University Hospital Grenoble
Grenoble, France
Location contact
Amaury Joie
CONTACT
XAVIER ROMAND, PHD
CONTACT
xavier romand, PHD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06998316
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Grenoble, France
Amaury Joie
CONTACT
XAVIER ROMAND, PHD
CONTACT
xavier romand, PHD
PRINCIPAL_INVESTIGATOR
This is not an actual interventionnal or observationnal study. Investigators will try to provide a statistical validation of 2 questionnaires on people followed in gastro-enterology for an inflammatory bowel disease.
In the first place, investigators will translate the 2 questionnaires
Investigators will then, with the help of 5 patients, determine if the translated final version is easy to understand, and eventually adjust the questionnaires if needed.
If a modification is needed, 5 other patients will be reached to look for any unclear formulation.
If no modification is needed, the questionnaire will be given to eligible patients until 200 answers are reached. People will be recruited during a standard care consultation or a one day-hospitalization for biological treatment
Invistigators will, on top of the questionnaires, be collecting the
At 1 month, participants will be contacted by mail, so that they fill the questionnaires again.
At last, with the answers to the 400 hundreds questionnaires (200 patients, baseline questionnaire + the one month reminder), investigators will be able to make the statistic analyzes required for the statistical validation of the questionnaires, in french.
Outside of the statistical validation, if the questionnaire are in favor of a rheumatologic disease, the gastro-enterologist can address patients to a rheumatology department.
General praticionner will then receive a report of the evaluation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Every patient will answer the 2 screening questionnaires given to them, once at baseline and a second time after 1 month.
Time frame: 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.
Time frame: Baseline and one month later
Time frame: baseline and one month later
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
Aims to determine if one rater answers the same questions the same way at two different moments.
Time frame: 13 months
this will be done by comparing the proportion of missing data for the 2 questionnaires
Time frame: 13 months
Through the comparaison of the average inter-item correlation, the average item-result correlation and cronbach's alpha coefficient
Time frame: 13 months
Through comparaison of an intra-rater reliability with the intra-class correlation.
Contact information is provided by the study sponsor or research team.
Rejane R ARC, nursing diploma
CONTACT
Xavier R university hospital practitioner, PhD
CONTACT
University Hospital, Grenoble
Other
Linguistical Validation of a Spondylo-arthritis Screening Tool for Patients Suffering From Inflammatory Bowel Disease
Acronym: QUESAM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02098694
Ankylosis, Arthritis
Ålesund, Norway
View Trial DetailsNCT02988674
Ankylosing Spondylitis (AS), Ankylosis
Kemerovo, Kemerovo Oblast, Russia
View Trial DetailsNCT01302730
Ankylosing Spondylitis, Ankylosis
Stanford, California, United States
View Trial DetailsNCT07721844
Arthritis, Bone Diseases
Asyut, Asyut Governorate, Egypt
View Trial Details