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NCT Number: NCT05254886

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nancy University Hospital, Vandœuvre-lès-Nancy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NEMO nurse-led program

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.

Primary outcomes

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

    Time frame: 6 months

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

    Time frame: 18 months

Secondary outcomes

  1. 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

  2. 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

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

    Time frame: 6 months

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

    Time frame: 18 months

  5. Level of patient satisfaction with the NEMO nurse-led program

    Time frame: 6 months

    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. Frequency of comorbidities and EIMs, confirmed by a medical specialist, associated with CD

    Time frame: 6 months

  7. Frequency of comorbidities and EIMs, confirmed by a medical specialist, associated with CD

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: NEMO-Nurse

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 24, 2022
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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