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

Primary Purpose

IgE Mediated Food Allergy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Therapeutic education group
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for IgE Mediated Food Allergy focused on measuring Food allergy, Children and families, Therapeutic education, Quality of life

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Necker hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Therapeutic education group

Control group

Arm 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).

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.

Outcomes

Primary Outcome Measures

Child FAQLQ global score

Secondary Outcome Measures

Child FAQLQ global score
Child FAQLQ global score
All cause which can be influence the quality of life, especially occurrence of anaphylactic reactions
Parent FAQLQ global score
Parent FAQLQ global score
Parent FAQLQ global score

Full Information

First Posted
April 3, 2014
Last Updated
April 15, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
French Society of Allergology, Stallergenes laboratories, Picot-Lactalis laboratory, ALK Industries
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1. Study Identification

Unique Protocol Identification Number
NCT02106169
Brief Title
Impact of the Therapeutic Education on the Quality of Life of the Child Suffering of Food Allergy IgE-mediated
Acronym
EducAA
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 5, 2014 (Actual)
Primary Completion Date
October 7, 2016 (Actual)
Study Completion Date
October 7, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
French Society of Allergology, Stallergenes laboratories, Picot-Lactalis laboratory, ALK Industries

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgE Mediated Food Allergy
Keywords
Food allergy, Children and families, Therapeutic education, Quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic education group
Arm Type
Experimental
Arm 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).
Arm Title
Control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic education group
Primary Outcome Measure Information:
Title
Child FAQLQ global score
Time Frame
month 12
Secondary Outcome Measure Information:
Title
Child FAQLQ global score
Time Frame
month 4
Title
Child FAQLQ global score
Time Frame
month 6
Title
All cause which can be influence the quality of life, especially occurrence of anaphylactic reactions
Time Frame
month 12
Title
Parent FAQLQ global score
Time Frame
month 4
Title
Parent FAQLQ global score
Time Frame
month 6
Title
Parent FAQLQ global score
Time Frame
month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chantal KARILA, MD, PhD
Organizational Affiliation
Necker hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Necker hospital
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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