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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: IgE Mediated Food Allergy

Treatments: Behavioral: Therapeutic education group

Study type: Interventional

Funder types: Other

Identifiers

NCT02106169

2013-A01104-41

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Therapeutic education group

Experimental group

Description:

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).

Treatment:

Behavioral: Therapeutic education group

Control group

No Intervention group

Description:

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.