Effect of eHealth Cardiac Rehabilitation Incorporating Mindfulness for Patients With Coronary Heart Disease

NCT ID: NCT07109752

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-20
• Study Completion Date: 2026-01-30

Brief 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. 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.

Conditions

Coronary Heart Disease (CHD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

eCR

Intervention arm

Group Type: EXPERIMENTAL

eHealth cardiac rehabilitation

Intervention Type: BEHAVIORAL

A face-to-face interview for goal setting and action planning, as well as learning the use of CR website and accelerometer.

Control

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

eHealth cardiac rehabilitation

A face-to-face interview for goal setting and action planning, as well as learning the use of CR website and accelerometer.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

People will be eligible for this study if they were:

1. diagnosed with CHD (within the past 6 months),

2. undergone conservative treatment, such as percutaneous coronary intervention (PCI) and/ or medication,

3. currently under stable medication regimen and discharged to home.

4. aged 18 years or older,

5. reported scores ranging from 3 (to some degree) to 5 (very much) scores on a single-item stress symptoms scale (Elo et al., 2003),

6. using a computer and/or smartphone to access the Internet at home,

7. and, read and speak Chinese.

Exclusion Criteria

1. diagnosis of acute psychotic disease;

2. presence of a life-limiting condition;

3. prescribed contradictions to physical activity; and,

4. presence of hearing, visual, or ambulatory disorders

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tung Wah College

OTHER

Sponsor Role: lead

Responsible Party

SU JingJing

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tung Wah College

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Jingjing Su, PhD

Role: CONTACT

jjsu@twc.edu.hk

852-37256115

Facility Contacts

Jingjing Su, PhD

Role: primary

jjsu@twc.edu.hk

852-3725 6115

References

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.

Reference Type: BACKGROUND

PMID: 36692413 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

REC2024214

Identifier Type: OTHER

Identifier Source: secondary_id

TungWC REC2024214

Identifier Type: -

Identifier Source: org_study_id