Eczema Action Plan Improves Patient and Caregiver Understanding and Perception of Atopic Dermatitis Management

Eczema Action Plan Improves Patient and Caregiver Understanding and Perception of Atopic Dermatitis Management: A Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01660217

Enrollment

Registered

2012-08-08

Start date

2011-06-30

Completion date

2012-05-31

Last updated

2012-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis, eczema action plan, patient education, written handout, investigator's global assessment, randomized controlled trial

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.

Interventions

OTHERA written Eczema Action Plan (EAP)

A written Eczema Action Plan (EAP) was given to the patients with their treatment regimen.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Participants understanding of atopic dermatitis and homecare regimen	At the beginning of the visit and at the end of the visit (approximately 45min later)

Secondary

Measure	Time frame
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026