Coronary Heart Disease (CHD)NCT07110389
Effectiveness of a Tele-cardiac Rehabilitation (Tele-CR) Program
A study testing A tele-CR program in people with Coronary Heart Disease (CHD) and Coronary Arterial Disease (CAD), run by Chang Gung University of Science and Technology at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Heart Disease (CHD), Coronary Arterial Disease (CAD)
- What is being tested?
- A tele-CR program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2025to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Chang Gung University of Science and Technology
Taoyuan, Guishan Dist., 333
About this study
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
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).
Read the 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.
- Being tested
- A tele-CR program, Attention-controlled
- Keywords
- coronary heart disease, cardiac rehabilitation, telemedicine, mobile health
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A tele-CR programBehavioural
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-controlledOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Attention-controlled |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: baseline, and 3, 6, 9, 12 months after discharge
Secondary outcomes (12)
Level of self-efficacy and self-management
This study used the Chinese version of the Heart Health Self-Efficacy and Self-Management (HH-SESM) scale, translated and revised by Wu et al. (2022). The scale comprises 12 items covering domains such as physical activity, diet, medication, psychosocial factors, weight management, and smoking. Each item includes two parts: self-efficacy and self-management. The self-efficacy subscale asks, "How confident are you that you can do the following?", while the self-management subscale asks, "How often do you do the following?" Both are scored using a 4-point Likert scale. Higher total scores indicate greater levels of self-efficacy and self-management. The internal consistency of the Chinese version of the HH-SESM ranges from 0.72 to 0.77; the two-week test-retest reliability ranges from 0.71 to 0.76; the split-half reliability is between 0.79 and 0.80; and the explained variance ranges from 25.2% to 31.1% (Wu et al., 2022).
Measured: baseline, and 3, 6, 9, 12 months after discharge
Level of medication adherence
The 8-item version Morisky Medication Adherence Scale (MMAS-8) consists of 8 items. Each of the first 7 items has 2 possible responses (yes/no), while the 8th item is answered with a 5-point Likert scale. The possible total medication adherence score ranges between 0 and 8, and the higher the score, the better the adherence level. A total score < 6 isconsidered low adherence, while a total score of ≥ 6 but < 8 indicates moderate adherence, and a scoreof 8 indicates high adherence (Berlowitz et al., 2017; Bress et al., 2017). The original MMAS-8 has demonstrated good reliability and validity (Moon et al., 2017). For the Chinese version, internal consistency ranges from 0.65 to 0.83, explaining approximately 46% of the variance, with a test-retest correlation coefficient of 0.80 (Ho \& Lee, 2014; Wang et al., 2013).
Measured: baseline, and 3, 6, 9, 12 months after discharge
Level of anxiety and depression
The original version of the Hospital Anxiety and Depression Scale (HADS) was developed by Zigmond and Snaith in 1983. The Chinese version of the HADS is used to assess anxiety and depression symptoms experienced by individuals over the past week. It consists of 14 items, with 7 items measuring anxiety and 7 items measuring depression. Each item is rated on a four-point scale (0-3), yielding subscale scores ranging from 0 to 21. Higher scores indicate more severe levels of anxiety or depression. The internal consistency of the Chinese version of the HADS ranges from 0.77 to 0.82, and the one-week test-retest reliability ranges from 0.64 to 0.83 (Chen et al., 1999).
Measured: baseline, and 3, 6, 9, 12 months after discharge
Body Mass Index (BMI)
Values will be extracted from medical records. The baseline value will be based on the closest hospitalization date within the three months before hospitalization. The post-discharge value will be based on the closest questionnaire filling date (i.e., at 3, 6, 9, and 12 months after discharge). BMI will be calculated using body weight (in kilograms) and height (in meters) according to the formula: BMI = weight (kg) / [height (m)]².
Unit of measure: Kilograms per square meter (kg/m²).
Measured: baseline, and 3, 6, 9, 12 months after discharge
Systolic Blood Pressure (SBP)
Values will be extracted from medical records. The baseline value will be based on the closest hospitalization date within the three months before hospitalization. The post-discharge value will be based on the closest questionnaire filling date (i.e., at 3, 6, 9, and 12 months after discharge).
Unit of measure: Millimeters of mercury (mmHg).
Measured: baseline, and 3, 6, 9, 12 months after discharge
Diastolic Blood Pressure (DBP)
Values will be extracted from medical records. The baseline value will be based on the closest hospitalization date within the three months before hospitalization. The post-discharge value will be based on the closest questionnaire filling date (i.e., at 3, 6, 9, and 12 months after discharge).
Unit of measure: Millimeters of mercury (mmHg).
Measured: baseline, and 3, 6, 9, 12 months after discharge
Fasting Blood Glucose (FBG)
Values will be extracted from medical records. The baseline value will be based on the closest hospitalization date within the three months before hospitalization. The post-discharge value will be based on the closest questionnaire filling date (i.e., at 3, 6, 9, and 12 months after discharge).
Unit of measure: Milligrams per deciliter (mg/dL).
Measured: baseline, and 3, 6, 9, 12 months after discharge
Glycosylated Hemoglobin (HbA1c)
Values will be extracted from medical records. The baseline value will be based on the closest hospitalization date within the three months before hospitalization. The post-discharge value will be based on the closest questionnaire filling date (i.e., at 3, 6, 9, and 12 months after discharge).
Unit of measure: Percentage (%).
Measured: baseline, and 3, 6, 9, 12 months after discharge
Triglycerides (TG)
Values will be extracted from medical records. The baseline value will be based on the closest hospitalization date within the three months before hospitalization. The post-discharge value will be based on the closest questionnaire filling date (i.e., at 3, 6, 9, and 12 months after discharge).
Unit of measure: Milligrams per deciliter (mg/dL).
Measured: baseline, and 3, 6, 9, 12 months after discharge
Total Cholesterol (TC)
Values will be extracted from medical records. The baseline value will be based on the closest hospitalization date within the three months before hospitalization. The post-discharge value will be based on the closest questionnaire filling date (i.e., at 3, 6, 9, and 12 months after discharge).
Unit of measure: Milligrams per deciliter (mg/dL).
Measured: baseline, and 3, 6, 9, 12 months after discharge
High-Density Lipoprotein (HDL)
Values will be extracted from medical records. The baseline value will be based on the closest hospitalization date within the three months before hospitalization. The post-discharge value will be based on the closest questionnaire filling date (i.e., at 3, 6, 9, and 12 months after discharge).
Unit of measure: Milligrams per deciliter (mg/dL).
Measured: baseline, and 3, 6, 9, 12 months after discharge
Low-Density Lipoprotein (LDL)
Values will be extracted from medical records. The baseline value will be based on the closest hospitalization date within the three months before hospitalization. The post-discharge value will be based on the closest questionnaire filling date (i.e., at 3, 6, 9, and 12 months after discharge).
Unit of measure: Milligrams per deciliter (mg/dL).
Measured: baseline, and 3, 6, 9, 12 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Oct 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart Disease (CHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, Chang Gung University, Chang Gung Memorial Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110389
- Sponsor's protocol ID
- 202301928B0-1
- Status last verified
- Mar 2026
- First submitted
- 25 Jul 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study involves sensitive health information, and the informed consent obtained from participants does not include permission for public sharing of individual-level data. Data sharing is also restricted by applicable privacy laws and institutional policies to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07110389
- Acronym / sponsor ID
- 202301928B0-1
- Keywords
- coronary heart disease, cardiac rehabilitation, telemedicine, mobile health
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Chang Gung University of Science and TechnologyUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, Chang Gung University, Chang Gung Memorial Hospital
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A tele-CR program | Experimental | Behavioral: A tele-CR programThe 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. |
| Attention-controlled | Other | Other: Attention-controlledThe 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A tele-CR programThe 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. | Behavioural | A tele-CR program |
| Attention-controlledThe 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. | Other | Attention-controlled |
Primary outcome
Level of health-related quality of life
Time frame: 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
Time frame: 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).
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study involves sensitive health information, and the informed consent obtained from participants does not include permission for public sharing of individual-level data. Data sharing is also restricted by applicable privacy laws and institutional policies to protect participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A tele-CR program in people with Coronary Heart Disease (CHD) and Coronary Arterial Disease (CAD), run by Chang Gung University of Science and Technology at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of health-related quality of life (time frame: baseline, and 3, 6, 9, 12 months after discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.