Development and Validation of a Comorbidity Index in Crohn's Disease
- Conditions
- Crohn Disease
- Registration Number
- NCT05253378
- Lead Sponsor
- Central Hospital, Nancy, France
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 458
- 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
- Subject unable to comply with study procedures
- Surgery for CD 3 months prior to inclusion visit
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
San Raffaele Hospital
🇮🇹Milano, Italy
Laurent PEYRIN-BIROULET
🇫🇷Vandoeuvre-lès-Nancy, France