Health Related Quality of Life in Children With Food Allergy: Comparison to Controls and Other Chronic Diseases

Children With Food Allergy Clinical Trial

Official title:

Health Related Quality of Life in Children With Food Allergy: Comparison to Healthy Children and Children With Other Chronic Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02008643
• Other study ID #: 12-AOI-07
• Status: Completed
• Phase: N/A
• First received: December 3, 2013
• Last updated: July 26, 2016
• Start date: February 2014
• Est. completion date: April 2016

Study information

• Verified date: March 2016
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

The number of studies concerning health related quality of life (HRQL) in children with food allergy is very limited.

Only one study to date has compared HRQL of a group of children with food allergy to data published on general population and other chronic diseases. This study concluded to lowest HRQL scores in food allergic children compared to type 1 diabetes mellitus with important impact on scores concerning social activities.

Description:

Primary aim:

To compare generic HRQL score in children with food allergy with other chronic diseases and with healthy chidren in an homogeneous socio-cultural context.

Secondary aims :

• To compare generic and specific HRQL scores in children with food allergy

• Identifify in chidren with food allergy, clinical factrors assocated with lowest scores in order to improve our management.

Methods

Generic HRQL questionnaire (CHQ-87) will be distributed :

• after hospital consultation for patients

• in schools for healthy children A specific HRQL questionnaire (FAQLQ-CF or TF) and the " Food Allergy Independent Measure " will also distributed to chidren with food allergy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 861
• Est. completion date: April 2016
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• Age between 8-18 year old

• IgE mediated food allergy diagnosed by a pediatric allergologist with following criteria:

Convincing history of allergic reaction with positive prick-test and specific IgE Or Open food challenge associated with positive prick-test and specific IgE

• Signed informed consent of the two parents

• Signed informed consent of the child

• Health insurance recipient

Exclusion Criteria:

• Association with another medical or psychiatric chronic disease (excepted for controlled asthma)

• Partially or not controlled asthma during last year

• No signed consent

Study Design

Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Children With Food Allergy
• Chronic Disease
• Food Hypersensitivity
• Hypersensitivity

Intervention

Other:
• filling questionnary to quality of life
filling questionnary to quality of life

Locations

Country	Name	City	State
France	Service de Pédiatrie	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison of12 scores of the generic health-related quality of life questionnaire CHQ-CF 87 between children with food allergy and healthy children scores.	12 scores concerning the 12 following dimensions: physical functioning; role functioning emotional; role functioning behavior; role functioning physical; bodily pain; general behavior; mental health; self-esteem; general health; change in health; family activities; family cohesion; Comparison between children with food allergy and healthy children scores.	Once at inclusion	No
Secondary	comparaison beetween all questionnary	Comparison of the CHQ-CF 87 scores between children with food allergy and chidren with other chronic diseases.; Comparison of the CHQ-CF 87 scores with the FAQLQ-CF (or -TF) score (global and 4 dimensions) and with the FAIM score.; Comparison of the FAQLQ-CF (or-TF) (global and 4 dimensions) with clinical characteristics of the children with food allergy	once at inclusion	No