Clinical trial NCT04180345: Development of a Questionnaire Based on Patients' Messages on an Internet Forum for Flare Detection in 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Keywords: Flare
Inflammatory Bowel Diseases
Questionnaire
Internet
Mixed methods
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Association François Aupetit, Paris, France
name: University of Lorraine
First posted: 2019-11-27
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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)

Primary outcomes:
measure: Scale calibration of the new developped questionnaire
timeFrame: About 30 minutes
measure: Construct validity of the new developped questionnaire
timeFrame: About 30 minutes
measure: Convergence proprieties of the new developped questionnaire
timeFrame: about 30 minutes
measure: Reproductibility of the new developped questionnaire
timeFrame: Up to 8 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.