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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06138379
Other study ID # 2023/4674
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date October 1, 2024

Study information

Verified date November 2023
Source Inonu University
Contact Zeliha Cengiz, Associate Professor
Phone : 905433277494
Email zeliha.cengiz@inonu.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Although there are studies on video-supported education in the literature, no research has been found examining the effect of video-assisted education in line with SIM on disease adaptation and medication use in liver transplant patients. For this reason, in this research, it is aimed to minimize the risks by obtaining information about the beliefs and tendencies of the patients, adapting to chronic diseases and medication use, with the video-supported training prepared in line with the use of SIM as an effective tool. The research is unique because it is the first study comparing the education provided with SIM and standard education. When the difference between the training given with SIM and standard training is determined, it can be stated with strong evidence that compliance with the disease and medication may be due to the training given with the model.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date October 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Experimental: 1st Experimental Group
Individuals will be sent relevant educational videos after liver transplantation and asked to watch them.
Experimental: 2nd Experimental Group
Individuals will be sent relevant educational videos after liver transplantation and asked to watch them.

Locations

Country Name City State
Turkey Turgut Ozal Medical Center Malatya

Sponsors (1)

Lead Sponsor Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Introduction Form 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. 6 months
Primary Chronic Illness Adjustment Scale 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. 6 months
Primary Compliance with Immunosuppressive Medication Use Scale 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. 6 months
Primary Rational Drug Use Scale 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 AIKÖ varies between 21 and 105. As the total score obtained from ADAS increases, rational drug use increases. When evaluating the total score received from AIKÖ; 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. 6 months
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