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临床试验/NCT02008643
NCT02008643已完成不适用

Health Related Quality of Life in Children With Food Allergy: Comparison to Healthy Children and Children With Other Chronic Diseases

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 861 人开始时间: 2014年2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
861
试验地点
2
主要终点
comparison of12 scores of the generic health-related quality of life questionnaire CHQ-CF 87 between children with food allergy and healthy children scores.

研究概览

简要总结

The number of studies concerning health related quality of life (HRQL) in children with food allergy is very limited.

Only one study to date has compared HRQL of a group of children with food allergy to data published on general population and other chronic diseases. This study concluded to lowest HRQL scores in food allergic children compared to type 1 diabetes mellitus with important impact on scores concerning social activities.

详细描述

Primary aim:

To compare generic HRQL score in children with food allergy with other chronic diseases and with healthy chidren in an homogeneous socio-cultural context.

Secondary aims :

  • To compare generic and specific HRQL scores in children with food allergy
  • Identifify in chidren with food allergy, clinical factrors assocated with lowest scores in order to improve our management.

Methods

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
盲法
None

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 8-18 year old
  • IgE mediated food allergy diagnosed by a pediatric allergologist with following criteria:
  • Convincing history of allergic reaction with positive prick-test and specific IgE Or Open food challenge associated with positive prick-test and specific IgE
  • Signed informed consent of the two parents
  • Signed informed consent of the child
  • Health insurance recipient

排除标准

  • Association with another medical or psychiatric chronic disease (excepted for controlled asthma)
  • Partially or not controlled asthma during last year
  • No signed consent

结局指标

主要结局

comparison of12 scores of the generic health-related quality of life questionnaire CHQ-CF 87 between children with food allergy and healthy children scores.

时间窗: Once at inclusion

12 scores concerning the 12 following dimensions: * physical functioning * role functioning emotional * role functioning behavior * role functioning physical * bodily pain * general behavior * mental health * self-esteem * general health * change in health * family activities * family cohesion Comparison between children with food allergy and healthy children scores.

次要结局

  • comparaison beetween all questionnary(once at inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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