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临床试验/NCT02152241
NCT02152241已完成不适用

Long-term Functional Outcome of Children With Inflammatory Bowel Disease

University of Manitoba1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
1
主要终点
Functional outcome (highest level of education attained and current occupation) of those with IBD compared to age and sex-matched healthy adult Manitobans

研究概览

简要总结

Inflammatory bowel diseases (IBD) are group of immune system disorders characterized by a chronic course with remission and relapses. Canada is one of the countries with the highest prevalence and incidence rates of IBD with 25% of patients present in children and adolescents.

As with any chronic illness, IBD diagnosed early in life has a significant impact on the physical, emotional and social development of those affected. Consequently, it is logical to speculate that patients with IBD may not do as well in education levels or employment status attained compared to their peers without IBD. If this were the case, then interventions could begin in childhood to better prepare patients with IBD for the challenges of living with a chronic disease. Alternatively, if it is shown that they reach comparable social or employment milestones as adults compared to unaffected peers then this would be enormously reassuring to children and their parents.

Properly designed studies to help in defining more appropriate interventions to these patients are needed.

The proposed study includes circulating a survey to evaluate the functioning level of adult patients with IBD who were diagnosed during their childhood. The participants will be asked a series of questions regarding their highest level of educational achievement, the nature of their current employment, and their current marital status. The question format will parallel that of the Canadian Community Health Survey from which data from an age matched healthy adult Manitobans will be extracted and used as another control group. Responses will be analysed for any possible differences between these groups.

研究设计

研究类型
Observational
时间视角
Cross Sectional

入排标准

年龄范围
24 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients who were initially diagnosed with IBD in childhood or adolescence (diagnosis was made < age of 18 years) and who were followed by the Section of Pediatric Gastroenterology at the Winnipeg Children's Hospital from 1974 - 2009.

排除标准

  • Patients in whom the diagnosis of IBD was not fully established following the current North American Society of Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) guidelines for diagnosing IBD i.e. had clinical, radiologic and endoscopic evidence of IBD (2).
  • Control participants with other chronic debilitating diseases (e.g. malignancy, rheumatoid arthritis, multiple sclerosis, etc..) that may affect quality of life and functional outcome

结局指标

主要结局

Functional outcome (highest level of education attained and current occupation) of those with IBD compared to age and sex-matched healthy adult Manitobans

时间窗: 12 months

The highest level of education attained and current occupation will be obtained from participants using structured questionnaire (non-validated interview questionnaire) e.g. Employed: Y N If No, Unemployed Y N, Disabled Y N , Homemaker Y N Student Y N, Retired Y N Is the cause of not working disease-related Y N

次要结局

  • Functional outcome of patients with Crohn's disease (CD) versus those with ulcerative colitis (UC)(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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