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NCT05254886Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 6 May 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
198 (estimated)
First submitted
14 Feb 2022
Start date
12 Dec 2022
Primary completion date
1 Jan 2027
Lead sponsor
Central Hospital, Nancy, France
NCT number
NCT05254886

What you commit to

  • Study type: Interventional
  • Planned participants: 198
  • From 12 Dec 2022 to the primary completion date, 1 Jan 2027
  • 2 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to 59 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nancy University Hospital
Coordinator of this site? Confirm its status
Vandœuvre-lès-NancyFranceUnknown status
San Raffaele Hospital
Coordinator of this site? Confirm its status
MilanItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.