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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05253378
Recruitment Status : Not yet recruiting
First Posted : February 23, 2022
Last Update Posted : February 23, 2022
Sponsor:
Information provided by (Responsible Party):
Dr Laurent PEYRIN-BIROULET, Central Hospital, Nancy, France

Tracking Information
First Submitted Date February 10, 2022
First Posted Date February 23, 2022
Last Update Posted Date February 23, 2022
Estimated Study Start Date March 1, 2022
Estimated Primary Completion Date March 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 22, 2022)
To develop and validate a clinical index to evaluate the impact of comorbidities on disability in patients with CD. [ Time Frame: Through study completion, an average of 3 years ]
Probability of having an IBD disability index ≥ 35 (i.e. moderate and severe disability).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Development and Validation of a Comorbidity Index in Crohn's Disease
Official Title Development and Validation of a Comorbidity Index in Crohn's Disease
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population CD patients
Condition Crohn Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: February 22, 2022)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2025
Estimated Primary Completion Date March 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries France,   Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT05253378
Other Study ID Numbers 2021PI158
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Dr Laurent PEYRIN-BIROULET, Central Hospital, Nancy, France
Original Responsible Party Same as current
Current Study Sponsor Central Hospital, Nancy, France
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Central Hospital, Nancy, France
Verification Date February 2022