Study of the Psychometric Properties of Two Questionnaires for Measuring Disease Flare-up in IBD (Flare-IBD)

EPSTEIN Jonathan

Status: Not yet enrolling

Conditions: Chronic Inflammatory Bowel Diseases

Study type: Observational

Funder types: Other

Identifiers

NCT06214299

2023PI116

Details and patient eligibility

About

Validating two questionnaires for measuring relapse in IBD (Crohn's / UC)

Full description

IBD (Chronic Inflammatory Bowel Diseases) includes Crohn's disease and ulcerative colitis (UC). In France, an estimated 300,000 people suffer from IBD (source afa Crohn RCH France).

To our knowledge, there are no Patient Reported Outcomes (PROs) validated in French to measure the relapse phenomenon in IBD. Such an instrument would complement the available indicators and enable clinicians to detect treatment response at an early stage, as well as failure to respond to treatment, as manifested by the resumption or increased frequency of relapses, and thus enable rapid adjustment of the proposed therapeutic strategy.

Two questionnaires have been developed, their psychometric properties need to be studied.

The project's deliverable will therefore be two validated questionnaires for measuring relapse from the patient's perspective in IBD for routine use. For this reason, the questionnaires will be short, simple to use, easy to interpret and designed to integrate online applications for patient self-monitoring of IBD disease activity.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient member of the AFA Crohn RCH, and registered in the mailing list
• Person having received full information on the organization of the research and not having objected to his/her participation and to the use of his/her data.

Exclusion criteria

• There were no non-inclusion criteria.