<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/NCT01710059</url>
  </required_header>
  <id_info>
    <org_study_id>10010402</org_study_id>
    <secondary_id>5K23HL092292-04</secondary_id>
    <nct_id>NCT01710059</nct_id>
  </id_info>
  <brief_title>Using Mobile Phones to Improve Adherence to Inhaled Steroids</brief_title>
  <acronym>ADEPT4</acronym>
  <official_title>Refined ADEPT: Human Augmentics for Sustained Wellbeing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Rush University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study has two main goals. The first goal is to test whether a mobile phone intervention&#xD;
      can increase adherence to daily inhaled steroid medications in African American adolescents&#xD;
      prescribed this type of medication by his/her asthma doctor. The second goal is to use a&#xD;
      mobile phone intervention to better understand real life patterns of use of quick-relief&#xD;
      (beta2-adrenergic agonist) asthma medication in this population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to inhaled corticosteroids, measured objectively using an electronic dose counter</measure>
    <time_frame>10 weeks</time_frame>
    <description>Adherence is measured as the mean of daily adherence to prescription inhaled corticosteroid dose over 14 days both at baseline and at week 10 of the active treatment phase. For the primary outcome, we will compare adherence at week 10 to adherence at baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To understand patterns of use of quick-relief medication for asthma</measure>
    <time_frame>10 weeks</time_frame>
    <description>This study will use an electronic dose counter and mobile phone technology to track participants real time use of quick-relief (beta2-adrenergic agonist) medication for asthma during the 10 weeks of active treatment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Experimental: Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental: Intervention Group&#xD;
1) Asthma Supervision; 2) Mobile Phone with talking, texting, and data plan; 3) Inhaled Corticosteroid Mobile Phone Application to provide virtual doctor supervision, immediate feedback, and positive reinforcement for taking inhaled corticosteroid medication as indicated; and 4) Beta2-adrenergic agonist Mobile Phone Application to monitor real time patterns of use of beta2-adrenergic agonist medication for asthma.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Asthma Supervision</intervention_name>
    <description>Each participant will be provided with a spacer and a peak flow meter, and instructions on proper technique, by a member of the study team during the baseline period. They will also meet with study staff at study visits during the active treatment phase to review their adherence to daily inhaled corticosteroids and usage patterns of short acting B2-agonist medication.</description>
    <arm_group_label>Experimental: Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mobile Phone</intervention_name>
    <description>Each participant will receive a mobile phone with talking, texting and a data plan. They will get to keep the mobile phone at the end of the study, but the talking, texting and data plan will only be active during their participation in the study.</description>
    <arm_group_label>Experimental: Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Inhaled Corticosteroid Mobile Phone Application</intervention_name>
    <description>The Inhaled Corticosteroid Mobile Phone Application will be used to provide virtual doctor supervision, immediate feedback, and positive reinforcement for taking inhaled corticosteroid medication as indicated.</description>
    <arm_group_label>Experimental: Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Beta2-adrenergic agonist Mobile Phone Application</intervention_name>
    <description>The Beta2-adrenergic agonist Mobile Phone Application will be used to track real time patterns of use of beta2-adrenergic agonist medication.</description>
    <arm_group_label>Experimental: Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  11-16 years of age&#xD;
&#xD;
          -  self-identify as African American&#xD;
&#xD;
          -  have persistent asthma&#xD;
&#xD;
          -  be on a prescription daily inhaled corticosteroid medication for asthma&#xD;
&#xD;
          -  be on a prescription inhaled beta2-adrenergic agonist medication for asthma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  candidate refusal&#xD;
&#xD;
          -  the presence of other co-morbidities that could interfere wtih study participation&#xD;
&#xD;
          -  &gt; 60% adherence to inhaled corticosteroid medication, measured by the electronic dose&#xD;
             counter, during the run-in period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giselle S. Mosnaim, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rush University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>February 10, 2014</last_update_submitted>
  <last_update_submitted_qc>February 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rush University Medical Center</investigator_affiliation>
    <investigator_full_name>Giselle Mosnaim</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Health Status Disparities</keyword>
  <keyword>Minority Health</keyword>
  <keyword>Pediatrics</keyword>
  <keyword>Behavioral Intervention</keyword>
  <keyword>Cellular Phone</keyword>
  <keyword>Peer Group</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adrenergic Agents</mesh_term>
    <mesh_term>Adrenergic Agonists</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01710059
org study id: 10010402
secondary id: 5K23HL092292-04
nct id: NCT01710059
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study has two main goals. The first goal is to test whether a mobile phone intervention
      can increase adherence to daily inhaled steroid medications in African American adolescents
      prescribed this type of medication by his/her asthma doctor. The second goal is to use a
      mobile phone intervention to better understand real life patterns of use of quick-relief
      (beta2-adrenergic agonist) asthma medication in this population.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Adherence to inhaled corticosteroids, measured objectively using an electronic dose counter
time frame: 10 weeks
description: Adherence is measured as the mean of daily adherence to prescription inhaled corticosteroid dose over 14 days both at baseline and at week 10 of the active treatment phase. For the primary outcome, we will compare adherence at week 10 to adherence at baseline.
measure: To understand patterns of use of quick-relief medication for asthma
time frame: 10 weeks
description: This study will use an electronic dose counter and mobile phone technology to track participants real time use of quick-relief (beta2-adrenergic agonist) medication for asthma during the 10 weeks of active treatment.
arm group label: Experimental: Intervention Group
arm group type: Experimental
description: Experimental: Intervention Group
1) Asthma Supervision; 2) Mobile Phone with talking, texting, and data plan; 3) Inhaled Corticosteroid Mobile Phone Application to provide virtual doctor supervision, immediate feedback, and positive reinforcement for taking inhaled corticosteroid medication as indicated; and 4) Beta2-adrenergic agonist Mobile Phone Application to monitor real time patterns of use of beta2-adrenergic agonist medication for asthma.
intervention type: Behavioral
intervention name: Asthma Supervision
description: Each participant will be provided with a spacer and a peak flow meter, and instructions on proper technique, by a member of the study team during the baseline period. They will also meet with study staff at study visits during the active treatment phase to review their adherence to daily inhaled corticosteroids and usage patterns of short acting B2-agonist medication.
arm group label: Experimental: Intervention Group
intervention type: Behavioral
intervention name: Mobile Phone
description: Each participant will receive a mobile phone with talking, texting and a data plan. They will get to keep the mobile phone at the end of the study, but the talking, texting and data plan will only be active during their participation in the study.
arm group label: Experimental: Intervention Group
intervention type: Behavioral
intervention name: Inhaled Corticosteroid Mobile Phone Application
description: The Inhaled Corticosteroid Mobile Phone Application will be used to provide virtual doctor supervision, immediate feedback, and positive reinforcement for taking inhaled corticosteroid medication as indicated.
arm group label: Experimental: Intervention Group
intervention type: Behavioral
intervention name: Beta2-adrenergic agonist Mobile Phone Application
description: The Beta2-adrenergic agonist Mobile Phone Application will be used to track real time patterns of use of beta2-adrenergic agonist medication.
arm group label: Experimental: Intervention Group
criteria: 
gender: All
minimum age: 11 Years
maximum age: 16 Years
healthy volunteers: No
last name: Giselle S. Mosnaim, MD, MS
role: Principal Investigator
affiliation: Rush University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rush University Medical Center
investigator full name: Giselle Mosnaim
investigator title: Principal Investigator
mesh term: Adrenergic Agents
mesh term: Adrenergic Agonists