Identification and Management of Comorbidities and Extra-intestinal Manifestations in Crohn's Disease: the NEMO Nurse-led Program (NEMO-Nurse)
Primary Purpose
Crohn Disease
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
NEMO nurse-led program
Sponsored by
About this trial
This is an interventional prevention trial for Crohn Disease
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.
Sites / Locations
- Nancy University HospitalRecruiting
- San Raffaele HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Routine practice
Routine practice + nurse-led program
Arm Description
Patients who benefit from the classic management of CD (i.e. clinical + biological ± radiological ± endoscopic follow-up ± therapeutic education 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.
Outcomes
Primary Outcome Measures
Number of measures taken by a physician in order to prevent or treat comorbidities and EIMs associated with CD
Number of measures taken by a physician in order to prevent or treat comorbidities and EIMs associated with CD
Secondary Outcome Measures
Number of measures taken by a physician for each comorbidity and EIM associated with CD in order to prevent or treat them
Number of measures taken by a physician for each comorbidity and EIM associated with CD in order to prevent or treat them
Percentage of patients who comply with recommendations issued by the nurse following completion of the NEMO nurse-led program
Percentage of patients who comply with recommendations issued by the nurse following completion of the NEMO nurse-led program
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.
Frequency of comorbidities and EIMs, confirmed by a medical specialist, associated with CD
Frequency of comorbidities and EIMs, confirmed by a medical specialist, associated with CD
Full Information
NCT ID
NCT05254886
First Posted
February 14, 2022
Last Updated
October 16, 2023
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT05254886
Brief Title
Identification and Management of Comorbidities and Extra-intestinal Manifestations in Crohn's Disease: the NEMO Nurse-led Program
Acronym
NEMO-Nurse
Official Title
Identification and Management of Comorbidities and Extra-intestinal Manifestations in Crohn's Disease: the NEMO Nurse-led Program
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
January 1, 2027 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Routine practice
Arm Type
No Intervention
Arm Description
Patients who benefit from the classic management of CD (i.e. clinical + biological ± radiological ± endoscopic follow-up ± therapeutic education program).
Arm Title
Routine practice + nurse-led program
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
NEMO nurse-led program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of measures taken by a physician in order to prevent or treat comorbidities and EIMs associated with CD
Time Frame
6 months
Title
Number of measures taken by a physician in order to prevent or treat comorbidities and EIMs associated with CD
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Number of measures taken by a physician for each comorbidity and EIM associated with CD in order to prevent or treat them
Time Frame
6 months
Title
Number of measures taken by a physician for each comorbidity and EIM associated with CD in order to prevent or treat them
Time Frame
18 months
Title
Percentage of patients who comply with recommendations issued by the nurse following completion of the NEMO nurse-led program
Time Frame
6 months
Title
Percentage of patients who comply with recommendations issued by the nurse following completion of the NEMO nurse-led program
Time Frame
18 months
Title
Level of patient satisfaction with the NEMO nurse-led program
Description
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.
Time Frame
6 months
Title
Frequency of comorbidities and EIMs, confirmed by a medical specialist, associated with CD
Time Frame
6 months
Title
Frequency of comorbidities and EIMs, confirmed by a medical specialist, associated with CD
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent Peyrin-Biroulet, MD, PhD
Phone
0033383155529
Email
peyrinbiroulet@gmail.com
Facility Information:
Facility Name
Nancy University Hospital
City
Vandoeuvre-lès-Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Peyrin-Biroulet, MD, PhD
Facility Name
San Raffaele Hospital
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvio Danese, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Identification and Management of Comorbidities and Extra-intestinal Manifestations in Crohn's Disease: the NEMO Nurse-led Program
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