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

Official title

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

Overview

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.

Interventions

• 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 t

Primary outcome measures

• Change in 6-minute walk distance (i.e., functional capacity) at 6 months post randomization [Time frame: At 6 months post randomization]

Secondary outcome measures (6)

• Change in functional capacity at 3 months postrandomization [Time frame: At 3 months postrandomization]
• Change in conventional CVD risk factors at 3, 6 months post randomization [Time frame: At 3, 6 months post randomization]
• Change in quality of life at 3, 6 months post randomization [Time frame: At 3, 6 months post randomization]
• Change in psychological status at 3, 6 months post randomization [Time frame: At 3, 6 months post randomization]
• Change in physical activity levels at 3, 6 months post randomization [Time frame: At 3, 6 months post randomization]
• Change in medication adherence at 3, 6 months post randomization [Time frame: At 3, 6 months post randomization]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

China · 1 center

• West China Hospital — Chengdu

Publications

• 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/ PMID 40735550

Identifiers

NCT: NCT06542575 · WestChinaH-CVD-006

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗