Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06542575

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in 6-minute walk distance (i.e., functional capacity) at 6 months post randomization

    Time frame: 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.

Secondary outcomes

  1. Change in functional capacity at 3 months postrandomization

    Time frame: 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.

  2. Change in conventional CVD risk factors at 3, 6 months post randomization

    Time frame: At 3, 6 months post randomization

    Changes in conventional CVD risk factors, such as lipid profile, glycosylated hemoglobin, BMI, BP, and smoking habits.

  3. Change in quality of life at 3, 6 months post randomization

    Time frame: At 3, 6 months post randomization

    Quality of life as assessed by the Seattle Angina Questionnaire41 and the EuroQol 5-Dimensions Questionnaire.

  4. Change in psychological status at 3, 6 months post randomization

    Time frame: 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.

  5. Change in physical activity levels at 3, 6 months post randomization

    Time frame: At 3, 6 months post randomization

    Qhysical activity levels as assessed by the International Physical Activity Questionnaire.

  6. Change in medication adherence at 3, 6 months post randomization

    Time frame: At 3, 6 months post randomization

    Medication adherence as assessed by the 8-item Morisky Medication Adherence Scale.

Other outcomes

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

    Time frame: 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.

  2. User satisfaction

    Time frame: At 6 months post randomization

    User satisfaction as assessed the System Usability Scale modified for the Huaxiaoxin program.

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 7, 2024
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.