Quality of Life in Food Allergic Families

Food Allergy Clinical Trial

Official title:

Quality of Life in Food Allergic Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01054950
• Other study ID #: HUM 33980
• Status: Completed
• Phase: N/A
• First received: January 21, 2010
• Last updated: June 29, 2016
• Start date: January 2010
• Est. completion date: August 2010

Study information

• Verified date: June 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Food Allergy

Intervention

Behavioral:
• Counseling
Our food allergy nurse will contact our intervention group and discuss any questions or concerns they may have regarding their child's food allergy.
• Placebo phone call
Phone call w/ no behavioral counseling

Locations

Country	Name	City	State
United States	University of Michigan Allergy and Immunology Clinic	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Ep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in validated quality of life survey		twelve months	No