Identification and Management of Comorbidities and Extra-intestinal Manifestations in Crohn's Disease: the NEMO Nurse-led Program
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Number of measures taken by a physician in order to prevent or treat comorbidities and EIMs associated with CD
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Number of measures taken by a physician in order to prevent or treat comorbidities and EIMs associated with CD
时间窗: 18 months
次要结局
- Percentage of patients who comply with recommendations issued by the nurse following completion of the NEMO nurse-led program(18 months)
- Frequency of comorbidities and EIMs, confirmed by a medical specialist, associated with CD(18 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)
- Level of patient satisfaction with the NEMO nurse-led program(6 months)
研究者
Dr Laurent PEYRIN-BIROULET
Principal Investigator
Central Hospital, Nancy, France