Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-25 @ 8:03 PM
Study NCT ID:
NCT03892135
Status:
COMPLETED
Last Update Posted:
2019-04-29
First Post:
2019-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Representation and Medication Use in Juvenile Idiopathic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}, {'id': 'D010820', 'term': 'Physicians'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-25', 'studyFirstSubmitDate': '2019-03-18', 'studyFirstSubmitQcDate': '2019-03-25', 'lastUpdatePostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interview with parents', 'timeFrame': '1 day', 'description': 'Interview with parents to learn about role of parents in the management of juvenile idiopathic arthritis in their children'}], 'secondaryOutcomes': [{'measure': 'Interview with children', 'timeFrame': '1 day', 'description': 'Interview with children to learn about role of children in the management of their juvenile idiopathic arthritis'}, {'measure': 'Interview with physicians', 'timeFrame': '1 day', 'description': 'Interview with physicians to learn about role of physicians in the management of juvenile idiopathic arthritis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Role of parents, children and physician', 'Qualitative', 'Interview', 'Juvenile idiopathic arthritis', 'Adherence', 'mechanisms of adherence in juvenile idiopathic arthritis'], 'conditions': ['Juvenile Idiopathic Arthritis']}, 'descriptionModule': {'briefSummary': 'According to the International League of Associations for Rheumatology classification, Juvenile Idiopathic Arthritis (JIA) comprises a heterogeneous group of arthritis of unknown cause and with onset before 16 years of age, characterized by joint inflammation lasting for 6 or more weeks. Few studies exist regarding the care experience of children affected by this rheumatic condition. On the other hand, methotrexate and biologics constitute the primary treatment for children with JIA. As with adults undergoing the same treatment, adherence is critical. Difficulties for children to take the drugs have been reported. Notwithstanding, if adherence promotion in pediatric chronic conditions has been the subject of recommendations with regard to care management, the investigators lack information to understand the grounds for adherence specifically in JIA. In order to understand and decipher the parent-child adherence mechanisms and practices, the RUMAJI study will be conducted. Indeed, improving the relational approach between children and their caregivers as well as unrestricted drug adherence involves researching and understanding how appropriation of the disease and treatment could be achieved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with JIA and their parents', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* all JIA forms\n* all treatment type (NSAIDs, MTX, bDMARDs)\n\nExclusion criteria:\n\n\\- none'}, 'identificationModule': {'nctId': 'NCT03892135', 'acronym': 'RUMAJI', 'briefTitle': 'Representation and Medication Use in Juvenile Idiopathic Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Representation and Medication Use in Juvenile Idiopathic Arthritis - RUMAJI', 'orgStudyIdInfo': {'id': 'RECHMPL19_0171'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Physicians', 'description': '3 paediatricians and 3 rheumatologists', 'interventionNames': ['Other: Interviews with Physicians']}, {'label': 'Parents', 'description': 'Parents', 'interventionNames': ['Other: Interviews with parents of children with juvenile idiopathic arthritis']}, {'label': 'Children', 'description': 'Children', 'interventionNames': ['Other: Interviews with children with juvenile idiopathic arthritis']}], 'interventions': [{'name': 'Interviews with parents of children with juvenile idiopathic arthritis', 'type': 'OTHER', 'description': 'Interviews with parents of children with juvenile idiopathic arthritis', 'armGroupLabels': ['Parents']}, {'name': 'Interviews with children with juvenile idiopathic arthritis', 'type': 'OTHER', 'description': 'Interviews with children with juvenile idiopathic arthritis', 'armGroupLabels': ['Children']}, {'name': 'Interviews with Physicians', 'type': 'OTHER', 'description': 'Interviews with Physicians', 'armGroupLabels': ['Physicians']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Jean-David COHEN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'collaborators': [{'name': 'Research department, unknowns, Strategic & innovation consulting, Paris (anthropologists)', 'class': 'UNKNOWN'}, {'name': 'NORDIC pharma (funding)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}