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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chronic Inflammatory Bowel Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No