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

Information source: Dermatology & Aesthetics of Wicker Park
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atopic Dermatitis

Intervention: A written Eczema Action Plan (EAP) (Other)

Phase: N/A

Status: Completed

Sponsored by: Dermatology & Aesthetics of Wicker Park

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Participants understanding of atopic dermatitis and homecare regimen

Secondary outcome: Changes in emotional distress level on disease self-management

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Dermatology & Aesthetics of Wicker Park, Chicago, Illinois 60622, United States
Additional Information

Starting date: June 2011
Last updated: August 3, 2012

Page last updated: August 23, 2015

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