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Clinical Trial Summary

Crohn's disease and ulcerative colitis, the two major forms of inflammatory bowel disease (IBD) are chronic disabling conditions characterized by flares followed by periods of remission. However, IBD patients are seen every 3 to 6 months in the outpatient clinic, and the occurrence of a flare between two outpatient visits is not captured. In the current state of knowledge, there is no validated patient-reported outcome (PRO) tool to measure the phenomenon of flare in IBD. This study aimed to use an innovative methodology to collect messages posted by patients in an Internet forum for developing and validating a PRO measuring flare in IBD.

The design involves 1) Engineering sciences for scraping extraction of messages posted in an Internet forum and for Identification of messages related to flare, 2) Qualitative methods for thematic content analyze of the messages posted, for candidate items generation, for items selection (Delphi process) and for items adjustment ("think aloud" interviews), 3) Quantitative methods for psychometric validation of the PRO.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04180345
Study type Observational
Source Central Hospital, Nancy, France
Contact Jonathan Epstein, MD, PhD
Phone 0033382852342
Email j.epstein@chru-nancy.fr
Status Not yet recruiting
Phase
Start date January 2020
Completion date February 2021

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