Effectiveness of a Tele-cardiac Rehabilitation (Tele-CR) Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: A tele-CR program, Attention-controlled.
- Who it may be relevant to
- Registry conditions: Coronary Heart Disease (CHD), Coronary Arterial Disease (CAD). Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of a Mobile Application-Based Tele-cardiac Rehabilitation (Tele-CR) Program for Patients With Coronary Heart Disease (CHD): A Randomized Clinical Trial
Overview
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.
Interventions
- 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 wee - 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.
Primary outcome measures
- Level of health-related quality of life [Time frame: baseline, and 3, 6, 9, 12 months after discharge]
- Level of general quality of life [Time frame: baseline, and 3, 6, 9, 12 months after discharge]
Secondary outcome measures (12)
- Level of self-efficacy and self-management [Time frame: baseline, and 3, 6, 9, 12 months after discharge]
- Level of medication adherence [Time frame: baseline, and 3, 6, 9, 12 months after discharge]
- Level of anxiety and depression [Time frame: baseline, and 3, 6, 9, 12 months after discharge]
- Body Mass Index (BMI) [Time frame: baseline, and 3, 6, 9, 12 months after discharge]
- Systolic Blood Pressure (SBP) [Time frame: baseline, and 3, 6, 9, 12 months after discharge]
- Diastolic Blood Pressure (DBP) [Time frame: baseline, and 3, 6, 9, 12 months after discharge]
- Fasting Blood Glucose (FBG) [Time frame: baseline, and 3, 6, 9, 12 months after discharge]
- Glycosylated Hemoglobin (HbA1c) [Time frame: baseline, and 3, 6, 9, 12 months after discharge]
- Triglycerides (TG) [Time frame: baseline, and 3, 6, 9, 12 months after discharge]
- Total Cholesterol (TC) [Time frame: baseline, and 3, 6, 9, 12 months after discharge]
- High-Density Lipoprotein (HDL) [Time frame: baseline, and 3, 6, 9, 12 months after discharge]
- Low-Density Lipoprotein (LDL) [Time frame: baseline, and 3, 6, 9, 12 months after discharge]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
Taiwan · 1 center
- Chang Gung University of Science and Technology — Taoyuan
Identifiers
NCT: NCT07110389 · 202301928B0-1