<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/NCT03036267</url>
  </required_header>
  <id_info>
    <org_study_id>AAAR0605</org_study_id>
    <nct_id>NCT03036267</nct_id>
  </id_info>
  <brief_title>Feasibility of the BREATHE Asthma Intervention Trial</brief_title>
  <official_title>Self-care Decision-making: Feasibility of the BREATHE Asthma Intervention Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      Asthma rates are high and asthma control is greatly reduced in Black, Medicaid-insured&#xD;
      adults, due in part to their poor adherence to inhaled corticosteroids (ICS), which in turn&#xD;
      may be due to erroneous health beliefs about asthma and negative beliefs regarding ICS. A&#xD;
      brief shared decision-making intervention for use by primary care providers in Federally&#xD;
      Qualified Health Centers (FQHCs) has the potential to be a novel avenue to greatly improve&#xD;
      asthma control in this high-risk patient group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Uncontrolled asthma disproportionally impacts Black and poor adults. Adherence to inhaled&#xD;
      corticosteroids (ICS), which plays a significant role in asthma control, is relatively low in&#xD;
      poor and minority populations. Non-adherence to ICS is associated with erroneous personal&#xD;
      health beliefs regarding asthma care and with negative beliefs regarding ICS. Despite this,&#xD;
      no intervention concurrently addresses beliefs regarding asthma self-care and ICS. Shared&#xD;
      decision-making interventions have not been tested in underserved Black adults, despite this&#xD;
      model's success in pediatric populations and in White, privately insured patients with&#xD;
      asthma. Federally Qualified Health Centers (FQHCs) have unique challenges to helping patients&#xD;
      achieve asthma control but are overlooked in asthma intervention research. Process&#xD;
      evaluations are often lacking during intervention development. We will address these&#xD;
      treatment and methodological gaps.&#xD;
&#xD;
      Objectives: This pilot study will (1) develop a brief shared decision-making intervention&#xD;
      delivered by primary care providers (PCPs) to improve asthma control in Black adults&#xD;
      receiving care in FQHCs; (2) evaluate the intervention's feasibility and acceptability; and&#xD;
      (3) assess preliminary evidence of intervention effects on asthma control, ICS adherence,&#xD;
      forced expiratory volume in one second (FEV1) - an objective lung function measure - and&#xD;
      asthma quality of life (QOL) over a 3-month follow-up period.&#xD;
&#xD;
      Hypotheses: (1) The intervention will be feasible and acceptable, and (2) over 3 months,&#xD;
      relative to controls, patients whose PCPs are trained in the intervention will have&#xD;
      significant improvement on asthma control (primary outcome), ICS adherence, FEV1 and asthma&#xD;
      QOL (secondary outcomes).&#xD;
&#xD;
      Methods: Using community-based participatory research and including a Patient Advocate, we&#xD;
      will develop the intervention, Brief Evaluation of Asthma Therapy (BREATHE). Intervention&#xD;
      development is guided by patient and family/support persons of asthma patients input, as well&#xD;
      as PCP feedback. We will then conduct a randomized trial of the intervention with 8 PCPs from&#xD;
      2 FQHCs in Philadelphia, PA; for each PCP we will enroll 10 Black adults (N=80) with&#xD;
      uncontrolled asthma, and with erroneous asthma care beliefs and negative ICS beliefs. PCPs&#xD;
      will be randomized within FQHC to intervention and control; patients will be followed for 3&#xD;
      months. Process evaluation interviews with patients and PCPs will obtain feedback regarding&#xD;
      intervention procedures.&#xD;
&#xD;
      Significance: This study has high public health significance because it (1) targets a highly&#xD;
      vulnerable population for poor asthma control - Black poor adults with erroneous asthma care&#xD;
      beliefs and with negative ICS beliefs; (2) adapts a model-based intervention to develop a&#xD;
      novel intervention delivered by PCPs that simultaneously targets erroneous asthma beliefs and&#xD;
      negative ICS beliefs, and which has the potential to amplify intervention effects and&#xD;
      increase the likelihood of sustainability; and (3) includes a process evaluation, bridging&#xD;
      the gap between science and practice, and aiding in the design of a full-scale randomized&#xD;
      controlled trial (RCT).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 4, 2017</start_date>
  <completion_date type="Actual">September 22, 2017</completion_date>
  <primary_completion_date type="Actual">September 22, 2017</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>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Asthma Control Questionnaire</measure>
    <time_frame>Baseline - for descriptive purposes only</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>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Asthma Chronic</condition>
  <condition>Health Behavior</condition>
  <arm_group>
    <arm_group_label>BREATHE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7-minute brief shared decision-making intervention using a 4-step motivational interviewing approach</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attention Control Condition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>7-minute diet and exercise discussion</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>BREATHE</intervention_name>
    <description>Primary care providers (PCPs) randomized to BREATHE will be trained to deliver the 7-minute brief shared decision-making intervention using a 4-step motivational interviewing approach.</description>
    <arm_group_label>BREATHE</arm_group_label>
    <other_name>Shared decision-making using motivational interviewing</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Attention Control Condition</intervention_name>
    <description>PCPs randomized to the control intervention will not receive any specific training. To control for contact, they will be instructed to engage in a 7-minute diet and exercise discussion as this will not confound results.</description>
    <arm_group_label>Attention Control Condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        The intervention trial will be informed by focus groups&#xD;
&#xD;
        Focus Group Inclusion Criteria:&#xD;
&#xD;
        - Adult patients with persistent asthma or loved ones of adult patients with persistent&#xD;
        asthma (prescribed ICS regardless of whether they are using ICS or not) receiving care at&#xD;
        the participating FQHCs&#xD;
&#xD;
        Focus Group Exclusion Criteria:&#xD;
&#xD;
        - Patients with persistent asthma or loved ones of patients with persistent asthma under&#xD;
        they age of 18 OR NOT prescribed ICS or NOT receiving care at the participating FQHCs&#xD;
&#xD;
        Intervention Inclusion Criteria:&#xD;
&#xD;
        Patients must be:&#xD;
&#xD;
          1. Adults (18 years of age or older)&#xD;
&#xD;
          2. PCP-diagnosed persistent asthma&#xD;
&#xD;
          3. Currently prescribed ICS&#xD;
&#xD;
          4. Receiving asthma care at participating FQHCs&#xD;
&#xD;
          5. Who screen positive for uncontrolled asthma&#xD;
&#xD;
          6. Have erroneous personal health and/or negative ICS beliefs&#xD;
&#xD;
        Intervention Exclusion Criteria:&#xD;
&#xD;
          1. Participation in focus groups during the development phase&#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>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Spectrum Health Services</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19139</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greater Philadelphia Health Action</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>George M, Arcia A, Chung A, Coleman D, Bruzzese JM. African Americans Want a Focus on Shared Decision-Making in Asthma Adherence Interventions. Patient. 2020 Feb;13(1):71-81. doi: 10.1007/s40271-019-00382-x.</citation>
    <PMID>31414396</PMID>
  </reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <results_first_submitted>June 9, 2021</results_first_submitted>
  <results_first_submitted_qc>December 3, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 6, 2021</results_first_posted>
  <last_update_submitted>December 3, 2021</last_update_submitted>
  <last_update_submitted_qc>December 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 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</investigator_title>
  </responsible_party>
  <keyword>health disparity</keyword>
  <keyword>motivational interviewing</keyword>
  <keyword>African American adults</keyword>
  <keyword>Federally Qualified Health Centers</keyword>
  <keyword>adherence</keyword>
  <keyword>health beliefs</keyword>
  <keyword>self-management</keyword>
  <keyword>asthma control</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>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>September 21, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03036267/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Focus Groups</title>
          <description>Six focus group were held with adults with asthma and their (adult) loved ones</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Focus Groups</title>
          <description>Six focus group were held with adults with asthma and their (adult) loved ones</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="46"/>
          </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="47.7" spread="11.26"/>
                  </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="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Asthma Control Questionnaire</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 - for descriptive purposes only</time_frame>
        <population>only those with asthma completed the survey</population>
        <group_list>
          <group group_id="O1">
            <title>Focus Groups</title>
            <description>Six focus group were held with adults with asthma and their (adult) loved ones</description>
          </group>
        </group_list>
        <measure>
          <title>Asthma Control Questionnaire</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>
          <population>only those with asthma completed the survey</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="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.34" spread="1.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.</time_frame>
      <desc>All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Focus Groups</title>
          <description>Six focus group were held with adults with asthma and their (adult) loved ones</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="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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/NCT03036267
org study id: AAAR0605
nct id: NCT03036267
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Asthma rates are high and asthma control is greatly reduced in Black, Medicaid-insured
      adults, due in part to their poor adherence to inhaled corticosteroids (ICS), which in turn
      may be due to erroneous health beliefs about asthma and negative beliefs regarding ICS. A
      brief shared decision-making intervention for use by primary care providers in Federally
      Qualified Health Centers (FQHCs) has the potential to be a novel avenue to greatly improve
      asthma control in this high-risk patient group.
Uncontrolled asthma disproportionally impacts Black and poor adults. Adherence to inhaled
      corticosteroids (ICS), which plays a significant role in asthma control, is relatively low in
      poor and minority populations. Non-adherence to ICS is associated with erroneous personal
      health beliefs regarding asthma care and with negative beliefs regarding ICS. Despite this,
      no intervention concurrently addresses beliefs regarding asthma self-care and ICS. Shared
      decision-making interventions have not been tested in underserved Black adults, despite this
      model's success in pediatric populations and in White, privately insured patients with
      asthma. Federally Qualified Health Centers (FQHCs) have unique challenges to helping patients
      achieve asthma control but are overlooked in asthma intervention research. Process
      evaluations are often lacking during intervention development. We will address these
      treatment and methodological gaps.

      Objectives: This pilot study will (1) develop a brief shared decision-making intervention
      delivered by primary care providers (PCPs) to improve asthma control in Black adults
      receiving care in FQHCs; (2) evaluate the intervention's feasibility and acceptability; and
      (3) assess preliminary evidence of intervention effects on asthma control, ICS adherence,
      forced expiratory volume in one second (FEV1) - an objective lung function measure - and
      asthma quality of life (QOL) over a 3-month follow-up period.

      Hypotheses: (1) The intervention will be feasible and acceptable, and (2) over 3 months,
      relative to controls, patients whose PCPs are trained in the intervention will have
      significant improvement on asthma control (primary outcome), ICS adherence, FEV1 and asthma
      QOL (secondary outcomes).

      Methods: Using community-based participatory research and including a Patient Advocate, we
      will develop the intervention, Brief Evaluation of Asthma Therapy (BREATHE). Intervention
      development is guided by patient and family/support persons of asthma patients input, as well
      as PCP feedback. We will then conduct a randomized trial of the intervention with 8 PCPs from
      2 FQHCs in Philadelphia, PA; for each PCP we will enroll 10 Black adults (N=80) with
      uncontrolled asthma, and with erroneous asthma care beliefs and negative ICS beliefs. PCPs
      will be randomized within FQHC to intervention and control; patients will be followed for 3
      months. Process evaluation interviews with patients and PCPs will obtain feedback regarding
      intervention procedures.

      Significance: This study has high public health significance because it (1) targets a highly
      vulnerable population for poor asthma control - Black poor adults with erroneous asthma care
      beliefs and with negative ICS beliefs; (2) adapts a model-based intervention to develop a
      novel intervention delivered by PCPs that simultaneously targets erroneous asthma beliefs and
      negative ICS beliefs, and which has the potential to amplify intervention effects and
      increase the likelihood of sustainability; and (3) includes a process evaluation, bridging
      the gap between science and practice, and aiding in the design of a full-scale randomized
      controlled trial (RCT).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Asthma Control Questionnaire
time frame: Baseline - for descriptive purposes only
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
arm group label: BREATHE
arm group type: Experimental
description: 7-minute brief shared decision-making intervention using a 4-step motivational interviewing approach
arm group label: Attention Control Condition
arm group type: Active Comparator
description: 7-minute diet and exercise discussion
intervention type: Behavioral
intervention name: BREATHE
description: Primary care providers (PCPs) randomized to BREATHE will be trained to deliver the 7-minute brief shared decision-making intervention using a 4-step motivational interviewing approach.
arm group label: BREATHE
other name: Shared decision-making using motivational interviewing
intervention type: Other
intervention name: Attention Control Condition
description: PCPs randomized to the control intervention will not receive any specific training. To control for contact, they will be instructed to engage in a 7-minute diet and exercise discussion as this will not confound results.
arm group label: Attention Control Condition
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: Columbia University
facility: 
facility: 
country: United States
citation: George M, Arcia A, Chung A, Coleman D, Bruzzese JM. African Americans Want a Focus on Shared Decision-Making in Asthma Adherence Interventions. Patient. 2020 Feb;13(1):71-81. doi: 10.1007/s40271-019-00382-x.
PMID: 31414396
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Maureen George
investigator title: Associate Professor of Nursing
mesh term: Asthma
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 