Clinical trial NCT02106169: Impact of the Therapeutic Education on the Quality of Life of the Child Suffering of Food Allergy IgE-mediated
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IgE Mediated Food Allergy
Keywords: Food allergy
Children and families
Therapeutic education
Quality of life
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: French Society of Allergology
name: Stallergenes laboratories
name: Picot-Lactalis laboratory
name: ALK Industries
First posted: 2014-04-08
Enrollment: 46
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Child FAQLQ global score
timeFrame: month 12
Secondary outcomes:
measure: Child FAQLQ global score
timeFrame: month 4
measure: Child FAQLQ global score
timeFrame: month 6
measure: All cause which can be influence the quality of life, especially occurrence of anaphylactic reactions
timeFrame: month 12
measure: Parent FAQLQ global score
timeFrame: month 4
measure: Parent FAQLQ global score
timeFrame: month 6
measure: Parent FAQLQ global score
timeFrame: month 12
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker hospital
Study officials:
affiliation: Necker hospital
name: Chantal KARILA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: