Back to resultsWeb Based Cardiac Rehabilitation Support in Coronary Artery Patients
Primary Purpose
Cardiac Rehabilitation, Healthy Lifestyle, Medication Adherence
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
cardiac rehabilitation support program
Sponsored by
About this trial
This is an interventional prevention trial for Cardiac Rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Patients with a diagnosis of Coronary artery disease, adult patients, those for whom no surgical operation was planned, those who were clinically stable, those who were literate, those who could communicate verbally, use the Internet, those who had a computer, tablet or smartphone, and those who agreed to participate in the study.
Exclusion Criteria:
- Those who have a disease that is not suitable for the CR program, those who did not agree to participate in the study, those who did not log in after registering on the website, did not read the trainings and could not communicate with the patient during the study
Sites / Locations
- Health Science University Ahi Evren thoracic and cardiovascular surgery training and research hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Web based Cardiac Rehabilitation program and follow-up telephone
Standard care
Arm Description
The website was created under the name of "Cardiac Rehabilitation Support Program". The language of the website is Turkish. Designed for computer, tablet and mobile phone use. Patients must be registered to access the website. After creating a six-digit password during registration, they log in to the website with their e-mail address and this password. The password is determined specifically for the patient. There is a welcome text on the home page of the website. The main headings in the menu section; trainings, disease management questions, questionnaires, ask questions to the researcher.
patients received their training before discharge from the hospital and no intervention was made for 12 weeks.
Outcomes
Primary Outcome Measures
Comparison of the total and sub-dimension total scores of the healthy lifestyle behaviors scale of the patients in the experimental and control groups
Healthy Lifestyle Behaviors Scale II: The scale has 52 items and six factors.The lowest score obtained from the scale is 52, and the highest score is 208.Healthy lifestyle behaviors score is obtained from the overall score of the scale.High scores obtained from the scale indicate a high level of healthy lifestyle behaviors.
Comparison of experimental and control group patients' compliance with medication adherence
Medication Adherence Questions:
There are three questions in order to evaluate the patients' compliance with drug therapy. These; It consists of questions such as "Do you have problems remembering to take your medicine regularly, do you stop taking your medicine without your doctor's advice when your complaints subside/end, if you don't feel well when you take your medicine (side effects etc.) do you stop taking your medicine?"
Comparison of general quality of life scale index and general quality of life scale vas scores of experimental and control group patients
EQ-5D General Quality of Life Scale: It was developed by the Western European Quality of Life Research Society. It consists of five dimensions. In these five dimensions; mobility and walking or walking, doing daily activities with normal daily activities, feeling of pain/discomfort and anxiety/depression and feeling anxious, etc. are evaluated. For the answers given to each dimension, there is no problem, there is some problem, and major problem options are included. A score between -0.59 and 1 is calculated from the five dimensions of the scale. A value of 0 is death, a value of 1 is perfect health, negative values are unconscious and bedridden, etc. points to the results. The scale also includes an easily understandable version of the rated Visual Analog Scale (VAS). Here, participants rate their overall health status from 0 to 100. A score of 100 represents the best health imaginable, while 0 represents the worst.
Comparison of international physical activity questionnaire total scores and physical activity levels of experimental and control group patients
International Physical Activity Questionnaire-Short Form: In the scale, walking for at least 10 minutes in the last 7 days, moderate-intensity and intense activities, and sedentary time spent in an average day are asked and metabolic equivalent (MET) scores are calculated. Total time (minutes) and frequency (days) are required to calculate the score. Results are evaluated in three categories: low level, intermediate level and high level. The low level is evaluated as <600 MET, the intermediate level 600-3000 MET, and the high level >3000 MET. The acceptable value in terms of health is expressed as intermediate level, ie 600-3000 MET.
Comparison of body mass index values of experimental and control group patients
The formula used to calculate the body mass index is as follows: height (cm)/weight (kg)*weight (kg). After calculating the body mass index of each patient according to this formula, the data were compared.
Comparison of LDL values of experimental and control group patients
Comparison of smoking status of experimental and control group patients
In the patient information form, patients were asked whether they smoked or not.
Post-test Computer System Usability Questionaire Short Version total and sub-dimension scores of the experimental group patients
Availability of a computer system; system usefulness (items 1-6), information quality (items 7-9), and interface dimensions (items 10-12) with 13 items. Each item is scored as 1 (strongly agree) and 7 (strongly disagree). The scale was set up in reverse, and low scores indicate good usability of the system.
Comparison of triglyceride values of experimental and control group patients
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05489913
Brief Title
Web Based Cardiac Rehabilitation Support in Coronary Artery Patients
Official Title
The Effect of Web Based Cardiac Rehabilitation Support on the Healthy Lifestyle Behaviors, Medication Adherence and Quality of Life in Coronary Artery Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Semiha ALKAN KAYHAN
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study was carried out as a randomized controlled experimental study to evaluate the effect of web-based cardiac rehabilitation support on the healthy lifestyle behaviors, medication adherence and quality of life in coronary heart patients.
Detailed Description
Hypothesis 1:
H0: Web-based cardiac rehabilitation support has no effect on increasing the healthy lifestyle behaviors of patients with coronary artery disease.
H1: Web-based cardiac rehabilitation support has an effect on increasing the healthy lifestyle behaviors of patients with coronary artery disease.
Hypothesis 2:
H0: Web-based cardiac rehabilitation support in patients with coronary artery disease has no effect on increasing the compliance of patients to drug therapy.
H1: Web-based cardiac rehabilitation support in patients with coronary artery disease has an effect on increasing the compliance of patients to drug therapy.
Hypothesis 3:
H0: Web-based cardiac rehabilitation support has no effect on improving the quality of life of patients with coronary artery disease.
H1: Web-based cardiac rehabilitation support has an effect on improving the quality of life of patients with coronary artery disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Rehabilitation, Healthy Lifestyle, Medication Adherence, Quality of Life, Coronary Artery Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Web based Cardiac Rehabilitation program and follow-up telephone
Arm Type
Experimental
Arm Description
The website was created under the name of "Cardiac Rehabilitation Support Program". The language of the website is Turkish. Designed for computer, tablet and mobile phone use. Patients must be registered to access the website. After creating a six-digit password during registration, they log in to the website with their e-mail address and this password. The password is determined specifically for the patient. There is a welcome text on the home page of the website. The main headings in the menu section; trainings, disease management questions, questionnaires, ask questions to the researcher.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
patients received their training before discharge from the hospital and no intervention was made for 12 weeks.
Intervention Type
Other
Intervention Name(s)
cardiac rehabilitation support program
Intervention Description
First of all, a preliminary interview was made with the patients in the experimental group, and their information needs were evaluated individually. Which trainings he should receive and his priorities were determined with the patient. After the training requirements were determined, the general introduction of the website was made and they were allowed to register. Experimental group patients received both training on the website and counseling over the phone for 12 weeks after they started working. A total of 3 phone calls were made with the patients in the first week, 4th and 8th weeks. The interviews lasted an average of 20 minutes. In each phone call, patients were informed and reminded. When patients needed, an average of 2-3 more phone calls were made and information was provided on the subjects they needed.
Primary Outcome Measure Information:
Title
Comparison of the total and sub-dimension total scores of the healthy lifestyle behaviors scale of the patients in the experimental and control groups
Description
Healthy Lifestyle Behaviors Scale II: The scale has 52 items and six factors.The lowest score obtained from the scale is 52, and the highest score is 208.Healthy lifestyle behaviors score is obtained from the overall score of the scale.High scores obtained from the scale indicate a high level of healthy lifestyle behaviors.
Time Frame
twelve weeks
Title
Comparison of experimental and control group patients' compliance with medication adherence
Description
Medication Adherence Questions:
There are three questions in order to evaluate the patients' compliance with drug therapy. These; It consists of questions such as "Do you have problems remembering to take your medicine regularly, do you stop taking your medicine without your doctor's advice when your complaints subside/end, if you don't feel well when you take your medicine (side effects etc.) do you stop taking your medicine?"
Time Frame
twelve weeks
Title
Comparison of general quality of life scale index and general quality of life scale vas scores of experimental and control group patients
Description
EQ-5D General Quality of Life Scale: It was developed by the Western European Quality of Life Research Society. It consists of five dimensions. In these five dimensions; mobility and walking or walking, doing daily activities with normal daily activities, feeling of pain/discomfort and anxiety/depression and feeling anxious, etc. are evaluated. For the answers given to each dimension, there is no problem, there is some problem, and major problem options are included. A score between -0.59 and 1 is calculated from the five dimensions of the scale. A value of 0 is death, a value of 1 is perfect health, negative values are unconscious and bedridden, etc. points to the results. The scale also includes an easily understandable version of the rated Visual Analog Scale (VAS). Here, participants rate their overall health status from 0 to 100. A score of 100 represents the best health imaginable, while 0 represents the worst.
Time Frame
twelve weeks
Title
Comparison of international physical activity questionnaire total scores and physical activity levels of experimental and control group patients
Description
International Physical Activity Questionnaire-Short Form: In the scale, walking for at least 10 minutes in the last 7 days, moderate-intensity and intense activities, and sedentary time spent in an average day are asked and metabolic equivalent (MET) scores are calculated. Total time (minutes) and frequency (days) are required to calculate the score. Results are evaluated in three categories: low level, intermediate level and high level. The low level is evaluated as <600 MET, the intermediate level 600-3000 MET, and the high level >3000 MET. The acceptable value in terms of health is expressed as intermediate level, ie 600-3000 MET.
Time Frame
twelve weeks
Title
Comparison of body mass index values of experimental and control group patients
Description
The formula used to calculate the body mass index is as follows: height (cm)/weight (kg)*weight (kg). After calculating the body mass index of each patient according to this formula, the data were compared.
Time Frame
twelve weeks
Title
Comparison of LDL values of experimental and control group patients
Time Frame
twelve weeks
Title
Comparison of smoking status of experimental and control group patients
Description
In the patient information form, patients were asked whether they smoked or not.
Time Frame
twelve weeks
Title
Post-test Computer System Usability Questionaire Short Version total and sub-dimension scores of the experimental group patients
Description
Availability of a computer system; system usefulness (items 1-6), information quality (items 7-9), and interface dimensions (items 10-12) with 13 items. Each item is scored as 1 (strongly agree) and 7 (strongly disagree). The scale was set up in reverse, and low scores indicate good usability of the system.
Time Frame
twelve weeks
Title
Comparison of triglyceride values of experimental and control group patients
Time Frame
twelve weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with a diagnosis of Coronary artery disease, adult patients, those for whom no surgical operation was planned, those who were clinically stable, those who were literate, those who could communicate verbally, use the Internet, those who had a computer, tablet or smartphone, and those who agreed to participate in the study.
Exclusion Criteria:
Those who have a disease that is not suitable for the CR program, those who did not agree to participate in the study, those who did not log in after registering on the website, did not read the trainings and could not communicate with the patient during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Semiha ALKAN KAYHAN
Organizational Affiliation
ahi Evren thoracic and cardiovascular surgery training and research hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Science University Ahi Evren thoracic and cardiovascular surgery training and research hospital
City
Trabzon
ZIP/Postal Code
61100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Web Based Cardiac Rehabilitation Support in Coronary Artery Patients
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