NCT06214299|Unknown
Study of the Psychometric Properties of Two Questionnaires for Measuring Disease Flare-up in IBD
Flare-IBD
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Flare-IBD
Sponsor study identifier
observational
400
0 countries
N/A
Study Start
January 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
February 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Validating two questionnaires for measuring relapse in IBD (Crohn's / UC)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 20, 2023
Actual (reported)January 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 19, 2024
Actual (reported)February 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Psychometric properties measurable in a cross-sectional study as described by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN), using classical test theory and item response theory
day 0
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
day 15
The population is all patients who are members of the AFA Crohn RCH and belong to their mailing list.
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.
First Submitted
December 20, 2023
First Posted
January 19, 2024
Study Start
January 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
February 2024
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 19, 2024
Record last verified: 2024-01
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