Eczema Action Plan Improves Patient and Caregiver Understanding and Perception of Atopic Dermatitis Management
Information source: Dermatology & Aesthetics of Wicker Park
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atopic Dermatitis
Intervention: A written Eczema Action Plan (EAP) (Other)
Phase: N/A
Status: Completed
Sponsored by: Dermatology & Aesthetics of Wicker Park
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.
Clinical Details
Official title: Eczema Action Plan Improves Patient and Caregiver Understanding and Perception of Atopic Dermatitis Management: A Randomized Controlled Trial
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: Participants understanding of atopic dermatitis and homecare regimen
Secondary outcome: Changes in emotional distress level on disease self-management
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Dermatology & Aesthetics of Wicker Park, Chicago, Illinois 60622, United States
Additional Information
Starting date: June 2011
Last updated: August 3, 2012
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