Development and Validation of a Comorbidity Index in Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 458
- 试验地点
- 2
- 主要终点
- To develop and validate a clinical index to evaluate the impact of comorbidities on disability in patients with CD.
研究概览
简要总结
Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD). Like other chronic diseases, patients with CD may be affected by other diseases called comorbidities. The prevalence of comorbidities in IBD patients ranges from 30 to 70 %. Unlike other chronic diseases, there is currently no CD-specific tool to assess the impact of comorbidities on patients' lives in order to take appropriate medical measures. Several clinical indexes have been developed for the study of comorbidities, including the Charlson index and the Groll index, which are widely used. The disadvantage of these indexes is that they are not adapted to patients with CD. The primary objective of this study is to develop and validate a clinical index to evaluate the impact of comorbidities on disability in patients with CD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients between 18 and 59 years old
- •Established diagnosis of CD with a minimum disease duration of 3 months
- •Disease considered by the treating gastroenterologist to have been stable for at least 3 months
排除标准
- •Subject unable to comply with study procedures
- •Surgery for CD 3 months prior to inclusion visit
结局指标
主要结局
To develop and validate a clinical index to evaluate the impact of comorbidities on disability in patients with CD.
时间窗: Through study completion, an average of 3 years
Probability of having an IBD disability index ≥ 35 (i.e. moderate and severe disability).
次要结局
未报告次要终点
研究者
Dr Laurent PEYRIN-BIROULET
MD, PhD
Central Hospital, Nancy, France