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

Inflammatory Bowel Diseases Clinical Trial

— FLARE_IBD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04180345
• Other study ID #: 2019-A01520-57
• Status: Not yet recruiting
• Start date: January 2020
• Est. completion date: February 2021

Study information

• Verified date: September 2019
• Source: Central Hospital, Nancy, France
• Contact: Jonathan Epstein, MD, PhD
• Phone: 0033382852342
• Email: j.epstein[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: February 2021
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Association François Aupetit, Paris, France, University of Lorraine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scale calibration of the new developped questionnaire	Weighing scale calibration	About 30 minutes
Primary	Construct validity of the new developped questionnaire	Exploratory factor analysis, discriminant validity by Kruskal-Wallis tests	About 30 minutes
Primary	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
Primary	Reproductibility of the new developped questionnaire	Investigation of test-retest reliability with a second questionnaire administered 8 days later.	Up to 8 days