Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06112873 |
| Other study ID # |
2023/818 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 5, 2023 |
| Est. completion date |
November 5, 2025 |
Study information
| Verified date |
June 2023 |
| Source |
Centre Hospitalier Universitaire de Besancon |
| Contact |
Youcef SHAHALI, PhD |
| Phone |
+33 3 81 21 84 39 |
| Email |
yshahali[@]chu-besancon.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
