- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07309861
Effect Of Education On Adherence, Self Care And Well-Being Of Patients With Chronic Kidney Disease
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Centre
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Edirne, Centre, Turkey (Türkiye), 22030
- Trakya University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Effect of education on adherence, self care and well-being of patients with chronic kidney disease
Patients who diagnosed with stage 3 to stage 4 chronic kidney disease
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Adaptation to Chronic Illness Scale
Time Frame: through study completion, an average of 19 months
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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.
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through study completion, an average of 19 months
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The Self-Care Management Process in Chronic Illness (SCMP-G)
Time Frame: through study completion, an average of 19 months
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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.
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through study completion, an average of 19 months
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WHO-5 Well-Being Index
Time Frame: through study completion, an average of 19 months
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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.
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through study completion, an average of 19 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Özgül Erol, Professor, Trakya University
- Principal Investigator: Lale Yacan, Trakya University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
- Renal Insufficiency, Chronic
Other Study ID Numbers
- TUTF-BAEK 2019/206
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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