Back to resultsQuality of Life in Food Allergic Families
Primary Purpose
Food Allergy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counseling
Placebo phone call
Sponsored by
About this trial
This is an interventional supportive care trial for Food Allergy
Eligibility Criteria
Inclusion Criteria:
- IgE mediated food allergy
- Ages 0-17
- Willing to participate
Exclusion Criteria:
- Food sensitivities
- Unable to understand or read survey
- Unable to be available for follow up survey and nurse phone calls.
Sites / Locations
- University of Michigan Allergy and Immunology Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Education and counseling
Control
Arm Description
Phone calls using behavioral techniques
Single phone call
Outcomes
Primary Outcome Measures
Difference in validated quality of life survey
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01054950
Brief Title
Quality of Life in Food Allergic Families
Official Title
Quality of Life in Food Allergic Families
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Education and counseling
Arm Type
Experimental
Arm Description
Phone calls using behavioral techniques
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Single phone call
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Placebo phone call
Intervention Description
Phone call w/ no behavioral counseling
Primary Outcome Measure Information:
Title
Difference in validated quality of life survey
Time Frame
twelve months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
IgE mediated food allergy
Ages 0-17
Willing to participate
Exclusion Criteria:
Food sensitivities
Unable to understand or read survey
Unable to be available for follow up survey and nurse phone calls.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Baptist, M.D
Organizational Affiliation
University of Michigan Allergy and Immunology Clinic
Official's Role
Study Director
Facility Information:
Facility Name
University of Michigan Allergy and Immunology Clinic
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22541244
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.
Results Reference
result
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Quality of Life in Food Allergic Families
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