Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-25 @ 2:15 PM
Study NCT ID:
NCT06000566
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2023-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Compliance and Affecting Factors in Juvenile Idiopathic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-02', 'studyFirstSubmitDate': '2023-06-12', 'studyFirstSubmitQcDate': '2023-08-17', 'lastUpdatePostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Drug Compliance by Morisky Medication Adherence Scale 8 (MMAS-8)', 'timeFrame': 'November 2022 - August 2023', 'description': 'Drug adherence is a hot topic and a big issue among children and adolescents. Drug adherence among chronically ill pediatric patients will be evaluated with Morisky Medication Adherence Scale 8. With a sum of scores equalling 8, 6 to \\<8, or \\<6, patients can be categorized as having high, medium or low adherence to therapy, respectively.'}, {'measure': 'Disease activation score', 'timeFrame': 'November 2022 - August 2023', 'description': "The activation score of the disease which will be measured by JADAS. This will help to understand the severity of the disease. JADAS consists of four items; the joint count, the physician and the patient's/parent's global assessment and the erythrocyte sedimentation rate (ESR) as an inflammatory marker. C-reactive protein (CRP) has been suggested as an alternative inflammatory marker. A higher JADAS score indicates higher disease activity as a lower JADAS score indicates lower disease activity"}, {'measure': 'PedsQL (Pediatric Quality of Life Inventory)', 'timeFrame': 'November 2022 - August 2023', 'description': 'The quality of life will be evaluated by Pediatric Quality of Life Inventory (PedsQL). Items in PedsQL are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better quality of live.\n\nIt is aimed to evaluate the quality of life scores of juvenile idiopathic arthritis patients.'}], 'secondaryOutcomes': [{'measure': 'Descriptice characteristics outcome measure', 'timeFrame': 'November 2022 - May 2023', 'description': 'The correlation between the education level of the patients, nutritional habits of the patients, the socio-cultural status of the families and drug compliance is also evaluated for each patient.'}, {'measure': 'Details of medication', 'timeFrame': 'November 2022 - May 2023', 'description': 'The number of drugs used and the number of swintches between drugs will be evaluated in detail and these data will be evaluated in terms of drug compliance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthritis, Juvenile Rheumatoid', 'Medication Adherence', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the drug compliance of patients with juvenile idiopathic arthritis and, to figure our factors that affect the compliance.\n\nThe main questions it aims to answer are:\n\n* Medication use and compliance in children with chronic diseases is an important problem, but do patients with JIA really use their medications in harmony?\n* Does the level of adherence to medications affect the quality of life of patients with JIA?\n\nParticipants will be asked to fill the demographic form which includes personal information and nutritional habbits, Morisky Drug Compliance Scale - 8 and the pediatric quality of life inventory forms, with attending researcher Yesfa Sebnem Ozbay, M.D.\n\nThis study is not an interventional study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric group of age (0 to 18 years), all patients diagnosed with JIA, all patients are using drugs for their diagnose', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being followed up with the diagnosis of Juvenile Idiopathic Artritis (JIA) from the pediatric rheumatology outpatient clinic of Istanbul University, Istanbul Faculty of Medicine\n\nExclusion Criteria:\n\n* Refusal of patients or their parents to participate in the study\n* Although the patient is followed up with the diagnosis of JIA, not using medication'}, 'identificationModule': {'nctId': 'NCT06000566', 'briefTitle': 'Drug Compliance and Affecting Factors in Juvenile Idiopathic Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Drug Compliance and Affecting Factors in Juvenile Idiopathic Arthritis', 'orgStudyIdInfo': {'id': 'Sponsor-Investigator'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric JIA patients', 'description': 'No interventions will be administered'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Fatih', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Nuray Aktay Ayaz, M.D, M.Sci, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'IstabulU'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yesfa Sebnem Ozbay', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'M.D., Assistant Professor, Principal investigator', 'investigatorFullName': 'Yesfa Sebnem Ozbay', 'investigatorAffiliation': 'Istanbul University'}}}}