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

August 3, 2012 updated by: Peter A. Lio, MD, Dermatology & Aesthetics of Wicker Park

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Other: A written Eczema Action Plan (EAP)
A written Eczema Action Plan (EAP) was given to the patients with their treatment regimen.
Experimental: Written Eczema Action Plan (EAP)
The group given a written EAP after verbal instruction
Other: A written Eczema Action Plan (EAP)
A written Eczema Action Plan (EAP) was given to the patients with their treatment regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
At the beginning of the visit and at the end of the visit (approximately 45min later)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
At the beginning of the visit and at the end of the visit (approximately 45min later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dermatology & Aesthetics of Wicker Park

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

July 31, 2012

First Submitted That Met QC Criteria

August 3, 2012

First Posted (Estimate)

August 8, 2012

Study Record Updates

Last Update Posted (Estimate)

August 8, 2012

Last Update Submitted That Met QC Criteria

August 3, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EAP-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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