<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/NCT03300752</url>
  </required_header>
  <id_info>
    <org_study_id>AAAR5216</org_study_id>
    <nct_id>NCT03300752</nct_id>
  </id_info>
  <brief_title>Validation of the BREATHE Asthma Intervention Trial</brief_title>
  <official_title>Self-care Decision-making: Feasibility of the BREATHE Asthma Intervention Trial - Phase II (Part 2 - a Pilot Randomized Trial Phase)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goal of this study to preliminarily validate a novel intervention delivered by&#xD;
      primary care providers (PCPs) to their Black adult patients with uncontrolled asthma in&#xD;
      federally qualified health centers (FQHCs).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nearly every asthma related hospitalization and death could be prevented with appropriate&#xD;
      self-management that achieves and maintains disease control. However, as many as 64% of&#xD;
      adults have uncontrolled asthma; minorities are disproportionately represented within that&#xD;
      population. While inhaled corticosteroids (ICS) are a safe and effective treatment for&#xD;
      uncontrolled asthma, relative to Whites, Blacks have lower rates of ICS adherence.&#xD;
&#xD;
      Black adults with uncontrolled asthma experience profound health disparities. Despite data&#xD;
      that point to the critical need for enhanced asthma self-management, rates of controlled&#xD;
      asthma are well below Healthy People 2020 targets, particularly among vulnerable populations.&#xD;
      This Brief Evaluation of Asthma Therapy (BREATHE) intervention has the potential to offer a&#xD;
      new avenue to asthma control via shared decision-making that supports ICS adherence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">May 30, 2019</completion_date>
  <primary_completion_date type="Actual">May 29, 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Asthma Control Questionnaire (ACQ) Score</measure>
    <time_frame>Baseline, 1 Month, 2 Months, 3 Months (post-intervention)</time_frame>
    <description>Full title: Asthma Control Questionnaire Construct measured: self-reported asthma control Scoring: 0 points = total asthma control/ best outcome, 6 points = completely uncontrolled asthma/ worst outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Asthma Quality of Life Questionnaire (AQLQ) Score</measure>
    <time_frame>Baseline, 1 Month, 2 Months, 3 Months (post-intervention)</time_frame>
    <description>Full title: Asthma Quality of Life Questionnaire Construct: quality of life for patients with asthma Scoring: 32 items, each scored 1-7. The total score is calculated as a mean of all 32 items (1= low quality of life/ worse outcome, 7= high quality of life/ best outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Adherence Record Scale-Asthma (MARS-A) Score</measure>
    <time_frame>Baseline, 1 Month, 2 Months, 3 Months (post-intervention)</time_frame>
    <description>Full title: Medication Adherence Record Scale- Asthma Construct: Adherence to inhaled corticosteroid medications Scoring: Total score is calculated as a mean of the 10 items, scores range from 1-5 (1= low adherence/ worse outcome, 5= high adherence/ best outcome)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>BREATHE Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patient's primary care provider (PCP) will deliver the active intervention (shared decision-making discussion of asthma control status and treatment) - BREATHE Intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patient's primary care provider (PCP) will deliver the control intervention (discussion of healthy lifestyles).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>BREATHE Intervention</intervention_name>
    <description>PCPs randomized to BREATHE will receive the tablet which, when the screen is advanced by the PCP, will prompt the PCP through a 7-minute, 4-step brief intervention tailored to respond to the patient's specific beliefs, and shared decision-making discussion of asthma control status and treatment.</description>
    <arm_group_label>BREATHE Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control Intervention</intervention_name>
    <description>PCP will provide discussion of healthy lifestyles.</description>
    <arm_group_label>Control Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        PROVIDER RECRUITMENT&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  PCPs (MDs and Nurse Practitioners (NPs)/Physician Assistants (PAs)) working in family,&#xD;
             primary or internal medicine care services&#xD;
&#xD;
          -  Who have at least 40 adult patients with persistent asthma (defined as having been&#xD;
             prescribed ICS) on their patient panel&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PCPs whose primary focus is outside of adult health services (family, primary or&#xD;
             internal medicine), such as behavioral health, pediatrics and Obstetrics and&#xD;
             Gynaecology (OB-GYN)&#xD;
&#xD;
        PATIENT RECRUITMENT&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        Patients must be&#xD;
&#xD;
          1. adults (&gt; or = 18 years of age) who self-report race as Black or African American&#xD;
&#xD;
          2. with PCP-diagnosed persistent asthma&#xD;
&#xD;
          3. prescribed ICS&#xD;
&#xD;
          4. receiving asthma care at participating FQHCs&#xD;
&#xD;
          5. who have uncontrolled asthma&#xD;
&#xD;
          6. have erroneous personal health and/or negative ICS beliefs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. participation in Phase 1 (Part 1) of the BREATHE trial (focus groups)&#xD;
&#xD;
          2. non-English speaking&#xD;
&#xD;
          3. serious mental health conditions (e.g., psychosis) that preclude completion of study&#xD;
             procedures or confound analyses&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maureen George, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor of Nursing at Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>George M, Pantalon MV, Sommers MLS, Glanz K, Jia H, Chung A, Norful AA, Poghosyan L, Coleman D, Bruzzese JM. Shared decision-making in the BREATHE asthma intervention trial: A research protocol. J Adv Nurs. 2019 Apr;75(4):876-887. doi: 10.1111/jan.13916. Epub 2019 Jan 24.</citation>
    <PMID>30479020</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <results_first_submitted>June 9, 2021</results_first_submitted>
  <results_first_submitted_qc>September 1, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 28, 2021</results_first_posted>
  <last_update_submitted>September 1, 2021</last_update_submitted>
  <last_update_submitted_qc>September 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Maureen George</investigator_full_name>
    <investigator_title>Associate Professor of Nursing at the Columbia University Medical Center, Nursing Scholarship &amp; Research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT03300752/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>BREATHE Intervention</title>
          <description>The patient's primary care provider (PCP) will deliver the active intervention (shared decision-making discussion of asthma control status and treatment) - BREATHE Intervention.&#xD;
BREATHE Intervention: PCPs randomized to BREATHE will receive the tablet which, when the screen is advanced by the PCP, will prompt the PCP through a 7-minute, 4-step brief intervention tailored to respond to the patient's specific beliefs, and shared decision-making discussion of asthma control status and treatment.</description>
        </group>
        <group group_id="P2">
          <title>Control Intervention</title>
          <description>The patient's primary care provider (PCP) will deliver the control intervention (discussion of healthy lifestyles).&#xD;
Control Intervention: PCP will provide discussion of healthy lifestyles.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>BREATHE Intervention</title>
          <description>The patient's primary care provider (PCP) will deliver the active intervention (shared decision-making discussion of asthma control status and treatment) - BREATHE Intervention.&#xD;
BREATHE Intervention: PCPs randomized to BREATHE will receive the tablet which, when the screen is advanced by the PCP, will prompt the PCP through a 7-minute, 4-step brief intervention tailored to respond to the patient's specific beliefs, and shared decision-making discussion of asthma control status and treatment.</description>
        </group>
        <group group_id="B2">
          <title>Control Intervention</title>
          <description>The patient's primary care provider (PCP) will deliver the control intervention (discussion of healthy lifestyles).&#xD;
Control Intervention: PCP will provide discussion of healthy lifestyles.</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="40"/>
            <count group_id="B2" value="40"/>
            <count group_id="B3" value="80"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.35" spread="12.80"/>
                    <measurement group_id="B2" value="42.9" spread="13.06"/>
                    <measurement group_id="B3" value="45.1" spread="13.1"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="14"/>
                  </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>
              <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="38"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="73"/>
                  </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="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Asthma Control Questionnaire (ACQ) Score</title>
        <description>Full title: Asthma Control Questionnaire Construct measured: self-reported asthma control Scoring: 0 points = total asthma control/ best outcome, 6 points = completely uncontrolled asthma/ worst outcome</description>
        <time_frame>Baseline, 1 Month, 2 Months, 3 Months (post-intervention)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>BREATHE Intervention</title>
            <description>The patient's primary care provider (PCP) will deliver the active intervention (shared decision-making discussion of asthma control status and treatment) - BREATHE Intervention.&#xD;
BREATHE Intervention: PCPs randomized to BREATHE will receive the tablet which, when the screen is advanced by the PCP, will prompt the PCP through a 7-minute, 4-step brief intervention tailored to respond to the patient's specific beliefs, and shared decision-making discussion of asthma control status and treatment.</description>
          </group>
          <group group_id="O2">
            <title>Control Intervention</title>
            <description>The patient's primary care provider (PCP) will deliver the control intervention (discussion of healthy lifestyles).&#xD;
Control Intervention: PCP will provide discussion of healthy lifestyles.</description>
          </group>
        </group_list>
        <measure>
          <title>Asthma Control Questionnaire (ACQ) Score</title>
          <description>Full title: Asthma Control Questionnaire Construct measured: self-reported asthma control Scoring: 0 points = total asthma control/ best outcome, 6 points = completely uncontrolled asthma/ worst outcome</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.94" spread="0.15"/>
                    <measurement group_id="O2" value="2.63" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-month post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.17" spread="0.17"/>
                    <measurement group_id="O2" value="2.16" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2-month post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.22" spread="0.16"/>
                    <measurement group_id="O2" value="2.35" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-month post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.40" spread="0.15"/>
                    <measurement group_id="O2" value="2.24" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Asthma Quality of Life Questionnaire (AQLQ) Score</title>
        <description>Full title: Asthma Quality of Life Questionnaire Construct: quality of life for patients with asthma Scoring: 32 items, each scored 1-7. The total score is calculated as a mean of all 32 items (1= low quality of life/ worse outcome, 7= high quality of life/ best outcome)</description>
        <time_frame>Baseline, 1 Month, 2 Months, 3 Months (post-intervention)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>BREATHE Intervention</title>
            <description>The patient's primary care provider (PCP) will deliver the active intervention (shared decision-making discussion of asthma control status and treatment) - BREATHE Intervention.&#xD;
BREATHE Intervention: PCPs randomized to BREATHE will receive the tablet which, when the screen is advanced by the PCP, will prompt the PCP through a 7-minute, 4-step brief intervention tailored to respond to the patient's specific beliefs, and shared decision-making discussion of asthma control status and treatment.</description>
          </group>
          <group group_id="O2">
            <title>Control Intervention</title>
            <description>The patient's primary care provider (PCP) will deliver the control intervention (discussion of healthy lifestyles).&#xD;
Control Intervention: PCP will provide discussion of healthy lifestyles.</description>
          </group>
        </group_list>
        <measure>
          <title>Asthma Quality of Life Questionnaire (AQLQ) Score</title>
          <description>Full title: Asthma Quality of Life Questionnaire Construct: quality of life for patients with asthma Scoring: 32 items, each scored 1-7. The total score is calculated as a mean of all 32 items (1= low quality of life/ worse outcome, 7= high quality of life/ best outcome)</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.50" spread="0.18"/>
                    <measurement group_id="O2" value="3.65" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-month post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.03" spread="0.20"/>
                    <measurement group_id="O2" value="4.07" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2-month post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.97" spread="0.19"/>
                    <measurement group_id="O2" value="4.18" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-month post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.02" spread="0.18"/>
                    <measurement group_id="O2" value="4.22" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Medication Adherence Record Scale-Asthma (MARS-A) Score</title>
        <description>Full title: Medication Adherence Record Scale- Asthma Construct: Adherence to inhaled corticosteroid medications Scoring: Total score is calculated as a mean of the 10 items, scores range from 1-5 (1= low adherence/ worse outcome, 5= high adherence/ best outcome)</description>
        <time_frame>Baseline, 1 Month, 2 Months, 3 Months (post-intervention)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>BREATHE Intervention</title>
            <description>The patient's primary care provider (PCP) will deliver the active intervention (shared decision-making discussion of asthma control status and treatment) - BREATHE Intervention.&#xD;
BREATHE Intervention: PCPs randomized to BREATHE will receive the tablet which, when the screen is advanced by the PCP, will prompt the PCP through a 7-minute, 4-step brief intervention tailored to respond to the patient's specific beliefs, and shared decision-making discussion of asthma control status and treatment.</description>
          </group>
          <group group_id="O2">
            <title>Control Intervention</title>
            <description>The patient's primary care provider (PCP) will deliver the control intervention (discussion of healthy lifestyles).&#xD;
Control Intervention: PCP will provide discussion of healthy lifestyles.</description>
          </group>
        </group_list>
        <measure>
          <title>Medication Adherence Record Scale-Asthma (MARS-A) Score</title>
          <description>Full title: Medication Adherence Record Scale- Asthma Construct: Adherence to inhaled corticosteroid medications Scoring: Total score is calculated as a mean of the 10 items, scores range from 1-5 (1= low adherence/ worse outcome, 5= high adherence/ best outcome)</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.95" spread="0.12"/>
                    <measurement group_id="O2" value="3.88" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-month post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.07" spread="0.13"/>
                    <measurement group_id="O2" value="4.12" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2- month post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.28" spread="0.12"/>
                    <measurement group_id="O2" value="4.18" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-month post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.08" spread="0.12"/>
                    <measurement group_id="O2" value="4.03" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 3 months post-intervention</time_frame>
      <group_list>
        <group group_id="E1">
          <title>BREATHE Intervention</title>
          <description>The patient's primary care provider (PCP) will deliver the active intervention (shared decision-making discussion of asthma control status and treatment) - BREATHE Intervention.&#xD;
BREATHE Intervention: PCPs randomized to BREATHE will receive the tablet which, when the screen is advanced by the PCP, will prompt the PCP through a 7-minute, 4-step brief intervention tailored to respond to the patient's specific beliefs, and shared decision-making discussion of asthma control status and treatment.</description>
        </group>
        <group group_id="E2">
          <title>Control Intervention</title>
          <description>The patient's primary care provider (PCP) will deliver the control intervention (discussion of healthy lifestyles).&#xD;
Control Intervention: PCP will provide discussion of healthy lifestyles.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>presumed myocardial infarction</sub_title>
                <description>The participant experienced a sudden unexplained death at home. The family reported that the participant's clinician attributed it as likely &quot;a heart attack'</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>emergency department visit</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
              </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>
    <point_of_contact>
      <name_or_title>Dr. Maureen George</name_or_title>
      <organization>Columbia University School of Nursing</organization>
      <phone>2123051175</phone>
      <email>mg3656@cumc.columbia.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/NCT03300752
org study id: AAAR5216
nct id: NCT03300752
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The overall goal of this study to preliminarily validate a novel intervention delivered by
      primary care providers (PCPs) to their Black adult patients with uncontrolled asthma in
      federally qualified health centers (FQHCs).
Nearly every asthma related hospitalization and death could be prevented with appropriate
      self-management that achieves and maintains disease control. However, as many as 64% of
      adults have uncontrolled asthma; minorities are disproportionately represented within that
      population. While inhaled corticosteroids (ICS) are a safe and effective treatment for
      uncontrolled asthma, relative to Whites, Blacks have lower rates of ICS adherence.

      Black adults with uncontrolled asthma experience profound health disparities. Despite data
      that point to the critical need for enhanced asthma self-management, rates of controlled
      asthma are well below Healthy People 2020 targets, particularly among vulnerable populations.
      This Brief Evaluation of Asthma Therapy (BREATHE) intervention has the potential to offer a
      new avenue to asthma control via shared decision-making that supports ICS adherence.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Asthma Control Questionnaire (ACQ) Score
time frame: Baseline, 1 Month, 2 Months, 3 Months (post-intervention)
description: Full title: Asthma Control Questionnaire Construct measured: self-reported asthma control Scoring: 0 points = total asthma control/ best outcome, 6 points = completely uncontrolled asthma/ worst outcome
measure: Asthma Quality of Life Questionnaire (AQLQ) Score
time frame: Baseline, 1 Month, 2 Months, 3 Months (post-intervention)
description: Full title: Asthma Quality of Life Questionnaire Construct: quality of life for patients with asthma Scoring: 32 items, each scored 1-7. The total score is calculated as a mean of all 32 items (1= low quality of life/ worse outcome, 7= high quality of life/ best outcome)
measure: Medication Adherence Record Scale-Asthma (MARS-A) Score
time frame: Baseline, 1 Month, 2 Months, 3 Months (post-intervention)
description: Full title: Medication Adherence Record Scale- Asthma Construct: Adherence to inhaled corticosteroid medications Scoring: Total score is calculated as a mean of the 10 items, scores range from 1-5 (1= low adherence/ worse outcome, 5= high adherence/ best outcome)
arm group label: BREATHE Intervention
arm group type: Experimental
description: The patient's primary care provider (PCP) will deliver the active intervention (shared decision-making discussion of asthma control status and treatment) - BREATHE Intervention.
arm group label: Control Intervention
arm group type: Active Comparator
description: The patient's primary care provider (PCP) will deliver the control intervention (discussion of healthy lifestyles).
intervention type: Behavioral
intervention name: BREATHE Intervention
description: PCPs randomized to BREATHE will receive the tablet which, when the screen is advanced by the PCP, will prompt the PCP through a 7-minute, 4-step brief intervention tailored to respond to the patient's specific beliefs, and shared decision-making discussion of asthma control status and treatment.
arm group label: BREATHE Intervention
intervention type: Behavioral
intervention name: Control Intervention
description: PCP will provide discussion of healthy lifestyles.
arm group label: Control Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Maureen George, PhD
role: Principal Investigator
affiliation: Associate Professor of Nursing at Columbia University
facility: 
country: United States
citation: George M, Pantalon MV, Sommers MLS, Glanz K, Jia H, Chung A, Norful AA, Poghosyan L, Coleman D, Bruzzese JM. Shared decision-making in the BREATHE asthma intervention trial: A research protocol. J Adv Nurs. 2019 Apr;75(4):876-887. doi: 10.1111/jan.13916. Epub 2019 Jan 24.
PMID: 30479020
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Maureen George
investigator title: Associate Professor of Nursing at the Columbia University Medical Center, Nursing Scholarship & Research
mesh term: Asthma
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 