Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-30 @ 6:49 PM
Study NCT ID:
NCT04475003
Status:
UNKNOWN
Last Update Posted:
2020-07-17
First Post:
2020-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Literacy Among Caregivers of Children With IgE-mediated Allergy With Risk of Anaphylaxis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000707', 'term': 'Anaphylaxis'}], 'ancestors': [{'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-16', 'studyFirstSubmitDate': '2020-07-14', 'studyFirstSubmitQcDate': '2020-07-16', 'lastUpdatePostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'General knowledge of anaphylaxis.', 'timeFrame': '1.5 year', 'description': 'Knowledge Quiz'}], 'secondaryOutcomes': [{'measure': 'The extent to which caregivers consider themselves able to recognize and to treat anaphylaxis.', 'timeFrame': '1.5 year', 'description': 'Numeric scoring scale (0= cannot do at all, 5= highly certain can do)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health Literacy', 'Anaphylaxis']}, 'descriptionModule': {'briefSummary': "Research on health literacy among caregivers of children with IgE-mediated allergy at risk of anaphylaxis (life-threatening allergic reaction). Health literacy is a person's ability to understand health information so that they can maintain or improve their health and quality of life (of themself and children).\n\nThe aim of the study is to test the general knowledge of anaphylaxis. Furthermore we test the extent to which caregivers consider themselves able to recognize and to treat anaphylaxis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'For each child that is known with IgE-mediated allergy with risk of anaphylaxis parents can invitate 4 Caregivers of children with IgE-mediated allergy with risk of anaphylaxis (adults, grandparents, school caregivers etc.).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* caregivers of children with IgE-mediated allergy with risk of anaphylaxis (adults, grandparents, school caregivers etc.).\n* minimum 18 years old.\n* signed informed consent\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04475003', 'briefTitle': 'Health Literacy Among Caregivers of Children With IgE-mediated Allergy With Risk of Anaphylaxis', 'organization': {'class': 'OTHER', 'fullName': 'Algemeen Ziekenhuis Maria Middelares'}, 'officialTitle': 'Health Literacy Among Caregivers of Children With IgE-mediated Allergy With Risk of Anaphylaxis', 'orgStudyIdInfo': {'id': 'MMS2020.017'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Teaching', 'type': 'OTHER', 'description': 'Teaching session about anaphylaxis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'Oost-Vlaanderen', 'country': 'Belgium', 'contacts': [{'name': 'Jasmine S Leus', 'role': 'CONTACT', 'email': 'jasmine.leus@azmmsj.be', 'phone': '+329 246 8200'}, {'name': 'Josefien L Vandekerckhove', 'role': 'CONTACT', 'email': 'josefien.vandekerckhove@gmail.com', 'phone': '+329 246 8200'}], 'facility': 'Algemeen Ziekenhuis Maria Middelares', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'centralContacts': [{'name': 'Jasmine S Leus', 'role': 'CONTACT', 'email': 'jasmine.leus@azmmsj.be', 'phone': '+329 246 8200'}, {'name': 'Josefien L Vandekerckhove', 'role': 'CONTACT', 'email': 'josefien.vandekerckhove@gmail.com', 'phone': '+329 246 8200'}], 'overallOfficials': [{'name': 'Jasmine S Leus', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Algemeen Ziekenhuis Maria Middelares'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Algemeen Ziekenhuis Maria Middelares', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Kinderarts', 'investigatorFullName': 'dr. Jasmine Leus', 'investigatorAffiliation': 'Algemeen Ziekenhuis Maria Middelares'}}}}