<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/NCT04454125</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY19120083</org_study_id>
    <nct_id>NCT04454125</nct_id>
  </id_info>
  <brief_title>AQI and Childhood Asthma: an Intervention</brief_title>
  <official_title>Air Quality Index (AQI) and Childhood Asthma: an Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Thoracic Society Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</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>
      This is a small pilot prospective intervention trial in children with asthma who will be&#xD;
      randomized to receive either (A) Air Quality Index (AQI) education + an asthma action plan&#xD;
      (control) or (B) AQI education + an asthma action plan which contains AQI behavioral&#xD;
      recommendations + demonstrate ability to navigate to AirNow either online or on smartphone&#xD;
      app (intervention).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over 3 million US children with asthma reported at least one attack in the prior year. Poorly&#xD;
      controlled asthma is a major cause of suffering, school absences, loss of caregiver&#xD;
      productivity, and healthcare costs (estimated as ~$80 billion/year). Over half of children on&#xD;
      controller medication are not well controlled, due to environmental exposures, non-adherence,&#xD;
      or true non-response to treatment. Outdoor air pollution is a known trigger of asthma.&#xD;
      Although sound health policies are the best long-term approaches to reduce the harmful&#xD;
      effects of air pollution, exposure avoidance is needed until &quot;clean air&quot; is ensured through&#xD;
      effective legislation. Despite this, healthcare providers infrequently provide pollution&#xD;
      exposure advice to children with asthma. The Environmental Protection Agency (EPA) monitors&#xD;
      air pollution and reports a daily Air Quality Index (AQI) that is easy to use and available&#xD;
      in most metropolitan areas. Practical recommendations regarding outdoor activity can be based&#xD;
      on AQI levels. Despite this, AQI-based recommendations are rarely addressed in asthma action&#xD;
      plans (AAP). No pediatric study has assessed the addition of the AQI to AAP to reduce asthma&#xD;
      morbidity. This proposal seeks to recruit a pilot cohort of 40 children with asthma. Using&#xD;
      this cohort, the investigators will test the hypotheses that (1) the addition of the AQI to&#xD;
      AAP will reduce asthma exacerbations and (2) the addition of the AQI to AAP will improve&#xD;
      asthma symptom control &amp; quality of life in children with asthma. The inclusion of the AQI&#xD;
      onto asthma action plans is novel in clinical asthma care; its wide availability would make&#xD;
      large-scale implementation feasible. The investigators expect this low-cost and low-tech&#xD;
      intervention will have a positive impact in reducing asthma morbidity. Given that 1 out of&#xD;
      every 12 children in the U.S. has asthma, this is relevant to health care professionals,&#xD;
      parents, and public health practitioners.&#xD;
&#xD;
      Optional, the investigators will collect nasal epithelial cells for use in future&#xD;
      genomic/epigenetic studies.&#xD;
&#xD;
      Additionally, 40 parents/guardians of the children were also recruited to complete a baseline&#xD;
      parental knowledge and usage of the AQI questionnaire administered at the randomization&#xD;
      visit. This was originally listed as a secondary outcome however was removed during reporting&#xD;
      of results as parental knowledge is not a true clinical trial outcome. Also, the secondary&#xD;
      outcome of baseline child AQI usage (checking AQI) was changed to reflect this was a measure&#xD;
      collected at all study visits and the secondary measure of physical activity was added.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 14, 2020</start_date>
  <completion_date type="Actual">March 22, 2021</completion_date>
  <primary_completion_date type="Actual">March 22, 2021</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>
    <intervention_model_description>40 child will be 1:1 randomization by age groups 8-12 years, 13-17 years.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Unblinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With at Least One Moderate or Severe Asthma Exacerbation Over Time</measure>
    <time_frame>Over study duration (up to 6 months)</time_frame>
    <description>Moderate and severe asthma exacerbations were captured via questionnaire administered monthly for up to 6 months. Severe and moderate exacerbations were defined by American Thoracic Society (ATS) criteria.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change in Asthma Control Over Time</measure>
    <time_frame>Over study duration (up to 6 months)</time_frame>
    <description>Asthma symptom control was measured by the validated Asthma Control Test (ACT) or Childhood Asthma Control Test (CACT) questionnaires as age appropriate (ACT in children 12 year of age or older; CACT for children younger than 12 years of age). ACT and CACT were obtained at baseline and every 4 weeks for up to 6 months. Differences in asthma control scores were compared both within arms and between arms at study end. ACT (min=5, max=25, score of &lt;=19 concerning for poor asthma control; &lt;=15 concerning for very poorly controlled). CACT (min=0, max=27, score of &lt;=19 concerning for poor asthma control; &lt;=12 concerning for very poorly controlled)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change in Pediatric Asthma Quality of Life Over Time</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Quality of life will be measured by the validated Pediatric Asthma Quality of Life Questionnaire with standardized activities (PAQLQ) at entrance and exit visits. Differences in PAQLQ scores will be compared both within arms and between arms at study end. PAQLQ (min=1 (extremely bothered/all the time), max=7 (not bothered/none of the time)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Reported Checking the AQI Prior to Going Outside to be Active</measure>
    <time_frame>Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.</time_frame>
    <description>Participant reported checking of AQI prior to going outside to be active assessed via questionnaire. Question: In the past 4 weeks, did you check the air quality index before going outside to be active? Response choices: Yes, No.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participated Who Reported Outdoor Activity Behavioral Change in Response to the AQI</measure>
    <time_frame>Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.</time_frame>
    <description>Usage of the AQI prior to exercise was monitored monthly via questionnaire. Question: In the past 4 weeks, how many times did you change your outdoor activity because of the air quality index? Response choices: All of the time, Most of the time, Some of the time, A little of the time, None of the time. A positive response was considered an answer of all, most, some, or a little of the time. A negative response was considered none of the time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Reported Moderate or Vigorous Physical Activity for at Least 10 Minutes Continuously Outside in a Typical Week</measure>
    <time_frame>Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.</time_frame>
    <description>Outcome obtained from physical activity questionnaire. Yes represents a positive response to at least one of the follow two questions: Question 1: In a typical week {do you/does SP} do any vigorous-intensity sports, fitness, or recreational activities that cause large increases in breathing or heart rate like running or basketball for at least 10 minutes continuously outside? Response choices: Yes, No, Refused, Don't Know. Note: refused and don't know were coded as negative. Question 2: In a typical week, {do you/does SP} do any moderate-intensity sports, fitness, or recreational activities that cause a small increase in breathing or heart rate such as brisk walking, bicycling, swimming, or volleyball for at least 10 minutes continuously outside? Response choices: Yes, No, Refused, Don't Know. Note: refused and don't know were coded as negative.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Asthma</condition>
  <condition>Asthma in Children</condition>
  <arm_group>
    <arm_group_label>Routine Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>AQI Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>AQI intervention</intervention_name>
    <description>The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).</description>
    <arm_group_label>AQI Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Routine care</intervention_name>
    <description>The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.</description>
    <arm_group_label>Routine Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Child Inclusion criteria includes:&#xD;
&#xD;
               1. physician diagnosis of persistent asthma- either mild, moderate, or severe;&#xD;
&#xD;
               2. family home internet access and/or smartphone access + willingness to download&#xD;
                  AirNow app on phone;&#xD;
&#xD;
               3. age 8-17 years.&#xD;
&#xD;
        Parent/guardian inclusion: parent or guardian of the child participant, of whom has met&#xD;
        inclusion criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child exclusion criteria includes:&#xD;
&#xD;
               1. diagnosis of other chronic respiratory disease (e.g. cystic fibrosis,&#xD;
                  bronchopulmonary dysplasia, etc)&#xD;
&#xD;
               2. immunodeficiency- acquired or congenital&#xD;
&#xD;
               3. neuromuscular disease&#xD;
&#xD;
               4. disability affecting ambulation&#xD;
&#xD;
               5. cyanotic congenital heart disease&#xD;
&#xD;
               6. only 1 child per household eligible&#xD;
&#xD;
               7. no plans to leave Pittsburgh area in next 6 months&#xD;
&#xD;
        Parental/guardian exclusion criteria: none.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Franziska Rosser, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>UPMC | Children's Hospital of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UPMC Children's Hospital of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Reyes-Angel J, Han YY, Forno E, Celedon JC, Rosser FJ. Parental knowledge and usage of air quality in childhood asthma management. Front Pediatr. 2022 Oct 26;10:966372. doi: 10.3389/fped.2022.966372. eCollection 2022.</citation>
    <PMID>36440347</PMID>
  </reference>
  <results_reference>
    <citation>Rosser FJ, Rothenberger SD, Han YY, Forno E, Celedon JC. Air Quality Index and Childhood Asthma: A Pilot Randomized Clinical Trial Intervention. Am J Prev Med. 2023 Jun;64(6):893-897. doi: 10.1016/j.amepre.2022.12.010. Epub 2023 Jan 13.</citation>
    <PMID>36642643</PMID>
  </results_reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <results_first_submitted>March 31, 2022</results_first_submitted>
  <results_first_submitted_qc>August 11, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 15, 2023</results_first_posted>
  <last_update_submitted>August 21, 2023</last_update_submitted>
  <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Franziska Rosser, MD MPH</investigator_full_name>
    <investigator_title>Assistant Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Air Quality Index (AQI)</keyword>
  <keyword>Childhood asthma exacerbations</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>
    <ipd_description>The investigators do not currently have an individual participant data sharing plan. However, de-identified research data/documents may be shared in the future with other investigators who share similar research interests.&#xD;
Specimens and data will not be released without (1) PI written permission and (2) appropriate Institutional Review Board (IRB) approval. Data use and/or material transfer agreements will also be required as applicable to outside researchers.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 17, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT04454125/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Routine Care</title>
          <description>Routine care: The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.</description>
        </group>
        <group group_id="P2">
          <title>AQI Intervention</title>
          <description>AQI intervention: The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="19"/>
              </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>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Routine Care</title>
          <description>Routine care: The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.</description>
        </group>
        <group group_id="B2">
          <title>AQI Intervention</title>
          <description>AQI intervention: The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).</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="20"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.5" spread="2.6"/>
                    <measurement group_id="B2" value="12.5" spread="2.9"/>
                    <measurement group_id="B3" value="12.5" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Black</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than 1 race</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>At least one severe asthma exacerbation in the past 12 months, yes</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Asthma Control Test (ACT)</title>
          <description>ACT score ranges from 5-25. Scores &lt;=19 concerning for poor asthma control, scores &lt;=15 concerning for very poor asthma control</description>
          <population>ACT administered to children aged 12 years and older.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="13"/>
                    <count group_id="B2" value="13"/>
                    <count group_id="B3" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.9" spread="4.6"/>
                    <measurement group_id="B2" value="21.2" spread="3.0"/>
                    <measurement group_id="B3" value="21.0" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Childhood Asthma Control Test (CACT)</title>
          <description>CACT score ranges from 0-27. Scores &lt;=19 concerning for poor asthma control, scores &lt;=12 concerning for very poor asthma control</description>
          <population>CACT administered to children aged 8-11 years of age</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.6" spread="1.3"/>
                    <measurement group_id="B2" value="20.7" spread="8.3"/>
                    <measurement group_id="B3" value="21.6" spread="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pediatric Asthma Quality of Life Questionnaire</title>
          <description>PAQLQ scores range from 1 (severe asthma impairment) to 7 (no asthma impairment)</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.96" spread="1.02"/>
                    <measurement group_id="B2" value="6.11" spread="0.84"/>
                    <measurement group_id="B3" value="6.03" spread="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index z-score (BMIz)</title>
          <description>BMI is calculated by dividing a child's weight (in kg) by height squared (in meters), age and sex specific, and expressed as z-scores which are based on standard normal distribution. A score of 0 represents the population mean. For children, a BMI z-score equal to or greater than 1.036 and less than 1.645 is defined as overweight. A z-score equal to or greater than 1.645 is defined as obese. Reference: Center for Disease Control and Prevention (CDC) growth charts.</description>
          <units>z score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.51" spread="1.35"/>
                    <measurement group_id="B2" value="1.03" spread="1.22"/>
                    <measurement group_id="B3" value="1.27" spread="1.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Reported checking the AQI prior to going outside to be active, yes</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Reported any change in outdoor activity because of the AQI, yes</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Reported moderate or vigorous activity for at least 10 minutes outside in a typical week, yes</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With at Least One Moderate or Severe Asthma Exacerbation Over Time</title>
        <description>Moderate and severe asthma exacerbations were captured via questionnaire administered monthly for up to 6 months. Severe and moderate exacerbations were defined by American Thoracic Society (ATS) criteria.</description>
        <time_frame>Over study duration (up to 6 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Routine Care</title>
            <description>Routine care: The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.</description>
          </group>
          <group group_id="O2">
            <title>AQI Intervention</title>
            <description>AQI intervention: The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least One Moderate or Severe Asthma Exacerbation Over Time</title>
          <description>Moderate and severe asthma exacerbations were captured via questionnaire administered monthly for up to 6 months. Severe and moderate exacerbations were defined by American Thoracic Society (ATS) criteria.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At least one severe asthma exacerbation during study, yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least one moderate asthma exacerbation during study, yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome= severe asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.32</p_value>
            <method>Generalized linear model, repeat measure</method>
            <method_desc>Generalized linear model (GLM) fitted with binomial distribution and logit link</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.23</ci_lower_limit>
            <ci_upper_limit>1.61</ci_upper_limit>
            <estimate_desc>Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group arm, visit, interaction term (arm*visit) and adjusting for visit 2 severe asthma exacerbation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome= severe asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.29</p_value>
            <method>generalized linear model, repeat measure</method>
            <method_desc>GLM fitted with binomial distribution and logit link</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.03</ci_lower_limit>
            <ci_upper_limit>2.76</ci_upper_limit>
            <estimate_desc>Estimate is for the intervention group (AQI intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group*visit) and adjusting for visit 2 severe asthma exacerbation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome= severe asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.58</p_value>
            <method>generalized linear model, repeat measure</method>
            <method_desc>GLM fitted with binomial distribution and logit link</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.51</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.05</ci_lower_limit>
            <ci_upper_limit>5.68</ci_upper_limit>
            <other_analysis_desc>Estimate is for the interaction term (group*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group*visit) and adjusting for visit 2 severe asthma exacerbation.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome= moderate asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.02</p_value>
            <method>generalized linear model, repeat measure</method>
            <method_desc>GLM fitted with binomial distribution and logit link</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.27</ci_lower_limit>
            <ci_upper_limit>0.91</ci_upper_limit>
            <estimate_desc>Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group*visit) and adjusting for visit 2 moderate asthma exacerbation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome= moderate asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.03</p_value>
            <method>generalized linear model, repeat measure</method>
            <method_desc>GLM fitted with binomial distribution and logit link</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.06</ci_lower_limit>
            <ci_upper_limit>0.86</ci_upper_limit>
            <estimate_desc>Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group*visit) and adjusting for visit 2 moderate asthma exacerbation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome= moderate asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.30</p_value>
            <method>generalized linear model, repeat measure</method>
            <method_desc>GLM fitted with binomial distribution and logit link</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.11</ci_lower_limit>
            <ci_upper_limit>1.95</ci_upper_limit>
            <estimate_desc>Estimate is for the interaction term (group*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group*visit) and adjusting for visit 2 moderate asthma exacerbation.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change in Asthma Control Over Time</title>
        <description>Asthma symptom control was measured by the validated Asthma Control Test (ACT) or Childhood Asthma Control Test (CACT) questionnaires as age appropriate (ACT in children 12 year of age or older; CACT for children younger than 12 years of age). ACT and CACT were obtained at baseline and every 4 weeks for up to 6 months. Differences in asthma control scores were compared both within arms and between arms at study end. ACT (min=5, max=25, score of &lt;=19 concerning for poor asthma control; &lt;=15 concerning for very poorly controlled). CACT (min=0, max=27, score of &lt;=19 concerning for poor asthma control; &lt;=12 concerning for very poorly controlled)</description>
        <time_frame>Over study duration (up to 6 months)</time_frame>
        <population>The mean change was obtained, via generalized linear modeling (glm), taking into account the correlation of repeat measures. The values are listed by group and contain all available time points averaged.</population>
        <group_list>
          <group group_id="O1">
            <title>Routine Care</title>
            <description>Routine care: The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.</description>
          </group>
          <group group_id="O2">
            <title>AQI Intervention</title>
            <description>AQI intervention: The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Asthma Control Over Time</title>
          <description>Asthma symptom control was measured by the validated Asthma Control Test (ACT) or Childhood Asthma Control Test (CACT) questionnaires as age appropriate (ACT in children 12 year of age or older; CACT for children younger than 12 years of age). ACT and CACT were obtained at baseline and every 4 weeks for up to 6 months. Differences in asthma control scores were compared both within arms and between arms at study end. ACT (min=5, max=25, score of &lt;=19 concerning for poor asthma control; &lt;=15 concerning for very poorly controlled). CACT (min=0, max=27, score of &lt;=19 concerning for poor asthma control; &lt;=12 concerning for very poorly controlled)</description>
          <population>The mean change was obtained, via generalized linear modeling (glm), taking into account the correlation of repeat measures. The values are listed by group and contain all available time points averaged.</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="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Asthma Control Test</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17" lower_limit="-1.17" upper_limit="1.51"/>
                    <measurement group_id="O2" value="2.02" lower_limit="0.88" upper_limit="3.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Childhood Asthma Control Test</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.31" lower_limit="-1.87" upper_limit="1.25"/>
                    <measurement group_id="O2" value="3.96" lower_limit="-1.27" upper_limit="9.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome=Asthma Control Test Score. Obtained at all visits.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.80</p_value>
            <method>generalized linear model, repeat measure</method>
            <method_desc>GLM fitted with Normal/Gaussian distribution and identity link</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.17</ci_lower_limit>
            <ci_upper_limit>1.51</ci_upper_limit>
            <estimate_desc>Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group*visit).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome=Asthma Control Test Score. Obtained at all visits.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>generalized linear model, repeat measure</method>
            <method_desc>GLM fitted with Normal/Gaussian distribution and identity link</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>2.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>3.15</ci_upper_limit>
            <estimate_desc>Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group*visit).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome=Asthma Control Test Score. Obtained at all visits.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.04</p_value>
            <method>generalized linear model, repeat measure</method>
            <method_desc>GLM fitted with Normal/Gaussian distribution and identity link</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.09</ci_lower_limit>
            <ci_upper_limit>3.61</ci_upper_limit>
            <estimate_desc>Estimate is for the interaction term (group*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group*visit).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome=Childhood Asthma Control Test Score. Obtained at all visits.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.70</p_value>
            <method>generalized linear model, repeat measure</method>
            <method_desc>GLM fitted with Normal/Gaussian distribution and identity link</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.87</ci_lower_limit>
            <ci_upper_limit>1.25</ci_upper_limit>
            <estimate_desc>Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group*visit).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome=Childhood Asthma Control Test Score. Obtained at all visits.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.14</p_value>
            <method>generalized linear model, repeat measure</method>
            <method_desc>GLM fitted with Normal/Gaussian distribution and identity link</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>3.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.27</ci_lower_limit>
            <ci_upper_limit>9.20</ci_upper_limit>
            <estimate_desc>Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group*visit).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome=Childhood Asthma Control Test Scores.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.13</p_value>
            <method>generalized linear model, repeat measure</method>
            <method_desc>GLM fitted with Normal/Gaussian distribution and identity link</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>4.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.19</ci_lower_limit>
            <ci_upper_limit>9.73</ci_upper_limit>
            <estimate_desc>Estimate is for the interaction term (group*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group*visit).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change in Pediatric Asthma Quality of Life Over Time</title>
        <description>Quality of life will be measured by the validated Pediatric Asthma Quality of Life Questionnaire with standardized activities (PAQLQ) at entrance and exit visits. Differences in PAQLQ scores will be compared both within arms and between arms at study end. PAQLQ (min=1 (extremely bothered/all the time), max=7 (not bothered/none of the time)</description>
        <time_frame>Baseline, 6 months</time_frame>
        <population>1 participant lost to follow up at exit visit</population>
        <group_list>
          <group group_id="O1">
            <title>Routine Care</title>
            <description>Routine care: The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.</description>
          </group>
          <group group_id="O2">
            <title>AQI Intervention</title>
            <description>AQI intervention: The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Pediatric Asthma Quality of Life Over Time</title>
          <description>Quality of life will be measured by the validated Pediatric Asthma Quality of Life Questionnaire with standardized activities (PAQLQ) at entrance and exit visits. Differences in PAQLQ scores will be compared both within arms and between arms at study end. PAQLQ (min=1 (extremely bothered/all the time), max=7 (not bothered/none of the time)</description>
          <population>1 participant lost to follow up at exit visit</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="20"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.25" lower_limit="-0.06" upper_limit="0.55"/>
                    <measurement group_id="O2" value="0.54" lower_limit="0.20" upper_limit="0.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome: Pediatric Asthma Quality of Life Questionnaire. Obtained at randomization and exit visits (visit 1 and visit 7).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.11</p_value>
            <method>generalized linear model, repeat measure</method>
            <method_desc>GLM fitted with Normal/Gaussian distribution and identity link</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.06</ci_lower_limit>
            <ci_upper_limit>0.55</ci_upper_limit>
            <estimate_desc>Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group*visit).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome: Pediatric Asthma Quality of Life Questionnaire. Obtained at randomization and exit visits (visit 1 and visit 7).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>generalized linear model, repeat measure</method>
            <method_desc>GLM fitted with Normal/Gaussian distribution and identity link</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.54</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.20</ci_lower_limit>
            <ci_upper_limit>0.88</ci_upper_limit>
            <estimate_desc>Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group*visit).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome: Pediatric Asthma Quality of Life Questionnaire. Obtained at randomization and exit visits (visit 1 and visit 7).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.20</p_value>
            <method>generalized linear model, repeat measure</method>
            <method_desc>GLM fitted with Normal/Gaussian distribution and identity link</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.16</ci_lower_limit>
            <ci_upper_limit>0.75</ci_upper_limit>
            <estimate_desc>Estimate is for the interaction term (group*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group*visit).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Reported Checking the AQI Prior to Going Outside to be Active</title>
        <description>Participant reported checking of AQI prior to going outside to be active assessed via questionnaire. Question: In the past 4 weeks, did you check the air quality index before going outside to be active? Response choices: Yes, No.</description>
        <time_frame>Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.</time_frame>
        <population>1 participant lost to follow up at exit visit; all participant data (n=40) was included in glm analyses as presented in statistical analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Routine Care</title>
            <description>Routine care: The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.</description>
          </group>
          <group group_id="O2">
            <title>AQI Intervention</title>
            <description>AQI intervention: The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Reported Checking the AQI Prior to Going Outside to be Active</title>
          <description>Participant reported checking of AQI prior to going outside to be active assessed via questionnaire. Question: In the past 4 weeks, did you check the air quality index before going outside to be active? Response choices: Yes, No.</description>
          <population>1 participant lost to follow up at exit visit; all participant data (n=40) was included in glm analyses as presented in statistical analyses.</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="20"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome: Reported checking the AQI prior to going outside to be active</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.87</p_value>
            <method>generalized linear model, repeat measure</method>
            <method_desc>GLM fitted with binomial distribution and logit link</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.45</ci_lower_limit>
            <ci_upper_limit>1.96</ci_upper_limit>
            <estimate_desc>Estimate is control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group*visit).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome: Reported checking the AQI prior to going outside to be active</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.004</p_value>
            <method>generalized linear model, repeat measure</method>
            <method_desc>GLM fitted with binomial distribution and logit link</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>6.89</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.85</ci_lower_limit>
            <ci_upper_limit>25.6</ci_upper_limit>
            <estimate_desc>Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group*visit).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome: Reported checking the AQI prior to going outside to be active</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.01</p_value>
            <method>generalized linear model, repeat measure</method>
            <method_desc>GLM fitted with binomial distribution and logit link</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>7.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.62</ci_lower_limit>
            <ci_upper_limit>32.9</ci_upper_limit>
            <estimate_desc>Estimate is for the interaction term (group*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group*visit).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participated Who Reported Outdoor Activity Behavioral Change in Response to the AQI</title>
        <description>Usage of the AQI prior to exercise was monitored monthly via questionnaire. Question: In the past 4 weeks, how many times did you change your outdoor activity because of the air quality index? Response choices: All of the time, Most of the time, Some of the time, A little of the time, None of the time. A positive response was considered an answer of all, most, some, or a little of the time. A negative response was considered none of the time.</description>
        <time_frame>Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.</time_frame>
        <population>1 participant lost to follow up at exit visit; all participant data (n=40) was included in glm analyses as presented in statistical analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Routine Care</title>
            <description>Routine care: The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.</description>
          </group>
          <group group_id="O2">
            <title>AQI Intervention</title>
            <description>AQI intervention: The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participated Who Reported Outdoor Activity Behavioral Change in Response to the AQI</title>
          <description>Usage of the AQI prior to exercise was monitored monthly via questionnaire. Question: In the past 4 weeks, how many times did you change your outdoor activity because of the air quality index? Response choices: All of the time, Most of the time, Some of the time, A little of the time, None of the time. A positive response was considered an answer of all, most, some, or a little of the time. A negative response was considered none of the time.</description>
          <population>1 participant lost to follow up at exit visit; all participant data (n=40) was included in glm analyses as presented in statistical analyses.</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="20"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome: Reported outdoor activity behavioral change in response to the AQI, obtained at all visits.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.15</p_value>
            <method>generalized linear model, repeat measure</method>
            <method_desc>GLM fitted with binomial distribution and logit link</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.34</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.08</ci_lower_limit>
            <ci_upper_limit>1.47</ci_upper_limit>
            <estimate_desc>Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group*visit).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome: Reported outdoor activity behavioral change in response to the AQI, obtained at all visits.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.94</p_value>
            <method>generalized linear model, repeat measure</method>
            <method_desc>GLM fitted with binomial distribution and logit link</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.35</ci_lower_limit>
            <ci_upper_limit>2.68</ci_upper_limit>
            <estimate_desc>Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group*visit).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome: Reported outdoor activity behavioral change in response to the AQI, obtained at all visits.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.26</p_value>
            <method>generalized linear model, repeat measure</method>
            <method_desc>GLM fitted with binomial distribution and logit link</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.79</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.47</ci_lower_limit>
            <ci_upper_limit>16.5</ci_upper_limit>
            <estimate_desc>Estimate is for the interaction term (group*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group*visit).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Reported Moderate or Vigorous Physical Activity for at Least 10 Minutes Continuously Outside in a Typical Week</title>
        <description>Outcome obtained from physical activity questionnaire. Yes represents a positive response to at least one of the follow two questions: Question 1: In a typical week {do you/does SP} do any vigorous-intensity sports, fitness, or recreational activities that cause large increases in breathing or heart rate like running or basketball for at least 10 minutes continuously outside? Response choices: Yes, No, Refused, Don't Know. Note: refused and don't know were coded as negative. Question 2: In a typical week, {do you/does SP} do any moderate-intensity sports, fitness, or recreational activities that cause a small increase in breathing or heart rate such as brisk walking, bicycling, swimming, or volleyball for at least 10 minutes continuously outside? Response choices: Yes, No, Refused, Don't Know. Note: refused and don't know were coded as negative.</description>
        <time_frame>Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.</time_frame>
        <population>1 participant lost to follow up at exit visit; all participant data (n=40) was included in glm analyses as presented in statistical analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Routine Care</title>
            <description>Routine care: The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.</description>
          </group>
          <group group_id="O2">
            <title>AQI Intervention</title>
            <description>AQI intervention: The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Reported Moderate or Vigorous Physical Activity for at Least 10 Minutes Continuously Outside in a Typical Week</title>
          <description>Outcome obtained from physical activity questionnaire. Yes represents a positive response to at least one of the follow two questions: Question 1: In a typical week {do you/does SP} do any vigorous-intensity sports, fitness, or recreational activities that cause large increases in breathing or heart rate like running or basketball for at least 10 minutes continuously outside? Response choices: Yes, No, Refused, Don't Know. Note: refused and don't know were coded as negative. Question 2: In a typical week, {do you/does SP} do any moderate-intensity sports, fitness, or recreational activities that cause a small increase in breathing or heart rate such as brisk walking, bicycling, swimming, or volleyball for at least 10 minutes continuously outside? Response choices: Yes, No, Refused, Don't Know. Note: refused and don't know were coded as negative.</description>
          <population>1 participant lost to follow up at exit visit; all participant data (n=40) was included in glm analyses as presented in statistical analyses.</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="20"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Obtained at all visits</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.004</p_value>
            <method>generalized linear model, repeat measure</method>
            <method_desc>GLM fitted with binomial distribution and logit link</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.24</ci_lower_limit>
            <ci_upper_limit>0.76</ci_upper_limit>
            <estimate_desc>Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group*visit).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Obtained at all visits.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>generalized linear model, repeat measure</method>
            <method_desc>GLM fitted with binomial distribution and logit link</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.05</ci_lower_limit>
            <ci_upper_limit>0.31</ci_upper_limit>
            <estimate_desc>Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group*visit).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Obtained at all visits.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.03</p_value>
            <method>generalized linear model, repeat measure</method>
            <method_desc>GLM fitted with binomial distribution and logit link</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.29</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.10</ci_lower_limit>
            <ci_upper_limit>0.87</ci_upper_limit>
            <estimate_desc>Estimate is for the interaction term (group*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group*visit).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were monitored during the 6 month study duration.</time_frame>
      <desc>Asthma is a chronic lung disease with varying impairment and risk, thus asthma exacerbations and loss of control are not unexpected. However, if a participant reported 3 severe asthma exacerbations, 3 consecutive control test scores &lt;=19, or had FEV1 &lt;80% at either visit, these were recorded, the parent was notified, and follow-up with managing asthma specialist was recommended. Hospitalizations for asthma were considered expected, serious adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Routine Care</title>
          <description>Routine care: The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.</description>
        </group>
        <group group_id="E2">
          <title>AQI Intervention</title>
          <description>AQI intervention: The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma exacerbation requiring hospitalization</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Three consecutive poor control scores</sub_title>
                <description>Having 3 consecutive ACT or CACT scores concerning for poor control (&lt;=19)</description>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Three severe asthma exacerbations</sub_title>
                <description>Reporting a severe asthma exacerbation at 3 study visits</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Low FEV1</sub_title>
                <description>Forced expiratory volume in 1 sec (FEV1) &lt;80% at randomization or exit visit</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Franziska Rosser</name_or_title>
      <organization>University of Pittsburgh</organization>
      <phone>412-692-8429</phone>
      <email>franziska.rosser2@chp.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/NCT04454125
org study id: STUDY19120083
nct id: NCT04454125
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a small pilot prospective intervention trial in children with asthma who will be
      randomized to receive either (A) Air Quality Index (AQI) education + an asthma action plan
      (control) or (B) AQI education + an asthma action plan which contains AQI behavioral
      recommendations + demonstrate ability to navigate to AirNow either online or on smartphone
      app (intervention).
Over 3 million US children with asthma reported at least one attack in the prior year. Poorly
      controlled asthma is a major cause of suffering, school absences, loss of caregiver
      productivity, and healthcare costs (estimated as ~$80 billion/year). Over half of children on
      controller medication are not well controlled, due to environmental exposures, non-adherence,
      or true non-response to treatment. Outdoor air pollution is a known trigger of asthma.
      Although sound health policies are the best long-term approaches to reduce the harmful
      effects of air pollution, exposure avoidance is needed until "clean air" is ensured through
      effective legislation. Despite this, healthcare providers infrequently provide pollution
      exposure advice to children with asthma. The Environmental Protection Agency (EPA) monitors
      air pollution and reports a daily Air Quality Index (AQI) that is easy to use and available
      in most metropolitan areas. Practical recommendations regarding outdoor activity can be based
      on AQI levels. Despite this, AQI-based recommendations are rarely addressed in asthma action
      plans (AAP). No pediatric study has assessed the addition of the AQI to AAP to reduce asthma
      morbidity. This proposal seeks to recruit a pilot cohort of 40 children with asthma. Using
      this cohort, the investigators will test the hypotheses that (1) the addition of the AQI to
      AAP will reduce asthma exacerbations and (2) the addition of the AQI to AAP will improve
      asthma symptom control & quality of life in children with asthma. The inclusion of the AQI
      onto asthma action plans is novel in clinical asthma care; its wide availability would make
      large-scale implementation feasible. The investigators expect this low-cost and low-tech
      intervention will have a positive impact in reducing asthma morbidity. Given that 1 out of
      every 12 children in the U.S. has asthma, this is relevant to health care professionals,
      parents, and public health practitioners.

      Optional, the investigators will collect nasal epithelial cells for use in future
      genomic/epigenetic studies.

      Additionally, 40 parents/guardians of the children were also recruited to complete a baseline
      parental knowledge and usage of the AQI questionnaire administered at the randomization
      visit. This was originally listed as a secondary outcome however was removed during reporting
      of results as parental knowledge is not a true clinical trial outcome. Also, the secondary
      outcome of baseline child AQI usage (checking AQI) was changed to reflect this was a measure
      collected at all study visits and the secondary measure of physical activity was added.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 40 child will be 1:1 randomization by age groups 8-12 years, 13-17 years.
primary purpose: Treatment
masking: None (Open Label)
masking description: Unblinded
measure: Number of Participants With at Least One Moderate or Severe Asthma Exacerbation Over Time
time frame: Over study duration (up to 6 months)
description: Moderate and severe asthma exacerbations were captured via questionnaire administered monthly for up to 6 months. Severe and moderate exacerbations were defined by American Thoracic Society (ATS) criteria.
measure: Mean Change in Asthma Control Over Time
time frame: Over study duration (up to 6 months)
description: Asthma symptom control was measured by the validated Asthma Control Test (ACT) or Childhood Asthma Control Test (CACT) questionnaires as age appropriate (ACT in children 12 year of age or older; CACT for children younger than 12 years of age). ACT and CACT were obtained at baseline and every 4 weeks for up to 6 months. Differences in asthma control scores were compared both within arms and between arms at study end. ACT (min=5, max=25, score of <=19 concerning for poor asthma control; <=15 concerning for very poorly controlled). CACT (min=0, max=27, score of <=19 concerning for poor asthma control; <=12 concerning for very poorly controlled)
measure: Mean Change in Pediatric Asthma Quality of Life Over Time
time frame: Baseline, 6 months
description: Quality of life will be measured by the validated Pediatric Asthma Quality of Life Questionnaire with standardized activities (PAQLQ) at entrance and exit visits. Differences in PAQLQ scores will be compared both within arms and between arms at study end. PAQLQ (min=1 (extremely bothered/all the time), max=7 (not bothered/none of the time)
measure: Number of Participants Who Reported Checking the AQI Prior to Going Outside to be Active
time frame: Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.
description: Participant reported checking of AQI prior to going outside to be active assessed via questionnaire. Question: In the past 4 weeks, did you check the air quality index before going outside to be active? Response choices: Yes, No.
measure: Number of Participated Who Reported Outdoor Activity Behavioral Change in Response to the AQI
time frame: Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.
description: Usage of the AQI prior to exercise was monitored monthly via questionnaire. Question: In the past 4 weeks, how many times did you change your outdoor activity because of the air quality index? Response choices: All of the time, Most of the time, Some of the time, A little of the time, None of the time. A positive response was considered an answer of all, most, some, or a little of the time. A negative response was considered none of the time.
measure: Number of Participants Who Reported Moderate or Vigorous Physical Activity for at Least 10 Minutes Continuously Outside in a Typical Week
time frame: Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.
description: Outcome obtained from physical activity questionnaire. Yes represents a positive response to at least one of the follow two questions: Question 1: In a typical week {do you/does SP} do any vigorous-intensity sports, fitness, or recreational activities that cause large increases in breathing or heart rate like running or basketball for at least 10 minutes continuously outside? Response choices: Yes, No, Refused, Don't Know. Note: refused and don't know were coded as negative. Question 2: In a typical week, {do you/does SP} do any moderate-intensity sports, fitness, or recreational activities that cause a small increase in breathing or heart rate such as brisk walking, bicycling, swimming, or volleyball for at least 10 minutes continuously outside? Response choices: Yes, No, Refused, Don't Know. Note: refused and don't know were coded as negative.
arm group label: Routine Care
arm group type: Active Comparator
arm group label: AQI Intervention
arm group type: Experimental
intervention type: Behavioral
intervention name: AQI intervention
description: The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).
arm group label: AQI Intervention
intervention type: Other
intervention name: Routine care
description: The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.
arm group label: Routine Care
criteria: 
gender: All
minimum age: 8 Years
maximum age: 17 Years
healthy volunteers: No
last name: Franziska Rosser, MD MPH
role: Principal Investigator
affiliation: UPMC | Children's Hospital of Pittsburgh
facility: 
country: United States
citation: Reyes-Angel J, Han YY, Forno E, Celedon JC, Rosser FJ. Parental knowledge and usage of air quality in childhood asthma management. Front Pediatr. 2022 Oct 26;10:966372. doi: 10.3389/fped.2022.966372. eCollection 2022.
PMID: 36440347
citation: Rosser FJ, Rothenberger SD, Han YY, Forno E, Celedon JC. Air Quality Index and Childhood Asthma: A Pilot Randomized Clinical Trial Intervention. Am J Prev Med. 2023 Jun;64(6):893-897. doi: 10.1016/j.amepre.2022.12.010. Epub 2023 Jan 13.
PMID: 36642643
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Franziska Rosser, MD MPH
investigator title: Assistant Professor of Pediatrics
mesh term: Asthma
sharing ipd: No
ipd description: The investigators do not currently have an individual participant data sharing plan. However, de-identified research data/documents may be shared in the future with other investigators who share similar research interests.
Specimens and data will not be released without (1) PI written permission and (2) appropriate Institutional Review Board (IRB) approval. Data use and/or material transfer agreements will also be required as applicable to outside researchers.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 