Atopic Dermatitis Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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