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

Development and Validation of Three Mini-questionnaires to Assess the Quality of Life in Food Allergic Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Food Allergy
• Intervention / Treatment: Other: Quality of Life Questionnaire

Detailed Description

The Réseau d'Allergologie de Franche-Comté (RAFT, University Hospital of Besançon), with the participation of the Allergodiet [1] working group of the French Society of Allergy (SFA), developed this work and contribute to the selection of relevant questions for each age range.

The selected items are divided into three areas: i) social and food limitations; ii) food anxiety; and iii) the risks of accidental ingestion. 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.

Study Procedures :

After receiving an information note, eligible patients and/or their parents will complete the questionnaires.

Outcome measures:

Patient-Reported Outcomes via specific questionnaires

Participant numbers:

200 patients will be recruited for each questionnaire

Participants and recruitment:

Inclusion criteria :

Patient or parent of a patient with an IgE-mediated allergy to any food, or a non-IgE-mediated allergy to cow's milk in infants.

Exclusion criteria :

All patients who do not fit the inclusion criteria mentioned above, lack of consent, mental or visual disturbances, not understanding the questionnaire language.

Resources :

This multicenter study will be conducted at CHU de Besançon, CHU de Toulouse, CHU Angers and CHU de Lyon.

Data management:

Data will be collected directly from the patients. All paper patient records will be kept in locked filing cabinet. Electronic files will be saved on password protected folder

Oversight :

i) Data will be entered from a professional computer station; ii) all documents containing the identity of the participating subjects (non-objection, list of correspondence, etc.) will be kept away from personal data; iii) if it is a paper document, it will be stored in a secure location known only to professionals involved in the research ; iv) If it is a computerized document, it will be kept on the center's information server with access control by password.

References:

1- Doc, A., Capelli, E., Le Pabic, F., Pouessel, G., Deschildre, A., Morisset, M., & Rame, J. M. (2020). Allergodiet: un groupe de travail de diététiciens nutritionnistes en allergologie. Revue Française d'Allergologie, 60(3), 143-149.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Youcef SHAHALI, PhD; Phone Number: +33 3 81 21 84 39; Email: yshahali@chu-besancon.fr
• Study Contact Backup: Name: Jean-Marc RAME, MD; Email: jmrame@chu-besancon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

All patients who do not fit the inclusion criteria mentioned above, lack of consent, mental or visual disturbances, not understanding the questionnaire language.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Patient (or Parent)-Reported Outcomes via specific questionnaires
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; Patient (or Parent)-Reported Outcomes via specific questionnaires
Adults over 18; A total of 200 adult patients will complete the adult self-reported questionnaire comprising 14 questions.	Other: Quality of Life Questionnaire; Patient (or Parent)-Reported Outcomes via specific questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Validity and Reliability of Questionnaires	6 months
Comparability with EUROPREVALL reference questionnaires	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Discriminative capacity of questionnaires	3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Collaborators: Hospices Civils de Lyon; University Hospital, Angers; University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Estimated): November 5, 2023
• Primary Completion (Estimated): November 5, 2024
• Study Completion (Estimated): November 5, 2025

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Children; Adult; Food Allergy; Self-reported questionnaire
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: 2023/818

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No