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

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

Sponsors

Lead sponsor: Central Hospital, Nancy, France

Collaborator: Association François Aupetit, Paris, France
University of Lorraine

Source Central Hospital, Nancy, France
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.

Overall Status Not yet recruiting
Start Date January 2020
Completion Date February 2021
Primary Completion Date July 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Scale calibration of the new developped questionnaire About 30 minutes
Construct validity of the new developped questionnaire About 30 minutes
Convergence proprieties of the new developped questionnaire about 30 minutes
Reproductibility of the new developped questionnaire Up to 8 days
Enrollment 260
Condition
Intervention

Intervention type: Other

Intervention name: Psychometric validation of the questionnaire

Description: 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)

Arm group label: Validation of the questionnaire

Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- Every patient consulting the gastroenterology unit of Nancy University Hospital with a confirmed IBD diagnosis, regardless of the patient's state or treatment will be considered for inclusion

Exclusion Criteria:

- 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)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Contact

Last name: Jonathan Epstein, MD, PhD

Phone: 0033382852342

Email: [email protected]

Verification Date

September 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Validation of the questionnaire

Description: Items reduction, ajustment and psychometric validation of the questionnaire

Acronym FLARE_IBD
Patient Data No
Study Design Info

Observational model: Case-Only

Time perspective: Retrospective

Source: ClinicalTrials.gov