Quality of Life in Food Allergic Families

June 29, 2016 updated by: Alan Baptist, University of Michigan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • University of Michigan Allergy and Immunology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in validated quality of life survey
Time Frame: twelve months
twelve months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Study Director: Alan Baptist, M.D, University of Michigan Allergy and Immunology Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

January 21, 2010

First Submitted That Met QC Criteria

January 21, 2010

First Posted (Estimate)

January 22, 2010

Study Record Updates

Last Update Posted (Estimate)

June 30, 2016

Last Update Submitted That Met QC Criteria

June 29, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM 33980

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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