NCT07110389

Effectiveness of a Tele-cardiac Rehabilitation (Tele-CR) Program

Effectiveness of a Mobile Application-Based Tele-cardiac Rehabilitation (Tele-CR) Program for Patients With Coronary Heart Disease (CHD): A Randomized Clinical Trial

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Chang Gung University of Science and Technology · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study represents the second phase of a three-year research project aimed at evaluating both the short- and long-term effects of a six-month tele-cardiac rehabilitation (tele-CR) program in patients with coronary heart disease (CHD). The primary outcomes include quality of life, self-efficacy, self-management, medication adherence, and mental health (anxiety and depression). In addition, comprehensive metabolic parameters will be assessed, including body mass index (BMI), systolic and diastolic blood pressure (SBP and DBP), fasting blood glucose (FBG), glycosylated hemoglobin (HbA1C), and lipid profile markers such as triglycerides (TG), total cholesterol (TC), high-density lipoprotein (HDL), and low-density lipoprotein (LDL).

Detailed description

Coronary heart disease (CHD) is a leading cause of death in Taiwan and a major contributor to premature and avoidable mortality worldwide. Cardiac rehabilitation (CR) is a multidisciplinary secondary prevention strategy that has been widely proven to reduce morbidity and mortality. However, despite its well-documented benefits, CR remains underutilized due to barriers such as transportation, time constraints, and limited access to facilities. Tele-cardiac rehabilitation (tele-CR), a technology-enabled alternative to traditional center-based CR, has been shown to be both safe and effective in improving clinical and behavioral outcomes. Nevertheless, research on the implementation and effectiveness of tele-CR in Taiwan is still limited. This project spans a three-year period and is divided into two phases. The present study represents the second phase and aims to evaluate the short- and long-term effects of a six-month tele-CR program in patients with CHD. The primary outcomes include quality of life, self-efficacy, self-management, medication adherence, and mental health status (anxiety and depression). In addition, a comprehensive set of metabolic parameters will be assessed, including BMI, SBP, DBP, FBG, HbA1C, and lipid profile markers such as TG, TC, HDL, and LDL. The research hypotheses are as follows: the tele-CR program will (1) improve quality of life, self-efficacy, self-management, and medication adherence; (2) reduce levels of anxiety and depression; and (3) lower blood pressure, blood glucose, BMI, and lipid levels, with these effects being sustained up to 12 months post-discharge. A single-blind, attention-controlled, prospective, randomized clinical trial will be conducted in the cardiology ward of a medical center in northern Taiwan from September 1, 2025, to August 31, 2027. A total of 126 patients diagnosed with CHD will be purposively recruited upon admission. After completing baseline assessments, participants will be randomly assigned in blocks to either the experimental group (n = 63) or the control group (n = 63). The experimental group will participate in a six-month tele-CR program, consisting of in-hospital motivational interviews, mobile application support, self-management education, and seven scheduled follow-up calls. The control group will receive standard care plus seven routine care calls over the same six-month period following discharge. Both groups will continue to receive usual medical and nursing care throughout the study. This study has been reviewed and approved by the Institutional Review Board (IRB) of the study hospital. Research assistants will explain the study's objectives and procedures in detail to all eligible participants. Informed written consent will be obtained only after participants' questions have been addressed. Questionnaire data will be collected either via self-administration or with assistance from trained research personnel, based on participant preference. All data collection will take place in a quiet and private environment to ensure accuracy and participant comfort. Data will be collected at baseline and at 3, 6, 9, and 12 months after discharge, using structured questionnaires and medical records. Baseline values for metabolic indicators will be based on the closest hospitalization date within the three months prior to admission. Post-discharge values will be based on the closest record to the date of each questionnaire completion. All statistical analyses will be performed using SPSS version 26.0. Descriptive statistics (frequencies, percentages, means, and standard deviations) will summarize the participant characteristics and study variables. An intention-to-treat approach will be adopted. To examine the short- and long-term effects of the intervention, generalized estimating equations (GEE) will be used. A two-tailed test with a significance level of p \< 0.05 will be considered statistically significant.

Conditions

• Coronary Heart Disease (CHD)
• Coronary Arterial Disease (CAD)

Interventions

Type	Name	Description
BEHAVIORAL	A tele-CR program	The tele-CR program is divided into three parts: motivational interviewing, app delivery, and self-management and tracking. Motivational interviewing was conducted during hospitalization and involved evaluating individual risk factors, setting behavioral goals, and providing training on the installation and operation of the tele-CR app (approximately 30-60 minutes per session). After discharge, researchers monitored app usage and conducted seven follow-up sessions via LINE or telephone at 1 week, and at 1, 2, 3, 4, 5, and 6 months post-discharge. These follow-ups, each lasting approximately 5-15 minutes, aimed to assess patients' living conditions, address any issues promptly, and provide encouragement or praise based on their engagement with the app. After the completion of the 6-month tele-CR intervention, participants could still actively contact the researchers via LINE or the app to seek health-related assistance according to their personal needs, up to 12 months post-discharge.
OTHER	Attention-controlled	The researchers conducted face-to-face communication with participants in the control group prior to discharge, aiming to establish a professional relationship and advise them to follow routine health education and adopt an appropriate lifestyle. After discharge, follow-up care was provided regularly via LINE or telephone at 1 week, and at 1, 2, 3, 4, 5, and 6 months post-discharge-a total of seven sessions, each lasting approximately 3-5 minutes-to inquire about any symptoms of discomfort.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-10-31
• Completion: 2027-10-31
• First posted: 2025-08-07
• Last updated: 2026-03-20

Locations

1 site across 1 country: Taiwan