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

Not Applicable

Active, not recruiting

• Conditions: Crohn Disease
• Interventions: Other: NEMO nurse-led program

• Registration Number: NCT05254886
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-14
• Study First Submitted QC: 2022-02-23
• Study First Posted: 2022-02-24
• Study Start: 2022-12-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 198

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine practice + nurse-led program	NEMO 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.

Primary Outcome Measures

Name	Time	Method
Number of measures taken by a physician in order to prevent or treat comorbidities and EIMs associated with CD	18 months

Secondary Outcome Measures

Name	Time	Method
Percentage of patients who comply with recommendations issued by the nurse following completion of the NEMO nurse-led program	18 months
Frequency of comorbidities and EIMs, confirmed by a medical specialist, associated with CD	18 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
Level of patient satisfaction with the NEMO nurse-led program	6 months	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.

Trial Locations

Locations (2)

Nancy University Hospital; 🇫🇷 Vandoeuvre-lès-Nancy, France

San Raffaele Hospital; 🇮🇹 Milan, Italy