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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Other: NEMO nurse-led program

• Study Type: Interventional
• Enrollment (Estimated): 198
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Vandoeuvre-lès-Nancy, France
    • Nancy University Hospital
• Italy
  • Milan, Italy
    • San Raffaele Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine practice; Patients who benefit from the classic management of CD (i.e. clinical + biological ± radiological ± endoscopic follow-up ± therapeutic education program).
Experimental: Routine practice + nurse-led program; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of measures taken by a physician for each comorbidity and EIM associated with CD in order to prevent or treat them		6 months
Number of measures taken by a physician for each comorbidity and EIM associated with CD in order to prevent or treat them		18 months
Percentage of patients who comply with recommendations issued by the nurse following completion of the NEMO nurse-led program		6 months
Percentage of patients who comply with recommendations issued by the nurse following completion of the NEMO nurse-led program		18 months
Level of patient satisfaction with the NEMO nurse-led program	Assessment with a Satisfaction Questionnaire. Answer options are presented on a 4-item Likert scale and ranges from 1 ('Not at all satisfied') to 4 ('Very satisfied'). Total score is summed up and ranges from 14 to 56, higher score indicating higher levels of satisfaction.	6 months
Frequency of comorbidities and EIMs, confirmed by a medical specialist, associated with CD		6 months
Frequency of comorbidities and EIMs, confirmed by a medical specialist, associated with CD		18 months

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: February 14, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 2021PI157

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No