SpondylarthritisQUESAMNCT06998316
Spondylo-arthritis Screening Tool Among Patient Suffering From Inflammatory Bowel Disease
An observational study of Spondylarthritis and Inflammatory Bowel Diseases, run by University Hospital, Grenoble at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondylarthritis, Inflammatory Bowel Diseases, Crohn Disease
- What is being tested?
- Screening questionnaire
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- May 2025to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is people with inflammatory bowel disease
Who may be able to join
- Patient with an inflammatory bowel disease according to gastroenterologist
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
University Hospital Grenoble
Grenoble
XAVIER ROMAND, PHD, +33 4 76 76 54 58, xromand@chu-grenoble.fr
Amaury Joie, ajoie@chu-grenoble.fr
About this study
Official title: Linguistical Validation of a Spondylo-arthritis Screening Tool for Patients Suffering From Inflammatory Bowel Disease
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.
Read more
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.
Read the detailed description
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
- "The DETection of Arthritis in Inflammatory boweL diseases (DETAIL) questionnaire: development and preliminary testing of a new tool to screen patients with inflammatory bowel disease for the presence of spondyloarthritis, Di Carlo et al (2017)"
- "The IBIS-Q [IBd Identification of Spondyloarthritis Questionnaire]: A Novel Tool to Detect Both Axial and Peripheral Arthritis in Inflammatory Bowel Disease Patients, Variola et al (2020) From english to french, with a specialized company in scientific translation.
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
- sex
- age
- study level
- type of inflammatory bowel disease
- presence of musculoskeletal pain
- duration of articulary and bowel disease
- previous treatment by biologic
- known spondylo-arthritis
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.
- Conditions
- Spondylarthritis, Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Spondylitis, Ankylosing
- Being tested
- Screening questionnaire
- Keywords
- spondylarthritis, Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases, screening tools
- Medical subject headings
- Spondylarthritis, Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening questionnaireOther
Every patient will answer the 2 screening questionnaires given to them, once at baseline and a second time after 1 month.
| Study group | Role | What they receive |
|---|---|---|
| People with inflammatory bowel disease | Patient followed in gastro-enterology for an inflammatory bowel disease. These represent every-patient in our study. Receives: Other: Screening questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 13 months
Secondary outcomes (6)
acceptability of the instrument via the proportion of missing data for each item
Measured: Baseline and one month later
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.
Measured: baseline and one month later
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.
Measured: Baseline and one month later
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
Measured: 13 months
Comparaison of internal consistency of the 2 questionnaires
Through the comparaison of the average inter-item correlation, the average item-result correlation and cronbach's alpha coefficient
Measured: 13 months
Comparaison of reliability of the 2 questionnaire
Through comparaison of an intra-rater reliability with the intra-class correlation.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study startMay 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Clinique des Cèdres, Echirolles
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998316
- Sponsor's protocol ID
- 38RC24.0348
- Acronym
- QUESAM
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linguistical Validation of a Spondylo-arthritis Screening Tool for Patients Suffering From Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06998316
- Acronym / sponsor ID
- QUESAM / 38RC24.0348
- Conditions
- Spondylarthritis, Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Spondylitis, Ankylosing
- Keywords
- spondylarthritis, Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases, screening tools
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Clinique des Cèdres, Echirolles
- Study start
- May 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- "The DETection of Arthritis in Inflammatory boweL diseases (DETAIL) questionnaire: development and preliminary testing of a new tool to screen patients with inflammatory bowel disease for the presence of spondyloarthritis, Di Carlo et al (2017)"
- "The IBIS-Q [IBd Identification of Spondyloarthritis Questionnaire]: A Novel Tool to Detect Both Axial and Peripheral Arthritis in Inflammatory Bowel Disease Patients, Variola et al (2020) From english to french, with a specialized company in scientific translation.
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
- sex
- age
- study level
- type of inflammatory bowel disease
- presence of musculoskeletal pain
- duration of articulary and bowel disease
- previous treatment by biologic
- known spondylo-arthritis
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with inflammatory bowel disease | – | Other: Screening questionnairePatient followed in gastro-enterology for an inflammatory bowel disease. These represent every-patient in our study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is people with inflammatory bowel disease
Key inclusion criteria (1 listed)
- Patient with an inflammatory bowel disease according to gastroenterologist
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening questionnaireEvery patient will answer the 2 screening questionnaires given to them, once at baseline and a second time after 1 month. | Other | People with inflammatory bowel disease |
Primary outcome
translation and cross-cultural adaptation in french of the questionnaires developped by Di Marco et al (2017) and Variola et al (2020)
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.
6 secondary outcomes
acceptability of the instrument via the proportion of missing data for each item
Time frame: Baseline and one month later
Evaluation of the internal consistency assessed by the average inter-item correlation, the average item-result correlation and cronbach's alpha coefficient
Time frame: baseline and one month later
evaluation of the reliability of the questionnaire through an intra-rater reliability with the intra-class correlation.
Time frame: Baseline and one month later
Comparaison of the acceptability of the instrument via the proportion of missing data for each item
Time frame: 13 months
Comparaison of internal consistency of the 2 questionnaires
Time frame: 13 months
Comparaison of reliability of the 2 questionnaire
Time frame: 13 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No
Related trials for Spondylarthritis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondylarthritis and Inflammatory Bowel Diseases, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xavier R university hospital practitioner, PhD (04 76 76 54 58, xromand@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
translation and cross-cultural adaptation in french of the questionnaires developped by Di Marco et al (2017) and Variola et al (2020) (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.