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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-12

Study Completion Date

2027-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Crohn Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Routine practice

Patients who benefit from the classic management of CD (i.e. clinical + biological ± radiological ± endoscopic follow-up ± therapeutic education program).

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

NEMO nurse-led program

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No