Development of a Questionnaire Based on Patients' Messages on an Internet Forum for Flare Detection in IBD
FLARE_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
1 other identifier
observational
260
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2019
CompletedFirst Posted
Study publicly available on registry
November 27, 2019
CompletedStudy Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedNovember 27, 2019
September 1, 2019
6 months
October 23, 2019
November 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Scale calibration of the new developped questionnaire
Weighing scale calibration
About 30 minutes
Construct validity of the new developped questionnaire
Exploratory factor analysis, discriminant validity by Kruskal-Wallis tests
About 30 minutes
Convergence proprieties of the new developped questionnaire
Convergence test of Flare-IBD scores with objective biological markers and clinical markers used in routine clinical practice
about 30 minutes
Reproductibility of the new developped questionnaire
Investigation of test-retest reliability with a second questionnaire administered 8 days later.
Up to 8 days
Study Arms (1)
Validation of the questionnaire
Items reduction, ajustment and psychometric validation of the questionnaire
Interventions
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)
Eligibility Criteria
Crohn's disease and ulcerative colitis, the two major forms of inflammatory bowel disease are chronic disabling conditions characterized by flares followed by periods of remission. To the current state of knowledge, there is no validated patient-reported outcome (PRO) tool to measure the phenomenon of flare in inflammatory bowel disease. 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 inflammatory bowel disease.
You may not qualify if:
- patients with a diagnosis \< 3 months.
- Protected persons (minors, adults under guardianship, pregnant or breastfeeding women, people living in a public health or social institution, patients in an emergency situation, incarcerated individuals)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Central Hospital, Nancy, Francelead
- Association François Aupetit, Paris, Francecollaborator
- University of Lorrainecollaborator
Related Publications (1)
Ricci L, Epstein J, Buisson A, Devos C, Toussaint Y, Peyrin-Biroulet L, Guillemin F. 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: study protocol. BMJ Open. 2020 Jul 1;10(7):e037211. doi: 10.1136/bmjopen-2020-037211.
PMID: 32611745DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2019
First Posted
November 27, 2019
Study Start
January 1, 2020
Primary Completion
July 1, 2020
Study Completion
February 1, 2021
Last Updated
November 27, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share