<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/NCT02228499</url>
  </required_header>
  <id_info>
    <org_study_id>00005030</org_study_id>
    <nct_id>NCT02228499</nct_id>
  </id_info>
  <brief_title>Academic Achievement in Children With Asthma</brief_title>
  <official_title>Academic Achievement in Children With Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shilpa Patel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's National Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Asthma is the most common chronic disease of childhood with a prevalence that is&#xD;
      1.6 times greater in African American children than in Non-Hispanic White children.1&#xD;
      Nationally, 700,000 children are seen for asthma in Emergency Departments every year, 1% of&#xD;
      which are seen at Children's National Health System in Washington, District of Columbia.&#xD;
      School performance and school attendance has not been well studied in urban children with&#xD;
      asthma, especially at the middle school level.&#xD;
&#xD;
      Objective: Our purpose is to test the hypothesis that middle school children with asthma have&#xD;
      worse school performance than middle school children without asthma in Washington DC and&#xD;
      Prince George's county schools.&#xD;
&#xD;
      Methods: The investigators will conduct a cross-sectional observational study of&#xD;
      middle-school (grades 6-8 in the 2013-2014 school year) aged children with and without asthma&#xD;
      recruited from the Emergency Departments and the IMPACT DC asthma clinic at CN. The&#xD;
      investigators will collect demographic information, asthma severity information (for cases),&#xD;
      and request that parents mail report cards and standardized test scores directly to the&#xD;
      investigators. The investigators will use multivariable linear and logistic regression to&#xD;
      determine if the presence of asthma is associated with school performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Academic Achievement in Children with Asthma&#xD;
&#xD;
      Research Plan A. Background and Specific Aims Asthma is the most common chronic disease of&#xD;
      childhood with a prevalence that is 1.6 times greater in African American children than in&#xD;
      Non-Hispanic White children. Nationally, 700,000 children are seen for asthma in Emergency&#xD;
      Departments (ED) every year, 1% of which are seen at Children's National (CN) Medical Center&#xD;
      in Washington, District of Columbia (DC). The asthma prevalence rate among African American&#xD;
      children and teens in Washington, District of Columbia is 20% higher than the national rate&#xD;
      and overall emergency department utilization rates for asthma are 4.3 times the national&#xD;
      rate. In 2007, approximately 10.5 million school days were lost due to asthma.&#xD;
&#xD;
      Asthma severity may impact academic performance due to increased absenteeism. A study of&#xD;
      Canadian school children showed that children with the most severe asthma had the lowest math&#xD;
      and reading scores.4 Tsakiris also showed that children with asthma on inhaled&#xD;
      corticosteroids had better academic achievement than children with asthma not on long-term&#xD;
      controller therapy, suggesting that poor control is associated with worse school&#xD;
      performance.5 However, academic performance is dependent on many other factors, such as&#xD;
      socio-economic status of the local district and resources available. Availability of skilled&#xD;
      nursing differs between schools, impacting children with asthma; Hillemeier's study of&#xD;
      children with asthma in Pennsylvania schools showed that less than half of secondary schools&#xD;
      had adequate school nurse coverage, and that this reduced services provided to children with&#xD;
      asthma.6 Children whose asthma is not managed at school may be absent more often. Parental&#xD;
      education also plays a part in a child's school performance. Tsakiris et al, showed that in&#xD;
      Greece, lower parental education level was independently associated with poor school&#xD;
      performance in children with asthma.5&#xD;
&#xD;
      Early adolescence (ages 10-13) is identified as a time of great transition with both&#xD;
      developmental and biologic changes; in this time period male children with asthma generally&#xD;
      improve and female with asthma develop worsening asthma, likely due to hormone effects. It&#xD;
      has been shown that programs to reduce asthma symptoms in both younger children (elementary&#xD;
      school) and older children (high school) do not work well in early adolescent children&#xD;
      (middle school).7&#xD;
&#xD;
      In addition, despite the National Asthma Education Prevention Program (NAEPP, 2007)&#xD;
      guidelines that encourage the assessment of the quality of life (QOL) in children, there has&#xD;
      been minimal research on QOL in children with asthma.&#xD;
&#xD;
      Given the scarcity of information on the association between pediatric asthma and academic&#xD;
      achievement, school attendance, and the QOL, and the need to establish baselines within&#xD;
      individual communities, we have designed a study to examine the association between asthma in&#xD;
      school-age (grades 3 through 8, inclusive) children and academic achievement, school&#xD;
      attendance, and the QOL. Our overall hypothesis is that children with asthma will have worse&#xD;
      school performance compared to children without asthma.&#xD;
&#xD;
      Specific Aim 1: To determine the association between asthma and school performance by&#xD;
      comparing unweighted grade point averages (GPA) in middle school aged children with and&#xD;
      without asthma. We will enroll 200 children in grades 3-8 with asthma (cases) from the&#xD;
      ED/IMPACT DC and compare them with a group of 200 children in grades 3-8 without asthma&#xD;
      (controls) recruited from the ED. Report cards will be collected between August 2014 and&#xD;
      December 1, 2014 or until 200 cases and 200 controls have been recruited, and GPAs will be&#xD;
      compared. We expect children with asthma will have lower GPAs .&#xD;
&#xD;
      B.&#xD;
&#xD;
      Significance:&#xD;
&#xD;
      School achievement in middle school students with asthma is not well understood; this study&#xD;
      will be pivotal in identifying if middle school students with asthma in the Washington DC are&#xD;
      are performing more poorly than their non-asthmatic counterparts.&#xD;
&#xD;
      C. Preliminary studies We have not previously studied academic success in children with&#xD;
      asthma.&#xD;
&#xD;
      D. Research Design and Methods&#xD;
&#xD;
      We are proposing a cross-sectional case-control observational study of school-age (grades&#xD;
      3-8) children to compare academic achievement and school attendance between children with and&#xD;
      without asthma. 200 children with asthma (cases) will be recruited from the IMPACT DC clinic&#xD;
      and/or ED and 200 children without asthma (controls) will be recruited from the ED.&#xD;
&#xD;
      Inclusion criteria for cases include asthma diagnosed by a clinician for greater than 1 year&#xD;
      with a history of exacerbation requiring systemic corticosteroids within the past 2 years.&#xD;
      Controls will have no history of asthma. All children, cases and controls, must (1) be in&#xD;
      grade level 3-8 in the 2013-2014 school year, attend public school in Washington, DC (DCPS),&#xD;
      and reside in their school district;(2) be accompanied by their parent or legal guardian.&#xD;
      Exclusion criteria for cases and controls will be (1) presence of a chronic medical condition&#xD;
      other than asthma; (2) triage category 1 or 2 in the emergency department; and (3) a family&#xD;
      that does not speak English or Spanish&#xD;
&#xD;
      Demographic Data for Cases and Controls Demographic information will be obtained by a&#xD;
      structured interview; the questionnaire (Appendix A) will be used on both cases and controls:&#xD;
      the parent/caregiver will be asked about the child's age, gender, race/ethnicity, insurance&#xD;
      type. health care utilization, medications usage, highest level of education of the parent/&#xD;
      caregiver, income of the household, and parental report of school services. Cases will&#xD;
      complete an additional 11 questions to determine asthma severity to determine NAEPP score and&#xD;
      the Asthma Control Test (ACT) score (Appendix F and G).&#xD;
&#xD;
      We will utilize the child's electronic medical record (Cerner for ED charts and&#xD;
      eClinicalWorks for the IMPACT DC charts) to determine insurance type and health care&#xD;
      utilization.&#xD;
&#xD;
      Reporting of Academic Achievement and School Attendance At the time of recruitment, families&#xD;
      will be given a self-addressed, stamped envelope to send the child's 2013 first term (if&#xD;
      available), standardized test score report (if available), and final report card to the&#xD;
      research team. All report cards/score reports will be returned to the family via US Mail with&#xD;
      a $25 gift card as incentive for sending in their report card. Academic achievement,&#xD;
      standardized test scores, and school attendance will be recorded from the report cards. All&#xD;
      report cards in the DCPS system use the same grading scale.. Both systems record attendance&#xD;
      on the report cards and there are 180 school days in a year in both systems.&#xD;
&#xD;
      Reporting of the Quality of Life using the Peds QL (Quality of Life) 4.0 Form QOL will be&#xD;
      measured using the validated PedsQL 4.0 for children, teens, and parents (Appendices B, C, D,&#xD;
      and E). The PedsQL 4.0 has four scales with 23 questions which ascertain physical&#xD;
      functioning, emotional functioning, social functioning, and school functioning. A 5-point&#xD;
      Likert scale is used in the child self-report and for the parent proxy reports. Items are&#xD;
      reverse scored and linearly transformed to a 0 to 100 scale (0=100, 1=75, 2=50, 3=25, and&#xD;
      4=0), so higher scores indicate better QOL.&#xD;
&#xD;
      E. Statistical analysis Descriptive statistics will be used to analyze demographic variables&#xD;
      (rates, proportions, means, medians, ranges). Univariate comparisons will be performed using&#xD;
      appropriate categorical or continuous statistical analyses. Multivariate testing will be&#xD;
      performed using logistic and/or liner regression where appropriate.&#xD;
&#xD;
      Sample Size: The study will be powered on the proportion of patients in each group with a&#xD;
      grade point average &gt;3.0. The overall proportion of DC public middle school students in the&#xD;
      2012-2013 school year with a GPA &gt;3.0 was approximately 35%. Assuming that this figure is&#xD;
      similar for children without asthma (controls), we will need 70 cases and 70 controls to have&#xD;
      80% power detect a 20% absolute difference in the proportion of children with asthma (cases)&#xD;
      with a grade point average &gt;3.0 (alpha = 0.05, two-sided).&#xD;
&#xD;
      We have chosen to include 200 children in each group, as we expect that less than 50% of all&#xD;
      included patients will return their final year report cards via the self-addressed, stamped&#xD;
      envelope.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 15, 2016</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">March 31, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Weeks</target_duration>
  <primary_outcome>
    <measure>GPA</measure>
    <time_frame>single time point</time_frame>
    <description>To determine the association between asthma and school performance by comparing grade point averages (GPA) in school aged children with and without asthma. We will enroll 200 children in grades 3-8 with asthma (cases) from the ED/IMPACT DC and compare them with a group of 200 children in grades 3-8 without asthma (controls) recruited from the ED. Report cards will be collected between June 2014 and November 1, 2014 or until 200 cases and 200 controls have been recruited, and GPAs will be compared. We expect children with asthma will have lower GPAs . GPAs are unweighted 0-4 scale.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">66</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Asthma</arm_group_label>
    <description>children with asthma who were in middle school for the 2013-2014 school year will take surveys on health and quality of life</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Children with no history of asthma who were in middle school for the 2013-2014 school year will take surveys on health and quality of life</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey</intervention_name>
    <description>We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group.</description>
    <arm_group_label>Asthma</arm_group_label>
    <arm_group_label>Controls</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We are proposing a cross-sectional case-control observational study of middle school&#xD;
        (grades 6-8) children to compare academic achievement and school attendance between&#xD;
        children with and without asthma. 200 children with asthma (cases) will be recruited from&#xD;
        the IMPACT DC clinic and/or ED and 200 children without asthma (controls) will be recruited&#xD;
        from the ED.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria for cases include asthma diagnosed by a clinician for greater than&#xD;
             1 year with a history of exacerbation requiring systemic corticosteroids within the&#xD;
             past 2 years. Controls will have no history of asthma. All children, cases and&#xD;
             controls, must (1) be in grade level 6-8 in the 2013-2014 school year, attend public&#xD;
             school in Washington, DC (DCPS) or Prince George's County Public Schools (PGCPS), and&#xD;
             reside in their school district;(2) be accompanied by their parent or legal guardian.&#xD;
&#xD;
        Exclusion Criteria: Exclusion criteria for cases and controls will be (1) presence of a&#xD;
        chronic medical condition other than asthma; (2) triage category 1 or 2 in the emergency&#xD;
        department; and (3) a family that does not speak English or Spanish&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shilpa Patel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's National Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's National Health Systems</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <results_first_submitted>April 3, 2018</results_first_submitted>
  <results_first_submitted_qc>February 2, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 7, 2019</results_first_posted>
  <last_update_submitted>February 2, 2019</last_update_submitted>
  <last_update_submitted_qc>February 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Children's National Research Institute</investigator_affiliation>
    <investigator_full_name>Shilpa Patel</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>asthma</keyword>
  <keyword>academics</keyword>
  <keyword>GPA</keyword>
  <keyword>attendance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 22, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT02228499/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>After participant enrollment the lead author of the study called to obtain report cards. Those participants for which a report card was unable to be obtained was not included in the GPA analysis.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Asthma</title>
          <description>children with asthma who were in middle school for the 2013-2014 school year will take surveys on health and quality of life&#xD;
Survey: We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group.</description>
        </group>
        <group group_id="P2">
          <title>Controls</title>
          <description>Children with no history of asthma who were in middle school for the 2013-2014 school year will take surveys on health and quality of life&#xD;
Survey: We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis population was not different from the original assignment.</population>
      <group_list>
        <group group_id="B1">
          <title>Asthma</title>
          <description>children with asthma who were in middle school for the 2013-2014 school year will take surveys on health and quality of life&#xD;
Survey: We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group.</description>
        </group>
        <group group_id="B2">
          <title>Controls</title>
          <description>Children with no history of asthma who were in middle school for the 2013-2014 school year will take surveys on health and quality of life&#xD;
Survey: We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group.</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="30"/>
            <count group_id="B2" value="36"/>
            <count group_id="B3" value="66"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>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>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="40"/>
                  </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/African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White/Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>GPA</title>
        <description>To determine the association between asthma and school performance by comparing grade point averages (GPA) in school aged children with and without asthma. We will enroll 200 children in grades 3-8 with asthma (cases) from the ED/IMPACT DC and compare them with a group of 200 children in grades 3-8 without asthma (controls) recruited from the ED. Report cards will be collected between June 2014 and November 1, 2014 or until 200 cases and 200 controls have been recruited, and GPAs will be compared. We expect children with asthma will have lower GPAs . GPAs are unweighted 0-4 scale.</description>
        <time_frame>single time point</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Asthma</title>
            <description>Children with asthma who were in school for the 2013-2014 school year will take surveys on health and quality of life&#xD;
Survey: We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group.</description>
          </group>
          <group group_id="O2">
            <title>Controls</title>
            <description>Children with no history of asthma who were in school for the 2013-2014 school year will take surveys on health and quality of life&#xD;
Survey: We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group.</description>
          </group>
        </group_list>
        <measure>
          <title>GPA</title>
          <description>To determine the association between asthma and school performance by comparing grade point averages (GPA) in school aged children with and without asthma. We will enroll 200 children in grades 3-8 with asthma (cases) from the ED/IMPACT DC and compare them with a group of 200 children in grades 3-8 without asthma (controls) recruited from the ED. Report cards will be collected between June 2014 and November 1, 2014 or until 200 cases and 200 controls have been recruited, and GPAs will be compared. We expect children with asthma will have lower GPAs . GPAs are unweighted 0-4 scale.</description>
          <units>GPA(unweighted)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mathematics Grade</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.75" spread="0.61"/>
                    <measurement group_id="O2" value="2.61" spread="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reading Grade</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.25" spread="0.76"/>
                    <measurement group_id="O2" value="2.50" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Asthma</title>
          <description>children with asthma who were in middle school for the 2013-2014 school year will take surveys on health and quality of life&#xD;
Survey: We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group.</description>
        </group>
        <group group_id="E2">
          <title>Controls</title>
          <description>Children with no history of asthma who were in middle school for the 2013-2014 school year will take surveys on health and quality of life&#xD;
Survey: We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Data for this study was analyzed used a mixed methods approach. The quality of life scores were examined quantitatively and the report card data was analyzed qualitatively.&#xD;
Not all families mailed report cards to the IMPACT DC clinic.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Seema Agrawal</name_or_title>
      <organization>The George Washington University</organization>
      <phone>202 699 1648</phone>
      <email>seema300@yahoo.com</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/NCT02228499
org study id: 00005030
nct id: NCT02228499
lead sponsor: 
has dmc: No
Background: Asthma is the most common chronic disease of childhood with a prevalence that is
      1.6 times greater in African American children than in Non-Hispanic White children.1
      Nationally, 700,000 children are seen for asthma in Emergency Departments every year, 1% of
      which are seen at Children's National Health System in Washington, District of Columbia.
      School performance and school attendance has not been well studied in urban children with
      asthma, especially at the middle school level.

      Objective: Our purpose is to test the hypothesis that middle school children with asthma have
      worse school performance than middle school children without asthma in Washington DC and
      Prince George's county schools.

      Methods: The investigators will conduct a cross-sectional observational study of
      middle-school (grades 6-8 in the 2013-2014 school year) aged children with and without asthma
      recruited from the Emergency Departments and the IMPACT DC asthma clinic at CN. The
      investigators will collect demographic information, asthma severity information (for cases),
      and request that parents mail report cards and standardized test scores directly to the
      investigators. The investigators will use multivariable linear and logistic regression to
      determine if the presence of asthma is associated with school performance.
Academic Achievement in Children with Asthma

      Research Plan A. Background and Specific Aims Asthma is the most common chronic disease of
      childhood with a prevalence that is 1.6 times greater in African American children than in
      Non-Hispanic White children. Nationally, 700,000 children are seen for asthma in Emergency
      Departments (ED) every year, 1% of which are seen at Children's National (CN) Medical Center
      in Washington, District of Columbia (DC). The asthma prevalence rate among African American
      children and teens in Washington, District of Columbia is 20% higher than the national rate
      and overall emergency department utilization rates for asthma are 4.3 times the national
      rate. In 2007, approximately 10.5 million school days were lost due to asthma.

      Asthma severity may impact academic performance due to increased absenteeism. A study of
      Canadian school children showed that children with the most severe asthma had the lowest math
      and reading scores.4 Tsakiris also showed that children with asthma on inhaled
      corticosteroids had better academic achievement than children with asthma not on long-term
      controller therapy, suggesting that poor control is associated with worse school
      performance.5 However, academic performance is dependent on many other factors, such as
      socio-economic status of the local district and resources available. Availability of skilled
      nursing differs between schools, impacting children with asthma; Hillemeier's study of
      children with asthma in Pennsylvania schools showed that less than half of secondary schools
      had adequate school nurse coverage, and that this reduced services provided to children with
      asthma.6 Children whose asthma is not managed at school may be absent more often. Parental
      education also plays a part in a child's school performance. Tsakiris et al, showed that in
      Greece, lower parental education level was independently associated with poor school
      performance in children with asthma.5

      Early adolescence (ages 10-13) is identified as a time of great transition with both
      developmental and biologic changes; in this time period male children with asthma generally
      improve and female with asthma develop worsening asthma, likely due to hormone effects. It
      has been shown that programs to reduce asthma symptoms in both younger children (elementary
      school) and older children (high school) do not work well in early adolescent children
      (middle school).7

      In addition, despite the National Asthma Education Prevention Program (NAEPP, 2007)
      guidelines that encourage the assessment of the quality of life (QOL) in children, there has
      been minimal research on QOL in children with asthma.

      Given the scarcity of information on the association between pediatric asthma and academic
      achievement, school attendance, and the QOL, and the need to establish baselines within
      individual communities, we have designed a study to examine the association between asthma in
      school-age (grades 3 through 8, inclusive) children and academic achievement, school
      attendance, and the QOL. Our overall hypothesis is that children with asthma will have worse
      school performance compared to children without asthma.

      Specific Aim 1: To determine the association between asthma and school performance by
      comparing unweighted grade point averages (GPA) in middle school aged children with and
      without asthma. We will enroll 200 children in grades 3-8 with asthma (cases) from the
      ED/IMPACT DC and compare them with a group of 200 children in grades 3-8 without asthma
      (controls) recruited from the ED. Report cards will be collected between August 2014 and
      December 1, 2014 or until 200 cases and 200 controls have been recruited, and GPAs will be
      compared. We expect children with asthma will have lower GPAs .

      B.

      Significance:

      School achievement in middle school students with asthma is not well understood; this study
      will be pivotal in identifying if middle school students with asthma in the Washington DC are
      are performing more poorly than their non-asthmatic counterparts.

      C. Preliminary studies We have not previously studied academic success in children with
      asthma.

      D. Research Design and Methods

      We are proposing a cross-sectional case-control observational study of school-age (grades
      3-8) children to compare academic achievement and school attendance between children with and
      without asthma. 200 children with asthma (cases) will be recruited from the IMPACT DC clinic
      and/or ED and 200 children without asthma (controls) will be recruited from the ED.

      Inclusion criteria for cases include asthma diagnosed by a clinician for greater than 1 year
      with a history of exacerbation requiring systemic corticosteroids within the past 2 years.
      Controls will have no history of asthma. All children, cases and controls, must (1) be in
      grade level 3-8 in the 2013-2014 school year, attend public school in Washington, DC (DCPS),
      and reside in their school district;(2) be accompanied by their parent or legal guardian.
      Exclusion criteria for cases and controls will be (1) presence of a chronic medical condition
      other than asthma; (2) triage category 1 or 2 in the emergency department; and (3) a family
      that does not speak English or Spanish

      Demographic Data for Cases and Controls Demographic information will be obtained by a
      structured interview; the questionnaire (Appendix A) will be used on both cases and controls:
      the parent/caregiver will be asked about the child's age, gender, race/ethnicity, insurance
      type. health care utilization, medications usage, highest level of education of the parent/
      caregiver, income of the household, and parental report of school services. Cases will
      complete an additional 11 questions to determine asthma severity to determine NAEPP score and
      the Asthma Control Test (ACT) score (Appendix F and G).

      We will utilize the child's electronic medical record (Cerner for ED charts and
      eClinicalWorks for the IMPACT DC charts) to determine insurance type and health care
      utilization.

      Reporting of Academic Achievement and School Attendance At the time of recruitment, families
      will be given a self-addressed, stamped envelope to send the child's 2013 first term (if
      available), standardized test score report (if available), and final report card to the
      research team. All report cards/score reports will be returned to the family via US Mail with
      a $25 gift card as incentive for sending in their report card. Academic achievement,
      standardized test scores, and school attendance will be recorded from the report cards. All
      report cards in the DCPS system use the same grading scale.. Both systems record attendance
      on the report cards and there are 180 school days in a year in both systems.

      Reporting of the Quality of Life using the Peds QL (Quality of Life) 4.0 Form QOL will be
      measured using the validated PedsQL 4.0 for children, teens, and parents (Appendices B, C, D,
      and E). The PedsQL 4.0 has four scales with 23 questions which ascertain physical
      functioning, emotional functioning, social functioning, and school functioning. A 5-point
      Likert scale is used in the child self-report and for the parent proxy reports. Items are
      reverse scored and linearly transformed to a 0 to 100 scale (0=100, 1=75, 2=50, 3=25, and
      4=0), so higher scores indicate better QOL.

      E. Statistical analysis Descriptive statistics will be used to analyze demographic variables
      (rates, proportions, means, medians, ranges). Univariate comparisons will be performed using
      appropriate categorical or continuous statistical analyses. Multivariate testing will be
      performed using logistic and/or liner regression where appropriate.

      Sample Size: The study will be powered on the proportion of patients in each group with a
      grade point average >3.0. The overall proportion of DC public middle school students in the
      2012-2013 school year with a GPA >3.0 was approximately 35%. Assuming that this figure is
      similar for children without asthma (controls), we will need 70 cases and 70 controls to have
      80% power detect a 20% absolute difference in the proportion of children with asthma (cases)
      with a grade point average >3.0 (alpha = 0.05, two-sided).

      We have chosen to include 200 children in each group, as we expect that less than 50% of all
      included patients will return their final year report cards via the self-addressed, stamped
      envelope.
observational model: Case-Control
time perspective: Prospective
measure: GPA
time frame: single time point
description: To determine the association between asthma and school performance by comparing grade point averages (GPA) in school aged children with and without asthma. We will enroll 200 children in grades 3-8 with asthma (cases) from the ED/IMPACT DC and compare them with a group of 200 children in grades 3-8 without asthma (controls) recruited from the ED. Report cards will be collected between June 2014 and November 1, 2014 or until 200 cases and 200 controls have been recruited, and GPAs will be compared. We expect children with asthma will have lower GPAs . GPAs are unweighted 0-4 scale.
arm group label: Asthma
description: children with asthma who were in middle school for the 2013-2014 school year will take surveys on health and quality of life
arm group label: Controls
description: Children with no history of asthma who were in middle school for the 2013-2014 school year will take surveys on health and quality of life
intervention type: Other
intervention name: Survey
description: We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group.
arm group label: Asthma
arm group label: Controls
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 11 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shilpa Patel, MD
role: Principal Investigator
affiliation: Children's National Research Institute
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Children's National Research Institute
investigator full name: Shilpa Patel
investigator title: MD
mesh term: Asthma
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Data for this study was analyzed used a mixed methods approach. The quality of life scores were examined quantitatively and the report card data was analyzed qualitatively.
Not all families mailed report cards to the IMPACT DC clinic.
point of contact: 