Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| REC2024214 | Other Identifier | Tung Wah College |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eCR | Experimental | Intervention arm |
|
| Control | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eHealth cardiac rehabilitation | Behavioral | A face-to-face interview for goal setting and action planning, as well as learning the use of CR website and accelerometer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perceived stress level | The Perceived Stress Scale (PSS-10), with total scores ranging from 0 to 40 and higher scores indicating higher psychological stress | baseline, 6-week, 12- week |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety level | Generalized Anxiety Disorder 7-item, seven items ranges from 0 to 21 scores. 0-4: minimal anxiety. 5-9: mild anxiety. 10-14: moderate anxiety. 15-21: severe anxiety. | baseline, 6-week, 12-week |
| Depression level |
Not provided
Inclusion Criteria:
People will be eligible for this study if they were:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingjing Su, PhD | Contact | 852-37256115 | jjsu@twc.edu.hk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tung Wah College | Recruiting | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36692413 | Background | Batalik L, Filakova K, Sladeckova M, Dosbaba F, Su J, Pepera G. The cost-effectiveness of exercise-based cardiac telerehabilitation intervention: a systematic review. Eur J Phys Rehabil Med. 2023 Apr;59(2):248-258. doi: 10.23736/S1973-9087.23.07773-0. Epub 2023 Jan 24. |
Not provided
Not provided
Participants may not have given explicit consent for their data to be shared beyond the initial study, limiting the ability to share their data legally and ethically.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 17, 2024 | Jul 30, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patient Health Questionnaire (PHQ-9) with total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.
| baseline, 6-week, 12-week |
| Physical activity | Daily steps measured by accelerometer | baseline, 6-week, 12-week |
| Sleep | Sleep time measured by accelerometer | baseline, 6-week, 12-week |
| Health Related Quality of life | Short-Form Six Dimensions (SF-6D), six items ranged from 6- 37 scores, with higher score indicate lower quality of life | baseline, 6-week, 12-week |