Overview

This trial is active, not recruiting.

Condition ige mediated food allergy
Treatment therapeutic education group
Sponsor Assistance Publique - Hôpitaux de Paris
Collaborator French Society of Allergology
Start date November 2014
End date December 2016
Trial size 46 participants
Trial identifier NCT02106169, 2013-A01104-41

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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).
therapeutic education group
(No Intervention)
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 patients randomized in this group will have the habitual medical care.

Primary Outcomes

Measure
Child FAQLQ global score
time frame: month 12

Secondary Outcomes

Measure
Child FAQLQ global score
time frame: month 4
Child FAQLQ global score
time frame: month 6
All cause which can be influence the quality of life, especially occurrence of anaphylactic reactions
time frame: month 12
Parent FAQLQ global score
time frame: month 4
Parent FAQLQ global score
time frame: month 6
Parent FAQLQ global score
time frame: month 12

Eligibility Criteria

Male or female participants from 8 years up to 12 years old.

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

Additional Information

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.
Principal investigator Chantal KARILA, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.