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OpenTrials
Completed

NCT Number: NCT01660217

Eczema Action Plan Improves Patient and Caregiver Understanding and Perception of Atopic Dermatitis Management

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Prior exposure to written action plans

Treatment and study plan

A written Eczema Action Plan (EAP)

Other

A written Eczema Action Plan (EAP) was given to the patients with their treatment regimen.

Primary outcomes

  1. Participants understanding of atopic dermatitis and homecare regimen

    Time frame: At the beginning of the visit and at the end of the visit (approximately 45min later)

Secondary outcomes

  1. Changes in emotional distress level on disease self-management

    Time frame: At the beginning of the visit and at the end of the visit (approximately 45min later)

Sponsors and collaborators

Lead sponsor

Dermatology & Aesthetics of Wicker Park

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 8, 2012
Registry last updated
Aug 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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