<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/NCT02205723</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 140934</org_study_id>
    <nct_id>NCT02205723</nct_id>
  </id_info>
  <brief_title>Smartphone-facilitated Asthma Control</brief_title>
  <acronym>SNAPP</acronym>
  <official_title>Smartphone-facilitated Medication Notification for Asthma Control in Pediatric Patients (SNAPP) Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aerocrine AB</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University Medical Center</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 objective of this protocol is to pilot an innovative approach to medication adherence to&#xD;
      determine if such an approach will improve inhaled corticosteroid (ICS) medication adherence,&#xD;
      a critical gap in improving the health of children with asthma. SNAPP incorporates&#xD;
      monitoring, reminders, and dynamic feedback through a smartphone that will improve ICS&#xD;
      medication adherence and that the investigators believe will influence the child's future&#xD;
      independence and chronic disease-management skills.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this protocol is to pilot an innovative approach to medication adherence to&#xD;
      determine if such an approach will improve inhaled corticosteroid (ICS) medication adherence,&#xD;
      a critical gap in improving the health of children with asthma.&#xD;
&#xD;
      Acute asthma exacerbations occur yearly in almost 60% of children with asthma. They are the&#xD;
      most frequent reason for childhood hospitalization and the most expensive component of&#xD;
      pediatric asthma care in the U.S. Exacerbations impair quality of life and disproportionately&#xD;
      affect African-American children, children with Medicaid insurance, and the poor. Up to 70%&#xD;
      of exacerbations are preventable if guideline-recommended inhaled corticosteroid (ICS)&#xD;
      medication adherence is achieved. However, ICS medication adherence in children with&#xD;
      persistent asthma is dismal at only 11 - 18%. Amongst children with Medicaid insurance&#xD;
      prescribed ICS, 63% discontinue the medication within 90 days. As a healthcare system,&#xD;
      investigators have been unable to meaningfully improve ICS medication adherence in a&#xD;
      cost-efficient way for patients with asthma, and particularly for the high-risk,&#xD;
      highest-potential population of children with moderate or severe persistent asthma. These&#xD;
      children suffer the greatest morbidity and mortality from asthma yet have highest-potential&#xD;
      to benefit from improved ICS medication adherence. There is an urgent need for an efficacious&#xD;
      adherence intervention for this population because, without it, these children will continue&#xD;
      to experience impaired health and disproportionate morbidity.&#xD;
&#xD;
      The investigators' long-term objective is to identify and disseminate an intervention that&#xD;
      will minimize the occurrence and severity of exacerbations in this population. The overall&#xD;
      objective of this pilot study is to test the feasibility of Smartphone-facilitated medication&#xD;
      Notification for Asthma Control in Pediatric Patients (SNAPP) using a wireless medication&#xD;
      monitor (WMM) and smartphone application that provides parents reminders for administration&#xD;
      of ICS medication, real-time feedback on preventive and controller medication adherence, and&#xD;
      wireless upload of this data to a secure online database. The central hypothesis is that for&#xD;
      children in this population, SNAPP will result in &gt;=25% improved Asthma Control Test (ACT)&#xD;
      scores in comparison with usual management. Secondary hypotheses are that the intervention&#xD;
      will result in a &gt;= 30% decrease in FeNO in comparison with usual care at 6 months and &gt;=40%&#xD;
      increase in ICS medication adherence at 6 months. The central hypothesis has been formulated&#xD;
      on the basis of reports that parents of children with acute exacerbations continue to have&#xD;
      insufficient knowledge of asthma self-management yet are motivated to do what is best for&#xD;
      their child. SNAPP incorporates monitoring, reminders, and dynamic feedback through a&#xD;
      smartphone that will improve ICS medication adherence and that will influence the child's&#xD;
      future independence and chronic disease-management skills. Importantly, the investigators&#xD;
      will use wireless medication monitors to accurately and objectively ascertain ICS medication&#xD;
      adherence without patient effort. Parents are facile with and use wireless technology to&#xD;
      organize their daily activities and for communicating. Incorporating this technology into&#xD;
      health care and medication adherence is a logical next-step.&#xD;
&#xD;
      The investigators propose to test the hypotheses through the following Aim: To determine&#xD;
      whether SNAPP meaningfully improves 6-month asthma control measured with the Asthma Control&#xD;
      Test, airway inflammation measured using exhaled nitric oxide and ICS adherence compared with&#xD;
      usual care, in an RCT of children with moderate or severe persistent asthma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study was not initiated because we could not secure funding.&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 3, 2021</start_date>
  <completion_date type="Anticipated">April 2025</completion_date>
  <primary_completion_date type="Anticipated">March 2025</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Childhood asthma control test</measure>
    <time_frame>6 months</time_frame>
    <description>Measurement of change of C-ACT at 6 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fractional excretion of exhaled nitric oxide</measure>
    <time_frame>6 months</time_frame>
    <description>Measurement of change of FeNO at 6 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Childhood Asthma</condition>
  <arm_group>
    <arm_group_label>Smartphone Asthma Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Smartphone Asthma Control</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Asthma teaching in ER</intervention_name>
    <description>Asthma teaching</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Smartphone Asthma Control</arm_group_label>
    <other_name>Asthma teaching</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Smartphone Asthma Control</intervention_name>
    <description>Smartphone Asthma Control</description>
    <arm_group_label>Smartphone Asthma Control</arm_group_label>
    <other_name>SNAPP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. TennCare Medicaid insurance, and an acute exacerbation (45% of our ED patients with&#xD;
             acute asthma, section C.11.)&#xD;
&#xD;
          2. Parent has a smartphone and wireless account that they agree to use for this study (if&#xD;
             randomized to intervention group), anticipated residence in the Nashville Metropolitan&#xD;
             Service Area for at least 12 months, willingness to participate in phone-based&#xD;
             (wireless or landline) ACT-scoring monthly, and willingness to return at 3, 6 and 12&#xD;
             months for FeNO testing.&#xD;
&#xD;
          3. The participant's PCP agrees that patient has moderate or severe persistent asthma and&#xD;
             should be on ICS for at least the subsequent 12 months in accordance with NIH-NAEPP&#xD;
             expert panel guidelines.87,88&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria include prior study enrollment, other medical condition&#xD;
             contributing to respiratory distress (e.g., pneumonia, cystic fibrosis) or other&#xD;
             diseases that may necessitate treatment with systemic corticosteroid (CCS; e.g.,&#xD;
             nephrotic syndrome).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Donald H Arnold, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt Children's Hospital</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>November 11, 2020</last_update_submitted>
  <last_update_submitted_qc>November 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Donald H Arnold</investigator_full_name>
    <investigator_title>Associate Professor of Pediatrics and Emergency Medicine</investigator_title>
  </responsible_party>
  <keyword>Asthma</keyword>
  <keyword>Asthma exacerbations</keyword>
  <keyword>Pediatric</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_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/NCT02205723
org study id: IRB 140934
nct id: NCT02205723
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this protocol is to pilot an innovative approach to medication adherence to
      determine if such an approach will improve inhaled corticosteroid (ICS) medication adherence,
      a critical gap in improving the health of children with asthma. SNAPP incorporates
      monitoring, reminders, and dynamic feedback through a smartphone that will improve ICS
      medication adherence and that the investigators believe will influence the child's future
      independence and chronic disease-management skills.
The objective of this protocol is to pilot an innovative approach to medication adherence to
      determine if such an approach will improve inhaled corticosteroid (ICS) medication adherence,
      a critical gap in improving the health of children with asthma.

      Acute asthma exacerbations occur yearly in almost 60% of children with asthma. They are the
      most frequent reason for childhood hospitalization and the most expensive component of
      pediatric asthma care in the U.S. Exacerbations impair quality of life and disproportionately
      affect African-American children, children with Medicaid insurance, and the poor. Up to 70%
      of exacerbations are preventable if guideline-recommended inhaled corticosteroid (ICS)
      medication adherence is achieved. However, ICS medication adherence in children with
      persistent asthma is dismal at only 11 - 18%. Amongst children with Medicaid insurance
      prescribed ICS, 63% discontinue the medication within 90 days. As a healthcare system,
      investigators have been unable to meaningfully improve ICS medication adherence in a
      cost-efficient way for patients with asthma, and particularly for the high-risk,
      highest-potential population of children with moderate or severe persistent asthma. These
      children suffer the greatest morbidity and mortality from asthma yet have highest-potential
      to benefit from improved ICS medication adherence. There is an urgent need for an efficacious
      adherence intervention for this population because, without it, these children will continue
      to experience impaired health and disproportionate morbidity.

      The investigators' long-term objective is to identify and disseminate an intervention that
      will minimize the occurrence and severity of exacerbations in this population. The overall
      objective of this pilot study is to test the feasibility of Smartphone-facilitated medication
      Notification for Asthma Control in Pediatric Patients (SNAPP) using a wireless medication
      monitor (WMM) and smartphone application that provides parents reminders for administration
      of ICS medication, real-time feedback on preventive and controller medication adherence, and
      wireless upload of this data to a secure online database. The central hypothesis is that for
      children in this population, SNAPP will result in >=25% improved Asthma Control Test (ACT)
      scores in comparison with usual management. Secondary hypotheses are that the intervention
      will result in a >= 30% decrease in FeNO in comparison with usual care at 6 months and >=40%
      increase in ICS medication adherence at 6 months. The central hypothesis has been formulated
      on the basis of reports that parents of children with acute exacerbations continue to have
      insufficient knowledge of asthma self-management yet are motivated to do what is best for
      their child. SNAPP incorporates monitoring, reminders, and dynamic feedback through a
      smartphone that will improve ICS medication adherence and that will influence the child's
      future independence and chronic disease-management skills. Importantly, the investigators
      will use wireless medication monitors to accurately and objectively ascertain ICS medication
      adherence without patient effort. Parents are facile with and use wireless technology to
      organize their daily activities and for communicating. Incorporating this technology into
      health care and medication adherence is a logical next-step.

      The investigators propose to test the hypotheses through the following Aim: To determine
      whether SNAPP meaningfully improves 6-month asthma control measured with the Asthma Control
      Test, airway inflammation measured using exhaled nitric oxide and ICS adherence compared with
      usual care, in an RCT of children with moderate or severe persistent asthma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Childhood asthma control test
time frame: 6 months
description: Measurement of change of C-ACT at 6 months.
measure: Fractional excretion of exhaled nitric oxide
time frame: 6 months
description: Measurement of change of FeNO at 6 months.
arm group label: Smartphone Asthma Control
arm group type: Experimental
description: Smartphone Asthma Control
arm group label: Control
arm group type: Active Comparator
description: Control group
intervention type: Behavioral
intervention name: Asthma teaching in ER
description: Asthma teaching
arm group label: Control
arm group label: Smartphone Asthma Control
other name: Asthma teaching
intervention type: Behavioral
intervention name: Smartphone Asthma Control
description: Smartphone Asthma Control
arm group label: Smartphone Asthma Control
other name: SNAPP
criteria: 
gender: All
minimum age: 4 Years
maximum age: 11 Years
healthy volunteers: No
last name: Donald H Arnold, MD, MPH
role: Principal Investigator
affiliation: Vanderbilt University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Donald H Arnold
investigator title: Associate Professor of Pediatrics and Emergency Medicine
mesh term: Asthma