Clinical trial NCT06648291: The Effectiveness of Telehealth for Cardiac Symptom Distress, Self-care and Quality of Life of Patients With Coronary Artery Disease After Coronary Artery Bypass Surgery: A Randomized Study
Official title: Telehealth's Effectiveness in Reducing Cardiac Symptom Distress, Improving Self-care, and Enhancing Quality of Life in Coronary Artery Disease Patients After Bypass Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Telehealth
Coronary Artery Bypass Surgery
Keywords: symptoms distress
self-care
quality of life
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this randomized trial is to compare the outcomes of telehealth 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 telehealth 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 telehealth 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 telehealth (experimental group) after CABG compared to those receiving usual care (control group).

Participants will be randomly assigned to one of two groups: either telehealth 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 telehealth, establishing it as an important care strategy for future integration with hospital-based care.

Detailed description: The purpose of this study is to investigate the effectiveness of telehealth for patients discharged from the hospital after coronary artery bypass surgery, aiming to evaluate whether telehealth improves symptom distress, refines self-care skills, and enhances quality of life compared to usual care.

Background:

Cardiovascular diseases (CVD) contribute substantially to global mortality rates and have consistently ranked as the second leading cause of death in Taiwan for many years.Coronary artery bypass graft (CABG) is an important and common surgical procedure for treating cardiovascular disease. However, one in four patients who undergo CABG suffers from postoperative complications, including pain, wound infections, and sleep disturbances, which can further impact their quality of life. Some of these symptoms may last from weeks to months, and if left unresolved, they may hinder the patient's recovery and increase the risk of death. Additionally, shorter hospital stays make it more challenging for patients to transition from hospital to home and adjust to changes in their lives, which can lead to poorer self-care behaviors and worsen complications such as heart failure, wound infections, and cardiac arrhythmia, seriously affecting their quality of life.

Telehealth refers to the use of communication technology, electronic medical equipment, and professional medical technology to provide the public with a wider range of medical care services in familiar community or home environments, facilitating local aging. Its functions and benefits encompass four major dimensions:

1. . Physiological information monitoring: This includes the transmission, storage, and utilization of data such as blood pressure, blood glucose, and pulse. The consolidated data can serve as a basis for adjusting medication.
2. . Contact and coordination of care services: This involves emergency responses from the patient side, monitoring of abnormal signals, and reminders for follow-up visits.
3. . Assistance in self-health management: This entails monitoring changes in the patient's daily physiological parameters and encouraging self-management and tracking, including exercise, medication, diet, and maintaining a healthy lifestyle.
4. Video consultations: Nurses and patients can communicate over long distances to achieve effective monitoring and control, breaking geographical constraints. This allows for customized health consultations and guidance, as well as emotional support.

International literature confirms that telehelth services can reduce healthcare costs, emergency room visits, readmission rates, and mortality rates.

Study Design and Interventions:

The study adopts an open-label, two-arm, parallel-group randomized controlled design. Participants will be randomly assigned into one of two groups:

Experimental group: Telehealth Control group:Usual care (Routine hospital discharge care) Experimental Group: Patients will be discharged from the hospital to telehealth services with the following interventions.

Telephone interviews were arranged every three days by the investigator, who had more than 10 years of experience in case management practice and was certified as a cardiovascular and diabetes health teacher. The main purpose of the telephone interviews was to encourage and supervise the patients to develop good self-health care behaviors, which included: (1) asking about the daily blood pressure, weight, and edema of the lower limbs (2) providing medication counseling, and exercise and dietary hygiene (3) wound care advice (4) providing advice on the use of wounds, and (5) providing advice on the use of wounds, and (6) providing advice on the use of wounds, and (7) providing advice on the use of wounds. Wound care guidance (4) Avoidance of heart disease risk factors such as smoking and second-hand smoke (5) Tracking of physical condition at the time of outpatient visit and assisting in referral to relevant outpatient clinics such as nutrition or rehabilitation clinics according to the patient's condition. In addition to this, a set of QOCA portable electrocardiogram (ECG) measuring device will be provided for use at home. During the hospitalization period, we will ask the vendor to assist in installing the ECG software on the patient's cell phone, instructing the patient on how to operate the device and repeat the instructions until the patient is able to operate it by themselves. Repeat the instructions until the patient is able to operate the device on his/her own, and bring back a manual with instructions for operation, informing the patient that the frequency of measurements should be once in the morning and once in the evening, but if he/she has chest congestion, he/she can upload the measurements at any time, and send the website address of the center's platform and the operation procedures to the patient by SMS, asking him/her to enter the daily physiological values of blood pressure and blood glucose, and the researcher will contact him/her to assess his/her medical condition when there are abnormalities in the cardiac rhythms, blood pressure, or blood glucose, and provide 24-hour online counseling services. Provide 24-hour online counseling service to detect problems as early as possible and handle them immediately to avoid deterioration of their symptoms.

In the control group, subjects were given routine discharge counseling and telephone follow-up within 7 days of discharge.

Study Duration and Data Collection: The study will last 4 weeks for each participant. Data will be collected from hospital records, patient self-reports and questionnaire scales. Measured outcomes will include:

Primary outcome: degree of improvement in symptom distress, self-care ability, and quality of life.

Secondary Outcome: Physiologic data (e.g., blood pressure, heart rate, and weight).

Randomization and Recruitment: Participants will be recruited from cardiology wards according to the inclusion criteria (patients undergoing first time coronary artery bypass surgery). Randomization will be randomly coded, with numbers placed in envelopes numbered from 1 to 160, which will be self-administered, with odd-numbered subjects assigned to the experimental group and even-numbered subjects assigned to the control group.

Significance: This study will demonstrate the effectiveness of telehealth interventions compared to traditional care and aim to improve the quality of telehealth services. It is expected to alleviate symptomatic distress for patients recovering from coronary artery bypass surgery when they return home, enhance their self-care behaviors, and ultimately lead to an improved quality of life. This way, telehealth can maximize its benefits and become an important care strategy worthy of promotion for hospital-based care in the future.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Cardiac Symptom Distress
timeFrame: Three time points: pre-test (before intervention, 0 weeks), mid-test (after intervention, approximately 7-10 days), post-test (after all interventions are completed, 4 weeks).
measure: Self-care
timeFrame: Three time points: pre-test (before intervention, 0 weeks), mid-test (after intervention, approximately 7-10 days), post-test (after all interventions are completed, 4 weeks).
measure: Quality of life
timeFrame: Three time points: pre-test (before intervention, 0 weeks), mid-test (after intervention, approximately 7-10 days), post-test (after all interventions are completed, 4 weeks).
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: Chih-Hui Shih
Study officials:
References: