Trial record 10 of 279 for:    eczema

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter A. Lio, MD, Northwestern University
ClinicalTrials.gov Identifier:
NCT01660217
First received: July 31, 2012
Last updated: August 3, 2012
Last verified: August 2012
  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

Resource links provided by NLM:


Further study details as provided by Dermatology & Aesthetics of Wicker Park:

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) ] [ Designated as safety issue: No ]

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) ] [ 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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, Atopic
Dermatitis
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 22, 2014