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

Crohn Disease Clinical Trial

— NEMO-Nurse  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05254886
• Other study ID #: 2021PI157
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2022
• Est. completion date: January 1, 2027

Study information

• Verified date: October 2023
• Source: Central Hospital, Nancy, France
• Contact: Laurent Peyrin-Biroulet, MD, PhD
• Phone: 0033383155529
• Email: peyrinbiroulet[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

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.

Locations

Country	Name	City	State
France	Nancy University Hospital	Vandoeuvre-lès-Nancy
Italy	San Raffaele Hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Countries where clinical trial is conducted

France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of measures taken by a physician in order to prevent or treat comorbidities and EIMs associated with CD		6 months
Primary	Number of measures taken by a physician in order to prevent or treat comorbidities and EIMs associated with CD		18 months
Secondary	Number of measures taken by a physician for each comorbidity and EIM associated with CD in order to prevent or treat them		6 months
Secondary	Number of measures taken by a physician for each comorbidity and EIM associated with CD in order to prevent or treat them		18 months
Secondary	Percentage of patients who comply with recommendations issued by the nurse following completion of the NEMO nurse-led program		6 months
Secondary	Percentage of patients who comply with recommendations issued by the nurse following completion of the NEMO nurse-led program		18 months
Secondary	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
Secondary	Frequency of comorbidities and EIMs, confirmed by a medical specialist, associated with CD		6 months
Secondary	Frequency of comorbidities and EIMs, confirmed by a medical specialist, associated with CD		18 months