Impact of the Therapeutic Education on the Quality of Life of the Child Suffering of Food Allergy IgE-mediated
EducAA
1 other identifier
interventional
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2014
CompletedFirst Posted
Study publicly available on registry
April 8, 2014
CompletedStudy Start
First participant enrolled
November 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2016
CompletedApril 8, 2026
April 1, 2019
1.9 years
April 3, 2014
April 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Child FAQLQ global score
month 12
Secondary Outcomes (6)
Child FAQLQ global score
month 4
Child FAQLQ global score
month 6
All cause which can be influence the quality of life, especially occurrence of anaphylactic reactions
month 12
Parent FAQLQ global score
month 4
Parent FAQLQ global score
month 6
- +1 more secondary outcomes
Study Arms (2)
Therapeutic education group
EXPERIMENTALAt 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).
Control group
NO INTERVENTIONAt 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- Patients who have a medical insurance.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- French Society of Allergologycollaborator
- Stallergenes laboratoriescollaborator
- Picot-Lactalis laboratorycollaborator
- ALK Industriescollaborator
- URC-CIC Paris Descartes Necker Cochincollaborator
Study Sites (1)
Necker hospital
Paris, 75015, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chantal KARILA, MD, PhD
Necker hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2014
First Posted
April 8, 2014
Study Start
November 5, 2014
Primary Completion
October 7, 2016
Study Completion
October 7, 2016
Last Updated
April 8, 2026
Record last verified: 2019-04