Chronic Kidney Disease (Stage 3-4)NCT07309861
Effect Of Education On Adherence, Self Care And Well-Being Of Patients With Chronic Kidney Disease
A study testing Educational with chronic kidney disease in people with Chronic Kidney Disease (Stage 3-4), run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
ABSTRACT Aim: The aim of the study was evaluate the effect of education provided to patients diagnosed with chronic kidney disease on adherence to illness, self-care, and well-being. Design: A randomised controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease (Stage 3-4)
- What is being tested?
- Educational with chronic kidney disease
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2020to 29 Aug 2022
- 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
- being over 18 years of age
- having stage 3 or stage 4 chronic kidney disease
- not having communication difficulties
- receiving outpatient treatment at the nephrology outpatient clinic
- and volunteering to take part in the research
Who cannot join
- being under 18 years of age
- having stage 1, 2 or stage 5 chronic kidney disease
- having communication difficulties
- not volunteering to take part in the research
- receiving hemodialysis or peritoneal dialysis
Trial locations and contacts
1 site in 1 country.
About this study
ABSTRACT Aim: The aim of the study was evaluate the effect of education provided to patients diagnosed with chronic kidney disease on adherence to illness, self-care, and well-being.
Design: A randomised controlled trial. Participants: The study sample consisted of total of 119 individuals diagnosed with stage 3 to stage 4 chronic kidney disease.
Methods: The data were collected with the Patient Information Form, Adaptation to Chronic Illness Scale, Self-Care Management Process in Chronic Illness and the World Health Organization-5 Well-Being Index. The data were evaluated using descriptive analyses, the Mann-Whitney U test, Pearson's chi-square test, Fisher-Freeman test, student's t-test, Wilcoxon test, and Friedman test.
Read the detailed description
Implications for the profession or patient care: This study contributes to the improvement of disease adaptation and self-care of individuals with stage 3 and stage chronic kidney disease.
Reporting Method: Consolidated Standards of Reporting Trials (CONSORT) Patient or Public Contribution: The study sample consisted of total of 119 individuals diagnosed with stage 3 to stage 4 chronic kidney disease.
- Conditions
- Chronic Kidney Disease (Stage 3-4)
- Being tested
- Educational with chronic kidney disease
- Keywords
- Adaptation to illness, chronic kidney disease, self-care, well-being
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational with chronic kidney diseaseDevice
Education Booklet for Patients with Chronic Kidney Disease It was prepared by the researchers in line with the literature review to be used as educational material for patients with stage 3 and stage 4 chronic kidney disease. The education booklet includes information about the kidneys (anatomy and functions of the kidneys), chronic kidney disease (definition of chronic kidney disease , risk factors, symptoms, nutrition in chronic kidney disease , salt consumption, the importance of potassium and phosphorus for our body, regular and balanced nutrition, exercise, the relationship between chronic kidney disease and diabetes, and the relationship between chronic kidney disease and hypertension), and treatment methods (hemodialysis, peritoneal dialysis, and kidney transplant).
| Study group | Role | What they receive |
|---|---|---|
| Effect of education on adherence, self care and well-being of patients with chronic kidney disease | Experimental | Patients who diagnosed with stage 3 to stage 4 chronic kidney disease Receives: Device: Educational with chronic kidney disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptation to Chronic Illness Scale
Adaptation to Chronic Illness Scale (ACIS): The scale includes 25 items, and a total score of 125 points is obtained from the scale. An increase in the scores from the subscales and/or the overall scale means that patients' adaptation levels to illness also increase.
Measured: through study completion, an average of 19 months
The Self-Care Management Process in Chronic Illness (SCMP-G)
The Self-Care Management Process in Chronic Illness (SCMP-G): The scale includes 35 items and is evaluated as 5 (Strongly Agree) and 1 (Strongly Disagree). Self-care management increases with the increasing score on the scale.
Measured: through study completion, an average of 19 months
WHO-5 Well-Being Index
WHO-5 Well-Being Index: The raw score is computed by summing the numbers belonging to 5 answers. Zero represents the worst possible quality of life, while 25 represents the best possible quality of life. To acquire a percentage score ranging from 0 to 100, the raw score is multiplied by 4. Whereas "zero percent" indicates the worst possible quality of life, "one hundred percent" indicates the best possible quality of life.
Measured: through study completion, an average of 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start3 Mar 2020
- Primary completion29 Oct 2021
- Study completion29 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (Stage 3-4)Studies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The study population comprised of patients diagnosed with chronic kidney disease and receiving treatment in the nephrology outpatient clinic of a hospital. Considering the sample size of the study, since there are not sufficient data in the literature on the effect of the education provided to individuals with chronic kidney disease on adherence to illness, self-care, and well-being, it was calculated that 64 individuals from each group (intervention=64, control=64) should be included in the research with a power value of 80% and a margin of error of 5% to test the prediction of a medium effect size (d=0.5) of the education to be provided. Considering the possible losses during the study process, 70 individuals were included in each group. Patients were assigned to the intervention and control groups using the computer program Researcher Randomizer and the simple randomization method. In randomization between groups, characteristics such as age and sex of the patients who volunteered.
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lale Yacan, Trakya University
- Investigators
- Özgül Erol, Professor, Study director, Trakya UniversityLale Yacan, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309861
- Sponsor's protocol ID
- TUTF-BAEK 2019/206
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Education On Adherence, Self Care And Well-Being Of Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07309861
- Acronym / sponsor ID
- TUTF-BAEK 2019/206
- Conditions
- Chronic Kidney Disease (Stage 3-4)
- Keywords
- Adaptation to illness, chronic kidney disease, self-care, well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Aug 2022 (actual)
- First posted
- 30 Dec 2025 (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.
ABSTRACT Aim: The aim of the study was evaluate the effect of education provided to patients diagnosed with chronic kidney disease on adherence to illness, self-care, and well-being.
Design: A randomised controlled trial. Participants: The study sample consisted of total of 119 individuals diagnosed with stage 3 to stage 4 chronic kidney disease.
Methods: The data were collected with the Patient Information Form, Adaptation to Chronic Illness Scale, Self-Care Management Process in Chronic Illness and the World Health Organization-5 Well-Being Index. The data were evaluated using descriptive analyses, the Mann-Whitney U test, Pearson's chi-square test, Fisher-Freeman test, student's t-test, Wilcoxon test, and Friedman test.
Detailed description
Implications for the profession or patient care: This study contributes to the improvement of disease adaptation and self-care of individuals with stage 3 and stage chronic kidney disease.
Reporting Method: Consolidated Standards of Reporting Trials (CONSORT) Patient or Public Contribution: The study sample consisted of total of 119 individuals diagnosed with stage 3 to stage 4 chronic kidney disease.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study population comprised of patients diagnosed with chronic kidney disease and receiving treatment in the nephrology outpatient clinic of a hospital. Considering the sample size of the study, since there are not sufficient data in the literature on the effect of the education provided to individuals with chronic kidney disease on adherence to illness, self-care, and well-being, it was calculated that 64 individuals from each group (intervention=64, control=64) should be included in the research with a power value of 80% and a margin of error of 5% to test the prediction of a medium effect size (d=0.5) of the education to be provided. Considering the possible losses during the study process, 70 individuals were included in each group. Patients were assigned to the intervention and control groups using the computer program Researcher Randomizer and the simple randomization method. In randomization between groups, characteristics such as age and sex of the patients who volunteered.
| Arm | Type | Receives |
|---|---|---|
| Effect of education on adherence, self care and well-being of patients with chronic kidney disease | Experimental | Device: Educational with chronic kidney diseasePatients who diagnosed with stage 3 to stage 4 chronic kidney disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- being over 18 years of age
- having stage 3 or stage 4 chronic kidney disease
- not having communication difficulties
- receiving outpatient treatment at the nephrology outpatient clinic
- and volunteering to take part in the research
Key exclusion criteria (5 listed)
- being under 18 years of age
- having stage 1, 2 or stage 5 chronic kidney disease
- having communication difficulties
- not volunteering to take part in the research
- receiving hemodialysis or peritoneal dialysis
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 |
|---|---|---|
| Educational with chronic kidney diseaseEducation Booklet for Patients with Chronic Kidney Disease It was prepared by the researchers in line with the literature review to be used as educational material for patients with stage 3 and stage 4 chronic kidney disease. The education booklet includes information about the kidneys (anatomy and functions of the kidneys), chronic kidney disease (definition of chronic kidney disease , risk factors, symptoms, nutrition in chronic kidney disease , salt consumption, the importance of potassium and phosphorus for our body, regular and balanced nutrition, exercise, the relationship between chronic kidney disease and diabetes, and the relationship between chronic kidney disease and hypertension), and treatment methods (hemodialysis, peritoneal dialysis, and kidney transplant). | Device | Effect of education on adherence, self care and well-being of patients with chronic kidney disease |
Primary outcome
Adaptation to Chronic Illness Scale
Time frame: through study completion, an average of 19 months
Adaptation to Chronic Illness Scale (ACIS): The scale includes 25 items, and a total score of 125 points is obtained from the scale. An increase in the scores from the subscales and/or the overall scale means that patients' adaptation levels to illness also increase.
The Self-Care Management Process in Chronic Illness (SCMP-G)
Time frame: through study completion, an average of 19 months
The Self-Care Management Process in Chronic Illness (SCMP-G): The scale includes 35 items and is evaluated as 5 (Strongly Agree) and 1 (Strongly Disagree). Self-care management increases with the increasing score on the scale.
WHO-5 Well-Being Index
Time frame: through study completion, an average of 19 months
WHO-5 Well-Being Index: The raw score is computed by summing the numbers belonging to 5 answers. Zero represents the worst possible quality of life, while 25 represents the best possible quality of life. To acquire a percentage score ranging from 0 to 100, the raw score is multiplied by 4. Whereas "zero percent" indicates the worst possible quality of life, "one hundred percent" indicates the best possible quality of life.
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 30 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Özgül Erol, Professor study director
Trakya University
Lale Yacan principal investigator
Trakya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational with chronic kidney disease in people with Chronic Kidney Disease (Stage 3-4), 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 5 inclusion and 5 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 30 Dec 2025. 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?
Adaptation to Chronic Illness Scale (time frame: through study completion, an average of 19 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2025.