post randomization	At 3, 6 months post randomization	Quality of life as assessed by the Seattle Angina Questionnaire41 and the EuroQol 5-Dimensions Questionnaire.
Change in physical activity levels at 3, 6 months post randomization	At 3, 6 months post randomization	Qhysical activity levels as assessed by the International Physical Activity Questionnaire.
Change in medication adherence at 3, 6 months post randomization	At 3, 6 months post randomization	Medication adherence as assessed by the 8-item Morisky Medication Adherence Scale.

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China