Crohn DiseaseNEMO-NurseNCT05254886
Identification and Management of Comorbidities and Extra-intestinal Manifestations in Crohn's Disease: the NEMO Nurse-led Program
A study testing NEMO nurse-led program in people with Crohn Disease, run by Central Hospital, Nancy, France at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- NEMO nurse-led program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Dec 2022to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
Read more
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.
- Conditions
- Crohn Disease
- Being tested
- NEMO nurse-led program
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEMO nurse-led programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine practice | No intervention | Patients who benefit from the classic management of CD (i.e. clinical + biological ± radiological ± endoscopic follow-up ± therapeutic education program). |
| Routine practice + nurse-led program | Experimental | 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. Receives: Other: NEMO nurse-led program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of measures taken by a physician in order to prevent or treat comorbidities and EIMs associated with CD
Measured: 6 months
Number of measures taken by a physician in order to prevent or treat comorbidities and EIMs associated with CD
Measured: 18 months
Secondary outcomes (7)
Number of measures taken by a physician for each comorbidity and EIM associated with CD in order to prevent or treat them
Measured: 6 months
Number of measures taken by a physician for each comorbidity and EIM associated with CD in order to prevent or treat them
Measured: 18 months
Percentage of patients who comply with recommendations issued by the nurse following completion of the NEMO nurse-led program
Measured: 6 months
Percentage of patients who comply with recommendations issued by the nurse following completion of the NEMO nurse-led program
Measured: 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.
Measured: 6 months
Frequency of comorbidities and EIMs, confirmed by a medical specialist, associated with CD
Measured: 6 months
Frequency of comorbidities and EIMs, confirmed by a medical specialist, associated with CD
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start12 Dec 2022
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Laurent PEYRIN-BIROULET, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254886
- Sponsor's protocol ID
- 2021PI157
- Acronym
- NEMO-Nurse
- Status last verified
- May 2025
- First submitted
- 14 Feb 2022
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Management of Comorbidities and Extra-intestinal Manifestations in Crohn's Disease: the NEMO Nurse-led Program
- ClinicalTrials.gov ID
- NCT05254886
- Acronym / sponsor ID
- NEMO-Nurse / 2021PI157
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine practice | No intervention | –Patients who benefit from the classic management of CD (i.e. clinical + biological ± radiological ± endoscopic follow-up ± therapeutic education program). |
| Routine practice + nurse-led program | Experimental | Other: NEMO nurse-led programPatients 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEMO nurse-led programThe 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. | Other | Routine practice + nurse-led program |
Primary outcome
Number of measures taken by a physician in order to prevent or treat comorbidities and EIMs associated with CD
Time frame: 6 months
Number of measures taken by a physician in order to prevent or treat comorbidities and EIMs associated with CD
Time frame: 18 months
7 secondary outcomes
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
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
Percentage of patients who comply with recommendations issued by the nurse following completion of the NEMO nurse-led program
Time frame: 6 months
Percentage of patients who comply with recommendations issued by the nurse following completion of the NEMO nurse-led program
Time frame: 18 months
Level of patient satisfaction with the NEMO nurse-led program
Time frame: 6 months
Frequency of comorbidities and EIMs, confirmed by a medical specialist, associated with CD
Time frame: 6 months
Frequency of comorbidities and EIMs, confirmed by a medical specialist, associated with CD
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
Related trials for Crohn Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEMO nurse-led program in people with Crohn Disease, run by Central Hospital, Nancy, France at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of measures taken by a physician in order to prevent or treat comorbidities and EIMs associated with CD (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.