<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/NCT02251340</url>
  </required_header>
  <id_info>
    <org_study_id>ChildrensH</org_study_id>
    <nct_id>NCT02251340</nct_id>
  </id_info>
  <brief_title>Randomized Controlled Trial of an Eczema Care Plan</brief_title>
  <official_title>Randomized Controlled Trial of an Eczema Care Plan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this project are to increase families' understanding of eczema and improve&#xD;
      eczema management in the primary care setting. We have created an &quot;Eczema Care Plan&quot; similar&#xD;
      to those used in the management of asthma. It gives specific instructions about medications,&#xD;
      bathing and moisturizing, as well as when to seek further treatment. We will conduct a&#xD;
      randomized controlled trial of the plan in Primary Care at Longwood for a 10 month period.&#xD;
      Specifically, we aim to (1) decrease eczema severity (2) improve patient quality of life and&#xD;
      (3) increase parental knowledge and confidence about eczema management. We also plan to track&#xD;
      provider uptake and documentation of the plan and elicit feedback from parents and providers&#xD;
      on the utility and feasibility of the plan.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>proportion of patients with moderate/severe/very severe eczema</measure>
    <time_frame>1 month for each patient</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>quality of life measured via validated survey</measure>
    <time_frame>1 month for each patient</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>parental knowledge measured via survey</measure>
    <time_frame>1 month for each patient</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">211</enrollment>
  <condition>Eczema</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Families in the intervention group will receive an Eczema Care Plan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Families in the control group will not receive an Eczema Care Plan</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Eczema Care Plan</intervention_name>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:a) accompanying adult speaks English b) patient has a history of eczema&#xD;
        c) patient is between the ages of 1 month and 16 years d) family is coming for an eczema&#xD;
        visit or plans to discuss eczema e) accompanying adult is a primary caregiver f) child is&#xD;
        not in foster care g) caregiver has not received an eczema care plan previously. -&#xD;
&#xD;
        Exclusion Criteria: a) accompanying adult does not speak English b) patient does not have a&#xD;
        history of eczema c) patient is younger than 1 month or older than 16 years of age d)&#xD;
        eczema will not be discussed at the visit e) accompanying adult is not the primary&#xD;
        caregiver f) child is in foster care g) caregiver has received an eczema care plan&#xD;
        previously.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>November 30, 2016</last_update_submitted>
  <last_update_submitted_qc>November 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Corinna Rea</investigator_full_name>
    <investigator_title>Staff Physician, Instructor in Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02251340
org study id: ChildrensH
nct id: NCT02251340
lead sponsor: 
has dmc: No
The objectives of this project are to increase families' understanding of eczema and improve
      eczema management in the primary care setting. We have created an "Eczema Care Plan" similar
      to those used in the management of asthma. It gives specific instructions about medications,
      bathing and moisturizing, as well as when to seek further treatment. We will conduct a
      randomized controlled trial of the plan in Primary Care at Longwood for a 10 month period.
      Specifically, we aim to (1) decrease eczema severity (2) improve patient quality of life and
      (3) increase parental knowledge and confidence about eczema management. We also plan to track
      provider uptake and documentation of the plan and elicit feedback from parents and providers
      on the utility and feasibility of the plan.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: proportion of patients with moderate/severe/very severe eczema
time frame: 1 month for each patient
measure: quality of life measured via validated survey
time frame: 1 month for each patient
measure: parental knowledge measured via survey
time frame: 1 month for each patient
arm group label: Intervention
arm group type: Experimental
description: Families in the intervention group will receive an Eczema Care Plan
arm group label: Control
arm group type: No Intervention
description: Families in the control group will not receive an Eczema Care Plan
intervention type: Behavioral
intervention name: Eczema Care Plan
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Corinna Rea
investigator title: Staff Physician, Instructor in Medicine
mesh term: Eczema