Telehealth Program Effectiveness in Reducing Cardiac Symptom Distress, Improving Self-care, and Enhancing Quality of Life Among Coronary Artery Disease Patients After Bypass Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Cardiac Symptom Distress
研究概览
简要总结
The goal of this randomized trial is to compare the outcomes of a telehealth program with conventional discharge care for patients aged 18 years and older with coronary artery disease following coronary artery bypass surgery. The main question it seeks to answer are:
- To investigate whether there is a difference in symptom distress between patients with coronary artery disease receiving a telehealth program after CABG (experimental group) and those receiving usual care (control group).
- To examine whether there is a difference in self-care behaviors between patients with coronary artery disease receiving a telehealth program after CABG (experimental group) and those receiving usual care (control group).
- To investigate whether there is a difference in the quality of life of patients with coronary artery disease receiving a telehealth program (experimental group) after CABG compared to those receiving usual care (control group).
Participants will be randomly assigned to one of two groups: either a telehealth program or usual care. The Symptom Distress, Self-Care, and SF-12 Quality of Life Questionnaire will be used to assess and track symptom distress, self-care, and quality of life two days prior to discharge, during the first post-discharge visit (days 7 to 10), and in the fourth week post-discharge. The aim is to alleviate symptom distress in patients returning home after coronary artery bypass surgery, enhance self-care behaviors, and ultimately improve quality of life. This study seeks to maximize the benefits of a telehealth program, establishing it as an important care strategy for future integration with hospital-based care.
详细描述
The purpose of this study is to evaluate the effectiveness of a telehealth program for patients discharged after coronary artery bypass surgery, specifically examining whether it reduces symptom distress, improves self-care skills, and enhances quality of life compared to usual care.
Background:
Cardiovascular diseases (CVD) contribute substantially to global mortality rates and have consistently ranked as the second leading cause of death in Taiwan for many years.Coronary artery bypass graft (CABG) is an important and common surgical procedure for treating cardiovascular disease. However, one in four patients who undergo CABG suffers from postoperative complications, including pain, wound infections, and sleep disturbances, which can further impact their quality of life. Some of these symptoms may last from weeks to months, and if left unresolved, they may hinder the patient's recovery and increase the risk of death. Additionally, shorter hospital stays make it more challenging for patients to transition from hospital to home and adjust to changes in their lives, which can lead to poorer self-care behaviors and worsen complications such as heart failure, wound infections, and cardiac arrhythmia, seriously affecting their quality of life.
Telehealth refers to the use of communication technology, electronic medical equipment, and professional medical technology to provide the public with a wider range of medical care services in familiar community or home environments, facilitating local aging. Its functions and benefits encompass four major dimensions:
- . Physiological information monitoring: This includes the transmission, storage, and utilization of data such as blood pressure, blood glucose, and pulse. The consolidated data can serve as a basis for adjusting medication.
- . Contact and coordination of care services: This involves emergency responses from the patient side, monitoring of abnormal signals, and reminders for follow-up visits.
- . Assistance in self-health management: This entails monitoring changes in the patient's daily physiological parameters and encouraging self-management and tracking, including exercise, medication, diet, and maintaining a healthy lifestyle.
- Video consultations: Nurses and patients can communicate over long distances to achieve effective monitoring and control, breaking geographical constraints. This allows for customized health consultations and guidance, as well as emotional support.
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult ≧18 years old
- •Ability to read and answer questionnaires in Chinese.
- •After coronary artery bypass surgery (CABG)
- •Able to install and download the QOCA ECG software on their cell phones
排除标准
- •Inability to communicate effectively and cognitive impairment
- •Unable to take care of themselves or are physically disabled.
研究组 & 干预措施
Telehealth
Through remote monitoring of various physiological data uploaded by the patient, immediate contact will be made when abnormal values are detected to provide individualized health education. This approach encourages the maintenance of a healthy lifestyle and facilitates early problem detection to prevent the worsening of symptoms.
干预措施: QOCA EKG Device (Device)
Usual care
Provide post-operative education on the day of discharge and follow up with a phone call one week after discharge to check on the patient.
干预措施: Usual Care (Other)
结局指标
主要结局
Cardiac Symptom Distress
时间窗: Three time points: pre-test (before intervention, 0 weeks), mid-test (after intervention, approximately 7-10 days), post-test (after all interventions are completed, 4 weeks).
Through regular monitoring and 24-hour online counseling services, telehealth can provide timely solutions to patients' physical symptoms, thus reducing their symptoms and discomfort.
Self-care
时间窗: Three time points: pre-test (before intervention, 0 weeks), mid-test (after intervention, approximately 7-10 days), post-test (after all interventions are completed, 4 weeks).
Enhance self-care skills and provide individualized hygiene education to improve patients' ability to cope with changes.
Cardiac Symptom Distress Score
时间窗: Assessed at three time points: baseline (2 days before hospital discharge), 7-10 days after hospital discharge, and 4 weeks after hospital discharge
Cardiac symptom distress was assessed using the Cardiac Symptom Survey (CSS). The CSS consists of 10 items assessing common cardiac-related symptoms, including angina, shortness of breath, fatigue, depression, sleep disturbance, incisional pain, leg edema, palpitations, anxiety, and loss of appetite. For each symptom, participants rated symptom frequency and severity on separate 0-10 scales (0 = none, 10 = extremely severe). A mean score for each symptom was calculated by averaging the frequency and severity ratings. The total cardiac symptom distress score was obtained by summing the mean scores of all 10 symptoms, with higher scores indicating greater symptom distress.
次要结局
- Self-care Behavior Score(Assessed at three time points: baseline (2 days before hospital discharge), 7-10 days after hospital discharge, and 4 weeks after hospital discharge)
- SF-12 Physical Component Summary (PCS)(Assessed at three time points: baseline (2 days before hospital discharge), 7-10 days after hospital discharge, and 4 weeks after hospital discharge)
- SF-12 Mental Component Summary (MCS)(Assessed at three time points: baseline (2 days before hospital discharge), 7-10 days after hospital discharge, and 4 weeks after hospital discharge)