Coronary Heart Disease (CHD)eCRNCT07109752
Effect of eHealth Cardiac Rehabilitation Incorporating Mindfulness for Patients With Coronary Heart Disease
A study testing eHealth cardiac rehabilitation in people with Coronary Heart Disease (CHD), run by Tung Wah College at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease (CHD)
- What is being tested?
- eHealth cardiac rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Jul 2024to 30 Jan 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- diagnosis of acute psychotic disease;
- presence of a life-limiting condition;
- prescribed contradictions to physical activity; and,
- presence of hearing, visual, or ambulatory disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Tung Wah College
Hong Kong
Jingjing Su, PhD, 852-3725 6115, jjsu@twc.edu.hk
About this study
Official title: Effect of Mindfulness-based eHealth Cardiac Rehabilitation on Psychological Wellbeing and Risk Factor Management of Patients With Coronary Heart Disease: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Coronary Heart Disease (CHD)
- Being tested
- eHealth cardiac rehabilitation
- Keywords
- cardiac rehabilitation, mindfulness, eHealth
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eHealth cardiac rehabilitationBehavioural
A face-to-face interview for goal setting and action planning, as well as learning the use of CR website and accelerometer.
| Study group | Role | What they receive |
|---|---|---|
| eCR | Experimental | Intervention arm Receives: Behavioral: eHealth cardiac rehabilitation |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived stress level
The Perceived Stress Scale (PSS-10), with total scores ranging from 0 to 40 and higher scores indicating higher psychological stress
Measured: baseline, 6-week, 12- week
Secondary outcomes (5)
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.
Measured: baseline, 6-week, 12-week
Depression level
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.
Measured: baseline, 6-week, 12-week
Physical activity
Daily steps measured by accelerometer
Measured: baseline, 6-week, 12-week
Sleep
Sleep time measured by accelerometer
Measured: 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
Measured: baseline, 6-week, 12-week
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 start20 Jul 2024
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tung Wah College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SU JingJing, Tung Wah College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109752
- Sponsor's protocol ID
- TungWC REC2024214
- Other IDs
- REC2024214
- Acronym
- eCR
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 36692413
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mindfulness-based eHealth Cardiac Rehabilitation on Psychological Wellbeing and Risk Factor Management of Patients With Coronary Heart Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07109752
- Acronym / sponsor ID
- eCR / TungWC REC2024214
- Conditions
- Coronary Heart Disease (CHD)
- Keywords
- cardiac rehabilitation, mindfulness, eHealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Tung Wah CollegeUniversity, hospital or other
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jan 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eCR | Experimental | Behavioral: eHealth cardiac rehabilitationIntervention arm |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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),
Key exclusion criteria (4 listed)
- diagnosis of acute psychotic disease;
- presence of a life-limiting condition;
- prescribed contradictions to physical activity; and,
- presence of hearing, visual, or ambulatory disorders
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 |
|---|---|---|
| eHealth cardiac rehabilitationA face-to-face interview for goal setting and action planning, as well as learning the use of CR website and accelerometer. | Behavioural | eCR |
Primary outcome
Perceived stress level
Time frame: 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
5 secondary outcomes
Anxiety level
Time frame: baseline, 6-week, 12-week
Depression level
Time frame: baseline, 6-week, 12-week
Physical activity
Time frame: baseline, 6-week, 12-week
Sleep
Time frame: baseline, 6-week, 12-week
Health Related Quality of life
Time frame: baseline, 6-week, 12-week
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 7 Aug 2025.
- Background: PubMed 36692413Batalik 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.
- Individual participant dataSharing planned: No. 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eHealth cardiac rehabilitation in people with Coronary Heart Disease (CHD), run by Tung Wah College at 1 site in Hong Kong.
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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 7 Aug 2025. 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 Hong Kong. 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?
Contact Jingjing Su, PhD (852-37256115, jjsu@twc.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived stress level (time frame: baseline, 6-week, 12- week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07109752, which also lists 1 linked publication.
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 7 Aug 2025.