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

NCT06542575 | Enrolling By Invitation

• 1 other identifier: WestChinaH-CVD-006
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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 psychological status 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

Other Outcomes (2)

• The incidence of major adverse cardiovascular events (MACEs) at 1 year post randomization

  At 1 year post randomization

• User satisfaction

  At 6 months post randomization

Study Arms (2)

DTx-guided HBCR group

EXPERIMENTAL

Other: DTx-guided HBCR

Usual care group

NO INTERVENTION

Interventions

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.

DTx-guided HBCR group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

• 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.

  PMID: 40735550 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 4, 2024
• First Posted: August 7, 2024
• Study Start: December 4, 2024
• Primary Completion: November 1, 2025
• Study Completion: May 1, 2026
• Last Updated: January 14, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR

Locations

CN (1)