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

NCT ID: NCT01660217

Last Updated: 2012-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-05-31

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.

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis; eczema action plan; patient education; written handout; investigator's global assessment; randomized controlled trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Initial Verbal Instruction Group

The group who initially received only verbal instruction, and then later (in the "crossover portion") received a written Eczema Action Plan (EAP)

Group Type: EXPERIMENTAL

A written Eczema Action Plan (EAP)

Intervention Type: OTHER

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

Written Eczema Action Plan (EAP)

The group given a written EAP after verbal instruction

Group Type: EXPERIMENTAL

A written Eczema Action Plan (EAP)

Intervention Type: OTHER

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

Interventions

A written Eczema Action Plan (EAP)

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

Intervention Type: OTHER

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dermatology & Aesthetics of Wicker Park

OTHER

Sponsor Role: lead

Responsible Party

Peter A. Lio, MD

Attending Physician in Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dermatology & Aesthetics of Wicker Park

Chicago, Illinois, United States

Countries

United States

Other Identifiers

EAP-1

Identifier Type: -

Identifier Source: org_study_id