Quality of Life in Pediatric Inflammatory Bowel Disease
Measurement of the quality of life (QoL) of children and adolescents with inflammatory bowel diseases (IBD) has had little attention, despite the importance of understanding key factors affecting QoL, especially for measuring the effects of clinical trials to improve IBD outcomes.
The main purpose of this pilot study is to examine the impact of clinical severity and treatment social factors on the quality of life (QoL) of a diverse population of children and adolescents with inflammatory bowel disease (IBD).
Secondary purposes include determining the effects of sociodemographic factors on QoL and exploring the concordance of views of parents and children of QoL.
The study aims are to 1) determine the associations of of clinical characteristics (condition type, activity/severity, and treatment) with specific components of general health-related quality of life and IBD-specific QoL; 2) describe the effects of sociodemographic characteristics (SES, age, and gender) on these measures; and 3) compare the views of different observers (parent and child with IBD) of the child's QoL.
The study will apply both general and condition-specific QoL measures among a random sample of 250 children and adolescents with IBD, ages 5-18 years, in six clinical sites.
We will obtain measures of QoL from both the child and a parent in each case.
The study will obtain additional data regarding the subjects' clinical condition (condition type, severity/activity, treatment [including surgery], age of onset) and socioeconomic status (household structure and income).
Main analyses will compare general and specific measures of QoL and examine the influence of clinical and sociodemographic variables on QoL, through multivariate regression techniques.
We will also examine the differences in child and parent assessments of QoL.
The information from this study will provide a stronger base for future studies of treatment and natural history of IBD.
It will help to clarify the life domains that are affected by IBD and will inform interventions to improve QoL for children with IBD.
研究概览
研究类型
观察性的
注册 (预期的)
350
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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California
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San Francisco、California、美国
- University of California San Francisco
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Georgia
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Atlanta、Georgia、美国
- Children's Health Care of Atlanta
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Illinois
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Chicago、Illinois、美国
- University of Chicago Children's Hospital
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Massachusetts
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Boston、Massachusetts、美国
- MassGeneral Hospital for Children
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Pennsylvania
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Philadelphia、Pennsylvania、美国
- Children's Hospital of Philadelphia
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Texas
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Houston、Texas、美国
- Texas Children's Hospital
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
8年 至 17年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
All children ages 8-17 years in any of six centers for inflammatory bowel disease in children who have already enrolled in the IBD consortium database.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2003年1月1日
研究注册日期
首次提交
2003年6月3日
首先提交符合 QC 标准的
2003年6月3日
首次发布 (估计)
2003年6月4日
研究记录更新
最后更新发布 (估计)
2010年1月13日
上次提交的符合 QC 标准的更新
2010年1月12日
最后验证
2010年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.