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

NCT07110389 | Enrolling By Invitation

• 1 other identifier: 202301928B0-1
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

coronary heart disease; cardiac rehabilitation; telemedicine; mobile health

Outcome Measures

Primary Outcomes (2)

• Level of health-related quality of life

  The Chinese version of the Seattle Angina Questionnaire (SAQ), translated by Tsai and Chie (2002), is used to assess participants' health-related quality of life over the past month. The questionnaire consists of 19 items covering five domains. Each question is scored using an ordinal scale, and each aspect is converted into \[(total score of the aspect question - minimum total score)/scoring range \* 100\] from 0 to 100 points, with higher scores indicating better status in that domain. In this study, the average of three domains-physical activity, angina frequency, and disease perception (each with a score range of 0-100)-is considered the overall SAQ score. A higher total score reflects better overall health-related quality of life (Patel et al., 2018). The test-retest reliability of the Chinese version of the SAQ over 3 to 4 weeks ranges from 0.44 to 0.79; internal consistency ranges from 0.43 to 0.84; and criterion-related validity ranges from 0.44 to 0.84 (Tsai and Chie, 2002).

  baseline, and 3, 6, 9, 12 months after discharge

• Level of general quality of life

  The EuroQol-5-Dimensions-5-Level (EQ-5D-5L) is a widely used generic quality-of-life scale that has been translated into multiple languages and has demonstrated good reliability and validity (EuroQol Research Foundation, 2019; Feng et al., 2021). The five-digit health state profiles are converted into a utility value using a set of weights derived from a Taiwanese population study, ensuring suitability for the Chinese population. The utility value ranges from -1.0259 to 1, where lower values indicate poorer health-related quality of life (Lin et al., 2018). The second component of the EQ-5D-5L is a visual analog scale (VAS) ranging from 0 to 100, where higher scores reflect better self-perceived quality of life (EuroQol Research Foundation, 2019).

  baseline, and 3, 6, 9, 12 months after discharge

Secondary Outcomes (12)

• Level of self-efficacy and self-management

  baseline, and 3, 6, 9, 12 months after discharge

• Level of medication adherence

  baseline, and 3, 6, 9, 12 months after discharge

• Level of anxiety and depression

  baseline, and 3, 6, 9, 12 months after discharge

• Body Mass Index (BMI)

  baseline, and 3, 6, 9, 12 months after discharge

• Systolic Blood Pressure (SBP)

  baseline, and 3, 6, 9, 12 months after discharge

Study Arms (2)

A tele-CR program

EXPERIMENTAL

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.

Behavioral: A tele-CR program

Attention-controlled

OTHER

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.

Other: Attention-controlled

Interventions

A tele-CR program 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.

A tele-CR program

Attention-controlled 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.

Attention-controlled

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The main diagnosis at admission of CHD.
• Age ≥20 years.
• Owns an iOS or Android smartphone and can use it.
• Conscious, clear and can communicate.
• Agrees to participate in the research after explanation and is willing to use the App.

You may not qualify if:

• Level IV on the New York Heart Association Functional Classification.
• Left ventricular ejection fraction\<40%.
• Have a history of severe arrhythmia (e.g., ventricular tachycardia, ventricular fibrillation, complete atrioventricular block).
• Combined with other serious heart diseases (e.g., congenital heart disease, cardiomyopathy).
• Mental disorders, end-stage renal disease and other systemic diseases diagnosed by a physician.
• Severe infection, injury, surgery (e.g., coronary artery bypass graft) or cancer treatment has occurred in the past three months.
• Physical activities are affected by neurological, respiratory, skeletal, or peripheral vascular diseases.
• Restricted use of the App due to sensory or cognitive impairment.
• Already participated in other clinical trials.
• Planning to receive surgery (e.g., coronary artery bypass graft).

Sponsors & Collaborators

• Chang Gung University of Science and Technology: lead
• Chang Gung University: collaborator
• Chang Gung Memorial Hospital: collaborator
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Chang Gung University of Science and Technology

Taoyuan District, Guishan Dist., 333, Taiwan

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The tele-cardiac rehabilitation (tele-CR) program for the intervention group and the attention control for the control group were delivered by the same two researchers. Both researchers are clinical specialists with over 20 years of experience in cardiology. One researcher provided the intervention during hospitalization, while the other managed the post-discharge follow-up and mobile application support. Standard care was provided to both groups throughout the study. Data collection was performed by a single research assistant who was blinded to group allocation. Additionally, ward and outpatient clinical staff involved in patient care and outcome data collection were also blinded to participant group assignments.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 7, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)