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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06112873
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Centre Hospitalier Universitaire de Besancon
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Food Allergy

Additional Details

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.

Arms & Interventions

Arms

: The parents of allergic children 0 to 17 years

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

: 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.

: Adults over 18

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

Interventions

Other: - Quality of Life Questionnaire

Patient (or Parent)-Reported Outcomes via specific questionnaires

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Youcef SHAHALI, PhD

[email protected]

+33 3 81 21 84 39

For additional contact information, you can also visit the trial on clinicaltrials.gov.

Clinical Trial Finder