Eczema Action Plan Improves Patient and Caregiver Understanding and Perception of Atopic Dermatitis Management: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Participants understanding of atopic dermatitis and homecare regimen
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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)
Intervention: A written Eczema Action Plan (EAP) (Other)
Written Eczema Action Plan (EAP)
The group given a written EAP after verbal instruction
Intervention: A written Eczema Action Plan (EAP) (Other)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Changes in emotional distress level on disease self-management(At the beginning of the visit and at the end of the visit (approximately 45min later))
Investigators
Peter A. Lio, MD
Attending Physician in Dermatology
Northwestern University