<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/NCT03032744</url>
  </required_header>
  <id_info>
    <org_study_id>IMPACT1</org_study_id>
    <secondary_id>UL1TR001412</secondary_id>
    <nct_id>NCT03032744</nct_id>
  </id_info>
  <brief_title>Aligning With Schools To Help Manage Asthma (Project ASTHMA)</brief_title>
  <official_title>Aligning With Schools To Help Manage Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State University of New York at Buffalo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Advancing Translational Sciences (NCATS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>State University of New York at Buffalo</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>
      Project ASTHMA is a school-based health center intervention program that institutes&#xD;
      guideline-based chronic asthma care and provides supervised administration with daily&#xD;
      preventive asthma medications to improve asthma symptoms and lung function, reduce emergency&#xD;
      visits, and decrease missed days of school among children from communities with health&#xD;
      disparities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Project ASTHMA in schools is a 7 month randomized control intervention pilot trial. Forty&#xD;
      students, ages 4 to 14 years, with persistent asthma, or who utilize acute care facilities&#xD;
      frequently for their asthma, will be recruited from 3 urban SBHCs in the fall of 2018. All&#xD;
      students will receive NHLBI guideline-based asthma assessments to determine eligibility and&#xD;
      proper dosing of preventive medication. The asthma assessment will include spirometry&#xD;
      testing. All enrolled students and parents will receive asthma education at the time of&#xD;
      enrollment. Eligible students will be randomized to an intervention or usual care group using&#xD;
      permuted block randomization stratified by SBHCs. In collaboration with the student's PCP,&#xD;
      the SBHCs' mid-level providers will prescribe the preventive medication to the students in&#xD;
      the intervention group. These students will receive the morning dose of their preventive&#xD;
      medication from the school nurse each school day for the remainder of the school year.&#xD;
      Students and their parents will be responsible to administer the evening and non-school day&#xD;
      doses. Students randomized to the usual care group will be referred back to their PCP for&#xD;
      further asthma management. All participants will be re-evaluated at 1, 3 and 7 months after&#xD;
      enrollment, and medication dose adjustments will be made in the intervention group as needed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2017</start_date>
  <completion_date type="Actual">June 2020</completion_date>
  <primary_completion_date type="Actual">July 2019</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>Intervention group will receive the morning dose of their daily preventive asthma medication at school. The student &amp; family will be responsible to administer the evening dose &amp; both doses on non-school days.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Asthma Symptoms</measure>
    <time_frame>7 months</time_frame>
    <description>decrease in asthma symptoms as defined by NAEPP-EPR3 guidelines, including ACT score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in ACT Score</measure>
    <time_frame>7 months</time_frame>
    <description>Improvement in ACT score, a validated questionnaire for the assessment of asthma symptoms, which is included in the NAEPP-EPR3 guidelines for components of control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Lung function</measure>
    <time_frame>7 months</time_frame>
    <description>improvement in spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ED/urgent care visits</measure>
    <time_frame>2 years</time_frame>
    <description>Decrease in ED/urgent care visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hospitalizations</measure>
    <time_frame>2 years</time_frame>
    <description>Decrease in hospitalizations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Oral/parenteral steroid use</measure>
    <time_frame>2 years</time_frame>
    <description>Decrease in oral/parenteral steroid use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Missed days of school</measure>
    <time_frame>2 years</time_frame>
    <description>decrease in missed days of school</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the intervention group will be prescribed the appropriate asthma therapy based on their assessment (i.e. providing 'asthma assessment &amp; management'), and receive the morning dose of their daily asthma controller medication at school on school days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the usual care group will be provided with the results of their asthma assessment and be instructed to follow up with their primary care provider. They will continue to receive all of their daily asthma controller medication at home.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Asthma Assessment &amp; Management</intervention_name>
    <description>Asthma Assessment &amp; Management based on NAEPP-EPR3 guidelines</description>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Asthma Education</intervention_name>
    <description>Asthma education on medications</description>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Controller medication at school</intervention_name>
    <description>Students will receive the morning dose of their daily preventive asthma medication at school on school days.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Active asthma&#xD;
&#xD;
          -  Diagnosed with asthma for at least 12 months&#xD;
&#xD;
          -  Enrolled in the school-based health center&#xD;
&#xD;
          -  Persistent asthma as defined by NAEPP-EPR3 guidelines OR at least 1 hospitalizations&#xD;
             OR at least 2 ED/urgent care visits OR at least 2 courses of oral steroids for asthma&#xD;
             in the previous 12 months for asthma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Underlying heart or lung disease other than asthma&#xD;
&#xD;
          -  Student has well controlled asthma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lucy C Holmes, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University at Buffalo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>John R. Oishei Children's Hospital</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>August 17, 2023</last_update_submitted>
  <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State University of New York at Buffalo</investigator_affiliation>
    <investigator_full_name>Lucy Holmes, MD</investigator_full_name>
    <investigator_title>Clinical Associate Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Pediatric</keyword>
  <keyword>School Based Health Center</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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03032744
org study id: IMPACT1
secondary id: UL1TR001412
nct id: NCT03032744
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Project ASTHMA is a school-based health center intervention program that institutes
      guideline-based chronic asthma care and provides supervised administration with daily
      preventive asthma medications to improve asthma symptoms and lung function, reduce emergency
      visits, and decrease missed days of school among children from communities with health
      disparities.
Project ASTHMA in schools is a 7 month randomized control intervention pilot trial. Forty
      students, ages 4 to 14 years, with persistent asthma, or who utilize acute care facilities
      frequently for their asthma, will be recruited from 3 urban SBHCs in the fall of 2018. All
      students will receive NHLBI guideline-based asthma assessments to determine eligibility and
      proper dosing of preventive medication. The asthma assessment will include spirometry
      testing. All enrolled students and parents will receive asthma education at the time of
      enrollment. Eligible students will be randomized to an intervention or usual care group using
      permuted block randomization stratified by SBHCs. In collaboration with the student's PCP,
      the SBHCs' mid-level providers will prescribe the preventive medication to the students in
      the intervention group. These students will receive the morning dose of their preventive
      medication from the school nurse each school day for the remainder of the school year.
      Students and their parents will be responsible to administer the evening and non-school day
      doses. Students randomized to the usual care group will be referred back to their PCP for
      further asthma management. All participants will be re-evaluated at 1, 3 and 7 months after
      enrollment, and medication dose adjustments will be made in the intervention group as needed.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Intervention group will receive the morning dose of their daily preventive asthma medication at school. The student & family will be responsible to administer the evening dose & both doses on non-school days.
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Asthma Symptoms
time frame: 7 months
description: decrease in asthma symptoms as defined by NAEPP-EPR3 guidelines, including ACT score
measure: Change in ACT Score
time frame: 7 months
description: Improvement in ACT score, a validated questionnaire for the assessment of asthma symptoms, which is included in the NAEPP-EPR3 guidelines for components of control.
measure: Change in Lung function
time frame: 7 months
description: improvement in spirometry
measure: Change in ED/urgent care visits
time frame: 2 years
description: Decrease in ED/urgent care visits
measure: Change in Hospitalizations
time frame: 2 years
description: Decrease in hospitalizations
measure: Change in Oral/parenteral steroid use
time frame: 2 years
description: Decrease in oral/parenteral steroid use
measure: Change in Missed days of school
time frame: 2 years
description: decrease in missed days of school
arm group label: Intervention
arm group type: Experimental
description: All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the intervention group will be prescribed the appropriate asthma therapy based on their assessment (i.e. providing 'asthma assessment & management'), and receive the morning dose of their daily asthma controller medication at school on school days.
arm group label: Usual Care
arm group type: Active Comparator
description: All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the usual care group will be provided with the results of their asthma assessment and be instructed to follow up with their primary care provider. They will continue to receive all of their daily asthma controller medication at home.
intervention type: Other
intervention name: Asthma Assessment & Management
description: Asthma Assessment & Management based on NAEPP-EPR3 guidelines
arm group label: Intervention
arm group label: Usual Care
intervention type: Other
intervention name: Asthma Education
description: Asthma education on medications
arm group label: Intervention
arm group label: Usual Care
intervention type: Other
intervention name: Controller medication at school
description: Students will receive the morning dose of their daily preventive asthma medication at school on school days.
arm group label: Intervention
criteria: 
gender: All
minimum age: 4 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lucy C Holmes, MD, MPH
role: Principal Investigator
affiliation: University at Buffalo
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: State University of New York at Buffalo
investigator full name: Lucy Holmes, MD
investigator title: Clinical Associate Professor of Pediatrics
mesh term: Asthma
sharing ipd: No