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

NCT06542575 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2025-01-14

No results posted yet for this study

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

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 the 12-month study period.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-04
Primary Completion
2025-11-30
Completion
2026-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06542575 on ClinicalTrials.gov