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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
  Purpose
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.

Condition Intervention
Food Allergy
Behavioral: Counseling
Behavioral: Placebo phone call

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Quality of Life in Food Allergic Families

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Difference in validated quality of life survey [ Time Frame: twelve months ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: January 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Education and counseling
Phone calls using behavioral techniques
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 Comparator: Control
Single phone call
Behavioral: Placebo phone call
Phone call w/ no behavioral counseling

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.
  Eligibility

Ages Eligible for Study:   up to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01054950

Locations
United States, Michigan
University of Michigan Allergy and Immunology Clinic
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
Investigators
Study Director: Alan Baptist, M.D University of Michigan Allergy and Immunology Clinic
  More Information

Publications:
Responsible Party: Alan Baptist, MD, University of Michigan
ClinicalTrials.gov Identifier: NCT01054950     History of Changes
Other Study ID Numbers: HUM 33980 
Study First Received: January 21, 2010
Last Updated: June 29, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on December 02, 2016