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

NCT ID: NCT07110389

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-08-31

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

A tele-CR program

The six-month tele-cardiac rehabilitation (tele-CR) program consists of three components: motivational interviewing, mobile application (App) implementation, and self-management with follow-up tracking.

Group Type: EXPERIMENTAL

A tele-CR program

Intervention Type: BEHAVIORAL

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.

Attention-controlled

The control group received regular contact via LINE or telephone for six months following discharge, matched in frequency and duration to the follow-up provided in the intervention group.

Group Type: OTHER

Attention-controlled

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. The main diagnosis at admission of CHD.

2. Age ≥20 years.

3. Owns an iOS or Android smartphone and can use it.

4. Conscious, clear and can communicate.

5. Agrees to participate in the research after explanation and is willing to use the App.

Exclusion Criteria

1. Level IV on the New York Heart Association Functional Classification.

2. Left ventricular ejection fraction<40%.

3. Have a history of severe arrhythmia (e.g., ventricular tachycardia, ventricular fibrillation, complete atrioventricular block).

4. Combined with other serious heart diseases (e.g., congenital heart disease, cardiomyopathy).

5. Mental disorders, end-stage renal disease and other systemic diseases diagnosed by a physician.

6. Severe infection, injury, surgery (e.g., coronary artery bypass graft) or cancer treatment has occurred in the past three months.

7. Physical activities are affected by neurological, respiratory, skeletal, or peripheral vascular diseases.

8. Restricted use of the App due to sensory or cognitive impairment.

9. Already participated in other clinical trials.

10. Planning to receive surgery (e.g., coronary artery bypass graft).

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Chang Gung University

OTHER

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: collaborator

Chang Gung University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chang Gung University of Science and Technology

Taoyuan District, Guishan Dist., Taiwan

Countries

Taiwan

Central Contacts

Ching-Ching Tsai, PhD

Role: CONTACT

cctsai@gw.cgust.edu.tw

886+32118999 ext. 3325

Other Identifiers

202301928B0-1

Identifier Type: -

Identifier Source: org_study_id