The Effect of Education Given According to Roy's Adaptation Model

NCT07430449 | Completed

• 1 other identifier: TÜTF-GOBAEK 2024/392
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Background and Aim: Immunosuppressive therapies administered after chronic kidney disease and kidney transplantation are critically important for patients' life adaptation and the continued success of transplantation. However, the process of compliance with immunosuppressive therapy is not limited to regular medication use; it is closely related to multidimensional factors such as disease adjustment, physical adjustment, psychological balance, social functioning, and the individual's level of self-efficacy. This study aimed to examine the effect of Roy's Adaptation Model-based education on the adherence of patients with chronic kidney disease or kidney transplantation undergoing immunosuppressive therapy to immunosuppressive therapy, their adaptation to the disease, and their self-efficacy levels. Material and Methods: This quasi-experimental study with a pretest-posttest control group design was conducted with 78 chronic kidney disease patients who were scheduled to receive immunosuppressive therapy for the first time between November 2024 and June 2025 at the nephrology and transplantation services of a university hospital. Data were collected using the "Patient Information Form," "Immunosuppressive Drug Adherence Scale," "Chronic Disease Coping Scale," and "General Self-Efficacy Scale."

Conditions

Immunosuppressive Therapy; Chronic Kidney Disease

Keywords

Immunosuppressive therapy; compliance; education; self-efficacy

Outcome Measures

Primary Outcomes (5)

• Patient Information Form-1

  The Patient Information Form-1 contains questions regarding patients' individual characteristics, such as age, gender, educational status, marital status, and place of residence.

  at baseline

• The Patient Information Form-2

  The Patient Information Form-2 contains treatment-related questions, such as types of immunosuppressive drugs, experience of side effects, whether a special diet is being followed, and the level of compliance with the diet.

  at baseline, and at the first and third months.

• Immunosuppressive Drug Compliance Scale

  The scale was developed by Özdemir et al. to assess compliance with immunosuppressive drug use in patients who have undergone solid organ transplantation. The scale consists of 11 items in a unidimensional structure and uses both a 5-point Likert-type and a 2-point (Yes-No) rating system for scoring. In the 5-point Likert-type rating, positive items are scored from 1 to 5, while negative items are scored in the opposite direction, from 5 to 1. For items answered with "Yes-No," the 'Yes' response is scored as 1, and the "No" response is scored as 5. All items except the 4th and 6th items are negative and are scored in reverse. The total score that can be obtained from the scale ranges from 11 to 55, with high scores indicating a high level of compliance with immunosuppressive drug use. In the validity-reliability study conducted by Özdemir and colleagues, the Cronbach's alpha coefficient of the scale was found to be 0.611.

  at baseline, and at the first and third months

• Chronic Disease Adjustment Scale

  The scale was developed by Atik and Karatepe and consists of three subscales: physical, social, and psychological adjustment. The physical adjustment subscale consists of 11 items (1, 9, 10, 13, 14, 15, 16, 18, 22, 23, 24), the social adjustment subscale consists of 7 items (2, 3, 5, 7, 17, 19, 25), and the psychological adjustment subscale consists of 7 items (4, 6, 8, 11, 12, 20, 21). This scale, consisting of a total of 25 items, is evaluated using a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). The total score that can be obtained from the scale ranges from 25 to 125. High scores on the subscales or the total scale indicate a high level of adaptation to the illness. The Cronbach alpha value reported in the study where the scale was developed is 0.88.

  at baseline, and at the first and third months.

• General Self-Efficacy Scale

  The General Self-Efficacy Scale was developed by Aypay to assess individuals' perceptions of their competence in coping with difficulties they encounter. The scale consists of 10 items with a four-point Likert-type rating. Participants respond to each item with options ranging from "Not at all true (1)" to "Completely true (4)". The total score range that can be obtained from the scale is between 10 and 40, and an increase in the score level indicates that the individual's perception of self-efficacy is also high. The Cronbach alpha value of the scale was stated as 0.83 in the study in which it was developed.

  at baseline, and at the first and third months.

Study Arms (2)

Intervetion Group

EXPERIMENTAL

group given training in accordance with the training booklet

Device: training booklet

control group

NO INTERVENTION

group that is not interfered with

Interventions

training booklet DEVICE

Developed by researchers in line with the Roy Adaptation Model, this educational material was created to support patients with chronic kidney disease or kidney transplantation who are undergoing immunosuppressive therapy for the first time, helping them adapt more effectively to their disease and treatment process. The content of the training booklet includes topics such as what immunosuppressive treatment is, situations to be aware of during the treatment process, precautions to be taken while undergoing immunosuppressive treatment, problems patients may encounter, and recommendations. The booklet is structured in accordance with the four areas of adaptation in the Roy Adaptation Model: physiological, self-concept, role function, and interdependence.

Intervetion Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients receiving immunosuppressive therapy for the first time at the nephrology and transplantation clinics of Trakya University Hospital,
• Aged 18 years or older,
• Literate,
• Without communication or mental disorders,
• Without motor skill impairments,
• Patients who consent to participate in the study

You may not qualify if:

• Patients who are not willing to participate in the study,
• Patients who are illiterate,
• Patients with communication or mental problems,
• Patients with motor skill problems,
• Patients who wish to withdraw from the study at any stage,
• Patients who do not attend follow-up appointments,
• Patients undergoing dialysis treatment and not receiving immunosuppressive therapy

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University Hospital

Edirne, Edirne, 22100, Turkey (Türkiye)

Location

Related Publications (3)

• Atik D, Karatepe H. Scale development study: Adaptation to chronic illness. Acta Med Mediterr. 2016;32:135.

  RESULT

• Aypay A. Genel öz yeterlik ölçeği'nin Türkçe'ye uyarlama çalışması. İnönü Üniversitesi Eğitim Fakültesi Dergisi. 2010;11:113-131.

  RESULT

• Özdemir Z, Talas M. Solid organ transplantasyonu sonrası immünsupresif ilaç kullanımına uyum. Anadolu Hem Sağlık Bilimleri Dergisi. 2017;20(4):304-10

  RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Patient Compliance

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Kubilay Göktaş

  Trakya University Institute of Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master student

Model Details: A quasi-experimental study with a pre test post test control group design

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 24, 2026
• Study Start: November 1, 2024
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)