Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-02 @ 1:54 AM
Study NCT ID:
NCT02106169
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2014-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of the Therapeutic Education on the Quality of Life of the Child Suffering of Food Allergy IgE-mediated
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': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2016-10-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-15', 'studyFirstSubmitDate': '2014-04-03', 'studyFirstSubmitQcDate': '2014-04-07', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child FAQLQ global score', 'timeFrame': 'month 12'}], 'secondaryOutcomes': [{'measure': 'Child FAQLQ global score', 'timeFrame': 'month 4'}, {'measure': 'Child FAQLQ global score', 'timeFrame': 'month 6'}, {'measure': 'All cause which can be influence the quality of life, especially occurrence of anaphylactic reactions', 'timeFrame': 'month 12'}, {'measure': 'Parent FAQLQ global score', 'timeFrame': 'month 4'}, {'measure': 'Parent FAQLQ global score', 'timeFrame': 'month 6'}, {'measure': 'Parent FAQLQ global score', 'timeFrame': 'month 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Food allergy', 'Children and families', 'Therapeutic education', 'Quality of life'], 'conditions': ['IgE Mediated Food Allergy']}, 'descriptionModule': {'briefSummary': "The purpose of the study is to determine whether therapeutic education can improve the quality of life of the child from 8 to 12 years old suffering of food allergy.\n\nThis study also show us if therapeutic education has an effect on the quality of life of child's family.", 'detailedDescription': 'Food allergy affects 5 - 6% of children. The major risk is anaphylaxis by ingestion of the forbidden allergen. The child and his family have to learn to deal with this risk. Therapeutic education can help the children to take care of their allergy.\n\nFood allergy limits the child socialisation, leads to anxiety/fear, and impairs health-related quality of life. In the day of today, there is no cure treatment. Also, improve the quality of life is one of the goals of the food allergy management.\n\nThe impact of therapeutic education on quality of life has never been studied. We intend to study the impact of therapeutic education on the quality of life of children from 8 to 12 years old with IgE mediated food allergy.\n\nOur hypothesis is the quality of life can be improved by therapeutic education.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* IgE mediated food allergy\n* Child from 8 to 12 years old (included)\n* Family who can have an internet access\n* Children which parents have received study's information\n* Child who can have a medical examination before inclusion (art. L.1121-11 du CSP).\n* Patients who have a medical insurance.\n\nExclusion Criteria:\n\n* Non IgE mediated food allergy\n* Child with chronic disease, except asthma and atopic dermatitis\n* Patients who already had a therapeutic education for food allergy\n* Patient already included in another study"}, 'identificationModule': {'nctId': 'NCT02106169', 'acronym': 'EducAA', 'briefTitle': 'Impact of the Therapeutic Education on the Quality of Life of the Child Suffering of Food Allergy IgE-mediated', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Impact of the Therapeutic Education on the Quality of Life of the Child From 8 to 12 Years Old (and His Family) Suffering of Food Allergy IgE-mediated.', 'orgStudyIdInfo': {'id': '2013-A01104-41'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapeutic education group', 'description': 'At first, all patients will be invited to participate in a study of troop having for objective to estimate their quality of life. Then, the doctors offer patients randomized to therapeutic education to have a therapeutic education before the 4th month.\n\nThe sessions will be led by a multidisciplinary equip. Each child and his family will have a therapeutic session (2 times 2 hours).', 'interventionNames': ['Behavioral: Therapeutic education group']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'At first, all patients will be invited to participate in a study of troop having for objective to estimate their quality of life. Then, the patients randomized in this group will have the habitual medical care.'}], 'interventions': [{'name': 'Therapeutic education group', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Therapeutic education group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Necker hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Chantal KARILA, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Necker hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'French Society of Allergology', 'class': 'UNKNOWN'}, {'name': 'Stallergenes laboratories', 'class': 'UNKNOWN'}, {'name': 'Picot-Lactalis laboratory', 'class': 'UNKNOWN'}, {'name': 'ALK Industries', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}