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NCT Number: NCT02008643

Health Related Quality of Life in Children With Food Allergy: Comparison to Controls and 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.

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Key information

Conditions

Children With Food Allergy Chronic Disease Disease Attributes Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Pédiatrie

Nice, 06000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

filling questionnary to quality of life

Other

filling questionnary to quality of life

Primary outcomes

  1. 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 outcomes

  1. comparaison beetween all questionnary

    Time frame: once at inclusion

    • 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2016
First posted
Dec 11, 2013
Registry last updated
Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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