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NEMO-Index: Development and Validation of a Comorbidity Index in Crohn's Disease

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05253378
Collaborator
(none)
500
Enrollment
2
Locations
36
Anticipated Duration (Months)
250
Patients Per Site
6.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD). Like other chronic diseases, patients with CD may be affected by other diseases called comorbidities. The prevalence of comorbidities in IBD patients ranges from 30 to 70 %. Unlike other chronic diseases, there is currently no CD-specific tool to assess the impact of comorbidities on patients' lives in order to take appropriate medical measures. Several clinical indexes have been developed for the study of comorbidities, including the Charlson index and the Groll index, which are widely used. The disadvantage of these indexes is that they are not adapted to patients with CD. The primary objective of this study is to develop and validate a clinical index to evaluate the impact of comorbidities on disability in patients with CD.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Development and Validation of a Comorbidity Index in Crohn's Disease
    Anticipated Study Start Date :
    Mar 1, 2022
    Anticipated Primary Completion Date :
    Mar 1, 2025
    Anticipated Study Completion Date :
    Mar 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. To develop and validate a clinical index to evaluate the impact of comorbidities on disability in patients with CD. [Through study completion, an average of 3 years]

      Probability of having an IBD disability index ≥ 35 (i.e. moderate and severe disability).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 59 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients between 18 and 59 years old

    2. Established diagnosis of CD with a minimum disease duration of 3 months

    3. Disease considered by the treating gastroenterologist to have been stable for at least 3 months

    Exclusion Criteria:

    1. Subject unable to comply with study procedures

    2. Surgery for CD 3 months prior to inclusion visit

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU Nancy Vandoeuvre-lès-Nancy France
    2 San Raffaele Hospital Milano Italy

    Sponsors and Collaborators

    • Central Hospital, Nancy, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Laurent PEYRIN-BIROULET, MD, PhD, Central Hospital, Nancy, France
    ClinicalTrials.gov Identifier:
    NCT05253378
    Other Study ID Numbers:
    • 2021PI158
    First Posted:
    Feb 23, 2022
    Last Update Posted:
    Feb 23, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Crohn Disease

    Study Results

    No Results Posted as of Feb 23, 2022