NCT04180345

Development of a Questionnaire Based on Patients' Messages on an Internet Forum for Flare Detection in IBD

Flare_IBD: Development and Validation of a Questionnaire Based on Patients' Messages on an Internet Forum for Early Detection of Flare in Inflammatory Bowel Disease

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 260 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
OTHER	Psychometric validation of the questionnaire	Delph Process : expert panel will include HCPs and patients. They will evaluate the relevance of items on a Likert scale (HCPs N = 25 ; Patients N = 25 ) "Think aloud" interviews (N = 10 patients) Psychometric validation ( N = 200 patients)

Timeline

• Start date: 2020-01-01
• Primary completion: 2020-07-01
• Completion: 2021-02-01
• First posted: 2019-11-27
• Last updated: 2019-11-27