Clinical trial NCT06214299: Study of the Psychometric Properties of Two Questionnaires for Measuring Disease Flare-up in IBD
Official title: Study of the Psychometric Properties of Two Questionnaires for Measuring Disease Flare-up in IBD (Crohn's Disease / Hemorrhagic Rectocolitis)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Inflammatory Bowel Diseases
Keywords: Psychometric properties
Patient-Reported Outcomes
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population is all patients who are members of the AFA Crohn RCH and belong to their mailing list.

Brief summary: Validating two questionnaires for measuring relapse in IBD (Crohn's / UC)

Detailed description: IBD (Chronic Inflammatory Bowel Diseases) includes Crohn's disease and ulcerative colitis (UC). In France, an estimated 300,000 people suffer from IBD (source afa Crohn RCH France).

To our knowledge, there are no Patient Reported Outcomes (PROs) validated in French to measure the relapse phenomenon in IBD. Such an instrument would complement the available indicators and enable clinicians to detect treatment response at an early stage, as well as failure to respond to treatment, as manifested by the resumption or increased frequency of relapses, and thus enable rapid adjustment of the proposed therapeutic strategy.

Two questionnaires have been developed, their psychometric properties need to be studied.

The project's deliverable will therefore be two validated questionnaires for measuring relapse from the patient's perspective in IBD for routine use. For this reason, the questionnaires will be short, simple to use, easy to interpret and designed to integrate online applications for patient self-monitoring of IBD disease activity.

Eligibility criteria: Inclusion Criteria:

* Patient member of the AFA Crohn RCH, and registered in the mailing list
* Person having received full information on the organization of the research and not having objected to his/her participation and to the use of his/her data.

Exclusion Criteria:

- There were no non-inclusion criteria.

Primary outcomes:
measure: Structural validity evaluated by a confirmatory factor analysis, thresholds: comparative fit index (CFI)>0.90, Tucker-Lewis index (TLI)>0.90, root mean square error of approximation (RMSEA)<0.08
timeFrame: day 0
Secondary outcomes:
measure: Reproducibility evaluated by answers to respondents' questions according to declared status corresponding to current absence of relapse. Measured by intraclass correlation coefficient (ICC), a value above 0.70 is expected for acceptable reproducibility
timeFrame: day 15
Other outcomes:
Locations:
Study officials:
References:
citation: Ricci L, Toussaint Y, Becker J, Najjar H, Renier A, Choukour M, Buisson A, Devos C, Epstein J, Peyrin Biroulet L, Guillemin F. Web-based and machine learning approaches for identification of patient-reported outcomes in inflammatory bowel disease. Dig Liver Dis. 2022 Apr;54(4):483-489. doi: 10.1016/j.dld.2021.09.005. Epub 2021 Sep 26.