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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patient with an inflammatory bowel disease according to gastroenterologist

Disqualifiers

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.

Trial population

The study population is people with inflammatory bowel disease

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Screening questionnaire

    Other intervention

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

Treatment groups

220 Participants
are divided into 1 treatment group
Group A: People with inflammatory bowel disease1 intervention

Trial outcomes

Primary outcomes

1

translation and cross-cultural adaptation in french of the questionnaires developped by Di Marco et al (2017) and Variola et al (2020)

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.

Time frame
13 months

Secondary outcomes

1

acceptability of the instrument via the proportion of missing data for each item

Time frame
Baseline and one month later
2

Evaluation of the internal consistency assessed by the average inter-item correlation, the average item-result correlation and cronbach's alpha coefficient

These tests aim to determine if the different items are close enough to measure the same thing and still different enough not to be redundant.

Time frame
baseline and one month later
3

evaluation of the reliability of the questionnaire through an intra-rater reliability with the intra-class correlation.

Aims to determine if one rater answers the same questions the same way at two different moments.

Time frame
Baseline and one month later
4

Comparaison of the acceptability of the instrument via the proportion of missing data for each item

this will be done by comparing the proportion of missing data for the 2 questionnaires

Time frame
13 months

Other outcomes

Sponsors and contacts

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University Hospital, Grenoble

Lead sponsor

Clinique des Cèdres, Echirolles

Collaborator

This trial is not recruiting at the moment. You can still explore other options: