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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660217
• Other study ID #: EAP-1
• Status: Completed
• Phase: N/A
• First received: July 31, 2012
• Last updated: August 3, 2012
• Start date: June 2011
• Est. completion date: May 2012

Study information

• Verified date: August 2012
• Source: Dermatology & Aesthetics of Wicker Park
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board (New England Institutional Review Board)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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

Locations

Country	Name	City	State
United States	Dermatology & Aesthetics of Wicker Park	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Dermatology & Aesthetics of Wicker Park

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants understanding of atopic dermatitis and homecare regimen		At the beginning of the visit and at the end of the visit (approximately 45min later)	No
Secondary	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)	No