Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-03-09 @ 12:07 AM
Study NCT ID:
NCT02226718
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2014-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Questionnaire for Measuring Quality of Life in Patients With Chronic Inflammation of the Middle Ear
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2014-08-14', 'studyFirstSubmitQcDate': '2014-08-25', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validity', 'timeFrame': 'day 1 (day of consultation)', 'description': 'Several aspects of Validity will be determined by different methods:\n\n* content validity is made certain by construction procedure of the questionnaire (e.g. involving of specialists and patients)\n* construct validity by factor analysis\n* criterion validity by correlating a global question with the overall questionnaire score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Otitis Media']}, 'descriptionModule': {'briefSummary': 'For measuring quality of life in patients with chronic inflammation of the middle ear, only two questionnaires currently exist. However, these questionnaires are designed only to measure either disease-specific health or hearing-related quality of life. The aim of this project is the validation of a pre-existing comprehensive questionnaire, which is routinely administered in the investigators clinic but has never been validated. Following a retrospective item reduction based on existing data, this questionnaire will be prospectively validated. Applying the resulting questionnaire in future studies on chronic middle ear inflammation, not only objective outcome parameters (e.g. audiograms) but also quality of life will be assessed. Therefore, the investigators questionnaire will add substantial information to these outcome studies by providing a subjective outcome parameter.', 'detailedDescription': 'See Summary that contains all the details'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients suffering from chronic otitis media, visiting a tertiary referral centre', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of chronic otitis media\n\nExclusion Criteria:\n\nnone'}, 'identificationModule': {'nctId': 'NCT02226718', 'briefTitle': 'Validation of a Questionnaire for Measuring Quality of Life in Patients With Chronic Inflammation of the Middle Ear', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Validation of a Questionnaire for Measuring Health-related Quality of Life in Patients With Chronic Otitis Media', 'orgStudyIdInfo': {'id': 'HRQOL-COM1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'questionnaire', 'description': 'Otitis patients and controls', 'interventionNames': ['Other: Administration of questionnaire']}], 'interventions': [{'name': 'Administration of questionnaire', 'type': 'OTHER', 'armGroupLabels': ['questionnaire']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Universitätsspital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Alexander Huber, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsspital Zürich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}