Occupational Insertion and Educational Level of Adult Patients With Pediatric Early Inflammatory Bowel Disease (IBD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 343
- 试验地点
- 2
- 主要终点
- Rate of active workers in employment
研究概览
简要总结
The main objective of this project is to assess the occupational insertion of these adult patients with pediatric-onset IBD and to compare it with the general population.
The secondary objectives are:
- to assess the level of education and compare it to that of the general population
- to assess occupational insertion and the educational level according to:
- The disease (Crohn's disease, ulcerative colitis or unclassified colitis)
- sex
- Age at diagnosis (<or ≥ 10 years)
- The occurence of surgery, the location of the disease, the treatments undertaken
- Quality of life
- Evaluate the patient's feelings about the impact of his illness on occupational insertion and the educational level
- To describe the quality of life of patients in relation to disease activity and health states (QALY calculation)
- To assess the responsivness to change of the functional handicap score IBD-DI (n = 200 patients)
详细描述
Chronic inflammatory bowel diseases (IBD) are responsible for high morbidity and impaired quality of life of patients throughout disease course.
Numerous studies have shown the impact of the disease on the quality of life of patients with IBD. However, very little data is available on the level of education and professional integration of patients who started their IBD in childhood.
The hypothesis behind the study project is that the level of education and consequently the professional integration of patients with early pediatric IBD: 1) could be different from those of the general population; 2) and that these differences could be influenced by the nature of IBD, the age of its onset and its main characteristics.
The main objective of this project is to assess the professional integration of these adult patients with pediatric-onset IBD and to compare it with the general population.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 25 and over at the time of the study
- •Subject listed in the EPIMAD registry suffering from certain or probable Crohn's disease, or certain or probable ulcerative colitis, or certain or probable ulcerated proctitis, unclassified colitis, diagnosed between 01/01 / 1988 and 12/31/2011, with an age at diagnosis of less than 17 years (definition of the pediatric cohort of the EPIMAD Registry)
- •Patient residing in the area of the EPIMAD registry: Nord, Pas-de-Calais, Somme or Seine-Maritime
- •Patient not opposed to the research
- •Patient not having objected to the use of their data for ancillary studies when registering in the EPIMAD register
排除标准
- 未提供
结局指标
主要结局
Rate of active workers in employment
时间窗: through study completion, an average of 18 months
Rate of active workers in employment collected using a standardized self-questionnaire
次要结局
- Educational level(through study completion, an average of 18 months)
- Disease activity for Ulcerative Colitis patients(through study completion, an average of 18 months)
- Association between occupational insertion and disease variables(through study completion, an average of 18 months)
- Percentage of patients for whom the disease had an influence on the choice of studies(through study completion, an average of 18 months)
- Percentage of patients for whom the disease had an influence on the course of the studies(through study completion, an average of 18 months)
- Percentage of patients for whom the disease had an influence on the choice of profession(through study completion, an average of 18 months)
- Disability in 200 patients(through study completion, an average of 18 months)
- Association between educational level and disease variables(through study completion, an average of 18 months)
- Association between educational level and quality of life(through study completion, an average of 18 months)
- Quality of life as measured by EQ5D-5L questionnaire(through study completion, an average of 18 months)
- Association between occupational insertion and quality of life(through study completion, an average of 18 months)
- Disease activity for Crohn's patients(through study completion, an average of 18 months)