Chronic Kidney DiseaseNCT07430449
The Effect of Education Given According to Roy's Adaptation Model
A study testing training booklet in people with Chronic Kidney Disease and Immunosuppressive Therapy, run by Trakya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Immunosuppressive Therapy
- What is being tested?
- training booklet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trakya University Hospital
Edirne, Edirne, 22100
About this study
Official title: 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."
- Conditions
- Chronic Kidney Disease, Immunosuppressive Therapy
- Being tested
- training booklet
- Keywords
- Immunosuppressive therapy, compliance, education, self-efficacy
- Medical subject headings
- Renal Insufficiency, Chronic, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training bookletDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervetion Group | Experimental | group given training in accordance with the training booklet Receives: Device: training booklet |
| control group | No intervention | group that is not interfered with |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at baseline, and at the first and third months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Nov 2024
- Primary completion15 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A quasi-experimental study with a pre test post test control group design
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İDİL ŞAHİN, Trakya University
- Investigators
- Kubilay Göktaş, Study chair, Trakya University Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430449
- Sponsor's protocol ID
- TÜTF-GOBAEK 2024/392
- Status last verified
- Feb 2026
- First submitted
- 15 Jan 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Sahin I, Bilgic S. Effect of Roy Adaptation Model-Based Patient Education on Self-Efficacy, Immunosuppressive Therapy Adherence, and Adaptation to Chronic Disease in Patients With Kidney Disease. West J Nurs Res. 2026 Oct 27:1939459261494039. doi: 10.1177/01939459261494039. Online ahead of print.
PubMed 42935173
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07430449
- Acronym / sponsor ID
- TÜTF-GOBAEK 2024/392
- Conditions
- Chronic Kidney Disease, Immunosuppressive Therapy
- Keywords
- Immunosuppressive therapy, compliance, education, self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A quasi-experimental study with a pre test post test control group design
| Arm | Type | Receives |
|---|---|---|
| Intervetion Group | Experimental | Device: training bookletgroup given training in accordance with the training booklet |
| control group | No intervention | –group that is not interfered with |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| training bookletDeveloped 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. | Device | Intervetion Group |
Primary outcome
Patient Information Form-1
Time frame: at baseline
The Patient Information Form-1 contains questions regarding patients' individual characteristics, such as age, gender, educational status, marital status, and place of residence.
The Patient Information Form-2
Time frame: at baseline, and at the first and third months.
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.
Immunosuppressive Drug Compliance Scale
Time frame: at baseline, and at the first and third months
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.
Chronic Disease Adjustment Scale
Time frame: at baseline, and at the first and third months.
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.
General Self-Efficacy Scale
Time frame: at baseline, and at the first and third months.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Results publicationAtik D, Karatepe H. Scale development study: Adaptation to chronic illness. Acta Med Mediterr. 2016;32:135.
- Results publicationAypay A. Genel öz yeterlik ölçeği'nin Türkçe'ye uyarlama çalışması. İnönü Üniversitesi Eğitim Fakültesi Dergisi. 2010;11:113-131.
- Results publicationÖzdemir Z, Talas M. Solid organ transplantasyonu sonrası immünsupresif ilaç kullanımına uyum. Anadolu Hem Sağlık Bilimleri Dergisi. 2017;20(4):304-10
- Derived from this study: PubMed 42935173Sahin I, Bilgic S. Effect of Roy Adaptation Model-Based Patient Education on Self-Efficacy, Immunosuppressive Therapy Adherence, and Adaptation to Chronic Disease in Patients With Kidney Disease. West J Nurs Res. 2026 Oct 27:1939459261494039. doi: 10.1177/01939459261494039. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kubilay Göktaş study chair
Trakya University Institute of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training booklet in people with Chronic Kidney Disease and Immunosuppressive Therapy, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Information Form-1 (time frame: at baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07430449, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.