<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/NCT02258308</url>
  </required_header>
  <id_info>
    <org_study_id>PHSKC</org_study_id>
    <nct_id>NCT02258308</nct_id>
  </id_info>
  <brief_title>CDC Medicaid Asthma Home Visit Project</brief_title>
  <official_title>Medicaid Asthma Home Visit Project: Improving Health and Reducing Costs of Health Care for Children With Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Public Health - Seattle and King County</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Public Health - Seattle and King County</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Asthmatic children age 3-17 from low income households in King County are randomly assigned&#xD;
      into a community health worker (CHW) intervention group and a control group. The intervention&#xD;
      is in-home education and support related to asthma self-management. The main outcome measures&#xD;
      are asthma symptom-free days, caretaker's asthma-related quality of life score, and health&#xD;
      care utilization for asthma measured at baseline and 12 months after baseline enrollment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized controlled trial. Potentially eligible subjects come from lists&#xD;
      generated by health plans (Community Health Plan of Washington and Molina, who insure the&#xD;
      majority of Medicaid enrollees in King County), individuals referred by primary care&#xD;
      providers, and self referral. Eligible subjects that agree to participate are randomly&#xD;
      assigned into a CHW intervention group or a control group. We expected to complete the study&#xD;
      with 200 in each group.&#xD;
&#xD;
      The intervention is in-home education and support by a community health worker (CHW). At the&#xD;
      first home visit, the CHW assesses the participant's knowledge and skills related to asthma&#xD;
      self-management, current status of the child's asthma, and resources and support for asthma&#xD;
      self-management using a baseline questionnaire. The CHW inspects the home environment using&#xD;
      an Environmental Home Checklist to identify environmental triggers that can cause asthma&#xD;
      symptoms and affect asthma control. The CHW makes up to three follow-up visits and two&#xD;
      telephone visits during the year the participant is in the study. Participants receive&#xD;
      resources to help them control asthma, including vacuum cleaner, dust covers for a pillow and&#xD;
      mattress and a &quot;green&quot; cleaning kit with cleaning supplies.&#xD;
&#xD;
      The control group receives standard asthma care, as provided by a primary health care&#xD;
      provider during the 12 months after enrollment. When the intervention period is over, the&#xD;
      control group receives one visit with a CHW and the resources provided to the intervention&#xD;
      group participants.&#xD;
&#xD;
      The main outcome variables include asthma symptom-free days, caretaker asthma-related quality&#xD;
      of life, and urgent health care utilization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2010</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Asthma symptom free days</measure>
    <time_frame>last 14 days</time_frame>
    <description>14 - During the past 14 days (that is, during the past fourteen 24 hour periods that include daytime and nighttime), on how many DAYS did your child have any asthma symptoms, such as wheezing, coughing, tightness in the chest, shortness of breath, waking up at night because of asthma symptoms, or slowing down of usual activities because of asthma?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Caretaker quality of life</measure>
    <time_frame>last week</time_frame>
    <description>Juniper Mini Asthma Quality of Life Questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health care utilization for asthma</measure>
    <time_frame>12 months</time_frame>
    <description>number of unscheduled clinic visits+emergency department visits+hospitalization for asthma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cost analysis</measure>
    <time_frame>12 months</time_frame>
    <description>costs associated with health care utilization for asthma</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>nights with asthma symptoms</measure>
    <time_frame>14 days</time_frame>
    <description>During the nighttime in the past 14 nights, how many nights did your child wake up because of asthma symptoms such as wheezing, shortness of breath, or tightness in the chest, or cough?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>days with activity limitation due to asthma</measure>
    <time_frame>14 days</time_frame>
    <description>During the past 14 days, how many days did your child have to slow down or stop his/her play or usual activities or missed school because of asthma, wheezing or tightness in the chest, or cough.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>days used asthma rescue medicine</measure>
    <time_frame>14 days</time_frame>
    <description>During the past 14 days, about how many days did your child use asthma rescue medicine (sometimes called a quick relief medicine) such as albuterol, proventil, or ventolin?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>asthma episodes</measure>
    <time_frame>3 months</time_frame>
    <description>During the past three months, about how many asthma episodes did your child have?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>asthma control level</measure>
    <time_frame>14 days</time_frame>
    <description>(% with well controlled asthma and % with very poorly controlled asthma)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">373</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>CHW intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The CHW intervention is in-home education and support by a community health worker (CHW). At the first home visit, the CHW assesses the participant's knowledge and skills related to asthma self-management, current status of the child's asthma, and resources and support for asthma self-management using a baseline questionnaire. The CHW will inspect the home environment using an Environmental Home Checklist to identify environmental triggers that can cause asthma symptoms and affect asthma control. The CHW makes up to three follow-up visits and two telephone visits during the year the participant is in the study. Participants receive resources to help them control asthma: vacuum cleaner, dust covers for a pillow and mattress and a &quot;green&quot; cleaning kit with cleaning supplies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group receives standard asthma care, as provided by a primary health care provider. When the intervention period is over, the control group receives one visit with a CHW and the resources provided to the intervention group participants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CHW intervention</intervention_name>
    <description>Home education and support for asthma self management</description>
    <arm_group_label>CHW intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  caretaker is age 18 or older and child is age 3-17&#xD;
&#xD;
          -  have not controlled as thma&#xD;
&#xD;
          -  residence in King County&#xD;
&#xD;
          -  spoken language is English or Spanish&#xD;
&#xD;
          -  Child is enrolled in a Medicaid managed care health plan offered by Community Health&#xD;
             Plan of Washington (CHPW) or Molina Health Plan of Washington, Inc (Molina).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parent/guardian plans to move out of King County within the next year or lacks&#xD;
             permanent housing.&#xD;
&#xD;
          -  Parent/guardian has a mental or physical disability making it impossible to&#xD;
             participate in the protocols.&#xD;
&#xD;
          -  The household appears to be unsafe for visitation by the CHW.&#xD;
&#xD;
          -  The child has other serious chronic medical conditions (e.g. poorly controlled sickle&#xD;
             cell disease, cystic fibrosis) that cause sufficient limitation in functional status&#xD;
             so that that asthma control is not a priority.&#xD;
&#xD;
          -  The family is enrolled in another asthma research study within the past three years.&#xD;
             This is to avoid the potential confounding effect from other studies.&#xD;
&#xD;
          -  The child is in foster care or group care settings.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Campbell JD, Brooks M, Hosokawa P, Robinson J, Song L, Krieger J. Community Health Worker Home Visits for Medicaid-Enrolled Children With Asthma: Effects on Asthma Outcomes and Costs. Am J Public Health. 2015 Nov;105(11):2366-72. doi: 10.2105/AJPH.2015.302685. Epub 2015 Aug 13.</citation>
    <PMID>26270287</PMID>
  </results_reference>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>April 12, 2017</last_update_submitted>
  <last_update_submitted_qc>April 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</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/NCT02258308
org study id: PHSKC
nct id: NCT02258308
lead sponsor: 
collaborator: 
has dmc: No
Asthmatic children age 3-17 from low income households in King County are randomly assigned
      into a community health worker (CHW) intervention group and a control group. The intervention
      is in-home education and support related to asthma self-management. The main outcome measures
      are asthma symptom-free days, caretaker's asthma-related quality of life score, and health
      care utilization for asthma measured at baseline and 12 months after baseline enrollment.
This is a randomized controlled trial. Potentially eligible subjects come from lists
      generated by health plans (Community Health Plan of Washington and Molina, who insure the
      majority of Medicaid enrollees in King County), individuals referred by primary care
      providers, and self referral. Eligible subjects that agree to participate are randomly
      assigned into a CHW intervention group or a control group. We expected to complete the study
      with 200 in each group.

      The intervention is in-home education and support by a community health worker (CHW). At the
      first home visit, the CHW assesses the participant's knowledge and skills related to asthma
      self-management, current status of the child's asthma, and resources and support for asthma
      self-management using a baseline questionnaire. The CHW inspects the home environment using
      an Environmental Home Checklist to identify environmental triggers that can cause asthma
      symptoms and affect asthma control. The CHW makes up to three follow-up visits and two
      telephone visits during the year the participant is in the study. Participants receive
      resources to help them control asthma, including vacuum cleaner, dust covers for a pillow and
      mattress and a "green" cleaning kit with cleaning supplies.

      The control group receives standard asthma care, as provided by a primary health care
      provider during the 12 months after enrollment. When the intervention period is over, the
      control group receives one visit with a CHW and the resources provided to the intervention
      group participants.

      The main outcome variables include asthma symptom-free days, caretaker asthma-related quality
      of life, and urgent health care utilization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Asthma symptom free days
time frame: last 14 days
description: 14 - During the past 14 days (that is, during the past fourteen 24 hour periods that include daytime and nighttime), on how many DAYS did your child have any asthma symptoms, such as wheezing, coughing, tightness in the chest, shortness of breath, waking up at night because of asthma symptoms, or slowing down of usual activities because of asthma?
measure: Caretaker quality of life
time frame: last week
description: Juniper Mini Asthma Quality of Life Questionnaire
measure: Health care utilization for asthma
time frame: 12 months
description: number of unscheduled clinic visits+emergency department visits+hospitalization for asthma
measure: cost analysis
time frame: 12 months
description: costs associated with health care utilization for asthma
measure: nights with asthma symptoms
time frame: 14 days
description: During the nighttime in the past 14 nights, how many nights did your child wake up because of asthma symptoms such as wheezing, shortness of breath, or tightness in the chest, or cough?
measure: days with activity limitation due to asthma
time frame: 14 days
description: During the past 14 days, how many days did your child have to slow down or stop his/her play or usual activities or missed school because of asthma, wheezing or tightness in the chest, or cough.
measure: days used asthma rescue medicine
time frame: 14 days
description: During the past 14 days, about how many days did your child use asthma rescue medicine (sometimes called a quick relief medicine) such as albuterol, proventil, or ventolin?
measure: asthma episodes
time frame: 3 months
description: During the past three months, about how many asthma episodes did your child have?
measure: asthma control level
time frame: 14 days
description: (% with well controlled asthma and % with very poorly controlled asthma)
arm group label: CHW intervention
arm group type: Experimental
description: The CHW intervention is in-home education and support by a community health worker (CHW). At the first home visit, the CHW assesses the participant's knowledge and skills related to asthma self-management, current status of the child's asthma, and resources and support for asthma self-management using a baseline questionnaire. The CHW will inspect the home environment using an Environmental Home Checklist to identify environmental triggers that can cause asthma symptoms and affect asthma control. The CHW makes up to three follow-up visits and two telephone visits during the year the participant is in the study. Participants receive resources to help them control asthma: vacuum cleaner, dust covers for a pillow and mattress and a "green" cleaning kit with cleaning supplies.
arm group label: control
arm group type: No Intervention
description: The control group receives standard asthma care, as provided by a primary health care provider. When the intervention period is over, the control group receives one visit with a CHW and the resources provided to the intervention group participants.
intervention type: Behavioral
intervention name: CHW intervention
description: Home education and support for asthma self management
arm group label: CHW intervention
criteria: 
gender: All
minimum age: 3 Years
maximum age: 17 Years
healthy volunteers: No
citation: Campbell JD, Brooks M, Hosokawa P, Robinson J, Song L, Krieger J. Community Health Worker Home Visits for Medicaid-Enrolled Children With Asthma: Effects on Asthma Outcomes and Costs. Am J Public Health. 2015 Nov;105(11):2366-72. doi: 10.2105/AJPH.2015.302685. Epub 2015 Aug 13.
PMID: 26270287
responsible party type: Sponsor
mesh term: Asthma