<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/NCT02253433</url>
  </required_header>
  <id_info>
    <org_study_id>PCORI AS-1308-05887</org_study_id>
    <secondary_id>H-34115</secondary_id>
    <nct_id>NCT02253433</nct_id>
  </id_info>
  <brief_title>The Houston HIITBAC for African Americans</brief_title>
  <acronym>HIIT-BAC</acronym>
  <official_title>The Houston Home-Based Integrated Intervention Targeting Better Asthma Control (HIITBAC) for African Americans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Harris County Hospital District</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Houston Department of Health and Human Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Texas A&amp;M University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>UTHealth School of Public Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to improve the health of African-American adults who have poorly&#xD;
      controlled asthma. The study compares a home-based exposure reduction and asthma control&#xD;
      intervention to enhanced in-clinic care that includes a standard clinical appointment as well&#xD;
      as information from a detailed exposure history, asthma education, assessment for allergies,&#xD;
      and a customized asthma self-management plan developed using motivational interviewing. The&#xD;
      interventional group receives enhanced in-clinic care, as well as a customized home-based&#xD;
      environmental exposure assessment and multicomponent exposure reduction and asthma control&#xD;
      intervention (five home visits over approximately 12 months).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study hypothesis is that the addition of a holistic, home-based environmental exposure&#xD;
      reduction and asthma control intervention to enhanced in-clinic care will result in&#xD;
      statistically significant improvements in key measures of health and quality of life among&#xD;
      Houston-area African-American adults with poorly controlled asthma.&#xD;
&#xD;
      This is a pragmatic randomized controlled clinical trial that compares the effectiveness of a&#xD;
      customized, holistic, patient-centered, home-based environmental intervention for improving&#xD;
      asthma control (the &quot;intervention&quot;) with enhanced clinic-based care. Both arms receive&#xD;
      identical in-clinic care, including collected self-report information from detailed health&#xD;
      and exposure questionnaires, asthma education, assessment for allergies, and a customized&#xD;
      asthma self-management plan developed using motivational interviewing. The intent of the&#xD;
      study is to assess-real-life effectiveness of a home-based intervention in African-American&#xD;
      adults with poorly controlled asthma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2015</start_date>
  <completion_date type="Actual">January 26, 2018</completion_date>
  <primary_completion_date type="Actual">January 26, 2018</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Asthma Control Test (ACT) Score</measure>
    <time_frame>At baseline (enrollment) and exit (approximately 12 mo after enrollment)</time_frame>
    <description>Self report. The ACT is a validated 5-question scale assessing asthma control over the previous four weeks. Each question has five possible responses, from 1 (worst) to 5 (best). The total score ranges from 5 (worst control) to 25 (best control). In general, a total score of 19 or less suggests poor control.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Juniper Mini Asthma Quality of Life Questionnaire Score (MiniAQLQ)</measure>
    <time_frame>At baseline (enrollment) and exit (approximately 12 mo after enrollment)</time_frame>
    <description>Self report. A validated 15-item questionnaire, with each question having seven possible answers score from 1 (worst) to 7 (best). Minimum total score is 15 (worst asthma quality of life). Maximum total score is 105 (best asthma quality of life). By design, an individual's score is reported as the mean (total score/15). Thus the possible mean reported score ranges from 1 (worst asthma quality of life) to 7 (best asthma quality of life).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Emergency Department (ED) Visits for Asthma</measure>
    <time_frame>At baseline (enrollment) and exit (approximately 12 mo after enrollment)</time_frame>
    <description>Self report. The healthcare utilization questions were from the validated CDC-BRFSS Asthma Survey. For this outcome measure, we used patient responses to a question that asked &quot;During the past 12 months, how many times to you visit an emergency room of urgent care center because of your asthma?&quot;. We collected this information for the 12 months preceding their baseline and exit clinic visits. A higher number of visits suggests poorer asthma control.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">264</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Enhanced Clinic Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm receives enhanced in-clinic care only.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Clinic Care + Home Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm receives the enhanced in-clinic care intervention, as well as a home-based intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enhanced Clinic Care</intervention_name>
    <description>The intervention includes a standard clinical appointment including spirometry, as well as collection of self-report information from detailed health and exposure questionnaires, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.</description>
    <arm_group_label>Enhanced Clinic Care</arm_group_label>
    <arm_group_label>Enhanced Clinic Care + Home Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enhanced Clinic Care + Home Intervention</intervention_name>
    <description>The home-based component includes environmental exposure assessment (observed and measured) and a multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).</description>
    <arm_group_label>Enhanced Clinic Care + Home Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA:&#xD;
&#xD;
          -  African-American&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Diagnosis of poorly controlled asthma*&#xD;
&#xD;
          -  Fixed address within Harris County, Texas, with no intention of moving within the&#xD;
             following 12 months&#xD;
&#xD;
          -  Working telephone number&#xD;
&#xD;
          -  Verbally fluent in English&#xD;
&#xD;
               -  Poorly controlled asthma was defined as (1) diagnosed by a physician as having&#xD;
                  asthma in the past and currently has asthma, and (2) fulfills one or more of the&#xD;
                  following criteria: (a) one or more emergency department (ED), urgent care visits&#xD;
                  or hospitalizations for asthma in the preceding year; (b) meets the definition of&#xD;
                  &quot;very poorly controlled&quot; asthma as defined by the National Asthma Education and&#xD;
                  Prevention Program, Third Expert Panel on the Diagnosis and Management of Asthma&#xD;
                  (definition includes daily asthma symptoms, nighttime awakenings two or more&#xD;
                  times per week, extremely limited normal activity, and/or daily use of a&#xD;
                  short-acting beta agonist for symptom control); and/or (c) an Asthma Control Test&#xD;
                  score of 19 or lower.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  Severe co-morbid conditions-such as a poorly controlled psychiatric illness or a&#xD;
             condition requiring intense medical treatment that could reasonably be expected to (1)&#xD;
             confound the effects of this study's intervention, (2) make it unlikely that a&#xD;
             participant could follow the treatment plan, or (3) pose a safety issue for the&#xD;
             home-visit team.&#xD;
&#xD;
          -  A concurrent pulmonary study that could reasonably be expected to confound the effects&#xD;
             of the intervention.&#xD;
&#xD;
          -  Living in a group living facility, such as a nursing home.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Winifred J Hamilton, PhD, SM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Harris Health Smith Clinic</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <results_first_submitted>May 31, 2018</results_first_submitted>
  <results_first_submitted_qc>November 9, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 14, 2018</results_first_posted>
  <last_update_submitted>November 9, 2018</last_update_submitted>
  <last_update_submitted_qc>November 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Winifred J. Hamilton, PhD</investigator_full_name>
    <investigator_title>Director, Environmental Health Service</investigator_title>
  </responsible_party>
  <keyword>asthma</keyword>
  <keyword>environmental triggers</keyword>
  <keyword>home-based intervention</keyword>
  <keyword>asthma home visits</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Participants receive their individual laboratory, exposure and other data, as well as their customized asthma control plan, to help them manage their asthma. This information is delivered to participants at clinic and/or at home visits as appropriate. Laboratory results may be mailed as well. Aggregate data were made available to participants at a regional Town Hall 5/1/2018 and by mail as requested at exit by participants. Aggregate and/or de-identified data were and are being made available to the Patient / Stakeholder Advisory Board and to researchers through presentations, websites, publications and data sharing arrangements. No identifiable IDP will be made available to other researchers except through consent of the participant and IRB approval.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>The study protocol and ICF have been shared and are available on request. At the aggregate level, the initial findings of the pragmatic clinical trial were made available to our Patient/Stakeholder Advisory Panel at the February 12, 2018 meeting of the panel; at a regional Town Hall on asthma on May 1, 2018; and to participants who requested results by mail in November 2018. The Draft Final Research Report was submitted to PCORI in September 2018 and is undergoing external peer review. Two manuscripts--on methods and initial results--are being finalized for journal submission. The SAP and analytic code are currently undergoing refinement as we begin our secondary analyses and should be available in 2019.</ipd_time_frame>
    <ipd_access_criteria>Access criteria are based on protection of individual participant data as described in the protocol and ICF. Aggregate and de-identified data will be made available electronically, in the Rice University Kinder Urban Data Base Platform, and in presentations and manuscripts.</ipd_access_criteria>
    <ipd_url>https://www.bcm.edu/environmentalhealth</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 21, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT02253433/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 20, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT02253433/ICF_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT02253433/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Enhanced Clinic Care</title>
          <description>This arm will receive enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.</description>
        </group>
        <group group_id="P2">
          <title>Enhanced Clinic Care + Home Intervention</title>
          <description>This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).&#xD;
Enhanced in-clinic care and intervention: This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="130"/>
                <participants group_id="P2" count="134"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="114"/>
                <participants group_id="P2" count="79"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Unable to Contact</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No Longer Interested</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Out of Study Area</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Uncomfortable with home visitors</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unstable Housing/Homeless</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Too Busy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Medical or Other Concerns</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Enhanced Clinic Care</title>
          <description>This arm will receive enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.</description>
        </group>
        <group group_id="B2">
          <title>Enhanced Clinic Care + Home Intervention</title>
          <description>This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).&#xD;
Enhanced in-clinic care and intervention: This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="130"/>
            <count group_id="B2" value="134"/>
            <count group_id="B3" value="264"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="130"/>
                    <count group_id="B2" value="134"/>
                    <count group_id="B3" value="264"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="117"/>
                    <measurement group_id="B2" value="118"/>
                    <measurement group_id="B3" value="235"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="130"/>
                    <count group_id="B2" value="134"/>
                    <count group_id="B3" value="264"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.4" spread="12.7"/>
                    <measurement group_id="B2" value="51.0" spread="13.3"/>
                    <measurement group_id="B3" value="50.2" spread="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="130"/>
                    <count group_id="B2" value="134"/>
                    <count group_id="B3" value="264"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="196"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="130"/>
                    <count group_id="B2" value="134"/>
                    <count group_id="B3" value="264"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="130"/>
                    <measurement group_id="B2" value="134"/>
                    <measurement group_id="B3" value="264"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="130"/>
                    <count group_id="B2" value="134"/>
                    <count group_id="B3" value="264"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="130"/>
                    <measurement group_id="B2" value="134"/>
                    <measurement group_id="B3" value="264"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Asthma Control Test (ACT)</title>
          <description>The ACT is a validated 5-question scale assessing asthma control over the previous four weeks. Each question has five possible responses, from 1 (worst) to 5 (best). The total score ranges from 5 (worst control) to 25 (best control). In general, a total score of 19 or less suggests poor control.</description>
          <population>One participant consented and withdrew before any baseline characteristics (aside from age, gender and race) were collected. A second participant chose not to answer all five questions.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="129"/>
                    <count group_id="B2" value="133"/>
                    <count group_id="B3" value="262"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.5" spread="4.3"/>
                    <measurement group_id="B2" value="12.5" spread="4.2"/>
                    <measurement group_id="B3" value="12.5" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Juniper Mini Asthma Quality of Life Questionnaire</title>
          <description>Self report. A validated 15-item questionnaire, with each question having seven possible answers score from 1 (worst) to 7 (best). Minimum total score is 15 (worst asthma quality of life). Maximum total score is 105 (best asthma quality of life). By design, an individual's score is reported as the mean (total score/15). Thus the possible mean reported score ranges from 1 (worst asthma quality of life) to 7 (best asthma quality of life).</description>
          <population>In the enhanced clinical care (&quot;control&quot;) group, one person withdrew immediately after consent, and two individuals chose not to answer one of the 15 questions. In the home-visit (&quot;intervention&quot;) group, three individuals chose not to answer one question. Interpolation (inserted worst answer) was used in some of the analyses.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="127"/>
                    <count group_id="B2" value="131"/>
                    <count group_id="B3" value="258"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.3" spread="1.2"/>
                    <measurement group_id="B2" value="3.2" spread="1.1"/>
                    <measurement group_id="B3" value="3.2" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <description>Measured at clinic. BMI = weight (kilograms) divided by height (meters) squared. It is an estimate of body fat in adults. 30 and higher = obese.</description>
          <population>One person withdrew immediately after consent.</population>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="129"/>
                    <count group_id="B2" value="134"/>
                    <count group_id="B3" value="263"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.0" spread="10.6"/>
                    <measurement group_id="B2" value="34.4" spread="10.1"/>
                    <measurement group_id="B3" value="35.2" spread="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Immunoglobulin E (Total IgE)</title>
          <description>Total IgE is a measure of the immunoglobulin E antibody in the blood, and an estimate of allergic status. The laboratory lowest level of detection was 18 kU/L. Guidelines vary and must be assessed in conjunction with clinical presentation and allergen-specific testing, but for this population we consider a Total IgE &gt; 100 kU/L to be of clinical relevance.</description>
          <population>One participant withdrew immediately after consent, permission for a blood draw was not given by two patients, and blood could not be obtained or was insufficient for analysis in four patients.</population>
          <units>kU/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="127"/>
                    <count group_id="B2" value="131"/>
                    <count group_id="B3" value="258"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="550.5" spread="1479.8"/>
                    <measurement group_id="B2" value="643.2" spread="1217.6"/>
                    <measurement group_id="B3" value="597.6" spread="1351.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Asthma Control Test (ACT) Score</title>
        <description>Self report. The ACT is a validated 5-question scale assessing asthma control over the previous four weeks. Each question has five possible responses, from 1 (worst) to 5 (best). The total score ranges from 5 (worst control) to 25 (best control). In general, a total score of 19 or less suggests poor control.</description>
        <time_frame>At baseline (enrollment) and exit (approximately 12 mo after enrollment)</time_frame>
        <population>At baseline, one individual in each group chose not to answer all five ACT questions; therefore a total ACT score could not be calculated for those two individuals (missing data are addressed in the analyses). At exit, among those who completed the study, one person in the enhanced in-clinic group chose not to answer all five ACT questions.</population>
        <group_list>
          <group group_id="O1">
            <title>Enhanced Clinic Care</title>
            <description>This arm will receive enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Clinic Care + Home Intervention</title>
            <description>This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).&#xD;
Enhanced in-clinic care and intervention: This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Asthma Control Test (ACT) Score</title>
          <description>Self report. The ACT is a validated 5-question scale assessing asthma control over the previous four weeks. Each question has five possible responses, from 1 (worst) to 5 (best). The total score ranges from 5 (worst control) to 25 (best control). In general, a total score of 19 or less suggests poor control.</description>
          <population>At baseline, one individual in each group chose not to answer all five ACT questions; therefore a total ACT score could not be calculated for those two individuals (missing data are addressed in the analyses). At exit, among those who completed the study, one person in the enhanced in-clinic group chose not to answer all five ACT questions.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                    <count group_id="O2" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" spread="4.3"/>
                    <measurement group_id="O2" value="12.5" spread="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Exit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="113"/>
                    <count group_id="O2" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.2" spread="5.1"/>
                    <measurement group_id="O2" value="16.8" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.575</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-.87</ci_lower_limit>
            <ci_upper_limit>2.07</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Juniper Mini Asthma Quality of Life Questionnaire Score (MiniAQLQ)</title>
        <description>Self report. A validated 15-item questionnaire, with each question having seven possible answers score from 1 (worst) to 7 (best). Minimum total score is 15 (worst asthma quality of life). Maximum total score is 105 (best asthma quality of life). By design, an individual's score is reported as the mean (total score/15). Thus the possible mean reported score ranges from 1 (worst asthma quality of life) to 7 (best asthma quality of life).</description>
        <time_frame>At baseline (enrollment) and exit (approximately 12 mo after enrollment)</time_frame>
        <population>Among the enhanced in-clinic care group, one person withdrew immediately after consent and two individuals chose not to fill out all of the answers, such that a score could not be computer. At exit, 3 control and 1 intervention were missing (1) or incomplete (3).</population>
        <group_list>
          <group group_id="O1">
            <title>Enhanced Clinic Care</title>
            <description>This arm will receive enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Clinic Care + Home Intervention</title>
            <description>This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).&#xD;
Enhanced in-clinic care and intervention: This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Juniper Mini Asthma Quality of Life Questionnaire Score (MiniAQLQ)</title>
          <description>Self report. A validated 15-item questionnaire, with each question having seven possible answers score from 1 (worst) to 7 (best). Minimum total score is 15 (worst asthma quality of life). Maximum total score is 105 (best asthma quality of life). By design, an individual's score is reported as the mean (total score/15). Thus the possible mean reported score ranges from 1 (worst asthma quality of life) to 7 (best asthma quality of life).</description>
          <population>Among the enhanced in-clinic care group, one person withdrew immediately after consent and two individuals chose not to fill out all of the answers, such that a score could not be computer. At exit, 3 control and 1 intervention were missing (1) or incomplete (3).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="127"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="1.2"/>
                    <measurement group_id="O2" value="3.2" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Exit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="1.5"/>
                    <measurement group_id="O2" value="4.5" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.141</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-.18</ci_lower_limit>
            <ci_upper_limit>.68</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Emergency Department (ED) Visits for Asthma</title>
        <description>Self report. The healthcare utilization questions were from the validated CDC-BRFSS Asthma Survey. For this outcome measure, we used patient responses to a question that asked &quot;During the past 12 months, how many times to you visit an emergency room of urgent care center because of your asthma?&quot;. We collected this information for the 12 months preceding their baseline and exit clinic visits. A higher number of visits suggests poorer asthma control.</description>
        <time_frame>At baseline (enrollment) and exit (approximately 12 mo after enrollment)</time_frame>
        <population>One patient from the enhanced in-clinic only group withdrew immediately after consenting.114 &quot;control&quot; and 79 &quot;intervention&quot; completed the study. Respondent number less than enrollment and/or exit numbers reflects individuals who chose not to respond to the question.</population>
        <group_list>
          <group group_id="O1">
            <title>Enhanced Clinic Care</title>
            <description>This arm will receive enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Clinic Care + Intervention</title>
            <description>This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).&#xD;
Enhanced in-clinic care and intervention: This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Emergency Department (ED) Visits for Asthma</title>
          <description>Self report. The healthcare utilization questions were from the validated CDC-BRFSS Asthma Survey. For this outcome measure, we used patient responses to a question that asked &quot;During the past 12 months, how many times to you visit an emergency room of urgent care center because of your asthma?&quot;. We collected this information for the 12 months preceding their baseline and exit clinic visits. A higher number of visits suggests poorer asthma control.</description>
          <population>One patient from the enhanced in-clinic only group withdrew immediately after consenting.114 &quot;control&quot; and 79 &quot;intervention&quot; completed the study. Respondent number less than enrollment and/or exit numbers reflects individuals who chose not to respond to the question.</population>
          <units>visits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="3.5"/>
                    <measurement group_id="O2" value="2.6" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Exit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="78"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="2.4"/>
                    <measurement group_id="O2" value="1.1" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.043</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>ED visits over the previous 12 months were positively skewed (skewness 2.95; kurtosis 14.1); the responses were dichotomized (0 vs. 1 or more).</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>.47</ci_lower_limit>
            <ci_upper_limit>1.57</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Enhanced Clinic Care</title>
          <description>This arm will receive enhanced in-clinic care that includes a standard clinical appointment as well as information from a detailed exposure history, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.</description>
        </group>
        <group group_id="E2">
          <title>Enhanced Clinic Care + Home Intervention</title>
          <description>This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).&#xD;
Enhanced in-clinic care and intervention: This arm receives enhanced in-clinic care, as well as a customized home-based environmental exposure assessment and multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Limitations included (1) lack of a control group (the enhanced clinic visit = a robust intervention), (2) mobility of the participants, (3) disproportionate lost to follow-up, (4) missing data, (5) out-of-window encounters, and (6) Hurricane Harvey.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Winifred J. Hamilton</name_or_title>
      <organization>Environmental Health, Baylor College of Medicine</organization>
      <phone>713-798-1052</phone>
      <email>hamilton@bcm.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02253433
org study id: PCORI AS-1308-05887
secondary id: H-34115
nct id: NCT02253433
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to improve the health of African-American adults who have poorly
      controlled asthma. The study compares a home-based exposure reduction and asthma control
      intervention to enhanced in-clinic care that includes a standard clinical appointment as well
      as information from a detailed exposure history, asthma education, assessment for allergies,
      and a customized asthma self-management plan developed using motivational interviewing. The
      interventional group receives enhanced in-clinic care, as well as a customized home-based
      environmental exposure assessment and multicomponent exposure reduction and asthma control
      intervention (five home visits over approximately 12 months).
The study hypothesis is that the addition of a holistic, home-based environmental exposure
      reduction and asthma control intervention to enhanced in-clinic care will result in
      statistically significant improvements in key measures of health and quality of life among
      Houston-area African-American adults with poorly controlled asthma.

      This is a pragmatic randomized controlled clinical trial that compares the effectiveness of a
      customized, holistic, patient-centered, home-based environmental intervention for improving
      asthma control (the "intervention") with enhanced clinic-based care. Both arms receive
      identical in-clinic care, including collected self-report information from detailed health
      and exposure questionnaires, asthma education, assessment for allergies, and a customized
      asthma self-management plan developed using motivational interviewing. The intent of the
      study is to assess-real-life effectiveness of a home-based intervention in African-American
      adults with poorly controlled asthma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Asthma Control Test (ACT) Score
time frame: At baseline (enrollment) and exit (approximately 12 mo after enrollment)
description: Self report. The ACT is a validated 5-question scale assessing asthma control over the previous four weeks. Each question has five possible responses, from 1 (worst) to 5 (best). The total score ranges from 5 (worst control) to 25 (best control). In general, a total score of 19 or less suggests poor control.
measure: Change in Juniper Mini Asthma Quality of Life Questionnaire Score (MiniAQLQ)
time frame: At baseline (enrollment) and exit (approximately 12 mo after enrollment)
description: Self report. A validated 15-item questionnaire, with each question having seven possible answers score from 1 (worst) to 7 (best). Minimum total score is 15 (worst asthma quality of life). Maximum total score is 105 (best asthma quality of life). By design, an individual's score is reported as the mean (total score/15). Thus the possible mean reported score ranges from 1 (worst asthma quality of life) to 7 (best asthma quality of life).
measure: Change in Emergency Department (ED) Visits for Asthma
time frame: At baseline (enrollment) and exit (approximately 12 mo after enrollment)
description: Self report. The healthcare utilization questions were from the validated CDC-BRFSS Asthma Survey. For this outcome measure, we used patient responses to a question that asked "During the past 12 months, how many times to you visit an emergency room of urgent care center because of your asthma?". We collected this information for the 12 months preceding their baseline and exit clinic visits. A higher number of visits suggests poorer asthma control.
arm group label: Enhanced Clinic Care
arm group type: Experimental
description: This arm receives enhanced in-clinic care only.
arm group label: Enhanced Clinic Care + Home Intervention
arm group type: Experimental
description: This arm receives the enhanced in-clinic care intervention, as well as a home-based intervention.
intervention type: Other
intervention name: Enhanced Clinic Care
description: The intervention includes a standard clinical appointment including spirometry, as well as collection of self-report information from detailed health and exposure questionnaires, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.
arm group label: Enhanced Clinic Care
arm group label: Enhanced Clinic Care + Home Intervention
intervention type: Other
intervention name: Enhanced Clinic Care + Home Intervention
description: The home-based component includes environmental exposure assessment (observed and measured) and a multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).
arm group label: Enhanced Clinic Care + Home Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Winifred J Hamilton, PhD, SM
role: Principal Investigator
affiliation: Baylor College of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Winifred J. Hamilton, PhD
investigator title: Director, Environmental Health Service
mesh term: Asthma
sharing ipd: Yes
ipd description: Participants receive their individual laboratory, exposure and other data, as well as their customized asthma control plan, to help them manage their asthma. This information is delivered to participants at clinic and/or at home visits as appropriate. Laboratory results may be mailed as well. Aggregate data were made available to participants at a regional Town Hall 5/1/2018 and by mail as requested at exit by participants. Aggregate and/or de-identified data were and are being made available to the Patient / Stakeholder Advisory Board and to researchers through presentations, websites, publications and data sharing arrangements. No identifiable IDP will be made available to other researchers except through consent of the participant and IRB approval.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: The study protocol and ICF have been shared and are available on request. At the aggregate level, the initial findings of the pragmatic clinical trial were made available to our Patient/Stakeholder Advisory Panel at the February 12, 2018 meeting of the panel; at a regional Town Hall on asthma on May 1, 2018; and to participants who requested results by mail in November 2018. The Draft Final Research Report was submitted to PCORI in September 2018 and is undergoing external peer review. Two manuscripts--on methods and initial results--are being finalized for journal submission. The SAP and analytic code are currently undergoing refinement as we begin our secondary analyses and should be available in 2019.
ipd access criteria: Access criteria are based on protection of individual participant data as described in the protocol and ICF. Aggregate and de-identified data will be made available electronically, in the Rice University Kinder Urban Data Base Platform, and in presentations and manuscripts.
ipd url: https://www.bcm.edu/environmentalhealth
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Limitations included (1) lack of a control group (the enhanced clinic visit = a robust intervention), (2) mobility of the participants, (3) disproportionate lost to follow-up, (4) missing data, (5) out-of-window encounters, and (6) Hurricane Harvey.
point of contact: 