<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/NCT03036982</url>
  </required_header>
  <id_info>
    <org_study_id>FP01013808</org_study_id>
    <nct_id>NCT03036982</nct_id>
  </id_info>
  <brief_title>Remote Use of the Asthma Control Test (ACT) to Improve Care of Children With Asthma</brief_title>
  <official_title>Remote Use of the Asthma Control Test (ACT) to Improve Care of Children With Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess whether adaption of the Asthma Control Test (ACT) and childhood Asthma&#xD;
      Control Test (cACT) for mobile devices improves rate of completion and improves control of&#xD;
      asthma in children and adolescents&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Asthma is the most prevalent chronic disease of childhood with an overall prevalence of 10%.&#xD;
      While effective therapies exist to control symptoms and prevent exacerbations, many asthma&#xD;
      patients experience significant morbidity including limitations on daily activities as well&#xD;
      as asthma exacerbations that lead to missed school (and work for care givers) and necessitate&#xD;
      emergency department visits and hospitalizations. Among children from lower socioeconomic&#xD;
      statues and in black and Hispanic families, asthma incidence and severity are even greater.&#xD;
      Reasons for this disparity included decreased access to effective asthma care, increased&#xD;
      exposure to tobacco smoke and environmental allergens, and underutilization of controller&#xD;
      medicines. These groups have significantly increased resource utilization due to emergency&#xD;
      department visits and hospitalizations. Optimal care for asthma patients, especially those&#xD;
      with at highest risk, will therefore require new strategies for evaluating ongoing control&#xD;
      and providing direct feedback to patients.&#xD;
&#xD;
      We propose to transform the way asthma care is provided through the use of an innovative&#xD;
      patient centered technology -Trivox Asthma - to improve quality of care and outcomes for&#xD;
      asthma patients while reducing the cost of care. Specifically we will extend Trivox Health to&#xD;
      facilitate closer monitoring of patients with asthma through the existing web platform and a&#xD;
      new mobile interface. This will allow asthma patients, their parents and school nurses to&#xD;
      remotely input data on asthma control through smartphones and/or tablets. We will use the&#xD;
      ACT+, an expansion of a validated measure currently utilized in both primary care and&#xD;
      specialty clinics, to measure both asthma control and risk.&#xD;
&#xD;
      Effectiveness of this intervention will be measured by examining resource utilization and&#xD;
      ongoing asthma control.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">April 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Well-controlled asthma</measure>
    <time_frame>Each month for one calendar year</time_frame>
    <description>Percent of ACT scores with value of 20 or greater</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Asthma Emergency Department visits and hospitalizations</measure>
    <time_frame>Total Emergency Department Visits and hospitalizations with asthma as one of top diagnosis in one year</time_frame>
    <description>Asked every 3 months</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">221</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Use of Mobile ACT</arm_group_label>
    <description>Will answer ACT (or cACT) and other asthma questions using mobile app</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with asthma seen in one of the clinics caring for patients with asthma at Boston&#xD;
        Children's Hospital Age 4-21&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of asthma&#xD;
&#xD;
          -  Cared for at Boston Children's Hospital (Primary or secondary care)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;4 or &gt;21&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew MacGinnitie, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hosptial</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Childrens Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 27, 2015</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>March 26, 2018</last_update_submitted>
  <last_update_submitted_qc>March 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Andrew MacGinnitie</investigator_full_name>
    <investigator_title>Associate Clinical Director, Division of Immunology</investigator_title>
  </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>Yes</sharing_ipd>
    <ipd_description>Will make deidentified data available for other researchers</ipd_description>
  </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/NCT03036982
org study id: FP01013808
nct id: NCT03036982
lead sponsor: 
has dmc: No
This study will assess whether adaption of the Asthma Control Test (ACT) and childhood Asthma
      Control Test (cACT) for mobile devices improves rate of completion and improves control of
      asthma in children and adolescents
Asthma is the most prevalent chronic disease of childhood with an overall prevalence of 10%.
      While effective therapies exist to control symptoms and prevent exacerbations, many asthma
      patients experience significant morbidity including limitations on daily activities as well
      as asthma exacerbations that lead to missed school (and work for care givers) and necessitate
      emergency department visits and hospitalizations. Among children from lower socioeconomic
      statues and in black and Hispanic families, asthma incidence and severity are even greater.
      Reasons for this disparity included decreased access to effective asthma care, increased
      exposure to tobacco smoke and environmental allergens, and underutilization of controller
      medicines. These groups have significantly increased resource utilization due to emergency
      department visits and hospitalizations. Optimal care for asthma patients, especially those
      with at highest risk, will therefore require new strategies for evaluating ongoing control
      and providing direct feedback to patients.

      We propose to transform the way asthma care is provided through the use of an innovative
      patient centered technology -Trivox Asthma - to improve quality of care and outcomes for
      asthma patients while reducing the cost of care. Specifically we will extend Trivox Health to
      facilitate closer monitoring of patients with asthma through the existing web platform and a
      new mobile interface. This will allow asthma patients, their parents and school nurses to
      remotely input data on asthma control through smartphones and/or tablets. We will use the
      ACT+, an expansion of a validated measure currently utilized in both primary care and
      specialty clinics, to measure both asthma control and risk.

      Effectiveness of this intervention will be measured by examining resource utilization and
      ongoing asthma control.
observational model: Cohort
time perspective: Prospective
measure: Well-controlled asthma
time frame: Each month for one calendar year
description: Percent of ACT scores with value of 20 or greater
measure: Asthma Emergency Department visits and hospitalizations
time frame: Total Emergency Department Visits and hospitalizations with asthma as one of top diagnosis in one year
description: Asked every 3 months
arm group label: Use of Mobile ACT
description: Will answer ACT (or cACT) and other asthma questions using mobile app
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: 21 Years
healthy volunteers: No
last name: Andrew MacGinnitie, MD PhD
role: Principal Investigator
affiliation: Boston Children's Hosptial
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Andrew MacGinnitie
investigator title: Associate Clinical Director, Division of Immunology
mesh term: Asthma
sharing ipd: Yes
ipd description: Will make deidentified data available for other researchers