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

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

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 Overview

• Status: Enrolling by invitation
• Conditions: Myocardial Infarction; Coronary Artery Disease
• Intervention / Treatment: Other: DTx-guided HBCR

• Study Type: Interventional
• Enrollment (Estimated): 366
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care group
Experimental: DTx-guided HBCR group	Other: DTx-guided HBCR; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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
User satisfaction	User satisfaction as assessed the System Usability Scale modified for the Huaxiaoxin program.	At 6 months post randomization

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: August 4, 2024
• First Submitted That Met QC Criteria: August 4, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 11, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Ischemia; Coronary Artery Disease; Myocardial Infarction; Infarction
• Other Study ID Numbers: WestChinaH-CVD-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No