<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/NCT02206061</url>
  </required_header>
  <id_info>
    <org_study_id>51912</org_study_id>
    <secondary_id>R18HL116244-01A1</secondary_id>
    <nct_id>NCT02206061</nct_id>
  </id_info>
  <brief_title>School-based Asthma Care for Teens (SB-ACT)</brief_title>
  <acronym>SB-ACT</acronym>
  <official_title>School-based Asthma Care for Teens (SB-ACT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Rochester</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to evaluate the widespread implementation of a developmentally&#xD;
      appropriate preventive asthma care intervention for urban teens. The School Based Asthma Care&#xD;
      for Teens (SB-ACT) program includes two core components: 1) a trial of directly observed&#xD;
      therapy (DOT) to allow the teen to experience the potential benefits from adhering to&#xD;
      guideline-based asthma treatment, and 2) a developmentally appropriate Motivational&#xD;
      Interviewing (MI) Counseling Intervention to help the teen transition to independent&#xD;
      long-term medication adherence. The investigators hypothesize that teens receiving the SB-ACT&#xD;
      program will 1) experience less asthma-related morbidity than an asthma education (AE)&#xD;
      attention-control comparison group, and 2) have improved adherence, less urgent healthcare&#xD;
      use, less absenteeism, improved quality of life, and reduced FeNO compared to AE. The&#xD;
      investigators also hypothesize that participants receiving DOT-only will have improved&#xD;
      asthma-related outcomes immediately following their DOT trial vs. teens receiving AE, but&#xD;
      will not have sustained, clinically significant improvement in outcomes once the DOT phase is&#xD;
      complete. This represents a unique opportunity to build upon existing community relationships&#xD;
      with an innovative and developmentally focused program to improve asthma outcomes for urban&#xD;
      teens.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">February 1, 2021</completion_date>
  <primary_completion_date type="Actual">March 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average Number of Days Without Asthma Symptoms (Symptom Free Days) During Post-intervention Follow-up Interviews (3, 5 and 7 Months)</measure>
    <time_frame>Average number of symptom free days, over 2 weeks, averaged across 3, 5, and 7 month post-intervention follow-up assessments.</time_frame>
    <description>The primary outcome measure is asthma morbidity between groups. The investigators will measure asthma morbidity by looking at the average number of days without asthma symptoms (symptom free days) over 2 weeks, during the post-intervention follow-up assessments (3, 5 and 7 months post baseline).&#xD;
Symptom free days are defined as 24 hour periods of no asthma symptoms including, coughing, wheezing, tightness in the chest or shortness of breath.&#xD;
Reported data reflects the number of symptom free days over 2 weeks averaged across 3, 5, and 7 month post-intervention follow-up assessments.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">430</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>School-Based Asthma Care for Teens (SB-ACT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SB-ACT consists of 2 components: Motivational Interviewing (MI) and Directly Observed Therapy (DOT) For the first 6-8 weeks, the teen will visit the school nurse to receive a daily dose of preventive asthma medication as directly observed therapy (DOT). The purpose of DOT is to establish a relationship with the nurse, learn proper medication technique, and experience potential benefits of consistent preventive therapy.&#xD;
The second component, Motivational Interviewing (MI) counseling , will start 4-6 weeks after the start of DOT. A counselor will conduct 3 in-person MI sessions with the teen at school to enhance the teen's motivation to adhere to their asthma treatment plan. The 3 sessions consist of an initial 40 minute counseling session (4-6 weeks after start of DOT), and two 30 minute follow-up sessions 2 and 6 weeks later. This component consists of an evidence-based self-management program to help the teen begin to transition to independence with preventive medication use.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Directly Observed Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For the first 6-8 weeks after enrollment, the teen will visit the school nurse once a day to receive a daily dose of preventive asthma medication as directly observed therapy (DOT).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Asthma Education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Asthma educators will provide an in-school asthma education program that will match the time and attention of the MI counseling portion of the primary intervention. Each teen will receive three 1-on-1 educational sessions at school, and sessions will cover 3 main topics: 1) lung physiology and asthma basics, 2) triggers, symptoms, and warning signs, and 3) medications and self-advocacy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>School-Based Asthma Care for Teens (SB-ACT)</intervention_name>
    <arm_group_label>School-Based Asthma Care for Teens (SB-ACT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Directly Observed Therapy</intervention_name>
    <arm_group_label>Directly Observed Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Asthma Education</intervention_name>
    <arm_group_label>Asthma Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physician-diagnosed asthma&#xD;
&#xD;
          -  Persistent asthma or poor asthma control (based on NHLBI guidelines).&#xD;
&#xD;
          -  Attending secondary school in Rochester City School District&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to speak and understand English&#xD;
&#xD;
          -  No access to a phone for follow-up surveys&#xD;
&#xD;
          -  Diagnosed developmental or intellectual disability&#xD;
&#xD;
          -  Other significant medical conditions, including congenital heart disease, cystic&#xD;
             fibrosis, or other chronic lung disease, that could interfere with the assessment of&#xD;
             asthma-related measures.&#xD;
&#xD;
          -  Teens in foster care or other situations in which consent cannot be obtained from a&#xD;
             guardian.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Frey SM, Fagnano M, Mammen JR, Halterman JS. Health-related internet use among adolescents with uncontrolled persistent asthma. J Asthma. 2021 Dec;58(12):1610-1615. doi: 10.1080/02770903.2020.1827420. Epub 2020 Oct 7.</citation>
    <PMID>32969289</PMID>
  </reference>
  <reference>
    <citation>Stern J, Chen M, Jusko TA, Fagnano M, Jarvinen KM, Halterman JS. Food allergy in at-risk adolescents with asthma: A key area for focus. Ann Allergy Asthma Immunol. 2020 Oct;125(4):405-409.e1. doi: 10.1016/j.anai.2020.06.004. Epub 2020 Jun 10.</citation>
    <PMID>32534023</PMID>
  </reference>
  <reference>
    <citation>Okelo SO, Bilderback AL, Fagnano M, Halterman JS. Validity of asthma disease direction, bother, and risk as self-reported asthma morbidity measures in urban teens. J Allergy Clin Immunol Pract. 2020 Mar;8(3):1129-1131.e2. doi: 10.1016/j.jaip.2019.09.026. Epub 2019 Oct 9. No abstract available.</citation>
    <PMID>31605762</PMID>
  </reference>
  <reference>
    <citation>Frey SM, Jones MR, Goldstein NPN, Fagnano M, Halterman JS. Comparing inhaled medications reported by adolescents with persistent asthma and their caregivers. J Asthma. 2020 Sep;57(9):999-1005. doi: 10.1080/02770903.2019.1631342. Epub 2019 Jul 2.</citation>
    <PMID>31264485</PMID>
  </reference>
  <reference>
    <citation>Shankar M, Fagnano M, Blaakman SW, Rhee H, Halterman JS. Depressive Symptoms Among Urban Adolescents with Asthma: A Focus for Providers. Acad Pediatr. 2019 Aug;19(6):608-614. doi: 10.1016/j.acap.2018.12.004. Epub 2018 Dec 20.</citation>
    <PMID>30578922</PMID>
  </reference>
  <reference>
    <citation>Jones MR, Frey SM, Riekert K, Fagnano M, Halterman JS. Transition Readiness for Talking With Providers in Urban Youth With Asthma: Associations With Medication Management. J Adolesc Health. 2019 Feb;64(2):265-271. doi: 10.1016/j.jadohealth.2018.08.026. Epub 2018 Oct 30.</citation>
    <PMID>30389202</PMID>
  </reference>
  <reference>
    <citation>Okelo SO, Bilderback AL, Fagnano M, Halterman JS. Validation of Asthma Control Assessment Among Urban Adolescents Using the Asthma Control and Communication Instrument. J Allergy Clin Immunol Pract. 2019 Mar;7(3):962-968.e1. doi: 10.1016/j.jaip.2018.10.001. Epub 2018 Oct 11.</citation>
    <PMID>30317005</PMID>
  </reference>
  <reference>
    <citation>Frey SM, Jones MR, Goldstein N, Riekert K, Fagnano M, Halterman JS. Knowledge of Inhaled Therapy and Responsibility for Asthma Management Among Young Teens With Uncontrolled Persistent Asthma. Acad Pediatr. 2018 Apr;18(3):317-323. doi: 10.1016/j.acap.2018.01.006. Epub 2018 Jan 31.</citation>
    <PMID>29369804</PMID>
  </reference>
  <results_reference>
    <citation>Halterman JS, Riekert KA, Fagnano M, Tremblay PJ, Blaakman SW, Tajon R, Wang H, Borrelli B. Effect of the School-Based Asthma Care for Teens (SB-ACT) program on asthma morbidity: a 3-arm randomized controlled trial. J Asthma. 2022 Mar;59(3):494-506. doi: 10.1080/02770903.2020.1856869. Epub 2021 Jan 8.</citation>
    <PMID>33307900</PMID>
  </results_reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <results_first_submitted>February 3, 2021</results_first_submitted>
  <results_first_submitted_qc>February 3, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 21, 2021</results_first_posted>
  <last_update_submitted>April 14, 2021</last_update_submitted>
  <last_update_submitted_qc>April 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Jill Halterman</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <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>February 1, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT02206061/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>School-Based Asthma Care for Teens (SB-ACT)</title>
          <description>SB-ACT consists of 2 components: Motivational Interviewing (MI) and Directly Observed Therapy (DOT) For the first 6-8 weeks, the teen will visit the school nurse to receive a daily dose of preventive asthma medication as directly observed therapy (DOT). The purpose of DOT is to establish a relationship with the nurse, learn proper medication technique, and experience potential benefits of consistent preventive therapy.&#xD;
The second component, Motivational Interviewing (MI) counseling , will start 4-6 weeks after the start of DOT. A counselor will conduct 3 in-person MI sessions with the teen at school to enhance the teen's motivation to adhere to their asthma treatment plan. The 3 sessions consist of an initial 40 minute counseling session (4-6 weeks after start of DOT), and two 30 minute follow-up sessions 2 and 6 weeks later. This component consists of an evidence-based self-management program to help the teen begin to transition to independence with preventive medication use.&#xD;
School-Based Asthma Care for Teens (SB-ACT)</description>
        </group>
        <group group_id="P2">
          <title>Directly Observed Therapy</title>
          <description>For the first 6-8 weeks after enrollment, the teen will visit the school nurse once a day to receive a daily dose of preventive asthma medication as directly observed therapy (DOT).&#xD;
Directly Observed Therapy</description>
        </group>
        <group group_id="P3">
          <title>Asthma Education</title>
          <description>Asthma educators will provide an in-school asthma education program that will match the time and attention of the MI counseling portion of the primary intervention. Each teen will receive three 1-on-1 educational sessions at school, and sessions will cover 3 main topics: 1) lung physiology and asthma basics, 2) triggers, symptoms, and warning signs, and 3) medications and self-advocacy.&#xD;
Asthma Education</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="149"/>
                <participants group_id="P2" count="142"/>
                <participants group_id="P3" count="139"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="131"/>
                <participants group_id="P2" count="128"/>
                <participants group_id="P3" count="118"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="21"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="20"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline data was collected for all enrolled participants.</population>
      <group_list>
        <group group_id="B1">
          <title>School-Based Asthma Care for Teens (SB-ACT)</title>
          <description>SB-ACT consists of 2 components: Motivational Interviewing (MI) and Directly Observed Therapy (DOT) For the first 6-8 weeks, the teen will visit the school nurse to receive a daily dose of preventive asthma medication as directly observed therapy (DOT). The purpose of DOT is to establish a relationship with the nurse, learn proper medication technique, and experience potential benefits of consistent preventive therapy.&#xD;
The second component, Motivational Interviewing (MI) counseling , will start 4-6 weeks after the start of DOT. A counselor will conduct 3 in-person MI sessions with the teen at school to enhance the teen's motivation to adhere to their asthma treatment plan. The 3 sessions consist of an initial 40 minute counseling session (4-6 weeks after start of DOT), and two 30 minute follow-up sessions 2 and 6 weeks later. This component consists of an evidence-based self-management program to help the teen begin to transition to independence with preventive medication use.&#xD;
School-Based Asthma Care for Teens (SB-ACT)</description>
        </group>
        <group group_id="B2">
          <title>Directly Observed Therapy</title>
          <description>For the first 6-8 weeks after enrollment, the teen will visit the school nurse once a day to receive a daily dose of preventive asthma medication as directly observed therapy (DOT).&#xD;
Directly Observed Therapy</description>
        </group>
        <group group_id="B3">
          <title>Asthma Education</title>
          <description>Asthma educators will provide an in-school asthma education program that will match the time and attention of the MI counseling portion of the primary intervention. Each teen will receive three 1-on-1 educational sessions at school, and sessions will cover 3 main topics: 1) lung physiology and asthma basics, 2) triggers, symptoms, and warning signs, and 3) medications and self-advocacy.&#xD;
Asthma Education</description>
        </group>
        <group group_id="B4">
          <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="149"/>
            <count group_id="B2" value="142"/>
            <count group_id="B3" value="139"/>
            <count group_id="B4" value="430"/>
          </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="13.4" spread="1.2"/>
                    <measurement group_id="B2" value="13.4" spread="1.2"/>
                    <measurement group_id="B3" value="13.5" spread="1.2"/>
                    <measurement group_id="B4" value="13.4" spread="1.2"/>
                  </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="70"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="65"/>
                    <measurement group_id="B4" value="190"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="87"/>
                    <measurement group_id="B3" value="74"/>
                    <measurement group_id="B4" value="240"/>
                  </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="102"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="97"/>
                    <measurement group_id="B4" value="291"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="42"/>
                    <measurement group_id="B4" value="139"/>
                  </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 group_id="B4" 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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </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="1"/>
                    <measurement group_id="B4" value="1"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="79"/>
                    <measurement group_id="B4" value="239"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="48"/>
                    <measurement group_id="B4" value="164"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </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="149"/>
                    <measurement group_id="B2" value="142"/>
                    <measurement group_id="B3" value="139"/>
                    <measurement group_id="B4" value="430"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Average Number of Days Without Asthma Symptoms (Symptom Free Days) During Post-intervention Follow-up Interviews (3, 5 and 7 Months)</title>
        <description>The primary outcome measure is asthma morbidity between groups. The investigators will measure asthma morbidity by looking at the average number of days without asthma symptoms (symptom free days) over 2 weeks, during the post-intervention follow-up assessments (3, 5 and 7 months post baseline).&#xD;
Symptom free days are defined as 24 hour periods of no asthma symptoms including, coughing, wheezing, tightness in the chest or shortness of breath.&#xD;
Reported data reflects the number of symptom free days over 2 weeks averaged across 3, 5, and 7 month post-intervention follow-up assessments.</description>
        <time_frame>Average number of symptom free days, over 2 weeks, averaged across 3, 5, and 7 month post-intervention follow-up assessments.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>School-Based Asthma Care for Teens (SB-ACT)</title>
            <description>SB-ACT consists of 2 components: Motivational Interviewing (MI) and Directly Observed Therapy (DOT) For the first 6-8 weeks, the teen will visit the school nurse to receive a daily dose of preventive asthma medication as directly observed therapy (DOT). The purpose of DOT is to establish a relationship with the nurse, learn proper medication technique, and experience potential benefits of consistent preventive therapy.&#xD;
The second component, Motivational Interviewing (MI) counseling , will start 4-6 weeks after the start of DOT. A counselor will conduct 3 in-person MI sessions with the teen at school to enhance the teen's motivation to adhere to their asthma treatment plan. The 3 sessions consist of an initial 40 minute counseling session (4-6 weeks after start of DOT), and two 30 minute follow-up sessions 2 and 6 weeks later. This component consists of an evidence-based self-management program to help the teen begin to transition to independence with preventive medication use.&#xD;
School-Based Asthma Care for Teens (SB-ACT)</description>
          </group>
          <group group_id="O2">
            <title>Directly Observed Therapy</title>
            <description>For the first 6-8 weeks after enrollment, the teen will visit the school nurse once a day to receive a daily dose of preventive asthma medication as directly observed therapy (DOT).&#xD;
Directly Observed Therapy</description>
          </group>
          <group group_id="O3">
            <title>Asthma Education</title>
            <description>Asthma educators will provide an in-school asthma education program that will match the time and attention of the MI counseling portion of the primary intervention. Each teen will receive three 1-on-1 educational sessions at school, and sessions will cover 3 main topics: 1) lung physiology and asthma basics, 2) triggers, symptoms, and warning signs, and 3) medications and self-advocacy.&#xD;
Asthma Education</description>
          </group>
        </group_list>
        <measure>
          <title>Average Number of Days Without Asthma Symptoms (Symptom Free Days) During Post-intervention Follow-up Interviews (3, 5 and 7 Months)</title>
          <description>The primary outcome measure is asthma morbidity between groups. The investigators will measure asthma morbidity by looking at the average number of days without asthma symptoms (symptom free days) over 2 weeks, during the post-intervention follow-up assessments (3, 5 and 7 months post baseline).&#xD;
Symptom free days are defined as 24 hour periods of no asthma symptoms including, coughing, wheezing, tightness in the chest or shortness of breath.&#xD;
Reported data reflects the number of symptom free days over 2 weeks averaged across 3, 5, and 7 month post-intervention follow-up assessments.</description>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="128"/>
                <count group_id="O3" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5" spread="2.9"/>
                    <measurement group_id="O2" value="11.4" spread="2.9"/>
                    <measurement group_id="O3" value="11.6" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Repeated measure analyses testing the overall treatment effect were performed by fitting the Generalized Estimating Equation (GEE) with SFD at the three follow-up time points (3, 5, 7 months) as the dependent variable and treatment as independent variable. Normal error and identity link was specified and standard error was calculated using Sandwich estimator. Baseline SFDs, poverty level, and the presence of smokers in the home were controlled in the regression model.</non_inferiority_desc>
            <p_value>&lt;.05</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>.9</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>2.6</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <desc>n/a - definition does not differ</desc>
      <group_list>
        <group group_id="E1">
          <title>School-Based Asthma Care for Teens (SB-ACT)</title>
          <description>SB-ACT consists of 2 components: Motivational Interviewing (MI) and Directly Observed Therapy (DOT) For the first 6-8 weeks, the teen will visit the school nurse to receive a daily dose of preventive asthma medication as directly observed therapy (DOT). The purpose of DOT is to establish a relationship with the nurse, learn proper medication technique, and experience potential benefits of consistent preventive therapy.&#xD;
The second component, Motivational Interviewing (MI) counseling , will start 4-6 weeks after the start of DOT. A counselor will conduct 3 in-person MI sessions with the teen at school to enhance the teen's motivation to adhere to their asthma treatment plan. The 3 sessions consist of an initial 40 minute counseling session (4-6 weeks after start of DOT), and two 30 minute follow-up sessions 2 and 6 weeks later. This component consists of an evidence-based self-management program to help the teen begin to transition to independence with preventive medication use.&#xD;
School-Based Asthma Care for Teens (SB-ACT)</description>
        </group>
        <group group_id="E2">
          <title>Directly Observed Therapy</title>
          <description>For the first 6-8 weeks after enrollment, the teen will visit the school nurse once a day to receive a daily dose of preventive asthma medication as directly observed therapy (DOT).&#xD;
Directly Observed Therapy</description>
        </group>
        <group group_id="E3">
          <title>Asthma Education</title>
          <description>Asthma educators will provide an in-school asthma education program that will match the time and attention of the MI counseling portion of the primary intervention. Each teen will receive three 1-on-1 educational sessions at school, and sessions will cover 3 main topics: 1) lung physiology and asthma basics, 2) triggers, symptoms, and warning signs, and 3) medications and self-advocacy.&#xD;
Asthma Education</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="149"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="142"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="142"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="142"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="139"/>
              </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>Jill Halterman, MD</name_or_title>
      <organization>University of Rochester</organization>
      <phone>5852755798</phone>
      <email>jill_halterman@urmc.rochester.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/NCT02206061
org study id: 51912
secondary id: R18HL116244-01A1
nct id: NCT02206061
lead sponsor: 
collaborator: 
has dmc: Yes
The goal of this study is to evaluate the widespread implementation of a developmentally
      appropriate preventive asthma care intervention for urban teens. The School Based Asthma Care
      for Teens (SB-ACT) program includes two core components: 1) a trial of directly observed
      therapy (DOT) to allow the teen to experience the potential benefits from adhering to
      guideline-based asthma treatment, and 2) a developmentally appropriate Motivational
      Interviewing (MI) Counseling Intervention to help the teen transition to independent
      long-term medication adherence. The investigators hypothesize that teens receiving the SB-ACT
      program will 1) experience less asthma-related morbidity than an asthma education (AE)
      attention-control comparison group, and 2) have improved adherence, less urgent healthcare
      use, less absenteeism, improved quality of life, and reduced FeNO compared to AE. The
      investigators also hypothesize that participants receiving DOT-only will have improved
      asthma-related outcomes immediately following their DOT trial vs. teens receiving AE, but
      will not have sustained, clinically significant improvement in outcomes once the DOT phase is
      complete. This represents a unique opportunity to build upon existing community relationships
      with an innovative and developmentally focused program to improve asthma outcomes for urban
      teens.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Average Number of Days Without Asthma Symptoms (Symptom Free Days) During Post-intervention Follow-up Interviews (3, 5 and 7 Months)
time frame: Average number of symptom free days, over 2 weeks, averaged across 3, 5, and 7 month post-intervention follow-up assessments.
description: The primary outcome measure is asthma morbidity between groups. The investigators will measure asthma morbidity by looking at the average number of days without asthma symptoms (symptom free days) over 2 weeks, during the post-intervention follow-up assessments (3, 5 and 7 months post baseline).
Symptom free days are defined as 24 hour periods of no asthma symptoms including, coughing, wheezing, tightness in the chest or shortness of breath.
Reported data reflects the number of symptom free days over 2 weeks averaged across 3, 5, and 7 month post-intervention follow-up assessments.
arm group label: School-Based Asthma Care for Teens (SB-ACT)
arm group type: Experimental
description: SB-ACT consists of 2 components: Motivational Interviewing (MI) and Directly Observed Therapy (DOT) For the first 6-8 weeks, the teen will visit the school nurse to receive a daily dose of preventive asthma medication as directly observed therapy (DOT). The purpose of DOT is to establish a relationship with the nurse, learn proper medication technique, and experience potential benefits of consistent preventive therapy.
The second component, Motivational Interviewing (MI) counseling , will start 4-6 weeks after the start of DOT. A counselor will conduct 3 in-person MI sessions with the teen at school to enhance the teen's motivation to adhere to their asthma treatment plan. The 3 sessions consist of an initial 40 minute counseling session (4-6 weeks after start of DOT), and two 30 minute follow-up sessions 2 and 6 weeks later. This component consists of an evidence-based self-management program to help the teen begin to transition to independence with preventive medication use.
arm group label: Directly Observed Therapy
arm group type: Active Comparator
description: For the first 6-8 weeks after enrollment, the teen will visit the school nurse once a day to receive a daily dose of preventive asthma medication as directly observed therapy (DOT).
arm group label: Asthma Education
arm group type: Active Comparator
description: Asthma educators will provide an in-school asthma education program that will match the time and attention of the MI counseling portion of the primary intervention. Each teen will receive three 1-on-1 educational sessions at school, and sessions will cover 3 main topics: 1) lung physiology and asthma basics, 2) triggers, symptoms, and warning signs, and 3) medications and self-advocacy.
intervention type: Behavioral
intervention name: School-Based Asthma Care for Teens (SB-ACT)
arm group label: School-Based Asthma Care for Teens (SB-ACT)
intervention type: Behavioral
intervention name: Directly Observed Therapy
arm group label: Directly Observed Therapy
intervention type: Behavioral
intervention name: Asthma Education
arm group label: Asthma Education
criteria: 
gender: All
minimum age: 12 Years
maximum age: 16 Years
healthy volunteers: No
facility: 
country: United States
citation: Frey SM, Fagnano M, Mammen JR, Halterman JS. Health-related internet use among adolescents with uncontrolled persistent asthma. J Asthma. 2021 Dec;58(12):1610-1615. doi: 10.1080/02770903.2020.1827420. Epub 2020 Oct 7.
PMID: 32969289
citation: Stern J, Chen M, Jusko TA, Fagnano M, Jarvinen KM, Halterman JS. Food allergy in at-risk adolescents with asthma: A key area for focus. Ann Allergy Asthma Immunol. 2020 Oct;125(4):405-409.e1. doi: 10.1016/j.anai.2020.06.004. Epub 2020 Jun 10.
PMID: 32534023
citation: Okelo SO, Bilderback AL, Fagnano M, Halterman JS. Validity of asthma disease direction, bother, and risk as self-reported asthma morbidity measures in urban teens. J Allergy Clin Immunol Pract. 2020 Mar;8(3):1129-1131.e2. doi: 10.1016/j.jaip.2019.09.026. Epub 2019 Oct 9. No abstract available.
PMID: 31605762
citation: Frey SM, Jones MR, Goldstein NPN, Fagnano M, Halterman JS. Comparing inhaled medications reported by adolescents with persistent asthma and their caregivers. J Asthma. 2020 Sep;57(9):999-1005. doi: 10.1080/02770903.2019.1631342. Epub 2019 Jul 2.
PMID: 31264485
citation: Shankar M, Fagnano M, Blaakman SW, Rhee H, Halterman JS. Depressive Symptoms Among Urban Adolescents with Asthma: A Focus for Providers. Acad Pediatr. 2019 Aug;19(6):608-614. doi: 10.1016/j.acap.2018.12.004. Epub 2018 Dec 20.
PMID: 30578922
citation: Jones MR, Frey SM, Riekert K, Fagnano M, Halterman JS. Transition Readiness for Talking With Providers in Urban Youth With Asthma: Associations With Medication Management. J Adolesc Health. 2019 Feb;64(2):265-271. doi: 10.1016/j.jadohealth.2018.08.026. Epub 2018 Oct 30.
PMID: 30389202
citation: Okelo SO, Bilderback AL, Fagnano M, Halterman JS. Validation of Asthma Control Assessment Among Urban Adolescents Using the Asthma Control and Communication Instrument. J Allergy Clin Immunol Pract. 2019 Mar;7(3):962-968.e1. doi: 10.1016/j.jaip.2018.10.001. Epub 2018 Oct 11.
PMID: 30317005
citation: Frey SM, Jones MR, Goldstein N, Riekert K, Fagnano M, Halterman JS. Knowledge of Inhaled Therapy and Responsibility for Asthma Management Among Young Teens With Uncontrolled Persistent Asthma. Acad Pediatr. 2018 Apr;18(3):317-323. doi: 10.1016/j.acap.2018.01.006. Epub 2018 Jan 31.
PMID: 29369804
citation: Halterman JS, Riekert KA, Fagnano M, Tremblay PJ, Blaakman SW, Tajon R, Wang H, Borrelli B. Effect of the School-Based Asthma Care for Teens (SB-ACT) program on asthma morbidity: a 3-arm randomized controlled trial. J Asthma. 2022 Mar;59(3):494-506. doi: 10.1080/02770903.2020.1856869. Epub 2021 Jan 8.
PMID: 33307900
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Jill Halterman
investigator title: Professor
mesh term: Asthma
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 