Effectiveness of a Mobile Application-Based Tele-cardiac Rehabilitation (Tele-CR) Program for Patients With Coronary Heart Disease (CHD): A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Level of health-related quality of life
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Level of health-related quality of life
时间窗: 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
时间窗: 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).
次要结局
- Level of self-efficacy and self-management(baseline, and 3, 6, 9, 12 months after discharge)
- Systolic Blood Pressure (SBP)(baseline, and 3, 6, 9, 12 months after discharge)
- Fasting Blood Glucose (FBG)(baseline, and 3, 6, 9, 12 months after discharge)
- Level of medication adherence(baseline, and 3, 6, 9, 12 months after discharge)
- High-Density Lipoprotein (HDL)(baseline, and 3, 6, 9, 12 months after discharge)
- Low-Density Lipoprotein (LDL)(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)
- Total Cholesterol (TC)(baseline, and 3, 6, 9, 12 months after discharge)
- Diastolic Blood Pressure (DBP)(baseline, and 3, 6, 9, 12 months after discharge)
- Glycosylated Hemoglobin (HbA1c)(baseline, and 3, 6, 9, 12 months after discharge)
- Triglycerides (TG)(baseline, and 3, 6, 9, 12 months after discharge)
