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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02008643
First Posted: December 11, 2013
Last Update Posted: July 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
  Purpose

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.


Condition Intervention
Children With Food Allergy Other: filling questionnary to quality of life

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Official Title: Health Related Quality of Life in Children With Food Allergy: Comparison to Healthy Children and Children With Other Chronic Diseases

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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


Enrollment: 861
Study Start Date: February 2014
Study Completion Date: April 2016
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02008643


Locations
France
Service de Pédiatrie
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Lisa GIOVANNINI-CHAMI, PH CHU de Nice-Lenval
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02008643     History of Changes
Other Study ID Numbers: 12-AOI-07
First Submitted: December 3, 2013
First Posted: December 11, 2013
Last Update Posted: July 27, 2016
Last Verified: March 2016

Keywords provided by Centre Hospitalier Universitaire de Nice:
Health related quality of life, food allergy, children, chronic diseases

Additional relevant MeSH terms:
Hypersensitivity
Chronic Disease
Food Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes
Hypersensitivity, Immediate