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

NCT01660217 | Completed

• 1 other identifier: EAP-1
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (2)

Initial Verbal Instruction Group

EXPERIMENTAL

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)

Written Eczema Action Plan (EAP)

EXPERIMENTAL

The group given a written EAP after verbal instruction

Other: A written Eczema Action Plan (EAP)

Interventions

A written Eczema Action Plan (EAP) OTHER

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

Initial Verbal Instruction Group; Written Eczema Action Plan (EAP)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior exposure to written action plans

Sponsors & Collaborators

• Dermatology & Aesthetics of Wicker Park: lead

Study Sites (1)

Dermatology & Aesthetics of Wicker Park

Chicago, Illinois, 60622, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician in Dermatology

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 8, 2012
• Study Start: June 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 8, 2012

Record last verified: 2012-08

Locations

US (1)