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临床试验/NCT03544866
NCT03544866已完成不适用

The Impact of Pediatric Skin Disorders: The "Big" Study

Northwestern University1 个研究点 分布在 1 个国家目标入组 1,666 人开始时间: 2018年11月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,666
试验地点
1
主要终点
Measure the stigma experienced by children as a function of the child's perceived skin lesion visibility using the altered Neuro-QoL stigma tool

研究概览

简要总结

This study leverages the availability of a validated series of instruments to measure the effect of highly visible, chronic skin disorders, including atopic dermatitis (AD), on patients 8 years of age and above in causing stigma and psychiatric issues, particularly anxiety and depression.

详细描述

This is a multi center study with Northwestern University/Lurie Children's Hospital serving as the Data Coordinating Center. Site selection has been completed through members of PeDRA.

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
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Subjects must be aged 8-17 years of age
  • Subject must be diagnosed with a chronic skin disease deemed to be severe enough and/or in a visible location that could be stigmatizing as determined by the study doctor
  • Subject and parent must both be English speaking with at least one parent/guardian who will complete the questionnaires
  • Subject and Parent/Guardian must be able to complete the relevant questionnaires

排除标准

  • Children under 8 years of age
  • Children with developmental delay and/or a behavioral disorder that would preclude participation in form completion
  • Children with a non-cutaneous disorder that is considered by the Study doctor to be stigmatizing

结局指标

主要结局

Measure the stigma experienced by children as a function of the child's perceived skin lesion visibility using the altered Neuro-QoL stigma tool

时间窗: Past 7 days

Measure the stigma experienced by children as a function of the child's perceived skin lesion visibility using the altered Neuro-QoL stigma tool

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amy Paller

Principal Investigator

Northwestern University

研究点 (1)

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