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临床试验/NCT01660217
NCT01660217已完成不适用

Eczema Action Plan Improves Patient and Caregiver Understanding and Perception of Atopic Dermatitis Management: A Randomized Controlled Trial

Dermatology & Aesthetics of Wicker Park2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
37
试验地点
2
主要终点
Participants understanding of atopic dermatitis and homecare regimen

研究概览

简要总结

This is a randomized controlled study. The control group will consist of adult subjects and the caregivers of pediatric subjects with an established diagnosis of atopic dermatitis (AD), who are visiting a dermatologist for a standard AD office visit. In the control group, only verbal instruction (VI), the standard of care, will be provided. The intervention group will receive a similar VI with an additional component: an eczema education handout, as well as an individualized written Eczema Action Plan (EAP) that will illustrate how to recognize disease flare-ups and subsequent remissions. In addition, the EAP will provide detailed step-wise instructions regarding treatment modifications for the above-mentioned variations in treatment severity. To ensure that all patients ultimately receive the same level of care, the control group will also receive an EAP at the end of their consultation.

The goal of this study is to assess subjects' perception in the provider's use of an EAP and its effectiveness in helping patients understand their disease and management plan. In order to evaluate the primary end-points, subjects in both the control and treatment groups will be asked to complete post-consultation surveys. Four post-consultation outcomes will be measured: (1) caregivers' understanding of the disease and treatment, (2) caregivers' comfort level in following the EAP at home, (3) caregivers' anxiety level in managing the AD at home, and (4) caregivers' preference for VI + EAP as compared to VI alone, EAP alone, or neither the EAP nor the VI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Age 18 or older fulfilling Hanifin and Rajka diagnostic criteria for AD, or adult caregivers for patients younger than 18 years of age, and the ability to comprehend study materials in English

排除标准

  • Prior exposure to written action plans

结局指标

主要结局

Participants understanding of atopic dermatitis and homecare regimen

时间窗: At the beginning of the visit and at the end of the visit (approximately 45min later)

次要结局

  • Changes in emotional distress level on disease self-management(At the beginning of the visit and at the end of the visit (approximately 45min later))

研究者

发起方
Dermatology & Aesthetics of Wicker Park
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter A. Lio, MD

Attending Physician in Dermatology

Northwestern University

研究点 (2)

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