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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Centre Hospitalier Universitaire de Nice
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT02008643
First received: December 3, 2013
Last updated: July 28, 2014
Last verified: December 2013
  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: 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 1137
Study Start Date: January 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: January 2015 (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

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02008643

Contacts
Contact: Vanessa ESPIN, CRA 0033 4 92 03 42 54 espin.v@chu-nice.fr

Locations
France
Service de Pédiatrie Recruiting
Nice, France, 06000
Contact: Lisa GIOVANNINI-CHAMI    0033 4 92 03 05 31    GIOVANNINI-CHAMI.L@pediatrie-chulenval-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Lisa GIOVANNINI-CHAMI, PH CHU de Nice-Lenval
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02008643     History of Changes
Other Study ID Numbers: 12-AOI-07
Study First Received: December 3, 2013
Last Updated: July 28, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

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

ClinicalTrials.gov processed this record on September 18, 2014