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

Central Hospital, Nancy, France

Status: Active, not recruiting

Conditions: Crohn Disease

Treatments: Other: NEMO nurse-led program

Study type: Interventional

Funder types: Other

Identifiers

NCT05254886

2021PI157

Details and patient eligibility

About

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.

Enrollment: 198 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 2 patient groups

Routine practice

No Intervention group

Description:

Patients who benefit from the classic management of CD (i.e. clinical + biological ± radiological ± endoscopic follow-up ± therapeutic education program).

Routine practice + nurse-led program

Experimental group

Description:

Patients who receive, in addition to routine practice, a single nursing consultation dedicated to the identification and management of comorbidities and EIMs in CD at the inclusion visit.

Treatment:

Other: NEMO nurse-led program