- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06138379
Video-supported Training in Line With the Health Belief Model
The Effect of Video-Assisted Education Given to Patients With Liver Transplantation in the Line of Health Belief Model on Adaptation to Disease and Drug Use
Summary The only treatment method for those with incurable, irreversible, progressive, acute or chronic liver disease is liver transplantation. Compliance with the disease and immunosuppressive treatment has an important place in the success of transplants. This study was planned to examine the effect of video-supported education given to liver transplant patients in line with the Health Belief Model on adaptation to chronic disease and medication use.
The research will be conducted as a randomized controlled experimental study. The population of the research will consist of adult patients who received liver transplantation at İnönü University Turgut Özal Medical Center. The sample will consist of 90 patients determined by power analysis. Patients will be divided into three groups: control (n=30), 1st experiment (n=30) and 2nd experiment (n=30). Data will be collected between August 2023 and December 2023 using the Patient Information Form, Chronic Disease Adaptation Scale, Immunosuppressive Drug Use Compliance Scale and Rational Drug Use Scale. Video-supported training will be provided to patients in the experimental group to increase compliance with the disease and immunosuppressive treatment and to ensure rational drug use. Patients in the 1st experimental group will receive video-supported training in line with the Health Belief Model for one month, and patients in the 2nd experimental group will receive video-supported standard training for one month. This video training will be given to the experimental group patients outside the routine nursing care of the clinic. The video-supported training is planned to last 20-30 minutes. Nursing care in the routine practice of the clinic will be applied to the control group. Evaluation of data; It will be done with number, percentage, mean, standard deviation, chi-square, paired t test, t test analysis in independent groups, ANOVA and ANCOVA.
As a result, it is predicted that video-supported education will increase compliance with chronic disease and medication use and reduce post-transplant symptoms and discomfort caused by these symptoms.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Malatya, Turkey (Türkiye), 44000
- Turgut Ozal Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:• No communication problems,
- Those who are 18 years of age and over,
- At least 2 months and at most 2 years have passed since the transplant,
- Having a device (phone, tablet, computer, etc.) that can watch the video,
- Patients who are literate will be included in the study.
Exclusion Criteria:• Do not watch research videos,
- Communication problems occur,
- Patients with distressing medical conditions will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control Group
No Intervention: Control group The research will begin after obtaining the necessary legal and ethical permissions to collect data. At this stage of the research, participants who agree to participate in the research will be asked to fill out an informed consent form. All forms will be filled in to obtain pre-test data for the research. These individuals who receive and continue to receive standard care will be informed about the research. Pre-test and post-test data from the control group will be obtained simultaneously with the study groups. |
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Experimental: 1. Experimental Group
Experimental: Experimental group given video-supported training in line with the health belief model. All forms (Patient Information Monitoring Form, Chronic Disease Adaptation Scale, Rational Drug Use Scale and Immunosuppressive Drug Form Scale) will be filled in to obtain pre-test data for the research. Individuals will be trained according to the training materials prepared for the Health Belief Model. They will be monitored one day each week. After 30 days, all forms will be filled out again to examine the sustainability of the training data. |
Individuals will be sent relevant educational videos after liver transplantation and asked to watch them.
Other Names:
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Experimental: 2. Experimental Group
Experimental: The experimental group was given video-supported training in line with Classical Education. All forms (Patient Information Monitoring Form, Chronic Disease Adaptation Scale, Rational Drug Use Scale and Immunosuppressive Drug Form Scale) will be filled in to obtain pre-test data for the research. Individuals will be trained according to the training materials prepared for the Health Belief Model. They will be monitored one day each week. After 30 days, all forms will be filled out again to examine the sustainability of the training data. |
Individuals will be sent relevant educational videos after liver transplantation and asked to watch them.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patient Introduction Form
Time Frame: 6 months
|
It is a form prepared by the researcher and examines the sociodemographic and medical characteristics of liver transplant patients.
This form includes 11 questions to determine the patients' age, gender, marital status, education level, employment status, income level, how long they have had liver disease, additional diseases, the presence of people assisting in the care, how long ago the transplant was performed, and the donor type.
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6 months
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Chronic Illness Adjustment Scale
Time Frame: 6 months
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It was developed by Derya Atik and Hilal Karatepe in 2016.
The scale consists of 25 items.
It consists of three subscales: Physical Adaptation (11 items), Social Adaptation (7 items), and Psychological Adaptation (7 items).
Subdimensions of the scale; 1. Physical Harmony; Items 1, 9, 10, 13, 14, 15, 16, 18, 22, 23, 24 (minimum 11, maximum 55 points), 2. Social Cohesion; 2nd, 3rd, 5th, 7th, 17th, 19th, 25th items (minimum 7, maximum 35 points), 3. Psychological Adjustment; Items 4, 6, 8, 11, 12, 20, 21 measure (minimum 7, maximum 35 points).
Scoring: 1st, 2nd, 3rd, 4th, 7th, 8th, 9th, 10th, 11th, 13th, 14th, 15th, 16th, 18th, 21st, 22nd, The 23rd items are normal (in the form of 1,2,3,4,5), the 5th, 6th, 12th, 17th, 19th, 20th, 24th, 25th items are reverse (5,4,3,2).
It is scored as .1).
The total score that can be obtained from the scale is 125.
Higher scores from the subscales and/or the entire scale mean that patients' adaptation levels to the disease increase.
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6 months
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Compliance with Immunosuppressive Medication Use Scale
Time Frame: 6 months
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In the scale developed by Özdemir, the compliance with medication use of patients who have had solid organ transplants and are taking immunosuppressive drugs is evaluated.
In order for the scale to be applied, patients must complete at least two months after transplantation.
The scale consists of 11 items in total.
Scoring is done with a 5-point and 2-point Likert type rating.
The scale includes positive and negative expressions.
Positive statements are 4 and 6, and negative statements are 1, 2, 3, 5, 7, 8, 9, 10 and 11.
Positive statements are scored from 1 to 5, while negative statements are scored from 5 to 1.
For positive items, 1 point is given for a 'yes' answer and 5 points are given for a 'no' answer.
The lowest score of the scale is 11 and the highest score is 55.
As the score from the scale increases, compliance with medication use increases, and as the score decreases, compliance with medication use decreases.
Cronbach's alpha value was calculated as 0.611 by Özdemir.
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6 months
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Rational Drug Use Scale
Time Frame: 6 months
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It consists of 21 items and a single dimension.
Items are scored on a 5-point Likert-type scale according to the situations in which they realize the statements (1-Never, 2-Rarely, 3-Occasionally, 4-Often and 5-Always).
Only the 17th item in the scale is reverse scored.
After the reverse-scored item is translated, the sum of all scale items gives the "total scale score".
The total score of AİKÖ varies between 21 and 105.
As the total score obtained from ADAS increases, rational drug use increases.
When evaluating the total score received from AİKÖ; If the total score is between 21 and 52, it is scored as low, between 53 and 67, as medium, and between 68 and 105, it is scored as high.
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sezai Yılmaz, Prof Dr, Turgut Ozal Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2023/4674
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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