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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTung Wah College

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: eCRExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Perceived stress level

The Perceived Stress Scale (PSS-10), with total scores ranging from 0 to 40 and higher scores indicating higher psychological stress

Time frame
baseline, 6-week, 12- week

Secondary outcomes

1

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.

Time frame
baseline, 6-week, 12-week
2

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.

Time frame
baseline, 6-week, 12-week
3

Physical activity

Daily steps measured by accelerometer

Time frame
baseline, 6-week, 12-week
4

Sleep

Sleep time measured by accelerometer

Time frame
baseline, 6-week, 12-week

Other outcomes

Sponsors and contacts

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