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

NCT06112873 | Unknown

• 1 other identifier: 2023/818
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief 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

Food Allergy

Keywords

Food Allergy; Quality of Life; Children; Adult; Self-reported questionnaire

Outcome Measures

Primary Outcomes (2)

• Validity and Reliability of Questionnaires

  6 months

• Comparability with EUROPREVALL reference questionnaires

  3 months

Secondary Outcomes (1)

• Discriminative capacity of questionnaires

  3 months

Study Arms (3)

The parents of allergic children 0 to 17 years

The parents of 200 eligible patients will complete the parent questionnaire comprising 15 questions

Other: Quality of Life Questionnaire

Allergic children aged 8 to 17 years

A total of 200 eligible patients aged 8 to 17 years will complete the children's self-reported questionnaire comprising 13 questions.

Other: Quality of Life Questionnaire

Adults over 18

A total of 200 adult patients will complete the adult self-reported questionnaire comprising 14 questions.

Other: Quality of Life Questionnaire

Interventions

Quality of Life Questionnaire OTHER

Patient (or Parent)-Reported Outcomes via specific questionnaires

Adults over 18; Allergic children aged 8 to 17 years; The parents of allergic children 0 to 17 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients (or patients parents) cared for food allergy at CHU de Besançon, CHU de Toulouse, CHU Angers and CHU de Lyon including: * 200 parents of allergic children * 200 allergic children aged 8 to 17 years * 200 adults with food allergy

You may qualify if:

• Patients with an IgE-mediated allergy to any food, or a non-IgE-mediated allergy to cow's milk in infants.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• University Hospital, Angers: collaborator
• University Hospital, Toulouse: collaborator
• Hospices Civils de Lyon: collaborator

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Youcef SHAHALI, PhD

CONTACT

+33 3 81 21 84 39; yshahali@chu-besancon.fr

Jean-Marc RAME, MD

CONTACT

jmrame@chu-besancon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: November 5, 2023
• Primary Completion: November 5, 2024
• Study Completion: November 5, 2025
• Last Updated: November 2, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share