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Starting soon Observational

Spondylo-arthritis Screening Tool Among Patient Suffering From Inflammatory Bowel Disease

NCT06998316 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-05
Last updated
2025-05-31

Condition(s) studied

SpondylarthritisInflammatory Bowel DiseasesCrohn DiseaseUlcerative ColitisSpondylitis, Ankylosing

Investigational drug(s) / intervention(s)

Screening questionnaire

Screening questionnaire: Every patient will answer the 2 screening questionnaires given to them, once at baseline and a second time after 1 month.

Study summary

The QUESAM study aims to translate into French and validate the traduction of 2 screening questionnaires for spondylo-arthritis among people with inflammatory bowel disease.

DETAIL (DETection of Arthritis in Inflammatory boweL diseases) and IBIS-Q (Inflammatory Bowel disease Identification of Spondyloarthritis Questionnaire) questionnaires are built to determine which patients might benefit from a rheumatologic consultation, for a potential rheumatologic inflammatory disease.

The investigators will translate the 2 questionnaire in french thanks to an external translation company, from english to french, then back to english to make sure the translation is correct.

Then, the main question is:

is there a conceptual and semantic equivalence beetween the original english questionnaire and the french-translated one.

Participant will answer the 2 screening questionnaire, one initial time during a consultation, and a second time after 1 month.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient with an inflammatory bowel disease according to gastroenterologist Exclusion Criteria: * No exclusion criteria * Difficulty for understanding or reading french * Persons covered by articles L1121-5 to L1121-8 of the French Public Health Code * Patients with no social security coverage. * Patients refusing to participate voluntarily.

Primary outcome measure(s)

  • translation and cross-cultural adaptation in french of the questionnaires developped by Di Marco et al (2017) and Variola et al (2020) — 13 months
    This is a composite criterion combining conceptual equivalence and semantic equivalence of items between the transcultural adaptation of the scale and its original version. Conceptual equivalence will be judged on the results of factorial analysis (exploratory and confirmatory). Semantic equivalence of items will be based on evaluation by a panel of experts.

Trial sites (1)

FacilityCityRegionStatus
University Hospital Grenoble Grenoble France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06998316 on ClinicalTrials.gov ↗ ← All trials in France