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

IgE Mediated Food Allergy Clinical Trial

— EducAA  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02106169
• Other study ID #: 2013-A01104-41
• Status: Completed
• Phase: N/A
• Start date: November 5, 2014
• Est. completion date: October 7, 2016

Study information

• Verified date: April 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 7, 2016
• Est. primary completion date: October 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Hypersensitivity
• Hypersensitivity
• IgE Mediated Food Allergy

Intervention

Behavioral:
• Therapeutic education group

Locations

Country	Name	City	State
France	Necker hospital	Paris

Sponsors (5)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	ALK Industries, French Society of Allergology, Picot-Lactalis laboratory, Stallergenes laboratories

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child FAQLQ global score		month 12
Secondary	Child FAQLQ global score		month 4
Secondary	Child FAQLQ global score		month 6
Secondary	All cause which can be influence the quality of life, especially occurrence of anaphylactic reactions		month 12
Secondary	Parent FAQLQ global score		month 4
Secondary	Parent FAQLQ global score		month 6
Secondary	Parent FAQLQ global score		month 12