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

The Effect of Education Given According to Roy's Adaptation Model to Kidney Patients Undergoing Immunosuppressive Therapy on Self-Efficacy, Immunosuppressive Therapy, and Chronic Disease Adaptation Levels

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."

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease; Immunosuppressive Therapy
• Intervention / Treatment: Device: training booklet

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Edirne
    • Edirne, Edirne, Turkey (Türkiye), 22100
      • Trakya University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervetion Group; group given training in accordance with the training booklet	Device: training booklet; 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.
No Intervention: control group; group that is not interfered with

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Trakya University
• Investigators: Study Chair: Kubilay Göktaş, Trakya University Institute of Health Sciences

Publications and helpful links

General Publications

• Atik D, Karatepe H. Scale development study: Adaptation to chronic illness. Acta Med Mediterr. 2016;32:135.
• Aypay A. Genel öz yeterlik ölçeği'nin Türkçe'ye uyarlama çalışması. İnönü Üniversitesi Eğitim Fakültesi Dergisi. 2010;11:113-131.
• Özdemir Z, Talas M. Solid organ transplantasyonu sonrası immünsupresif ilaç kullanımına uyum. Anadolu Hem Sağlık Bilimleri Dergisi. 2017;20(4):304-10

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Actual): June 15, 2025
• Study Completion (Actual): June 15, 2025

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: compliance; education; Immunosuppressive therapy; self-efficacy
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Renal Insufficiency, Chronic; Patient Compliance
• Other Study ID Numbers: TÜTF-GOBAEK 2024/392

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No