Quality of Life in Food Allergic Families

NCT ID: NCT01054950

Last Updated: 2016-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-08-31

Brief Summary

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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

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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.

Conditions

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Food Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Education and counseling

Phone calls using behavioral techniques

Group Type EXPERIMENTAL

Counseling

Intervention Type BEHAVIORAL

Our food allergy nurse will contact our intervention group and discuss any questions or concerns they may have regarding their child's food allergy.

Control

Single phone call

Group Type PLACEBO_COMPARATOR

Placebo phone call

Intervention Type BEHAVIORAL

Phone call w/ no behavioral counseling

Interventions

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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.

Intervention Type BEHAVIORAL

Placebo phone call

Phone call w/ no behavioral counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Alan Baptist

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alan Baptist, M.D

Role: STUDY_DIRECTOR

University of Michigan Allergy and Immunology Clinic

Locations

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University of Michigan Allergy and Immunology Clinic

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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. Epub 2012 Apr 26. No abstract available.

Reference Type RESULT
PMID: 22541244 (View on PubMed)

Other Identifiers

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HUM 33980

Identifier Type: -

Identifier Source: org_study_id

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