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Quality of Life in Food Allergy: Validation of Three Mini-questionnaires

NCT06112873 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2023-11-02

No results posted yet for this study

Summary

The evaluation of the quality of life (QOL) in food allergy (AA) is difficult due to the lack of a currently validated questionnaire. There are only a few tools available to assess the impact of nutritional care on the QOL of the allergic patient . Available questionnaires are poorly adapted to studies dealing with large cohorts where functionality and ease of use are determining factors. The aim of this work will be to develop and validate QOL questionnaires for AA, short and easy to use, also integrating the theme of collective catering in order to assess the evolution of QOL in patients with food allergy.

The target population of the questionnaires will be:

i) the parents of allergic children 0 to 17 years (15 questions) ii) allergic children aged 8 to 17 years (13 questions) iii) Adults over 18 (14 questions)

After receiving an information note, eligible patients or their parents will complete the questionnaires. A total of 200 patients will be recruited for each questionnaire.

A statistical evaluation will be carried out using 200 questionnaires for each targeted population in order to validate the psychometric properties of the questionnaire as well as investigate the degree of correlation between the scores of the mini-questionnaire and those obtained using the Europrevall reference questionnaire.

Conditions

Interventions

OTHER

Quality of Life Questionnaire

Patient (or Parent)-Reported Outcomes via specific questionnaires

Sponsors & Collaborators

  • University Hospital, Angers

    collaborator OTHER_GOV

  • University Hospital, Toulouse

    collaborator OTHER

  • Hospices Civils de Lyon

    collaborator OTHER

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-05
Primary Completion
2024-11-05
Completion
2025-11-05

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06112873 on ClinicalTrials.gov