<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/NCT03769519</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00100181</org_study_id>
    <nct_id>NCT03769519</nct_id>
  </id_info>
  <brief_title>AdheRence to Inhaled Corticosteroids in Asthma</brief_title>
  <acronym>ARICA</acronym>
  <official_title>AdheRence to Inhaled Corticosteroids in Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</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>
      It is widely recognized that asthma in adult African American patients is a significant&#xD;
      health problem, which is partly affected by relatively low inhaled corticosteroid (ICS)&#xD;
      adherence rates. The goal of this study is to pilot test an ICS adherence intervention,&#xD;
      ARICA, that aims to improve ICS adherence in adult African Americans.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will evaluate ARICA in Duke primary care clinics to study its feasibility&#xD;
      and acceptability using a quasi-experimental pre-post study design. The study will enroll&#xD;
      between 32 and 48 adult African Americans with persistent asthma and suboptimal ICS&#xD;
      adherence, and their health care providers, to study the use of the intervention and key&#xD;
      indicators of the intervention's potential effectiveness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 27, 2020</start_date>
  <completion_date type="Actual">August 19, 2020</completion_date>
  <primary_completion_date type="Actual">August 19, 2020</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Reported Experiences With the ARICA Program</measure>
    <time_frame>3 months</time_frame>
    <description>Assessment of participants experiences with and perceptions of the ARICA program, as assessed by in-depth semi-structured qualitative interview.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Reported Medication Adherence as Measured by the DOSE-Nonadherence (Voils) Questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>patients' medication adherence rates based on Voils adherence questionnaire adherence questionnaire. Difference from baseline to follow up. Scored 0-4, higher is more non-adherent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Asthma Control as Measured by the Asthma Control Test</measure>
    <time_frame>3 months</time_frame>
    <description>patient reported difference from baseline to follow up. Higher score is better asthma control. Range 5-25.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Asthma-Related Quality of Life as Measured by the Marks Asthma-Related Quality of Life Questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>Patient reported. Difference from baseline to follow up. Range 0-80, higher score means greater impact of asthma on quality of life.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Medication Adherence</condition>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Control (Group 1)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group is considered the control group. This group will have scheduled texts and emails for the monthly surveys after the participant completes the baseline questionnaires.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ARICA Intervention (Group 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group is considered the intervention group. Participants in this group will receive weekly texts and emails containing asthma facts and myths. They will also complete monthly surveys and participate in asthma education sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ARICA</intervention_name>
    <description>Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package.</description>
    <arm_group_label>ARICA Intervention (Group 2)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Self-identifying African American&#xD;
&#xD;
          -  Self-reported current asthma&#xD;
&#xD;
          -  Prescribed an inhaled corticosteroid (alone or combination) for ≥ 1 month&#xD;
&#xD;
          -  Presented at a Duke Primary Care clinic visit within the past 3 years or is&#xD;
             establishing care at Duke Primary Care&#xD;
&#xD;
          -  Follow up Duke Primary Care visit within the next 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable or unwilling to provide informed consent&#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>Isaretta L Riley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke Un.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke Un.</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>October 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <results_first_submitted>August 11, 2021</results_first_submitted>
  <results_first_submitted_qc>November 18, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 17, 2021</results_first_posted>
  <last_update_submitted>November 18, 2021</last_update_submitted>
  <last_update_submitted_qc>November 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>health disparities</keyword>
  <keyword>african american</keyword>
  <keyword>adult</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</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>December 14, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT03769519/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Control (Group 1)</title>
          <description>This group is considered the control group. This group will have scheduled texts and emails for the monthly surveys after the participant completes the baseline questionnaires.</description>
        </group>
        <group group_id="P2">
          <title>ARICA Intervention (Group 2)</title>
          <description>This group is considered the intervention group. Participants in this group will receive weekly texts and emails containing asthma facts and myths. They will also complete monthly surveys and participate in asthma education sessions.&#xD;
ARICA: Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control (Group 1)</title>
          <description>This group is considered the control group. This group will have scheduled texts and emails for the monthly surveys after the participant completes the baseline questionnaires.</description>
        </group>
        <group group_id="B2">
          <title>ARICA Intervention (Group 2)</title>
          <description>This group is considered the intervention group. Participants in this group will receive weekly texts and emails containing asthma facts and myths. They will also complete monthly surveys and participate in asthma education sessions.&#xD;
ARICA: Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package.</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="14"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="29"/>
          </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="52.7" spread="12.2"/>
                    <measurement group_id="B2" value="47.1" spread="10.5"/>
                    <measurement group_id="B3" value="49.8" spread="11.5"/>
                  </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="13"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="28"/>
                  </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>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="13"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="27"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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="14"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>DOSE-Nonadherence (Voils Adherence)</title>
          <description>patients' medication adherence rates based on Voils adherence questionnaire adherence questionnaire. Scored 0-4, higher is more non-adherent</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.6" spread="0.9"/>
                    <measurement group_id="B2" value="1.3" spread="1"/>
                    <measurement group_id="B3" value="1.5" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Asthma Control Test</title>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14" spread="5.5"/>
                    <measurement group_id="B2" value="16.1" spread="4"/>
                    <measurement group_id="B3" value="15.1" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marks Asthma Related Quality of Life</title>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.2" spread="17.7"/>
                    <measurement group_id="B2" value="23.2" spread="17.2"/>
                    <measurement group_id="B3" value="28" spread="17.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Reported Experiences With the ARICA Program</title>
        <description>Assessment of participants experiences with and perceptions of the ARICA program, as assessed by in-depth semi-structured qualitative interview.</description>
        <time_frame>3 months</time_frame>
        <population>Conducted qualitative interview of ARICA Intervention participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Control (Group 1)</title>
            <description>This group is considered the control group. This group will have scheduled texts and emails for the monthly surveys after the participant completes the baseline questionnaires.</description>
          </group>
          <group group_id="O2">
            <title>ARICA Intervention (Group 2)</title>
            <description>This group is considered the intervention group. Participants in this group will receive weekly texts and emails containing asthma facts and myths. They will also complete monthly surveys and participate in asthma education sessions.&#xD;
ARICA: Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Reported Experiences With the ARICA Program</title>
          <description>Assessment of participants experiences with and perceptions of the ARICA program, as assessed by in-depth semi-structured qualitative interview.</description>
          <population>Conducted qualitative interview of ARICA Intervention participants who completed the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Patient Reported Medication Adherence as Measured by the DOSE-Nonadherence (Voils) Questionnaire</title>
        <description>patients' medication adherence rates based on Voils adherence questionnaire adherence questionnaire. Difference from baseline to follow up. Scored 0-4, higher is more non-adherent</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control (Group 1)</title>
            <description>This group is considered the control group. This group will have scheduled texts and emails for the monthly surveys after the participant completes the baseline questionnaires.</description>
          </group>
          <group group_id="O2">
            <title>ARICA Intervention (Group 2)</title>
            <description>This group is considered the intervention group. Participants in this group will receive weekly texts and emails containing asthma facts and myths. They will also complete monthly surveys and participate in asthma education sessions.&#xD;
ARICA: Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Patient Reported Medication Adherence as Measured by the DOSE-Nonadherence (Voils) Questionnaire</title>
          <description>patients' medication adherence rates based on Voils adherence questionnaire adherence questionnaire. Difference from baseline to follow up. Scored 0-4, higher is more non-adherent</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.685" lower_limit="-0.0385" upper_limit="0.7528"/>
                    <measurement group_id="O2" value="0.738" lower_limit="0.1928" upper_limit="1.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Asthma Control as Measured by the Asthma Control Test</title>
        <description>patient reported difference from baseline to follow up. Higher score is better asthma control. Range 5-25.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control (Group 1)</title>
            <description>This group is considered the control group. This group will have scheduled texts and emails for the monthly surveys after the participant completes the baseline questionnaires.</description>
          </group>
          <group group_id="O2">
            <title>ARICA Intervention (Group 2)</title>
            <description>This group is considered the intervention group. Participants in this group will receive weekly texts and emails containing asthma facts and myths. They will also complete monthly surveys and participate in asthma education sessions.&#xD;
ARICA: Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Asthma Control as Measured by the Asthma Control Test</title>
          <description>patient reported difference from baseline to follow up. Higher score is better asthma control. Range 5-25.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.571" lower_limit="-5.1902" upper_limit="0.0473"/>
                    <measurement group_id="O2" value="-3.5" lower_limit="-6.0396" upper_limit="-0.9604"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Asthma-Related Quality of Life as Measured by the Marks Asthma-Related Quality of Life Questionnaire</title>
        <description>Patient reported. Difference from baseline to follow up. Range 0-80, higher score means greater impact of asthma on quality of life.</description>
        <time_frame>3 months</time_frame>
        <population>Participants who completed the Marks Asthma-Related Quality of Life Questionnaire.</population>
        <group_list>
          <group group_id="O1">
            <title>Control (Group 1)</title>
            <description>This group is considered the control group. This group will have scheduled texts and emails for the monthly surveys after the participant completes the baseline questionnaires.</description>
          </group>
          <group group_id="O2">
            <title>ARICA Intervention (Group 2)</title>
            <description>This group is considered the intervention group. Participants in this group will receive weekly texts and emails containing asthma facts and myths. They will also complete monthly surveys and participate in asthma education sessions.&#xD;
ARICA: Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Asthma-Related Quality of Life as Measured by the Marks Asthma-Related Quality of Life Questionnaire</title>
          <description>Patient reported. Difference from baseline to follow up. Range 0-80, higher score means greater impact of asthma on quality of life.</description>
          <population>Participants who completed the Marks Asthma-Related Quality of Life Questionnaire.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.769" lower_limit="-1.2527" upper_limit="12.7912"/>
                    <measurement group_id="O2" value="11.462" lower_limit="5.5068" upper_limit="17.4163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Study period, 3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Control (Group 1)</title>
          <description>This group is considered the control group. This group will have scheduled texts and emails for the monthly surveys after the participant completes the baseline questionnaires.</description>
        </group>
        <group group_id="E2">
          <title>ARICA Intervention (Group 2)</title>
          <description>This group is considered the intervention group. Participants in this group will receive weekly texts and emails containing asthma facts and myths. They will also complete monthly surveys and participate in asthma education sessions.&#xD;
ARICA: Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package.</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="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </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="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </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>Isaretta L. Riley, MD, MPH</name_or_title>
      <organization>Duke</organization>
      <phone>919-286-0411</phone>
      <email>isaretta.riley@duke.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/NCT03769519
org study id: Pro00100181
nct id: NCT03769519
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is widely recognized that asthma in adult African American patients is a significant
      health problem, which is partly affected by relatively low inhaled corticosteroid (ICS)
      adherence rates. The goal of this study is to pilot test an ICS adherence intervention,
      ARICA, that aims to improve ICS adherence in adult African Americans.
The investigators will evaluate ARICA in Duke primary care clinics to study its feasibility
      and acceptability using a quasi-experimental pre-post study design. The study will enroll
      between 32 and 48 adult African Americans with persistent asthma and suboptimal ICS
      adherence, and their health care providers, to study the use of the intervention and key
      indicators of the intervention's potential effectiveness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Number of Participants Who Reported Experiences With the ARICA Program
time frame: 3 months
description: Assessment of participants experiences with and perceptions of the ARICA program, as assessed by in-depth semi-structured qualitative interview.
measure: Change in Patient Reported Medication Adherence as Measured by the DOSE-Nonadherence (Voils) Questionnaire
time frame: 3 months
description: patients' medication adherence rates based on Voils adherence questionnaire adherence questionnaire. Difference from baseline to follow up. Scored 0-4, higher is more non-adherent
measure: Change in Asthma Control as Measured by the Asthma Control Test
time frame: 3 months
description: patient reported difference from baseline to follow up. Higher score is better asthma control. Range 5-25.
measure: Change in Asthma-Related Quality of Life as Measured by the Marks Asthma-Related Quality of Life Questionnaire
time frame: 3 months
description: Patient reported. Difference from baseline to follow up. Range 0-80, higher score means greater impact of asthma on quality of life.
arm group label: Control (Group 1)
arm group type: No Intervention
description: This group is considered the control group. This group will have scheduled texts and emails for the monthly surveys after the participant completes the baseline questionnaires.
arm group label: ARICA Intervention (Group 2)
arm group type: Experimental
description: This group is considered the intervention group. Participants in this group will receive weekly texts and emails containing asthma facts and myths. They will also complete monthly surveys and participate in asthma education sessions.
intervention type: Behavioral
intervention name: ARICA
description: Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package.
arm group label: ARICA Intervention (Group 2)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Isaretta L Riley, MD
role: Principal Investigator
affiliation: Duke Un.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 