Enrolling by invitation
Not applicable
Effectiveness of a Tele-cardiac Rehabilitation (Tele-CR) Program
Condition(s) studied
Coronary Heart Disease (CHD)Coronary Arterial Disease (CAD)
Investigational drug(s) / intervention(s)
A tele-CR programAttention-controlled
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.
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.
Study 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).
Eligibility
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).
Primary outcome measure(s)
- Level of health-related quality of life — baseline, and 3, 6, 9, 12 months after discharge
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).
- Level of general quality of life — baseline, and 3, 6, 9, 12 months after discharge
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).
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Chang Gung University of Science and Technology |
Taoyuan |
Guishan Dist. |
|
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