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

NCT ID: NCT06112873

Last Updated: 2023-11-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-05
• Study Completion Date: 2025-11-05

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.

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.

Conditions

Food Allergy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

The parents of allergic children 0 to 17 years

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

Quality of Life Questionnaire

Intervention Type: OTHER

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.

Quality of Life Questionnaire

Intervention Type: OTHER

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.

Quality of Life Questionnaire

Intervention Type: OTHER

Patient (or Parent)-Reported Outcomes via specific questionnaires

Interventions

Quality of Life Questionnaire

Patient (or Parent)-Reported Outcomes via specific questionnaires

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Youcef SHAHALI, PhD

Role: CONTACT

yshahali@chu-besancon.fr

+33 3 81 21 84 39

Jean-Marc RAME, MD

Role: CONTACT

jmrame@chu-besancon.fr

Other Identifiers

2023/818

Identifier Type: -

Identifier Source: org_study_id