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Completed

NCT Number: NCT02106169

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

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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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necker hospital

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapeutic education group

Behavioral

Primary outcomes

  1. Child FAQLQ global score

    Time frame: month 12

Secondary outcomes

  1. Child FAQLQ global score

    Time frame: month 4

  2. Child FAQLQ global score

    Time frame: month 6

  3. All cause which can be influence the quality of life, especially occurrence of anaphylactic reactions

    Time frame: month 12

  4. Parent FAQLQ global score

    Time frame: month 4

  5. Parent FAQLQ global score

    Time frame: month 6

  6. Parent FAQLQ global score

    Time frame: month 12

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • ALK Industries
  • French Society of Allergology
  • Picot-Lactalis laboratory
  • Stallergenes laboratories
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study 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.

Acronym: EducAA

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 8, 2014
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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