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

NCT06648291 | Completed Results

• 1 other identifier: 202307014RINA
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 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).

Conditions

Telehealth; Coronary Artery Bypass Surgery

Keywords

symptoms distress; self-care; quality of life

Outcome Measures

Primary Outcomes (1)

• Cardiac Symptom Distress Score

  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 scores of all 10 symptoms, with higher scores indicating greater symptom distress.

  Assessed at three time points: baseline (2 days before hospital discharge), 7-10 days after hospital discharge, and 4 weeks after hospital discharge

Secondary Outcomes (3)

• Self-care Behavior Score

  Assessed at three time points: baseline (2 days before hospital discharge), 7-10 days after hospital discharge, and 4 weeks after hospital discharge

• SF-12 Physical Component Summary (PCS)

  Assessed at three time points: baseline (2 days before hospital discharge), 7-10 days after hospital discharge, and 4 weeks after hospital discharge

• SF-12 Mental Component Summary (MCS)

  Assessed at three time points: baseline (2 days before hospital discharge), 7-10 days after hospital discharge, and 4 weeks after hospital discharge

Study Arms (2)

Telehealth

EXPERIMENTAL

Through remote monitoring of various physiological data uploaded by the patient, immediate contact will be made when abnormal values are detected to provide individualized health education. This approach encourages the maintenance of a healthy lifestyle and facilitates early problem detection to prevent the worsening of symptoms.

Device: QOCA EKG Device

Usual care

PLACEBO COMPARATOR

Provide post-operative education on the day of discharge and follow up with a phone call one week after discharge to check on the patient.

Other: Usual Care

Interventions

QOCA EKG Device DEVICE

The investigators scheduled telephone interviews every three days to encourage and monitor the development of good self-health care behaviors by: (1) asking about daily blood pressure, weight, and lower extremity edema; (2) providing medication counseling, as well as exercise and dietary hygiene recommendations; (3) offering wound care guidance; (4) advising on the proper use of wounds; (5) advising on avoiding cardiac risk factors such as smoking and secondhand smoke; and (6) following up on physical status at outpatient clinics and assisting with referrals to relevant clinics, such as nutrition or rehabilitation, based on the patient's condition. A QOCA portable electrocardiogram (ECG) measurement device will be provided for patients to use at home. In the event of abnormal physiological values, the investigator will contact the patient to assess his or her medical status and provide 24-hour online counseling.

Telehealth

Usual Care OTHER

Provide post-operative education on the day of discharge and follow up with a phone call one week after discharge to check on the patient.

Usual care

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult ≧18 years old
• Ability to read and answer questionnaires in Chinese.
• After coronary artery bypass surgery (CABG)
• Able to install and download the QOCA ECG software on their cell phones

You may not qualify if:

• Inability to communicate effectively and cognitive impairment
• Unable to take care of themselves or are physically disabled.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Chih-Hui Shih

Taipei County, Taiwan

Location

Results Point of Contact

• Title: Chih-Huei Szu, RN, Case Manager
• Organization: National Taiwan University Hospital

105303@ntuh.gov.tw

886-923-128-551

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: October 18, 2024
• Study Start: September 14, 2023
• Primary Completion: January 19, 2025
• Study Completion: January 19, 2025
• Last Updated: April 28, 2026
• Results First Posted: February 9, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)