Back to resultsEczema Action Plan Improves Patient and Caregiver Understanding and Perception of Atopic Dermatitis Management
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
A written Eczema Action Plan (EAP)
Sponsored by
About this trial
This is an interventional supportive care trial for Atopic Dermatitis focused on measuring atopic dermatitis, eczema action plan, patient education, written handout, investigator's global assessment, randomized controlled trial
Eligibility 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
Sites / Locations
- Dermatology & Aesthetics of Wicker Park
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Initial Verbal Instruction Group
Written Eczema Action Plan (EAP)
Arm Description
The group who initially received only verbal instruction, and then later (in the "crossover portion") received a written Eczema Action Plan (EAP)
The group given a written EAP after verbal instruction
Outcomes
Primary Outcome Measures
Participants understanding of atopic dermatitis and homecare regimen
Secondary Outcome Measures
Changes in emotional distress level on disease self-management
Full Information
NCT ID
NCT01660217
First Posted
July 31, 2012
Last Updated
August 3, 2012
Sponsor
Dermatology & Aesthetics of Wicker Park
1. Study Identification
Unique Protocol Identification Number
NCT01660217
Brief Title
Eczema Action Plan Improves Patient and Caregiver Understanding and Perception of Atopic Dermatitis Management
Official Title
Eczema Action Plan Improves Patient and Caregiver Understanding and Perception of Atopic Dermatitis Management: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dermatology & Aesthetics of Wicker Park
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
atopic dermatitis, eczema action plan, patient education, written handout, investigator's global assessment, randomized controlled trial
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Initial Verbal Instruction Group
Arm Type
Experimental
Arm Description
The group who initially received only verbal instruction, and then later (in the "crossover portion") received a written Eczema Action Plan (EAP)
Arm Title
Written Eczema Action Plan (EAP)
Arm Type
Experimental
Arm Description
The group given a written EAP after verbal instruction
Intervention Type
Other
Intervention Name(s)
A written Eczema Action Plan (EAP)
Intervention Description
A written Eczema Action Plan (EAP) was given to the patients with their treatment regimen.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Dermatology & Aesthetics of Wicker Park
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60622
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Eczema Action Plan Improves Patient and Caregiver Understanding and Perception of Atopic Dermatitis Management
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