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Clinical Trials/NCT02106169
NCT02106169
Completed
Not Applicable

Impact of the Therapeutic Education on the Quality of Life of the Child From 8 to 12 Years Old (and His Family) Suffering of Food Allergy IgE-mediated.

Assistance Publique - Hôpitaux de Paris1 site in 1 country46 target enrollmentNovember 5, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
IgE Mediated Food Allergy
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
46
Locations
1
Primary Endpoint
Child FAQLQ global score
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The purpose of the study is to determine whether therapeutic education can improve the quality of life of the child from 8 to 12 years old suffering of food allergy.

This study also show us if therapeutic education has an effect on the quality of life of child's family.

Detailed Description

Food allergy affects 5 - 6% of children. The major risk is anaphylaxis by ingestion of the forbidden allergen. The child and his family have to learn to deal with this risk. Therapeutic education can help the children to take care of their allergy. Food allergy limits the child socialisation, leads to anxiety/fear, and impairs health-related quality of life. In the day of today, there is no cure treatment. Also, improve the quality of life is one of the goals of the food allergy management. The impact of therapeutic education on quality of life has never been studied. We intend to study the impact of therapeutic education on the quality of life of children from 8 to 12 years old with IgE mediated food allergy. Our hypothesis is the quality of life can be improved by therapeutic education.

Registry
clinicaltrials.gov
Start Date
November 5, 2014
End Date
October 7, 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • IgE mediated food allergy
  • Child from 8 to 12 years old (included)
  • Family who can have an internet access
  • Children which parents have received study's information
  • Child who can have a medical examination before inclusion (art. L.1121-11 du CSP).
  • Patients who have a medical insurance.

Exclusion Criteria

  • Non IgE mediated food allergy
  • Child with chronic disease, except asthma and atopic dermatitis
  • Patients who already had a therapeutic education for food allergy
  • Patient already included in another study

Outcomes

Primary Outcomes

Child FAQLQ global score

Time Frame: month 12

Secondary Outcomes

  • Child FAQLQ global score(month 6)
  • All cause which can be influence the quality of life, especially occurrence of anaphylactic reactions(month 12)
  • Parent FAQLQ global score(month 12)

Study Sites (1)

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