Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:52 AM
Study NCT ID:
NCT07309861
Status:
COMPLETED
Last Update Posted:
2025-12-30
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect Of Education On Adherence, Self Care And Well-Being Of Patients With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.\n\nPatients 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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-12-15', 'lastUpdatePostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adaptation to Chronic Illness Scale', 'timeFrame': 'through study completion, an average of 19 months', 'description': "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."}, {'measure': 'The Self-Care Management Process in Chronic Illness (SCMP-G)', 'timeFrame': 'through study completion, an average of 19 months', 'description': '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.'}, {'measure': 'WHO-5 Well-Being Index', 'timeFrame': 'through study completion, an average of 19 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adaptation to illness', 'chronic kidney disease', 'self-care', 'well-being'], 'conditions': ['Chronic Kidney Disease (Stage 3-4)']}, 'descriptionModule': {'briefSummary': "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.\n\nDesign: A randomised controlled trial. Participants: The study sample consisted of total of 119 individuals diagnosed with stage 3 to stage 4 chronic kidney disease.\n\nMethods: 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.", 'detailedDescription': '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.\n\nReporting 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being over 18 years of age\n* having stage 3 or stage 4 chronic kidney disease\n* not having communication difficulties\n* receiving outpatient treatment at the nephrology outpatient clinic\n* and volunteering to take part in the research\n\nExclusion Criteria:\n\n* being under 18 years of age\n* having stage 1, 2 or stage 5 chronic kidney disease\n* having communication difficulties\n* not volunteering to take part in the research\n* receiving hemodialysis or peritoneal dialysis'}, 'identificationModule': {'nctId': 'NCT07309861', 'briefTitle': 'Effect Of Education On Adherence, Self Care And Well-Being Of Patients With Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Trakya University'}, 'officialTitle': 'Effect Of Education On Adherence, Self Care And Well-Being Of Patients With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'TUTF-BAEK 2019/206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Effect of education on adherence, self care and well-being of patients with chronic kidney disease', 'description': 'Patients who diagnosed with stage 3 to stage 4 chronic kidney disease', 'interventionNames': ['Device: Educational with chronic kidney disease']}], 'interventions': [{'name': 'Educational with chronic kidney disease', 'type': 'DEVICE', 'description': '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).', 'armGroupLabels': ['Effect of education on adherence, self care and well-being of patients with chronic kidney disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22030', 'city': 'Edirne', 'state': 'Centre', 'country': 'Turkey (Türkiye)', 'facility': 'Trakya University', 'geoPoint': {'lat': 41.67719, 'lon': 26.55597}}], 'overallOfficials': [{'name': 'Özgül Erol, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Trakya University'}, {'name': 'Lale Yacan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Trakya University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trakya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Lale Yacan', 'investigatorAffiliation': 'Trakya University'}}}}