<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01660217</url>
  </required_header>
  <id_info>
    <org_study_id>EAP-1</org_study_id>
    <nct_id>NCT01660217</nct_id>
  </id_info>
  <brief_title>Eczema Action Plan Improves Patient and Caregiver Understanding and Perception of Atopic Dermatitis Management</brief_title>
  <official_title>Eczema Action Plan Improves Patient and Caregiver Understanding and Perception of Atopic Dermatitis Management: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dermatology &amp; Aesthetics of Wicker Park</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dermatology &amp; Aesthetics of Wicker Park</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized controlled study. The control group will consist of adult subjects and&#xD;
      the caregivers of pediatric subjects with an established diagnosis of atopic dermatitis (AD),&#xD;
      who are visiting a dermatologist for a standard AD office visit. In the control group, only&#xD;
      verbal instruction (VI), the standard of care, will be provided. The intervention group will&#xD;
      receive a similar VI with an additional component: an eczema education handout, as well as an&#xD;
      individualized written Eczema Action Plan (EAP) that will illustrate how to recognize disease&#xD;
      flare-ups and subsequent remissions. In addition, the EAP will provide detailed step-wise&#xD;
      instructions regarding treatment modifications for the above-mentioned variations in&#xD;
      treatment severity. To ensure that all patients ultimately receive the same level of care,&#xD;
      the control group will also receive an EAP at the end of their consultation.&#xD;
&#xD;
      The goal of this study is to assess subjects' perception in the provider's use of an EAP and&#xD;
      its effectiveness in helping patients understand their disease and management plan. In order&#xD;
      to evaluate the primary end-points, subjects in both the control and treatment groups will be&#xD;
      asked to complete post-consultation surveys. Four post-consultation outcomes will be&#xD;
      measured: (1) caregivers' understanding of the disease and treatment, (2) caregivers' comfort&#xD;
      level in following the EAP at home, (3) caregivers' anxiety level in managing the AD at home,&#xD;
      and (4) caregivers' preference for VI + EAP as compared to VI alone, EAP alone, or neither&#xD;
      the EAP nor the VI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">May 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participants understanding of atopic dermatitis and homecare regimen</measure>
    <time_frame>At the beginning of the visit and at the end of the visit (approximately 45min later)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in emotional distress level on disease self-management</measure>
    <time_frame>At the beginning of the visit and at the end of the visit (approximately 45min later)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Initial Verbal Instruction Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The group who initially received only verbal instruction, and then later (in the &quot;crossover portion&quot;) received a written Eczema Action Plan (EAP)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Written Eczema Action Plan (EAP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The group given a written EAP after verbal instruction</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>A written Eczema Action Plan (EAP)</intervention_name>
    <description>A written Eczema Action Plan (EAP) was given to the patients with their treatment regimen.</description>
    <arm_group_label>Initial Verbal Instruction Group</arm_group_label>
    <arm_group_label>Written Eczema Action Plan (EAP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or older fulfilling Hanifin and Rajka diagnostic criteria for AD, or adult&#xD;
             caregivers for patients younger than 18 years of age, and the ability to comprehend&#xD;
             study materials in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior exposure to written action plans&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dermatology &amp; Aesthetics of Wicker Park</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60622</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>July 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2012</study_first_posted>
  <last_update_submitted>August 3, 2012</last_update_submitted>
  <last_update_submitted_qc>August 3, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 8, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Peter A. Lio, MD</investigator_full_name>
    <investigator_title>Attending Physician in Dermatology</investigator_title>
  </responsible_party>
  <keyword>atopic dermatitis</keyword>
  <keyword>eczema action plan</keyword>
  <keyword>patient education</keyword>
  <keyword>written handout</keyword>
  <keyword>investigator's global assessment</keyword>
  <keyword>randomized controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01660217
org study id: EAP-1
nct id: NCT01660217
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: 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)
measure: 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)
arm group label: Initial Verbal Instruction Group
arm group type: Experimental
description: The group who initially received only verbal instruction, and then later (in the "crossover portion") received a written Eczema Action Plan (EAP)
arm group label: Written Eczema Action Plan (EAP)
arm group type: Experimental
description: The group given a written EAP after verbal instruction
intervention type: Other
intervention name: A written Eczema Action Plan (EAP)
description: A written Eczema Action Plan (EAP) was given to the patients with their treatment regimen.
arm group label: Initial Verbal Instruction Group
arm group label: Written Eczema Action Plan (EAP)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Peter A. Lio, MD
investigator title: Attending Physician in Dermatology
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema