<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/NCT02994238</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 2016-698</org_study_id>
    <nct_id>NCT02994238</nct_id>
  </id_info>
  <brief_title>iTRACC (Improving Technology-Assisted Recording of Asthma Control in Children)</brief_title>
  <acronym>iTRACC</acronym>
  <official_title>iTRACC (Improving Technology-Assisted Recording of Asthma Control in Children)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Deneen Vojta</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>UnitedHealth Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to determine whether a sensor-enabled, clinically integrated,&#xD;
      mobile health asthma program can improve asthma outcomes among 4-17 year old children with&#xD;
      moderate-to-severe asthma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Aims:&#xD;
&#xD;
        -  Assess whether asthma control in patients enrolled in the intervention arm improved in&#xD;
           comparison to the control arm through the (ACT) measurement tool.&#xD;
&#xD;
        -  Assess healthcare utilization (asthma-related ED visits and hospitalizations,&#xD;
           asthma-related oral corticosteroid use) obtained through electronic medical record and&#xD;
           parent report.&#xD;
&#xD;
      Secondary Aims:&#xD;
&#xD;
      Investigators will use parent-report surveys of the following psycho-social outcome measures:&#xD;
&#xD;
        -  Days missed from school due to asthma; 2) pediatric asthma-related quality of life&#xD;
           (PACQLQ); and 3) Parental Asthma Management Self-Efficacy (PAMSE).&#xD;
&#xD;
        -  Enhance parental management through improved inhaler use. The investigators will use the&#xD;
           Propeller Sensor Platform (referenced as Remote Health Management Platform) to allow&#xD;
           parents to track their child's ICS and SABA inhaler use daily. The Platform also will&#xD;
           have specific educational messaging to help parents and their children achieve adherence&#xD;
           to their prescribed plan. This constant feedback and reinforcement may lead to improved&#xD;
           asthma control therefore reducing frequency and severity of asthma exacerbations. The&#xD;
           investigators will also be assessing the factors associated with the feasibility and&#xD;
           sustainability of the Propeller Sensor Platform by observing trends in utilization.&#xD;
           Utilization and drop-off will be measured by monitoring use of the inhalers and periodic&#xD;
           surveys of families.&#xD;
&#xD;
        -  Improve management by the healthcare team. The investigators will use the Remote Health&#xD;
           Management Platform to integrate inhaler use data into a web portal that the physician's&#xD;
           office can access. Through the development of this interface, the Propeller Sensor&#xD;
           Platform will be able to provide inhaler use feedback to healthcare teams.&#xD;
&#xD;
      Types of feedback:&#xD;
&#xD;
        -  Emergency Management: data on inhaled corticosteroids (ICS) and short-acting&#xD;
           beta-agonist (SABA) use&#xD;
&#xD;
        -  Long-term Management: data on ICS and SABA use. This interface will include data on both&#xD;
           ICS and SABA inhaler use. The interface will also have flags to notify the office of&#xD;
           under or overuse of inhalers, with a protocol in place to reach out to patients. The&#xD;
           investigators will also be assessing the factors associated with the feasibility and&#xD;
           sustainability of the Remote Health Management Platform by the healthcare team. This&#xD;
           will be done by weekly contact with the healthcare team, rapid cycle improvement of the&#xD;
           web portal, and written assessments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Asthma Control Test (ACT)</measure>
    <time_frame>12 month follow-up assessment</time_frame>
    <description>Investigators will use the children's Asthma Control Test completed by the caregiver or parent to report child's asthma control. The ACT is a 5 item scale, with a 4-week recall (on symptoms and daily functioning) ACT assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control via item-specific response options ranging from 1-5. Total ACT scores range from 5 (poorly controlled asthma, to 25 (well controlled asthma).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of Urgent Health Utilization</measure>
    <time_frame>the 12 month study period</time_frame>
    <description>Number of Asthma-related ED visits during the 12 month study period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>12 Month Rate of Medication Use</measure>
    <time_frame>Over a 12 month study period</time_frame>
    <description>Number of oral corticosteroid prescriptions obtained from the electronic medical record and parent/caregiver report</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of Asthma-related Hospitalizations</measure>
    <time_frame>the 12 month study period</time_frame>
    <description>Number of Asthma-related Hospitalizations during the 12 month study period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire</measure>
    <time_frame>12 month study follow-up</time_frame>
    <description>The Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire was administered. This scale is a self-administered instrument, which includes 13 items (4 concern activity limitations and 9 concern emotional function). Responses to each item of the PACQLQ are given on a seven-point scale, ranging from 1 to 7, with the higher scores indicating less impairment. A total average score was calculated to reflect Pediatric Asthma Caregiver Quality of Life, which also ranged from 1-7.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">252</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will have the full Remote Health Management Sensor Platform. Research staff will review uploaded sensor data on a daily basis. If participants are enrolled into the control group, they will only receive Standard Asthma Education. The Standard Asthma Education follows the National Asthma Education and Prevention Program (NAEPP) guidelines for asthma management. This will include the following topics: 1. Explanation of symptoms; 2. Asthma triggers (description and how to avoid them); 3. Using medications (how to use prescribed asthma medications, the difference between controller medications and rescue inhalers, how to use a spacer, how to use a mask); and 4. Managing asthma control (purpose of asthma control test, asthma action plan, how to use a peak flow meter).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will receive only standardized education.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Remote Health Management Sensor Platform</intervention_name>
    <description>The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Reciprocal Labs</other_name>
    <other_name>Propeller Health Systems</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English-speaking parents&#xD;
&#xD;
          -  Children 4-&lt;17 years of age. Using both NHLBI (National Heart, Lung, and Blood&#xD;
             Institute) guidelines and based off of a physician expert panel, the research team has&#xD;
             limited the ages to 4-&lt;17 years old. It has been shown to be difficult to properly&#xD;
             diagnose individuals less than 4 years of age with asthma. Usually, they are diagnosed&#xD;
             with reactive airway disease or bronchial virus. Individuals &lt;17 years old was the&#xD;
             oldest group because investigators wanted to avoid adolescence and make sure that&#xD;
             parents have an active role in the health management of the child.&#xD;
&#xD;
          -  Moderate or severe persistent asthma, defined by the National Heart, Lung, and Blood&#xD;
             Institute. This will be done by a physician-trained research assistant who will be&#xD;
             able to identify potential participants prior to recruitment.&#xD;
&#xD;
          -  At least one asthma exacerbations that required a course of oral corticosteroids in&#xD;
             the past year&#xD;
&#xD;
          -  Prescription and utilization of an ICS inhaler for at least the past year.&#xD;
&#xD;
          -  Who are seen at: Clark and Deming Resident Clinic, Lurie Children's Pulmonary Clinic,&#xD;
             Lurie Children's Uptown Clinic, Chicago Family Asthma and Allergy Clinic or Children's&#xD;
             Healthcare Associates&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking parents/families&#xD;
&#xD;
          -  Patients seen in the hospital who receive primary care outside of the study's clinics&#xD;
&#xD;
          -  Children with any comorbid conditions, which interfere with appropriate assessment of&#xD;
             asthma symptoms: Chronic Lung Disease, Broncho-Pulmonary Dysplasia, Cystic Fibrosis,&#xD;
             Pulmonary Hypertension, Interstitial Lung Disease, Immunodeficiency, Bronchiectasis,&#xD;
             Primary Ciliary Dyskinesia, Chronic Respiratory Insufficiency, Neuromuscular Weakness,&#xD;
             Sickle Cell Lung Disease, Restrictive Lung Disease, and Tracheostomy or&#xD;
             Ventilator-dependence&#xD;
&#xD;
          -  Child-patients who are participating in any other research studies that would&#xD;
             interfere with our ability to use and track the inhaler sensor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>November 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <results_first_submitted>July 1, 2021</results_first_submitted>
  <results_first_submitted_qc>July 29, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 24, 2021</results_first_posted>
  <last_update_submitted>September 20, 2021</last_update_submitted>
  <last_update_submitted_qc>September 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>UnitedHealth Group</investigator_affiliation>
    <investigator_full_name>Dr. Deneen Vojta</investigator_full_name>
    <investigator_title>Executive Vice President, Research and Development, UnitedHealth Group</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 6, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT02994238/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 6, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT02994238/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>The intervention group will have the full Remote Health Management Sensor Platform. Research staff will review uploaded sensor data on a daily basis. If participants are enrolled into the control group, they will only receive Standard Asthma Education. The Standard Asthma Education follows the National Asthma Education and Prevention Program (NAEPP) guidelines for asthma management. This will include the following topics: 1. Explanation of symptoms; 2. Asthma triggers (description and how to avoid them); 3. Using medications (how to use prescribed asthma medications, the difference between controller medications and rescue inhalers, how to use a spacer, how to use a mask); and 4. Managing asthma control (purpose of asthma control test, asthma action plan, how to use a peak flow meter).&#xD;
Remote Health Management Sensor Platform: The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>The control group will receive only standardized education.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="125"/>
                <participants group_id="P2" count="127"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="125"/>
                <participants group_id="P2" count="127"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>The intervention group will have the full Remote Health Management Sensor Platform. Research staff will review uploaded sensor data on a daily basis. If participants are enrolled into the control group, they will only receive Standard Asthma Education. The Standard Asthma Education follows the National Asthma Education and Prevention Program (NAEPP) guidelines for asthma management. This will include the following topics: 1. Explanation of symptoms; 2. Asthma triggers (description and how to avoid them); 3. Using medications (how to use prescribed asthma medications, the difference between controller medications and rescue inhalers, how to use a spacer, how to use a mask); and 4. Managing asthma control (purpose of asthma control test, asthma action plan, how to use a peak flow meter).&#xD;
Remote Health Management Sensor Platform: The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management.</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>The control group will receive only standardized education.</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="125"/>
            <count group_id="B2" value="127"/>
            <count group_id="B3" value="252"/>
          </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="125"/>
                    <count group_id="B2" value="127"/>
                    <count group_id="B3" value="252"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="125"/>
                    <measurement group_id="B2" value="127"/>
                    <measurement group_id="B3" value="252"/>
                  </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="125"/>
                    <count group_id="B2" value="127"/>
                    <count group_id="B3" value="252"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.3" spread="3.2"/>
                    <measurement group_id="B2" value="9.2" spread="3.5"/>
                    <measurement group_id="B3" value="9.2" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>some patients did not choose to identify sex as either male or female</population>
          <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="114"/>
                    <count group_id="B2" value="125"/>
                    <count group_id="B3" value="239"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="83"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="156"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Percentage of participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Non-Hispanic/White %</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="125"/>
                    <count group_id="B2" value="127"/>
                    <count group_id="B3" value="252"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.0"/>
                    <measurement group_id="B2" value="23.6"/>
                    <measurement group_id="B3" value="47.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Hispanic/Black %</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="125"/>
                    <count group_id="B2" value="127"/>
                    <count group_id="B3" value="252"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.2"/>
                    <measurement group_id="B2" value="33.1"/>
                    <measurement group_id="B3" value="56.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic %</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="125"/>
                    <count group_id="B2" value="127"/>
                    <count group_id="B3" value="252"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.0"/>
                    <measurement group_id="B2" value="28.4"/>
                    <measurement group_id="B3" value="68.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other Race/Ethnicity %</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="125"/>
                    <count group_id="B2" value="127"/>
                    <count group_id="B3" value="252"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.2"/>
                    <measurement group_id="B2" value="7.8"/>
                    <measurement group_id="B3" value="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Data %</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="125"/>
                    <count group_id="B2" value="127"/>
                    <count group_id="B3" value="252"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.6"/>
                    <measurement group_id="B2" value="7.1"/>
                    <measurement group_id="B3" value="12.7"/>
                  </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="125"/>
                    <count group_id="B2" value="127"/>
                    <count group_id="B3" value="252"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="125"/>
                    <measurement group_id="B2" value="127"/>
                    <measurement group_id="B3" value="252"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Insurance Type</title>
          <units>Percentage of participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Private Insurance %</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="125"/>
                    <count group_id="B2" value="127"/>
                    <count group_id="B3" value="252"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="43.3"/>
                    <measurement group_id="B3" value="42.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Public Insurance %</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="125"/>
                    <count group_id="B2" value="127"/>
                    <count group_id="B3" value="252"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.2"/>
                    <measurement group_id="B2" value="56.7"/>
                    <measurement group_id="B3" value="57.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ACT Score</title>
          <description>Investigators will use the children's Asthma Control Test completed by the caregiver or parent to report child's asthma control. The ACT is a 5 item scale, with a 4-week recall (on symptoms and daily functioning) ACT assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control via item-specific response options ranging from 1-5. Total ACT scores range from 5 (poorly controlled asthma, to 25 (well controlled asthma).</description>
          <units>units 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="125"/>
                    <count group_id="B2" value="127"/>
                    <count group_id="B3" value="252"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.8" spread="4.5"/>
                    <measurement group_id="B2" value="19.6" spread="3.8"/>
                    <measurement group_id="B3" value="19.2" spread="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PACQLQ</title>
          <description>The Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire was administered. This scale is a self-administered instrument, which includes 13 items (4 concern activity limitations and 9 concern emotional function). Responses to each item of the PACQLQ are given on a seven-point scale, ranging from 1 to 7, with the higher scores indicating less impairment. A total average score was calculated to reflect Pediatric Asthma Caregiver Quality of Life, which also ranged from 1-7.</description>
          <units>units 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="125"/>
                    <count group_id="B2" value="127"/>
                    <count group_id="B3" value="252"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.7" spread="1.3"/>
                    <measurement group_id="B2" value="5.8" spread="1.1"/>
                    <measurement group_id="B3" value="5.8" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Asthma Control Test (ACT)</title>
        <description>Investigators will use the children's Asthma Control Test completed by the caregiver or parent to report child's asthma control. The ACT is a 5 item scale, with a 4-week recall (on symptoms and daily functioning) ACT assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control via item-specific response options ranging from 1-5. Total ACT scores range from 5 (poorly controlled asthma, to 25 (well controlled asthma).</description>
        <time_frame>12 month follow-up assessment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The intervention group will have the full Remote Health Management Sensor Platform. Research staff will review uploaded sensor data on a daily basis. If participants are enrolled into the control group, they will only receive Standard Asthma Education. The Standard Asthma Education follows the National Asthma Education and Prevention Program (NAEPP) guidelines for asthma management. This will include the following topics: 1. Explanation of symptoms; 2. Asthma triggers (description and how to avoid them); 3. Using medications (how to use prescribed asthma medications, the difference between controller medications and rescue inhalers, how to use a spacer, how to use a mask); and 4. Managing asthma control (purpose of asthma control test, asthma action plan, how to use a peak flow meter).&#xD;
Remote Health Management Sensor Platform: The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive only standardized education.</description>
          </group>
        </group_list>
        <measure>
          <title>Asthma Control Test (ACT)</title>
          <description>Investigators will use the children's Asthma Control Test completed by the caregiver or parent to report child's asthma control. The ACT is a 5 item scale, with a 4-week recall (on symptoms and daily functioning) ACT assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control via item-specific response options ranging from 1-5. Total ACT scores range from 5 (poorly controlled asthma, to 25 (well controlled asthma).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
                <count group_id="O2" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.8" spread=".4"/>
                    <measurement group_id="O2" value="19.9" spread=".4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Frequency of Urgent Health Utilization</title>
        <description>Number of Asthma-related ED visits during the 12 month study period</description>
        <time_frame>the 12 month study period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The intervention group will have the full Remote Health Management Sensor Platform. Research staff will review uploaded sensor data on a daily basis. If participants are enrolled into the control group, they will only receive Standard Asthma Education. The Standard Asthma Education follows the National Asthma Education and Prevention Program (NAEPP) guidelines for asthma management. This will include the following topics: 1. Explanation of symptoms; 2. Asthma triggers (description and how to avoid them); 3. Using medications (how to use prescribed asthma medications, the difference between controller medications and rescue inhalers, how to use a spacer, how to use a mask); and 4. Managing asthma control (purpose of asthma control test, asthma action plan, how to use a peak flow meter).&#xD;
Remote Health Management Sensor Platform: The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive only standardized education.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Urgent Health Utilization</title>
          <description>Number of Asthma-related ED visits during the 12 month study period</description>
          <units>events (asthma-related ED visits)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
                <count group_id="O2" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread=".1"/>
                    <measurement group_id="O2" value=".6" spread=".1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>12 Month Rate of Medication Use</title>
        <description>Number of oral corticosteroid prescriptions obtained from the electronic medical record and parent/caregiver report</description>
        <time_frame>Over a 12 month study period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The intervention group will have the full Remote Health Management Sensor Platform. Research staff will review uploaded sensor data on a daily basis. If participants are enrolled into the control group, they will only receive Standard Asthma Education. The Standard Asthma Education follows the National Asthma Education and Prevention Program (NAEPP) guidelines for asthma management. This will include the following topics: 1. Explanation of symptoms; 2. Asthma triggers (description and how to avoid them); 3. Using medications (how to use prescribed asthma medications, the difference between controller medications and rescue inhalers, how to use a spacer, how to use a mask); and 4. Managing asthma control (purpose of asthma control test, asthma action plan, how to use a peak flow meter).&#xD;
Remote Health Management Sensor Platform: The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive only standardized education.</description>
          </group>
        </group_list>
        <measure>
          <title>12 Month Rate of Medication Use</title>
          <description>Number of oral corticosteroid prescriptions obtained from the electronic medical record and parent/caregiver report</description>
          <units>OCS Prescriptions</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
                <count group_id="O2" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread=".2"/>
                    <measurement group_id="O2" value=".9" spread=".2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire</title>
        <description>The Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire was administered. This scale is a self-administered instrument, which includes 13 items (4 concern activity limitations and 9 concern emotional function). Responses to each item of the PACQLQ are given on a seven-point scale, ranging from 1 to 7, with the higher scores indicating less impairment. A total average score was calculated to reflect Pediatric Asthma Caregiver Quality of Life, which also ranged from 1-7.</description>
        <time_frame>12 month study follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The intervention group will have the full Remote Health Management Sensor Platform. Research staff will review uploaded sensor data on a daily basis. If participants are enrolled into the control group, they will only receive Standard Asthma Education. The Standard Asthma Education follows the National Asthma Education and Prevention Program (NAEPP) guidelines for asthma management. This will include the following topics: 1. Explanation of symptoms; 2. Asthma triggers (description and how to avoid them); 3. Using medications (how to use prescribed asthma medications, the difference between controller medications and rescue inhalers, how to use a spacer, how to use a mask); and 4. Managing asthma control (purpose of asthma control test, asthma action plan, how to use a peak flow meter).&#xD;
Remote Health Management Sensor Platform: The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive only standardized education.</description>
          </group>
        </group_list>
        <measure>
          <title>Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire</title>
          <description>The Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire was administered. This scale is a self-administered instrument, which includes 13 items (4 concern activity limitations and 9 concern emotional function). Responses to each item of the PACQLQ are given on a seven-point scale, ranging from 1 to 7, with the higher scores indicating less impairment. A total average score was calculated to reflect Pediatric Asthma Caregiver Quality of Life, which also ranged from 1-7.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
                <count group_id="O2" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" spread="1.0"/>
                    <measurement group_id="O2" value="6.0" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Frequency of Asthma-related Hospitalizations</title>
        <description>Number of Asthma-related Hospitalizations during the 12 month study period</description>
        <time_frame>the 12 month study period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The intervention group will have the full Remote Health Management Sensor Platform. Research staff will review uploaded sensor data on a daily basis. If participants are enrolled into the control group, they will only receive Standard Asthma Education. The Standard Asthma Education follows the National Asthma Education and Prevention Program (NAEPP) guidelines for asthma management. This will include the following topics: 1. Explanation of symptoms; 2. Asthma triggers (description and how to avoid them); 3. Using medications (how to use prescribed asthma medications, the difference between controller medications and rescue inhalers, how to use a spacer, how to use a mask); and 4. Managing asthma control (purpose of asthma control test, asthma action plan, how to use a peak flow meter).&#xD;
Remote Health Management Sensor Platform: The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive only standardized education.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Asthma-related Hospitalizations</title>
          <description>Number of Asthma-related Hospitalizations during the 12 month study period</description>
          <units>Events (Asthma-related Hospitalizations)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
                <count group_id="O2" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".4" spread=".1"/>
                    <measurement group_id="O2" value=".1" spread=".06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>The intervention group will have the full Remote Health Management Sensor Platform. Research staff will review uploaded sensor data on a daily basis. If participants are enrolled into the control group, they will only receive Standard Asthma Education. The Standard Asthma Education follows the National Asthma Education and Prevention Program (NAEPP) guidelines for asthma management. This will include the following topics: 1. Explanation of symptoms; 2. Asthma triggers (description and how to avoid them); 3. Using medications (how to use prescribed asthma medications, the difference between controller medications and rescue inhalers, how to use a spacer, how to use a mask); and 4. Managing asthma control (purpose of asthma control test, asthma action plan, how to use a peak flow meter).&#xD;
Remote Health Management Sensor Platform: The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>The control group will receive only standardized education.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Kathy Boon- Clinical Research Associate</name_or_title>
      <organization>Northwestern University</organization>
      <phone>312-503-4687</phone>
      <email>kathy.boon@northwestern.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/NCT02994238
org study id: IRB 2016-698
nct id: NCT02994238
lead sponsor: 
collaborator: 
has dmc: No
The goal of this study is to determine whether a sensor-enabled, clinically integrated,
      mobile health asthma program can improve asthma outcomes among 4-17 year old children with
      moderate-to-severe asthma.
Primary Aims:

        -  Assess whether asthma control in patients enrolled in the intervention arm improved in
           comparison to the control arm through the (ACT) measurement tool.

        -  Assess healthcare utilization (asthma-related ED visits and hospitalizations,
           asthma-related oral corticosteroid use) obtained through electronic medical record and
           parent report.

      Secondary Aims:

      Investigators will use parent-report surveys of the following psycho-social outcome measures:

        -  Days missed from school due to asthma; 2) pediatric asthma-related quality of life
           (PACQLQ); and 3) Parental Asthma Management Self-Efficacy (PAMSE).

        -  Enhance parental management through improved inhaler use. The investigators will use the
           Propeller Sensor Platform (referenced as Remote Health Management Platform) to allow
           parents to track their child's ICS and SABA inhaler use daily. The Platform also will
           have specific educational messaging to help parents and their children achieve adherence
           to their prescribed plan. This constant feedback and reinforcement may lead to improved
           asthma control therefore reducing frequency and severity of asthma exacerbations. The
           investigators will also be assessing the factors associated with the feasibility and
           sustainability of the Propeller Sensor Platform by observing trends in utilization.
           Utilization and drop-off will be measured by monitoring use of the inhalers and periodic
           surveys of families.

        -  Improve management by the healthcare team. The investigators will use the Remote Health
           Management Platform to integrate inhaler use data into a web portal that the physician's
           office can access. Through the development of this interface, the Propeller Sensor
           Platform will be able to provide inhaler use feedback to healthcare teams.

      Types of feedback:

        -  Emergency Management: data on inhaled corticosteroids (ICS) and short-acting
           beta-agonist (SABA) use

        -  Long-term Management: data on ICS and SABA use. This interface will include data on both
           ICS and SABA inhaler use. The interface will also have flags to notify the office of
           under or overuse of inhalers, with a protocol in place to reach out to patients. The
           investigators will also be assessing the factors associated with the feasibility and
           sustainability of the Remote Health Management Platform by the healthcare team. This
           will be done by weekly contact with the healthcare team, rapid cycle improvement of the
           web portal, and written assessments.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Asthma Control Test (ACT)
time frame: 12 month follow-up assessment
description: Investigators will use the children's Asthma Control Test completed by the caregiver or parent to report child's asthma control. The ACT is a 5 item scale, with a 4-week recall (on symptoms and daily functioning) ACT assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control via item-specific response options ranging from 1-5. Total ACT scores range from 5 (poorly controlled asthma, to 25 (well controlled asthma).
measure: Frequency of Urgent Health Utilization
time frame: the 12 month study period
description: Number of Asthma-related ED visits during the 12 month study period
measure: 12 Month Rate of Medication Use
time frame: Over a 12 month study period
description: Number of oral corticosteroid prescriptions obtained from the electronic medical record and parent/caregiver report
measure: Frequency of Asthma-related Hospitalizations
time frame: the 12 month study period
description: Number of Asthma-related Hospitalizations during the 12 month study period
measure: Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire
time frame: 12 month study follow-up
description: The Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire was administered. This scale is a self-administered instrument, which includes 13 items (4 concern activity limitations and 9 concern emotional function). Responses to each item of the PACQLQ are given on a seven-point scale, ranging from 1 to 7, with the higher scores indicating less impairment. A total average score was calculated to reflect Pediatric Asthma Caregiver Quality of Life, which also ranged from 1-7.
arm group label: Intervention
arm group type: Experimental
description: The intervention group will have the full Remote Health Management Sensor Platform. Research staff will review uploaded sensor data on a daily basis. If participants are enrolled into the control group, they will only receive Standard Asthma Education. The Standard Asthma Education follows the National Asthma Education and Prevention Program (NAEPP) guidelines for asthma management. This will include the following topics: 1. Explanation of symptoms; 2. Asthma triggers (description and how to avoid them); 3. Using medications (how to use prescribed asthma medications, the difference between controller medications and rescue inhalers, how to use a spacer, how to use a mask); and 4. Managing asthma control (purpose of asthma control test, asthma action plan, how to use a peak flow meter).
arm group label: Control
arm group type: No Intervention
description: The control group will receive only standardized education.
intervention type: Device
intervention name: Remote Health Management Sensor Platform
description: The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management.
arm group label: Intervention
other name: Reciprocal Labs
other name: Propeller Health Systems
criteria: 
gender: All
minimum age: 4 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: UnitedHealth Group
investigator full name: Dr. Deneen Vojta
investigator title: Executive Vice President, Research and Development, UnitedHealth Group
mesh term: Asthma
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 