<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/NCT03304067</url>
  </required_header>
  <id_info>
    <org_study_id>EH-005</org_study_id>
    <nct_id>NCT03304067</nct_id>
  </id_info>
  <brief_title>Asthma Control Study</brief_title>
  <official_title>Digital Health Tool for Parental Management of Childhood Asthma -- Impact on Asthma Control Test Scores</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Evidation Health</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tueo Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Evidation Health</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>
      The &quot;Digital Health Tool for Parental Management of Childhood Asthma -- Impact on Asthma&#xD;
      Control Test Scores&quot; Study is a 16 week, prospective, intent-to-treat, 2-arm randomized&#xD;
      controlled trial that aims to evaluate the impact of the Tueo Health program on asthma&#xD;
      control as indicated by change in baseline and study end (week 16) score on the Childhood&#xD;
      Asthma Control Test score (ages 6- under 12 years) and the Asthma Control Test (ages 12-17&#xD;
      years) in children with uncontrolled asthma as the primary study objective.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 3, 2017</start_date>
  <completion_date type="Actual">May 3, 2018</completion_date>
  <primary_completion_date type="Actual">May 3, 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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in ACT/C-ACT scores</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>Change in ACT/C-ACT scores from baseline to study end</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">262</enrollment>
  <condition>Childhood Asthma</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tueo Program</intervention_name>
    <description>The asthma management solution utilizes devices (2 to attach on the child's bed and 1 for data transmission), which collect various metrics for a tailored smartphone application experience. The smartphone application provides access to view metrics from the devices, educational and clinical context content, and an asthma coach.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parent has a child who is &gt; 6 and &lt; 17.5 years old&#xD;
&#xD;
          -  Parent reports child has a diagnosis of asthma&#xD;
&#xD;
          -  Child takes daily asthma controller medication&#xD;
&#xD;
          -  Child has used rescue inhaler (e.g.albuterol, ProAir, etc) or nebulizer at least 2&#xD;
             times per week in the past 4 weeks&#xD;
&#xD;
          -  Child sleeps on a toddler, single, or double bed by themselves&#xD;
&#xD;
          -  Child will live in the same home for the majority of the next 16 weeks&#xD;
&#xD;
          -  Parent is &gt; 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child's asthma has been controlled over the past 4 weeks&#xD;
&#xD;
          -  Child has any of the following conditions: sleep apnea, congenital heart disease,&#xD;
             cardiac arrhythmias, or any other heart abnormalities, neurologic conditions including&#xD;
             seizures, cerebral palsy, muscular dystrophy, genetic conditions or developmental&#xD;
             disorders, autism, other major medical condition&#xD;
&#xD;
          -  Child is currently pregnant&#xD;
&#xD;
          -  Child was born premature (earlier than 36 weeks)&#xD;
&#xD;
          -  Parent is not fluent in English&#xD;
&#xD;
          -  No in-home WiFi&#xD;
&#xD;
          -  Parent does not use an Android phone as their primary phone&#xD;
&#xD;
          -  In a household with an existing enrolled participant in the study, even for a&#xD;
             different child (e.g. only one child in a household may have questions reported back&#xD;
             to the researchers by their parent)&#xD;
&#xD;
          -  Lives in Hawaii or Alaska&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Evidation Health</name>
      <address>
        <city>San Mateo</city>
        <state>California</state>
        <zip>94401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>July 13, 2018</last_update_submitted>
  <last_update_submitted_qc>July 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03304067
org study id: EH-005
nct id: NCT03304067
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The "Digital Health Tool for Parental Management of Childhood Asthma -- Impact on Asthma
      Control Test Scores" Study is a 16 week, prospective, intent-to-treat, 2-arm randomized
      controlled trial that aims to evaluate the impact of the Tueo Health program on asthma
      control as indicated by change in baseline and study end (week 16) score on the Childhood
      Asthma Control Test score (ages 6- under 12 years) and the Asthma Control Test (ages 12-17
      years) in children with uncontrolled asthma as the primary study objective.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in ACT/C-ACT scores
time frame: Baseline and Week 16
description: Change in ACT/C-ACT scores from baseline to study end
arm group label: Intervention
arm group type: Experimental
arm group label: Control
arm group type: No Intervention
intervention type: Behavioral
intervention name: Tueo Program
description: The asthma management solution utilizes devices (2 to attach on the child's bed and 1 for data transmission), which collect various metrics for a tailored smartphone application experience. The smartphone application provides access to view metrics from the devices, educational and clinical context content, and an asthma coach.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No