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临床试验/NCT03722706
NCT03722706已完成不适用

Improving Therapeutic Patient Education for Atopic Dermatitis: Evaluation of a Parent Handbook

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2019年2月26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
246
试验地点
2
主要终点
Patient-Oriented Eczema Measure (POEM)

研究概览

简要总结

The objective of this research is to evaluate the effectiveness of an educational handbook for parents of children with atopic dermatitis (AD) in improving clinical outcomes for pediatric patients with AD and their parents. The handbook was developed by an interdisciplinary team of healthcare providers to facilitate therapeutic patient education as a routine component of care for pediatric patients with atopic dermatitis (AD). Patient education is an important element of practice management guidelines for AD, particularly given complex treatment plans and high rates of non-adherence in this population. Parents of children with AD will be randomized into either the handbook arm (handbook provided as an adjunct to standard AD management with a healthcare provider at Boston Children's Hospital) or the control arm (standard management alone). Participants will complete study measures at two time points: baseline (prior to a clinic visit appointment for AD care at Boston Children's Hospital), and 3-month follow-up. Data will be analyzed for change on study outcome measures (AD symptoms, AD severity, quality of life) and satisfaction with the handbook.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
30 Days 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of atopic dermatitis
  • Scheduled for clinic visit for evaluation/management of atopic dermatitis at Boston Children's Hospital

排除标准

  • Parent is Spanish speaking
  • Parent is foster parent

结局指标

主要结局

Patient-Oriented Eczema Measure (POEM)

时间窗: baseline to 3-month follow-up

parent-report of child's atopic dermatitis symptoms

次要结局

  • Dermatology Family Impact Questionnaire (DFI)(baseline to 3-month follow-up)
  • Infant's Dermatitis Quality of Life Index (IDQOL)(baseline to 3-month follow-up)
  • Eczema Area and Severity Index (EASI)(baseline to 3-month follow-up)
  • Children's Dermatology Life Quality Index (CDLQI)(baseline to 3-month follow-up)

研究者

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

Jennifer LeBovidge

Attending Psychologist

Boston Children's Hospital

研究点 (2)

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