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

NCT01660217 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2012-08-08

No results posted yet for this study

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

Interventions

OTHER

A written Eczema Action Plan (EAP)

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

Sponsors & Collaborators

  • Dermatology & Aesthetics of Wicker Park

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01660217 on ClinicalTrials.gov