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

• Conditions: Inflammatory Bowel Diseases
• Interventions: Other: Psychometric validation of the questionnaire

• Registration Number: NCT04180345
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-11-26
• Last Update Submitted: 2019-11-26
• Study First Posted: 2019-11-27
• Last Update Posted: 2019-11-27
• Study Start: 2020-01
• Primary Completion: 2020-07
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Validation of the questionnaire	Psychometric validation of the questionnaire	Items reduction, ajustment and psychometric validation of the questionnaire

Primary Outcome Measures

Name	Time	Method
Scale calibration of the new developped questionnaire	About 30 minutes	Weighing scale calibration
Construct validity of the new developped questionnaire	About 30 minutes	Exploratory factor analysis, discriminant validity by Kruskal-Wallis tests
Convergence proprieties of the new developped questionnaire	about 30 minutes	Convergence test of Flare-IBD scores with objective biological markers and clinical markers used in routine clinical practice
Reproductibility of the new developped questionnaire	Up to 8 days	Investigation of test-retest reliability with a second questionnaire administered 8 days later.