Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-01-27 @ 1:50 AM
Study NCT ID:
NCT06523192
Status:
COMPLETED
Last Update Posted:
2024-07-26
First Post:
2024-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the English Version of the Drug Hypersensitivity Quality of Life Questionnaire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004342', 'term': 'Drug Hypersensitivity'}], 'ancestors': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-22', 'studyFirstSubmitDate': '2024-07-22', 'studyFirstSubmitQcDate': '2024-07-22', 'lastUpdatePostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validation of the English version of the Drug Hypersensitivity Questionnaire', 'timeFrame': 'March 2023 May 2024', 'description': 'Reliability and validity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Drug Hypersensitivity', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'We aim to validate the English (UK) translation of the DrHy-Q, and test its reliability in the UK population. This will facilitate for the subsequent economical evaluation of penicillin allergy delabelling.\n\nThis research project is part of an MSc in Allergy undertaken by the principal applicant, Dr Patricia Romero, supervised through Imperial College London.\n\nTarget population are patients with a drug allergy diagnosed by an Allergist prospectively at the Drug Allergy Clinic.\n\nIs the English version of the Drug Hypersensitivity Quality of Life Questionnaire suitable to be used in the UK population?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Our target population are patients with diagnosed drug allergy.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Age \\>18 years\n\n * Ability to read English and consent.\n * Confirmed diagnosis of a drug hypersensitivity reaction.\n * Written informed consent\n\nExclusion Criteria:\n\n* • \\< 18y/o.\n\n * Not able to read English. No mental capacity to consent or unwilling to consent.\n * Unconfirmed diagnosis of a drug hypersensitivity reaction.'}, 'identificationModule': {'nctId': 'NCT06523192', 'briefTitle': 'Validation of the English Version of the Drug Hypersensitivity Quality of Life Questionnaire', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals, Leicester'}, 'officialTitle': 'The English Version of the Drug Hypersensitivity Quality of Life Questionnaire: Validity and Reliability in the British Population.', 'orgStudyIdInfo': {'id': '151058'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaires', 'type': 'OTHER', 'description': 'No intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LE39QP', 'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'UNiversity Hospitals Leicester', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals, Leicester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}