Effect of Mindfulness-based eHealth Cardiac Rehabilitation on Psychological Wellbeing and Risk Factor Management of Patients With Coronary Heart Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Perceived stress level
研究概览
简要总结
People with coronary heart disease (CHD) often feel more stressed, which can increase the risk of having another heart problem. Cardiac rehabilitation (CR) is a common treatment for those with CHD, focusing on changing lifestyles and managing the disease. However, it often does not address stress management adequately. There is also a lack of psychological therapy and involvement of mental health professionals in online CR programs. Because traditional CR programs have low participation rates, online platforms are becoming more popular for providing rehabilitation support. This is important because more than half of people with CHD report high stress levels, which can cause or worsen heart problems. To address this issue, the proposed study will test an online CR program that includes mindfulness to help manage stress for CHD patients.
详细描述
The proposed project is a study designed to test the effects of an online cardiac rehabilitation program, which includes mindfulness, on stress and health outcomes for people with coronary heart disease (CHD). The study will last 12 weeks and will be structured as a single-blinded, two-group randomized controlled trial. This means that participants will be randomly assigned to either the treatment group or a control group, and they won't know which group they're in. After the trial, there will be an evaluation to gather more in-depth insights.
Participants will be asked to complete assessments using questionnaires and activity monitors at the start of the study, at 6 weeks, and at 12 weeks. Each assessment will take about 40 minutes, and there will also be a 30 to 40-minute interview.
Those in the intervention group will have a face-to-face meeting to set goals and learn how to use the CR website and activity monitors, which will take about 50 minutes. They will be encouraged to use the website weekly to learn about healthy lifestyle changes, like walking briskly for 30 minutes a day, eating a healthy diet, listening to mindfulness audios, and not smoking. A nurse will call them every two weeks for the first six weeks to check in.
The study is led by an Assistant Professor who has the necessary office space and access to various facilities to support the research. She specializes in cardiovascular health and has established connections in the field of cardiac rehabilitation, which are valuable for successfully conducting the study.
The team includes co-investigators with expertise in physiotherapy, exercise rehabilitation, psychiatric nursing, and intensive care nursing, ensuring the study is well-supported and that results are properly reported and published.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People will be eligible for this study if they were:
- •diagnosed with CHD (within the past 6 months),
- •undergone conservative treatment, such as percutaneous coronary intervention (PCI) and/ or medication,
- •currently under stable medication regimen and discharged to home.
- •aged 18 years or older,
- •reported scores ranging from 3 (to some degree) to 5 (very much) scores on a single-item stress symptoms scale (Elo et al., 2003),
- •using a computer and/or smartphone to access the Internet at home,
- •and, read and speak Chinese.
排除标准
- •diagnosis of acute psychotic disease;
- •presence of a life-limiting condition;
- •prescribed contradictions to physical activity; and,
- •presence of hearing, visual, or ambulatory disorders
结局指标
主要结局
Perceived stress level
时间窗: baseline, 6-week, 12- week
The Perceived Stress Scale (PSS-10), with total scores ranging from 0 to 40 and higher scores indicating higher psychological stress
次要结局
- Anxiety level(baseline, 6-week, 12-week)
- Depression level(baseline, 6-week, 12-week)
- Physical activity(baseline, 6-week, 12-week)
- Sleep(baseline, 6-week, 12-week)
- Health Related Quality of life(baseline, 6-week, 12-week)
研究者
SU JingJing
Assistant Professor
Tung Wah College