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

July 26, 2016 updated by: Centre Hospitalier Universitaire de Nice

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

861

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06000
        • Service de Pédiatrie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NON_RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: children with food allergy
Chidren aged 8-18 year with food allergy
Other: filling questionnary to quality of life
filling questionnary to quality of life
ACTIVE_COMPARATOR: children with chronic diseases
Other: filling questionnary to quality of life
filling questionnary to quality of life
ACTIVE_COMPARATOR: witnesses

Inclusion criteria Age between 8-18 year old Children attending schools of Nice City Signed informed consent of the two parents Signed informed consent of the child Health insurance recipient

Non inclusion criteria Association with another medical or psychiatric chronic disease No signed consent
Other: filling questionnary to quality of life
filling questionnary to quality of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison of12 scores of the generic health-related quality of life questionnaire CHQ-CF 87 between children with food allergy and healthy children scores.
Time Frame: Once at inclusion

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparaison beetween all questionnary
Time Frame: once at inclusion
  1. Comparison of the CHQ-CF 87 scores between children with food allergy and chidren with other chronic diseases.
  2. Comparison of the CHQ-CF 87 scores with the FAQLQ-CF (or -TF) score (global and 4 dimensions) and with the FAIM score.
  3. Comparison of the FAQLQ-CF (or-TF) (global and 4 dimensions) with clinical characteristics of the children with food allergy
once at inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Lisa GIOVANNINI-CHAMI, PH, CHU de Nice-Lenval

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

February 1, 2014

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

December 3, 2013

First Submitted That Met QC Criteria

December 6, 2013

First Posted (ESTIMATE)

December 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 27, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-AOI-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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