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Clinical Trials in Italy / NCT05254886
Active, not recruiting Not applicable

Identification and Management of Comorbidities and Extra-intestinal Manifestations in Crohn's Disease: the NEMO Nurse-led Program

NCT05254886 · tracked via the Priya Life Science Italy tracker
Sponsor
Central Hospital, Nancy, France
Phase
Not applicable
Started
2022-12-12
Last updated
2025-05-06

Condition(s) studied

Crohn Disease

Investigational drug(s) / intervention(s)

NEMO nurse-led program

NEMO nurse-led program: The NEMO nurse-led program will consist of a single nursing consultation conducted on the day of the inclusion visit during which the nurse will: * Report the presence of pre-existing comorbidities/EIMs * Detect the presence of risk factors * Implement recommendations for the detection and/or management of comorbidities/EIMs.

Study summary

Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal (GI) tract. Although inflammation is predominantly expressed in the GI tract, extra-intestinal manifestations (EIMs) are so frequent that the concept of systemic disease is now widely accepted. Moreover, similar to other chronic diseases, patients with CD can be affected by other unrelated diseases which are called comorbidities.

Although no specific guidelines on comorbidity and EIMs in CD are available, data from other immune-mediated diseases support the use of nurse-led programs to improve the cost-effectiveness for the management of cardiovascular risk factors, increase rates of pneumococcal vaccination in high-risk patients, provide preventive measures against osteoporosis and increased fracture risk in older women.

The investigators believe that such an initiative can be conducted for CD patients by developing a CD-specific nurse-led program. Moreover, it has been shown that CD patients highly appreciate the "communicator role" and "skilled companionship" performed by nurses to fulfill their needs for attention to the "complete picture".

Therefore, the investigators hypothesize that a nurse-led program would increase the number of measures taken to treat or identify EIMs and/or comorbidities in CD patients and thus revolutionize their management.

Eligibility

Sex
ALL
Min age
18 Years
Max age
59 Years
Healthy volunteers
No
Inclusion Criteria: * Established diagnosis of CD with a minimum disease duration of 3 months * CD considered by the treating gastroenterologist to have been stable for at least 3 months * No surgery planned within 6 months after the inclusion visit Exclusion Criteria: * Subject unable to attend all the study visits or comply with study procedures. * Subject unwilling or not able to understand or sign the informed consent.

Primary outcome measure(s)

  • Number of measures taken by a physician in order to prevent or treat comorbidities and EIMs associated with CD — 6 months
  • Number of measures taken by a physician in order to prevent or treat comorbidities and EIMs associated with CD — 18 months

Trial sites (2)

FacilityCityRegionStatus
Nancy University Hospital Vandœuvre-lès-Nancy France
San Raffaele Hospital Milan Italy

Other trials for the same condition

A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease Recruiting
Unveiling the Microbial Impact on Intestinal Fibrosis Starting soon
Spatially and Temporally Resolving Predictive Biomarkers of Postoperative Recurrence and Complications in Chronic Intestinal Inflammation Recruiting
A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease Recruiting
Evaluation of the Accuracy of Immunostaining of Claudin 2 to Detect Active or Inactive Inflammation in Endoscopic Biopsies of IBD Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05254886 on ClinicalTrials.gov ↗ ← All trials in Italy