Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-01-07 @ 5:16 AM
Study NCT ID:
NCT03286894
Status:
COMPLETED
Last Update Posted:
2018-10-24
First Post:
2017-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AQUAPed: Validation Study of AQUA© Questionnaire Modified for Childhood
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1264}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-23', 'studyFirstSubmitDate': '2017-09-15', 'studyFirstSubmitQcDate': '2017-09-15', 'lastUpdatePostDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Question difficulty', 'timeFrame': 'Study end (4 months)', 'description': 'Comprehensibility (or difficulty) of the questions, especially the "core questions", will be assessed by the percentages of non-response possibly stratified by children characteristics (in particular age, sex and physical activity).'}], 'secondaryOutcomes': [{'measure': 'Patterns of missing response', 'timeFrame': 'Study end (4 months)', 'description': 'Possible tendency to skip consecutive questions will be assessed by studying the association between the presence of missing (0 = answer missing, 1 = answer given) in sequence (tetrachoric correlation).'}, {'measure': 'Patterns of non-missing responses', 'timeFrame': 'Study end (4 months)', 'description': 'Analysis of the distribution of non-missing responses, possibly stratified by children characteristics (in particular age, sex and physical activity).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The AQUA© questionnaire developed in 2008 is a validated tools for the screening of allergic diseases in adult athletes. The objective of the present study is to develop and validate a modified version of the AQUA© questionnaire to be used in childhood. In this phase, the validation is intended to assess the reliability of the information collected through the AQUA© modified version: question difficulty and response patterns with respect to children characteristics (in particular age, sex and physical activity). In particular, the focus will be on the "core questions", i.e. the indicators of allergic disorders. This is a cross-sectional study on 1264 healthy schoolchildren aged 8 to 14 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of 1264 healthy schoolchildren, both males and females, aged 8 to 14 years, recruited in 7 primary and secondary schools of the city of Palermo.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aforementioned sex and age criteria.\n\nExclusion Criteria:\n\n* Respiratory infections in the previous 3 weeks;\n* Immunological or metabolic systemic disease;\n* Major malformations of the upper airways;\n* Active smoker.'}, 'identificationModule': {'nctId': 'NCT03286894', 'acronym': 'AQUAPed', 'briefTitle': 'AQUAPed: Validation Study of AQUA© Questionnaire Modified for Childhood', 'organization': {'class': 'OTHER', 'fullName': "Istituto per la Ricerca e l'Innovazione Biomedica"}, 'officialTitle': 'AQUAPed: Validation Study of AQUA© Questionnaire Modified for Childhood', 'orgStudyIdInfo': {'id': '7/2017_D'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1264 healthy schoolchildren', 'description': 'There is only one study group consisting of 1264 children recruited at school.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90146', 'city': 'Palermo', 'state': 'Sicily', 'country': 'Italy', 'facility': 'Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Istituto per la Ricerca e l'Innovazione Biomedica", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.', 'investigatorFullName': 'Stefania La Grutta, MD', 'investigatorAffiliation': "Istituto per la Ricerca e l'Innovazione Biomedica"}}}}