Trial Outcomes & Findings for 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 (NCT NCT06648291)
NCT ID: NCT06648291
Last Updated: 2026-04-28
Results Overview
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.
COMPLETED
NA
160 participants
Assessed at three time points: baseline (2 days before hospital discharge), 7-10 days after hospital discharge, and 4 weeks after hospital discharge
2026-04-28
Participant Flow
Participant milestones
| Measure |
Telehealth
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.
|
Usual Care
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.
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
80
|
|
Overall Study
COMPLETED
|
78
|
76
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Telehealth
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.
|
Usual Care
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
difficulty using the equipment
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Telehealth
n=80 Participants
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.
|
Usual Care
n=80 Participants
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.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.06 years
STANDARD_DEVIATION 9.06 • n=80 Participants
|
65.3 years
STANDARD_DEVIATION 10.10 • n=80 Participants
|
66.19 years
STANDARD_DEVIATION 9.58 • n=160 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=80 Participants
|
8 Participants
n=80 Participants
|
23 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=80 Participants
|
72 Participants
n=80 Participants
|
137 Participants
n=160 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Assessed at three time points: baseline (2 days before hospital discharge), 7-10 days after hospital discharge, and 4 weeks after hospital dischargePopulation: A total of 160 participants were randomized. Six participants did not complete follow-up assessments due to equipment issues, need for ECG monitoring, loss to follow-up, or death. Therefore, outcome analyses were conducted on 154 participants (78 in the intervention group and 76 in the control group
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.
Outcome measures
| Measure |
Telehealth
n=78 Participants
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.
|
Usual Care
n=76 Participants
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.
|
|---|---|---|
|
Cardiac Symptom Distress Score
Baseline (2 days before hospital discharge)
|
15.24 scores on a scale
Standard Deviation 10.61
|
12.84 scores on a scale
Standard Deviation 8.94
|
|
Cardiac Symptom Distress Score
7-10 days after hospital discharge
|
12.81 scores on a scale
Standard Deviation 11.57
|
11.87 scores on a scale
Standard Deviation 10.68
|
|
Cardiac Symptom Distress Score
4 weeks after hospital discharge
|
8.1 scores on a scale
Standard Deviation 8.07
|
11.76 scores on a scale
Standard Deviation 12.21
|
SECONDARY outcome
Timeframe: Assessed at three time points: baseline (2 days before hospital discharge), 7-10 days after hospital discharge, and 4 weeks after hospital dischargeSelf-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.
Outcome measures
| Measure |
Telehealth
n=76 Participants
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.
|
Usual Care
n=78 Participants
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.
|
|---|---|---|
|
Self-care Behavior Score
4 weeks after hospital discharge
|
59.94 scores on a scale
Standard Deviation 4.16
|
56.93 scores on a scale
Standard Deviation 6.31
|
|
Self-care Behavior Score
Baseline (2 days before hospital discharge)
|
50.57 scores on a scale
Standard Deviation 8.59
|
49.60 scores on a scale
Standard Deviation 8.4
|
|
Self-care Behavior Score
7-10 days after hospital discharge
|
58.59 scores on a scale
Standard Deviation 3.93
|
57.16 scores on a scale
Standard Deviation 5.53
|
SECONDARY outcome
Timeframe: Assessed at three time points: baseline (2 days before hospital discharge), 7-10 days after hospital discharge, and 4 weeks after hospital dischargeHealth-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.
Outcome measures
| Measure |
Telehealth
n=78 Participants
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.
|
Usual Care
n=76 Participants
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.
|
|---|---|---|
|
SF-12 Physical Component Summary (PCS)
Baseline (2 days before hospital discharge)
|
30.48 scores on a scale
Standard Deviation 5.75
|
32.49 scores on a scale
Standard Deviation 6.96
|
|
SF-12 Physical Component Summary (PCS)
7-10 days after hospital discharge
|
35.38 scores on a scale
Standard Deviation 8.94
|
35.21 scores on a scale
Standard Deviation 8.35
|
|
SF-12 Physical Component Summary (PCS)
4 weeks after hospital discharge
|
37.92 scores on a scale
Standard Deviation 8.53
|
37.36 scores on a scale
Standard Deviation 8.88
|
SECONDARY outcome
Timeframe: Assessed at three time points: baseline (2 days before hospital discharge), 7-10 days after hospital discharge, and 4 weeks after hospital dischargeHealth-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 on a scale.
Outcome measures
| Measure |
Telehealth
n=78 Participants
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.
|
Usual Care
n=76 Participants
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.
|
|---|---|---|
|
SF-12 Mental Component Summary (MCS)
Baseline (2 days before hospital discharge)
|
47.96 scores on a scale
Standard Deviation 10.71
|
49.27 scores on a scale
Standard Deviation 10.47
|
|
SF-12 Mental Component Summary (MCS)
7-10 days after hospital discharge
|
48.28 scores on a scale
Standard Deviation 9.63
|
50.36 scores on a scale
Standard Deviation 10.04
|
|
SF-12 Mental Component Summary (MCS)
4 weeks after hospital discharge
|
50.53 scores on a scale
Standard Deviation 9.29
|
50.18 scores on a scale
Standard Deviation 10.28
|
Adverse Events
Telehealth
Usual Care
Serious adverse events
| Measure |
Telehealth
n=78 participants at risk
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.
|
Usual Care
n=76 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
pneumonia
|
1.3%
1/78 • Number of events 1 • From baseline (hospital discharge) up to 4 weeks after hospital discharge.
Adverse events were assessed through routine follow-up and review of medical records. Serious adverse events, including all-cause mortality, were recorded for all enrolled participants in accordance with the International Council for Harmonisation (ICH) guidelines, specifically ICH E2A. The relationship between adverse events and the study intervention was determined by the study investigators.
|
1.3%
1/76 • Number of events 1 • From baseline (hospital discharge) up to 4 weeks after hospital discharge.
Adverse events were assessed through routine follow-up and review of medical records. Serious adverse events, including all-cause mortality, were recorded for all enrolled participants in accordance with the International Council for Harmonisation (ICH) guidelines, specifically ICH E2A. The relationship between adverse events and the study intervention was determined by the study investigators.
|
|
Injury, poisoning and procedural complications
Wound complication
|
1.3%
1/78 • Number of events 1 • From baseline (hospital discharge) up to 4 weeks after hospital discharge.
Adverse events were assessed through routine follow-up and review of medical records. Serious adverse events, including all-cause mortality, were recorded for all enrolled participants in accordance with the International Council for Harmonisation (ICH) guidelines, specifically ICH E2A. The relationship between adverse events and the study intervention was determined by the study investigators.
|
0.00%
0/76 • From baseline (hospital discharge) up to 4 weeks after hospital discharge.
Adverse events were assessed through routine follow-up and review of medical records. Serious adverse events, including all-cause mortality, were recorded for all enrolled participants in accordance with the International Council for Harmonisation (ICH) guidelines, specifically ICH E2A. The relationship between adverse events and the study intervention was determined by the study investigators.
|
|
Infections and infestations
Wound infection
|
0.00%
0/78 • From baseline (hospital discharge) up to 4 weeks after hospital discharge.
Adverse events were assessed through routine follow-up and review of medical records. Serious adverse events, including all-cause mortality, were recorded for all enrolled participants in accordance with the International Council for Harmonisation (ICH) guidelines, specifically ICH E2A. The relationship between adverse events and the study intervention was determined by the study investigators.
|
1.3%
1/76 • Number of events 1 • From baseline (hospital discharge) up to 4 weeks after hospital discharge.
Adverse events were assessed through routine follow-up and review of medical records. Serious adverse events, including all-cause mortality, were recorded for all enrolled participants in accordance with the International Council for Harmonisation (ICH) guidelines, specifically ICH E2A. The relationship between adverse events and the study intervention was determined by the study investigators.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/78 • From baseline (hospital discharge) up to 4 weeks after hospital discharge.
Adverse events were assessed through routine follow-up and review of medical records. Serious adverse events, including all-cause mortality, were recorded for all enrolled participants in accordance with the International Council for Harmonisation (ICH) guidelines, specifically ICH E2A. The relationship between adverse events and the study intervention was determined by the study investigators.
|
1.3%
1/76 • Number of events 1 • From baseline (hospital discharge) up to 4 weeks after hospital discharge.
Adverse events were assessed through routine follow-up and review of medical records. Serious adverse events, including all-cause mortality, were recorded for all enrolled participants in accordance with the International Council for Harmonisation (ICH) guidelines, specifically ICH E2A. The relationship between adverse events and the study intervention was determined by the study investigators.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/78 • From baseline (hospital discharge) up to 4 weeks after hospital discharge.
Adverse events were assessed through routine follow-up and review of medical records. Serious adverse events, including all-cause mortality, were recorded for all enrolled participants in accordance with the International Council for Harmonisation (ICH) guidelines, specifically ICH E2A. The relationship between adverse events and the study intervention was determined by the study investigators.
|
1.3%
1/76 • Number of events 1 • From baseline (hospital discharge) up to 4 weeks after hospital discharge.
Adverse events were assessed through routine follow-up and review of medical records. Serious adverse events, including all-cause mortality, were recorded for all enrolled participants in accordance with the International Council for Harmonisation (ICH) guidelines, specifically ICH E2A. The relationship between adverse events and the study intervention was determined by the study investigators.
|
Other adverse events
Adverse event data not reported
Additional Information
Chih-Huei Szu, RN, Case Manager
National Taiwan University Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place