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

NCT05254886 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2025-05-06

No results posted yet for this 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.

Conditions

  • Crohn Disease

Interventions

OTHER

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.

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-12
Primary Completion
2027-01-01
Completion
2027-01-01

Countries

  • France
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05254886 on ClinicalTrials.gov