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Clinical Trials/NCT01054950
NCT01054950CompletedNot Applicable

Quality of Life in Food Allergic Families

University of Michigan1 site in 1 country58 target enrollmentStarted: January 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
58
Locations
1
Primary Endpoint
Difference in validated quality of life survey

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
— to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Education and counseling

Experimental

Phone calls using behavioral techniques

Intervention: Counseling (Behavioral)

Control

Placebo Comparator

Single phone call

Intervention: Placebo phone call (Behavioral)

Outcomes

Primary Outcomes

Difference in validated quality of life survey

Time Frame: twelve months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alan Baptist

MD

University of Michigan

Study Sites (1)

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