NCT07309861

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2022

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

1.7 years

First QC Date

November 14, 2025

Last Update Submit

December 15, 2025

Conditions

Keywords

Adaptation to illnesschronic kidney diseaseself-carewell-being

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    through study completion, an average of 19 months

Study Arms (1)

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

Device: Educational with chronic kidney disease

Interventions

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).

Effect of education on adherence, self care and well-being of patients with chronic kidney disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University

Edirne, Centre, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Özgül Erol, Professor

    Trakya University

    STUDY DIRECTOR
  • Lale Yacan

    Trakya University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 14, 2025

First Posted

December 30, 2025

Study Start

March 3, 2020

Primary Completion

October 29, 2021

Study Completion

August 29, 2022

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations