Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-01-29 @ 8:10 AM
Study NCT ID:
NCT01054950
Status:
COMPLETED
Last Update Posted:
2016-06-30
First Post:
2010-01-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life in Food Allergic Families
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-29', 'studyFirstSubmitDate': '2010-01-21', 'studyFirstSubmitQcDate': '2010-01-21', 'lastUpdatePostDateStruct': {'date': '2016-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in validated quality of life survey', 'timeFrame': 'twelve months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Food Allergy']}, 'referencesModule': {'references': [{'pmid': '22541244', 'type': 'RESULT', 'citation': 'Baptist AP, Dever SI, Greenhawt MJ, Polmear-Swendris N, McMorris MS, Clark NM. A self-regulation intervention can improve quality of life for families with food allergy. J Allergy Clin Immunol. 2012 Jul;130(1):263-5.e6. doi: 10.1016/j.jaci.2012.03.029. Epub 2012 Apr 26. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "Food allergies are becoming more prevalent with more children being diagnosed with food allergies each year. Food allergies place a tremendous burden not just on the patient but on his/her family as well. In an attempt to provide better care to the investigators patients, the investigators would like to determine if regular contact with our food allergy nurse has a positive effect on a family's perceived quality of life.", 'detailedDescription': 'We intend to show a difference between the intervention group, who will receive a food allergy packet, along with three follow up phone calls from our trained allergy nurse, and the control group, will be given the food allergy packet only. We expect the intervention group to score higher on the quality of life survey, showing that the support and education of our allergy nurse has a positive effect on quality of life of our patients and their families.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IgE mediated food allergy\n* Ages 0-17\n* Willing to participate\n\nExclusion Criteria:\n\n* Food sensitivities\n* Unable to understand or read survey\n* Unable to be available for follow up survey and nurse phone calls.'}, 'identificationModule': {'nctId': 'NCT01054950', 'briefTitle': 'Quality of Life in Food Allergic Families', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Quality of Life in Food Allergic Families', 'orgStudyIdInfo': {'id': 'HUM 33980'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Education and counseling', 'description': 'Phone calls using behavioral techniques', 'interventionNames': ['Behavioral: Counseling']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Single phone call', 'interventionNames': ['Behavioral: Placebo phone call']}], 'interventions': [{'name': 'Counseling', 'type': 'BEHAVIORAL', 'description': "Our food allergy nurse will contact our intervention group and discuss any questions or concerns they may have regarding their child's food allergy.", 'armGroupLabels': ['Education and counseling']}, {'name': 'Placebo phone call', 'type': 'BEHAVIORAL', 'description': 'Phone call w/ no behavioral counseling', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Allergy and Immunology Clinic', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Alan Baptist, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Michigan Allergy and Immunology Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Alan Baptist', 'investigatorAffiliation': 'University of Michigan'}}}}