Clinical trial NCT01660217: Eczema Action Plan Improves Patient and Caregiver Understanding and Perception of Atopic Dermatitis Management
Official title: Eczema Action Plan Improves Patient and Caregiver Understanding and Perception of Atopic Dermatitis Management: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
eczema action plan
patient education
written handout
investigator's global assessment
randomized controlled trial
Lead sponsor: Dermatology & Aesthetics of Wicker Park
Sponsor class: OTHER
First posted: 2012-08-08
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Participants understanding of atopic dermatitis and homecare regimen
timeFrame: At the beginning of the visit and at the end of the visit (approximately 45min later)
Secondary outcomes:
measure: Changes in emotional distress level on disease self-management
timeFrame: At the beginning of the visit and at the end of the visit (approximately 45min later)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Dermatology & Aesthetics of Wicker Park
state: Illinois
Study officials:
References: