NCT06138379

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2024

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

November 7, 2023

Last Update Submit

February 10, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 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.

    6 months

Study Arms (3)

Control Group

NO INTERVENTION

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.

1. Experimental Group

EXPERIMENTAL

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.

Other: Experimental: 1st Experimental Group

2. Experimental Group

EXPERIMENTAL

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.

Other: Experimental: 2nd Experimental Group

Interventions

Individuals will be sent relevant educational videos after liver transplantation and asked to watch them.

Also known as: Video-supported teaching in line with the Health Belief Model
1. Experimental Group

Individuals will be sent relevant educational videos after liver transplantation and asked to watch them.

Also known as: Video assisted teaching
2. Experimental Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Communication problems occur,
  • Patients with distressing medical conditions will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turgut Ozal Medical Center

Malatya, 44000, Turkey (Türkiye)

Location

Study Officials

  • Sezai Yılmaz, Prof Dr

    Turgut Ozal Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
It will be collected using the Patient Introduction Form, Chronic Disease Adaptation Scale, Immunosuppressive Drug Use Compliance Scale and Rational Drug Use Scale.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Dr. Zeliha CENGİZ, Head of the Department of Nursing Principles

Study Record Dates

First Submitted

November 7, 2023

First Posted

November 18, 2023

Study Start

December 1, 2023

Primary Completion

April 16, 2024

Study Completion

August 16, 2024

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

It can be used as a source for other research.

Locations