Eczema Action Plan Improves Patient and Caregiver Understanding and Perception of Atopic Dermatitis Management
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Atopic Dermatitis |
Other: A written Eczema Action Plan (EAP) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Eczema Action Plan Improves Patient and Caregiver Understanding and Perception of Atopic Dermatitis Management: A Randomized Controlled Trial |
- 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) ] [ Designated as safety issue: No ]
- Changes in emotional distress level on disease self-management [ Time Frame: At the beginning of the visit and at the end of the visit (approximately 45min later) ] [ Designated as safety issue: No ]
| Enrollment: | 37 |
| Study Start Date: | June 2011 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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)
|
Other: A written Eczema Action Plan (EAP)
A written Eczema Action Plan (EAP) was given to the patients with their treatment regimen.
|
|
Experimental: Written Eczema Action Plan (EAP)
The group given a written EAP after verbal instruction
|
Other: A written Eczema Action Plan (EAP)
A written Eczema Action Plan (EAP) was given to the patients with their treatment regimen.
|
Eligibility| Genders Eligible for Study: | Both |
| 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Peter A. Lio, MD, Attending Physician in Dermatology, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT01660217 History of Changes |
| Other Study ID Numbers: | EAP-1 |
| Study First Received: | July 31, 2012 |
| Last Updated: | August 3, 2012 |
| Health Authority: | United States: Institutional Review Board (New England Institutional Review Board) |
Keywords provided by Dermatology & Aesthetics of Wicker Park:
|
atopic dermatitis eczema action plan patient education |
written handout investigator's global assessment randomized controlled trial |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Eczema Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013