Development and Validation of a Comorbidity Index in Crohn's Disease
NEMO-Index
1 other identifier
observational
458
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2022
CompletedFirst Posted
Study publicly available on registry
February 23, 2022
CompletedStudy Start
First participant enrolled
April 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedMay 6, 2025
May 1, 2025
3 years
February 10, 2022
May 5, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
To develop and validate a clinical index to evaluate the impact of comorbidities on disability in patients with CD.
Probability of having an IBD disability index ≥ 35 (i.e. moderate and severe disability).
Through study completion, an average of 3 years
Eligibility Criteria
CD patients
You may qualify if:
- Patients between 18 and 59 years old
- Established diagnosis of CD with a minimum disease duration of 3 months
- Disease considered by the treating gastroenterologist to have been stable for at least 3 months
You may not qualify if:
- Subject unable to comply with study procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Laurent PEYRIN-BIROULET
Vandœuvre-lès-Nancy, France
San Raffaele Hospital
Milan, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
February 10, 2022
First Posted
February 23, 2022
Study Start
April 4, 2022
Primary Completion
March 31, 2025
Study Completion
March 31, 2025
Last Updated
May 6, 2025
Record last verified: 2025-05