Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT01495767
Status:
COMPLETED
Last Update Posted:
2011-12-23
First Post:
2011-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quality of Life in Juvenile Patients With Uveitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-22', 'studyFirstSubmitDate': '2011-11-27', 'studyFirstSubmitQcDate': '2011-12-19', 'lastUpdatePostDateStruct': {'date': '2011-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life as assessed with the "Inventory for Assessing the Quality of Life in Children and Adolescents"', 'timeFrame': 'One day', 'description': 'psychometric inventory'}], 'secondaryOutcomes': [{'measure': 'Quality of life as assessed with the "Children Quality of Life Questionnaire"', 'timeFrame': 'One day', 'description': 'psychometric inventory'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['childhood uveitis', 'health-related quality of life', 'gender'], 'conditions': ['Uveitis']}, 'descriptionModule': {'briefSummary': "Data about psychodynamics in uveitis patients are scare. A negative impact of disease is described not only in adult patients with active, but also with quiescent disease. During adolescence even less is known about psychodynamics although this is an especially sensible and challenging stage of life. Given the assumption that juvenile patients with quiescent disease still could suffer from emotional distress, this would require special attention.\n\nIn this study the investigators evaluate the impact of juvenile uveitis on HRQoL and attempted to identify clinical and demographic factors contributing to an impaired health status. The investigators limit the study to patients with quiescent uveitis and good visual function in at least one eye to exclude additional negative stressors. As there are no validated uveitis-specific psychometric questionnaires evaluating QoL available yet, the investigators use age-appropriate generic instruments. This should allow obtaining an overview about the adolescents' general Health-related Quality of Life (HRQoL) and whether psychological interventions should be offered to this sensitive patient group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '11 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with uveitis, aged 11-18 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with uveitis\n* aged 11-18 years\n* willing to participate\n* parent or legal guardian agrees with participation of adolescent\n\nExclusion Criteria:\n\n* not willing to participate\n* parent or legal guardian does not agree with participation of adolescent'}, 'identificationModule': {'nctId': 'NCT01495767', 'briefTitle': 'Quality of Life in Juvenile Patients With Uveitis', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Hietzing'}, 'officialTitle': 'The Impact of Uveitis on Health-related Quality of Life in Adolescents', 'orgStudyIdInfo': {'id': 'MAC205'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'females, males', 'description': 'females: patients of female sex males: patients of male sex', 'interventionNames': ['Other: Filling in a psychometric questionnaire']}], 'interventions': [{'name': 'Filling in a psychometric questionnaire', 'type': 'OTHER', 'description': 'Juvenile patients attending the uveitis are asked to fill in a psychometric questionnaire', 'armGroupLabels': ['females, males']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Saskia M Maca, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Hietzing, Vienna + Medical University of Vienna, Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Hietzing', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical University of Vienna', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, principal investigator', 'investigatorFullName': 'Saskia M Maca', 'investigatorAffiliation': 'Hospital Hietzing'}}}}