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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01660217
First Posted: August 8, 2012
Last Update Posted: August 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Peter A. Lio, MD, Northwestern University
  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: None (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

Resource links provided by NLM:


Further study details as provided by Peter A. Lio, MD, Northwestern University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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) ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01660217


Locations
United States, Illinois
Dermatology & Aesthetics of Wicker Park
Chicago, Illinois, United States, 60622
Sponsors and Collaborators
Dermatology & Aesthetics of Wicker Park
  More Information

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
First Submitted: July 31, 2012
First Posted: August 8, 2012
Last Update Posted: August 8, 2012
Last Verified: August 2012

Keywords provided by Peter A. Lio, MD, Northwestern University:
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