Clinical trial NCT05254886: Identification and Management of Comorbidities and Extra-intestinal Manifestations in Crohn's Disease: the NEMO Nurse-led Program
Official title: Identification and Management of Comorbidities and Extra-intestinal Manifestations in Crohn's Disease: the NEMO Nurse-led Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Crohn Disease
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 criteria: 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 outcomes:
measure: Number of measures taken by a physician in order to prevent or treat comorbidities and EIMs associated with CD
timeFrame: 6 months
measure: Number of measures taken by a physician in order to prevent or treat comorbidities and EIMs associated with CD
timeFrame: 18 months
Secondary outcomes:
measure: Number of measures taken by a physician for each comorbidity and EIM associated with CD in order to prevent or treat them
timeFrame: 6 months
measure: Number of measures taken by a physician for each comorbidity and EIM associated with CD in order to prevent or treat them
timeFrame: 18 months
measure: Percentage of patients who comply with recommendations issued by the nurse following completion of the NEMO nurse-led program
timeFrame: 6 months
measure: Percentage of patients who comply with recommendations issued by the nurse following completion of the NEMO nurse-led program
timeFrame: 18 months
measure: Level of patient satisfaction with the NEMO nurse-led program
timeFrame: 6 months
measure: Frequency of comorbidities and EIMs, confirmed by a medical specialist, associated with CD
timeFrame: 6 months
measure: Frequency of comorbidities and EIMs, confirmed by a medical specialist, associated with CD
timeFrame: 18 months
Other outcomes:
Locations:
city: Vandoeuvre-lès-Nancy
country: France
facility: Nancy University Hospital
city: Milan
country: Italy
facility: San Raffaele Hospital
Study officials:
References: