Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648291
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-06
Brief Title:
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
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Telehealths Effectiveness in Reducing Cardiac Symptom Distress Improving Self-care and Enhancing Quality of Life in Coronary Artery Disease Patients After Bypass Surgery
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 yearsCoronary 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 patients 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 patients 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 groupUsual 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 patients 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 patients 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 hisher 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 heshe has chest congestion heshe can upload the measurements at any time and send the website address of the centers platform and the operation procedures to the patient by SMS asking himher to enter the daily physiological values of blood pressure and blood glucose and the researcher will contact himher to assess hisher 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 eg 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
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 yearsCoronary 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 patients 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 patients 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 groupUsual 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 patients 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 patients 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 hisher 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 heshe has chest congestion heshe can upload the measurements at any time and send the website address of the centers platform and the operation procedures to the patient by SMS asking himher to enter the daily physiological values of blood pressure and blood glucose and the researcher will contact himher to assess hisher 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None