Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
Study NCT ID:
NCT04955132
Status:
UNKNOWN
Last Update Posted:
2021-10-21
First Post:
2021-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of E-learning on Parental Confidence in Managing Food Allergy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}], 'ancestors': [{'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-13', 'studyFirstSubmitDate': '2021-07-03', 'studyFirstSubmitQcDate': '2021-07-03', 'lastUpdatePostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parental confidence in managing food allergy', 'timeFrame': 'After 1 month.', 'description': 'Parental confidence will be assessed using Food Allergy Self-Efficacy Scale for Parents (FASE-P). Single item minimum score - 0, maximum score - 100. Higher scores represent higher parental confidence.'}], 'secondaryOutcomes': [{'measure': 'Parental satisfaction', 'timeFrame': 'After 1 month.', 'description': 'Parental satisfaction will be assessed using Visual Analog Satisfaction Scale. Minimum score - 0, maximum score - 100. Higher score represents higher satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Food allergy', 'Milk', 'Egg', 'Wheat', 'Children'], 'conditions': ['Food Allergy in Children', 'Food Allergy in Infants']}, 'descriptionModule': {'briefSummary': "Education and dietary support are integral in managing food allergy in children. The study aim is to analyze the impact of E-learning on parental confidence in managing their child's food allergy.", 'detailedDescription': "Food allergy is a common childhood morbidity, that has increased in prevalence over the last few decades. Education and dietary support is integral in managing food allergy in children; however it is labor intensive and requires financial resources, which places an economic burden on the healthcare system. The study aim is analyze the impact of E-learning on parental confidence in managing their child's food allergy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Legal caregivers of a child that is allergic (confirmed by an allergist) to at least one of the main food allergens (cow's milk, egg or wheat) and is following an elimination diet to at least one of these allergens.\n* Internet access available.\n\nExclusion Criteria:\n\n* Participant non proficient in Lithuanian."}, 'identificationModule': {'nctId': 'NCT04955132', 'briefTitle': 'Impact of E-learning on Parental Confidence in Managing Food Allergy', 'organization': {'class': 'OTHER', 'fullName': 'Vilnius University'}, 'officialTitle': 'Impact of E-learning on Parental Confidence in Managing Food Allergy', 'orgStudyIdInfo': {'id': '18BMTV33'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'E-learning', 'description': 'Participants (parents of food-allergic children) will use an E-learning platform on food allergies for one month.', 'interventionNames': ['Behavioral: E-learning']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'Participants (parents of food-allergic children) will receive standard allergist consulting.'}], 'interventions': [{'name': 'E-learning', 'type': 'BEHAVIORAL', 'description': 'The participants in the experimental arm will be able to use a food allergy e-learning tool, that provides comprehensive knowledge of the most common food allergies (milk, egg and wheat), their management and dietary guidelines.', 'armGroupLabels': ['E-learning']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Vilnius University Hospital Santaros Clinics', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}], 'overallOfficials': [{'name': 'Ieva Adomaite', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vilnius University Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'All collected data, following deidentification will be available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vilnius University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ieva Adomaite', 'investigatorAffiliation': 'Vilnius University'}}}}