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Quality of Life in Food Allergic Families

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alan Baptist, University of Michigan
ClinicalTrials.gov Identifier:
NCT01054950
First received: January 21, 2010
Last updated: June 29, 2016
Last verified: June 2016

January 21, 2010
June 29, 2016
January 2010
August 2010   (final data collection date for primary outcome measure)
Difference in validated quality of life survey [ Time Frame: twelve months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01054950 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Quality of Life in Food Allergic Families
Quality of Life in Food Allergic Families
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.
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Food Allergy
  • 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.
  • Behavioral: Placebo phone call
    Phone call w/ no behavioral counseling
  • Experimental: Education and counseling
    Phone calls using behavioral techniques
    Intervention: Behavioral: Counseling
  • Placebo Comparator: Control
    Single phone call
    Intervention: Behavioral: Placebo phone call
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
August 2010
August 2010   (final data collection date for primary outcome measure)

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.
Both
up to 17 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01054950
HUM 33980
No
Not Provided
Not Provided
Alan Baptist, University of Michigan
University of Michigan
Not Provided
Study Director: Alan Baptist, M.D University of Michigan Allergy and Immunology Clinic
University of Michigan
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP