NCT06648291

The Effectiveness of a Telehealth Program on Cardiac Symptom Distress, Self-care and Quality of Life of Patients With Coronary Artery Disease After Coronary Artery Bypass Surgery: A Randomized Study

Completed NA Results posted Last updated 9 February 2026

What this trial tests

NA trial testing QOCA EKG Device in Telehealth in 160 participants. Completed in 19 January 2025.

Timeline

14 September 2023

Primary endpoint
19 January 2025

19 January 2025

Quick facts

Lead sponsor	National Taiwan University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	160
Start date	14 September 2023
Primary completion	19 January 2025
Estimated completion	19 January 2025
Sites	1 location across Taiwan

Drugs / interventions tested

• QOCA EKG Device
• Usual Care

Conditions studied

• Telehealth — all drugs for Telehealth →
• Coronary Artery Bypass Surgery — all drugs for Coronary Artery Bypass Surgery →

Sponsor

National Taiwan University Hospital

Who can join

Adults 18 to 99, any sex, with Telehealth or Coronary Artery Bypass Surgery. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cardiac Symptom Distress Score Primary · Assessed at three time points: baseline (2 days before hospital discharge), 7-10 days after hospital discharge, and 4 weeks after hospital discharge

Cardiac symptom distress was assessed using the Cardiac Symptom Survey (CSS). The CSS consists of 10 items assessing common cardiac-related symptoms, including angina, shortness of breath, fatigue, depression, sleep disturbance, incisional pain, leg edema, palpitations, anxiety, and loss of appetite. For each symptom, participants rated symptom frequency and severity on separate 0-10 scales (0 = none, 10 = extremely severe). A mean score for each symptom was calculated by averaging the frequency and severity ratings. The total cardiac symptom distress score was obtained by summing the mean sc

Baseline (2 days before hospital discharge)

Group	Value	95% CI
Telehealth	15.24	± 10.61
Usual Care	12.84	± 8.94

7-10 days after hospital discharge

Group	Value	95% CI
Telehealth	12.81	± 11.57
Usual Care	11.87	± 10.68

4 weeks after hospital discharge

Group	Value	95% CI
Telehealth	8.1	± 8.07
Usual Care	11.76	± 12.21

Self-care Behavior Score Secondary · Assessed at three time points: baseline (2 days before hospital discharge), 7-10 days after hospital discharge, and 4 weeks after hospital discharge

Self-care behavior was assessed using the Self-Care Behavior Scale developed for patients undergoing coronary artery bypass graft surgery. The scale consists of 16 items assessing engagement in self-care activities and control of cardiovascular risk factors. Each item is rated on a 4-point Likert scale (1 = never to 4 = always). Item scores are summed to yield a total score ranging from 16 to 64, with higher scores indicating better self-care behavior. Units of measure: scores on a scale.

Baseline (2 days before hospital discharge)

Group	Value	95% CI
Usual Care	50.57	± 8.59
Telehealth	49.60	± 8.4

7-10 days after hospital discharge

Group	Value	95% CI
Usual Care	58.59	± 3.93
Telehealth	57.16	± 5.53

4 weeks after hospital discharge

Group	Value	95% CI
Usual Care	59.94	± 4.16
Telehealth	56.93	± 6.31

SF-12 Physical Component Summary (PCS) Secondary · Assessed at three time points: baseline (2 days before hospital discharge), 7-10 days after hospital discharge, and 4 weeks after hospital discharge

Health-related quality of life was assessed using the 12-Item Short Form Health Survey (SF-12, Version 1). The Physical Component Summary (PCS) score reflects physical aspects of health-related quality of life and is derived from the physical health-related domains of the SF-12. PCS scores are standardized on a 0-100 scale, with higher scores indicating better physical health status. Units of measure: scores on a scale.

Baseline (2 days before hospital discharge)

Group	Value	95% CI
Telehealth	30.48	± 5.75
Usual Care	32.49	± 6.96

7-10 days after hospital discharge

Group	Value	95% CI
Telehealth	35.38	± 8.94
Usual Care	35.21	± 8.35

4 weeks after hospital discharge

Group	Value	95% CI
Telehealth	37.92	± 8.53
Usual Care	37.36	± 8.88

SF-12 Mental Component Summary (MCS) Secondary · Assessed at three time points: baseline (2 days before hospital discharge), 7-10 days after hospital discharge, and 4 weeks after hospital discharge

Health-related quality of life was assessed using the 12-Item Short Form Health Survey (SF-12, Version 1). The Mental Component Summary (MCS) score reflects the mental and emotional aspects of health-related quality of life, including vitality, social functioning, role limitations due to emotional problems, and mental health. The MCS score is a norm-based summary score derived from weighted combinations of SF-12 item responses according to standard scoring algorithms. Scores are standardized on a 0-100 scale, with higher scores indicating better mental health status. Units of measure: scores o

Baseline (2 days before hospital discharge)

Group	Value	95% CI
Telehealth	47.96	± 10.71
Usual Care	49.27	± 10.47

7-10 days after hospital discharge

Group	Value	95% CI
Telehealth	48.28	± 9.63
Usual Care	50.36	± 10.04

4 weeks after hospital discharge

Group	Value	95% CI
Telehealth	50.53	± 9.29
Usual Care	50.18	± 10.28

Sponsor's own description

The goal of this randomized trial is to compare the outcomes of a telehealth program with conventional discharge care for patients aged 18 years and older with coronary artery disease following coronary artery bypass surgery. The main question it seeks to answer are:

1. To investigate whether there is a difference in symptom distress between patients with coronary artery disease receiving a telehealth program after CABG (experimental group) and those receiving usual care (control group).
2. To examine whether there is a difference in self-care behaviors between patients with coronary artery disease receiving a telehealth program after CABG (experimental group) and those receiving usual care (control group).
3. To investigate whether there is a difference in the quality of life of patients with coronary artery disease receiving a telehealth program (experimental group) after CABG compared to those receiving usual care (control group).

Participants will be randomly assigned to one of two groups: either a telehealth program or usual care. The Symptom Distress, Self-Care, and SF-12 Quality of Life Questionnaire will be used to assess and track symptom distress, self-care, and quality of life two days prior to discharge, during the first post-discharge visit (days 7 to 10), and in the fourth week post-discharge. The aim is to alleviate symptom distress in patients returning home after coronary artery bypass surgery, enhance self-care behaviors, and ultimately improve quality of life. This study seeks to maximize the benefits of a telehealth program, establishing it as an important care strategy for future integration with hospital-based care.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.