Impact of the Therapeutic Education on the Quality of Life of the Child Suffering of Food Allergy IgE-mediated

Not Applicable

Completed

• Conditions: IgE Mediated Food Allergy
• Interventions: Behavioral: Therapeutic education group

• Registration Number: NCT02106169
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2014-04-03
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-08
• Study Start: 2014-11-05
• Primary Completion: 2016-10-07
• Study Completion: 2016-10-07
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic education group	Therapeutic education group	At first, all patients will be invited to participate in a study of troop having for objective to estimate their quality of life. Then, the doctors offer patients randomized to therapeutic education to have a therapeutic education before the 4th month. The sessions will be led by a multidisciplinary equip. Each child and his family will have a therapeutic session (2 times 2 hours).

Primary Outcome Measures

Name	Time	Method
Child FAQLQ global score	month 12

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Necker hospital; 🇫🇷 Paris, France