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ENROLLING BY INVITATION
NCT06542575
NA

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

Sponsor: West China Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

366

Start Date

2024-12-04

Completion Date

2026-05

Last Updated

2025-01-14

Healthy Volunteers

No

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.

Locations (1)

West China Hospital

Chengdu, Sichuan, China