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

Not Applicable

Completed

• Conditions: Atopic Dermatitis
• Interventions: Other: A written Eczema Action Plan (EAP)

• Registration Number: NCT01660217
• Lead Sponsor: Dermatology & Aesthetics of Wicker Park

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Study First Submitted: 2012-07-31
• Status Verified: 2012-08
• Study First Submitted QC: 2012-08-03
• Last Update Submitted: 2012-08-03
• Study First Posted: 2012-08-08
• Last Update Posted: 2012-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Initial Verbal Instruction Group	A written Eczema Action Plan (EAP)	The group who initially received only verbal instruction, and then later (in the "crossover portion") received a written Eczema Action Plan (EAP)
Written Eczema Action Plan (EAP)	A written Eczema Action Plan (EAP)	The group given a written EAP after verbal instruction

Primary Outcome Measures

Name	Time	Method
Participants understanding of atopic dermatitis and homecare regimen	At the beginning of the visit and at the end of the visit (approximately 45min later)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Dermatology & Aesthetics of Wicker Park; 🇺🇸 Chicago, Illinois, United States