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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-05

Study Completion Date

2016-10-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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IgE Mediated Food Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Therapeutic education group

Intervention Type BEHAVIORAL

Control 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 patients randomized in this group will have the habitual medical care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Therapeutic education group

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No