NCT05254886

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Dec 2022Jan 2027

First Submitted

Initial submission to the registry

February 14, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

December 12, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

4.1 years

First QC Date

February 14, 2022

Last Update Submit

May 5, 2025

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (2)

  • Number of measures taken by a physician in order to prevent or treat comorbidities and EIMs associated with CD

    6 months

  • Number of measures taken by a physician in order to prevent or treat comorbidities and EIMs associated with CD

    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

    6 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

  • Percentage of patients who comply with recommendations issued by the nurse following completion of the NEMO nurse-led program

    6 months

  • Percentage of patients who comply with recommendations issued by the nurse following completion of the NEMO nurse-led program

    18 months

  • Level of patient satisfaction with the NEMO nurse-led program

    6 months

  • +2 more secondary outcomes

Study Arms (2)

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.

Other: NEMO nurse-led program

Interventions

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.

Routine practice + nurse-led program

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nancy University Hospital

Vandœuvre-lès-Nancy, France

Location

San Raffaele Hospital

Milan, Italy

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 14, 2022

First Posted

February 24, 2022

Study Start

December 12, 2022

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

May 6, 2025

Record last verified: 2025-05

Locations

IT(1)FR(1)