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

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.

Study Overview

• Status: Unknown
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Other: Psychometric validation of the questionnaire

• Study Type: Observational
• Enrollment (Anticipated): 260

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Validation of the questionnaire; Items reduction, ajustment and psychometric validation of the questionnaire	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Collaborators: University of Lorraine; Association François Aupetit, Paris, France

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): November 27, 2019

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 26, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Questionnaire; Inflammatory Bowel Diseases; Internet; Mixed methods; Flare
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: 2019-A01520-57

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No