<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/NCT01696357</url>
  </required_header>
  <id_info>
    <org_study_id>5R01NR011169</org_study_id>
    <nct_id>NCT01696357</nct_id>
  </id_info>
  <brief_title>Automated Device for Asthma Monitoring</brief_title>
  <acronym>ADAM</acronym>
  <official_title>Developing an Automated Symptom Monitoring Device for Adolescents With Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Rochester</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine an innovative strategy to monitor asthma symptoms by using existing&#xD;
      technology to develop a non-invasive device for monitoring asthma symptoms in adolescents.&#xD;
      Using an iPod as a platform, and current sound data analysis techniques, a prototype device&#xD;
      will be developed that will directly monitor the chosen parameters of asthma symptoms,&#xD;
      including wheezing, coughing and activity levels. This small non-invasive device will be&#xD;
      continuously carried by or placed in close proximity to the adolescent on a daily basis. It&#xD;
      is hypothesized that such a device would be acceptable to adolescents and would lend accuracy&#xD;
      and objectivity to symptom assessment; something that existing monitoring strategies have yet&#xD;
      to achieve. It will also stimulate the adolescents' partnership in asthma self-monitoring and&#xD;
      ultimately lead to effective asthma management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prior research has generated compelling evidence that programs promoting self-management can&#xD;
      reduce morbidity and improve asthma outcomes in children. Successful asthma management&#xD;
      strategies require patients' active commitment to engage in care processes by establishing&#xD;
      self-monitoring routines. Adequate self-monitoring of asthma symptoms is considered to be the&#xD;
      cornerstone of appropriate asthma management leading to fewer cases of asthma exacerbation&#xD;
      and acute care visits as well as better functional outcomes and higher quality of life in&#xD;
      children and adolescents. Symptom monitoring informs patient decisions to initiate necessary&#xD;
      self-management behaviors (e.g., adjust medication, alter activity level, alter the&#xD;
      surrounding environment or seek medical assistance) as well as the providers' decisions&#xD;
      related to an appropriate treatment course such as step up, no change or step down therapy.&#xD;
      Thus, current guidelines by National Heart, Lung, and Blood Institute (NHLBI) Expert Panel&#xD;
      Review 3 (EPR3) highlight the importance of ongoing symptom monitoring.&#xD;
&#xD;
      Studies of children have raised concerns about adequacy and effectiveness of current methods&#xD;
      of asthma self-monitoring including symptom-based and peak expiratory flow (PEF) monitoring.&#xD;
      Symptom-based monitoring relies on the individual's symptom perception which is subjective&#xD;
      and influenced by a variety of factors such as the patient's emotional status, social&#xD;
      influences (e.g, family, peers) and previous experiences with symptoms. Thus, the accuracy&#xD;
      and objectivity of this monitoring method is uncertain. As an objective approach, PEF&#xD;
      monitoring has been encouraged, yet the efficacy of this method has also been a subject of&#xD;
      ongoing debate in the literature. Poor adherence and inadequate technique further diminish&#xD;
      the clinical usefulness of PEF monitoring. Thus, the uncertainty of current monitoring&#xD;
      strategies underscores the imperative of an alternative symptom monitoring strategy that&#xD;
      addresses the issues of accuracy and objectivity of symptom assessment.&#xD;
&#xD;
      Adolescence is an important period for consolidating and establishing self-management of and&#xD;
      adjustment to chronic health conditions. Yet an array of developmental challenges including&#xD;
      the desire for normalcy and peer approval, feelings of invulnerability and emerging&#xD;
      independence undermine adolescents' motivation and behaviors to engage in self-management and&#xD;
      present particular difficulties in achieving optimal asthma control in adolescents with&#xD;
      asthma. Parents become less able to manage asthma as children reach adolescence and many&#xD;
      researchers and clinicians have reported similar difficulties in managing asthma in&#xD;
      adolescents primarily due to inadequate adherence and counterproductive behaviors. Thus,&#xD;
      clinicians face serious challenges in providing optimal management for adolescents with&#xD;
      asthma primarily due to difficulties in soliciting patients' active partnership in asthma&#xD;
      management with sustainable and reliable symptom monitoring routines. Accurate symptom&#xD;
      monitoring by patients is the most fundamental antecedent to effective asthma management, yet&#xD;
      existing monitoring strategies have not been conducive to adolescents' cooperation or yielded&#xD;
      accurate or clinically useful information. Having recognized these limitations, this study&#xD;
      will examine an innovative strategy to monitor asthma symptoms that stimulates adolescents'&#xD;
      partnership and ultimately leads to effective asthma management.&#xD;
&#xD;
      The device will directly monitor the chosen parameters of asthma symptoms, including&#xD;
      wheezing, coughing and activity levels. A mobile phone will be employed as a platform for&#xD;
      processing, analyzing and storing data transmitted from a microphone and a wireless&#xD;
      accelerometer. This new approach is developmentally appropriate, given adolescents' affinity&#xD;
      for technology and its capacity to address adolescents' need for maintaining normalcy while&#xD;
      allowing continuous asthma monitoring during real-life situations. The device involves&#xD;
      biomedical engineering techniques enabling automatic sound and activity recording, analysis,&#xD;
      feedback, and storage function. A mobile phone will be employed as a platform for processing,&#xD;
      analyzing and storing data transmitted from a microphone and a wireless accelerometer. This&#xD;
      technology will automate daily symptom monitoring with minimal intrusiveness and maximum&#xD;
      accuracy, thereby reducing the risk of inappropriate treatment and ameliorating&#xD;
      asthma-related disability. Due to its foreseen safety, noninvasiveness, objectivity,&#xD;
      convenience, user-friendliness, and cost containment, the approach can greatly enhance asthma&#xD;
      management by adolescents and health care providers. This device has the potential to bring&#xD;
      about patient behavior changes such as avoiding triggers and adjusting medications as the&#xD;
      device will provide the opportunity for in-time review of symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Average Number of Coughs Per Hour</measure>
    <time_frame>7 days</time_frame>
    <description>The device is supposed to detect and count the number of coughs per 24 hours and register the numbers into the device.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">84</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Adolescents with asthma</arm_group_label>
    <description>Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adolescents without asthma</arm_group_label>
    <description>Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Automated Device for Asthma Monitoring (ADAM)</intervention_name>
    <description>Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device.</description>
    <arm_group_label>Adolescents with asthma</arm_group_label>
    <arm_group_label>Adolescents without asthma</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adolescents between the ages of 13-17 who received care at Strong Memorial Hospital,&#xD;
        Rochester NY.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: Asthma Group&#xD;
&#xD;
          -  Age 13 through 17 years,&#xD;
&#xD;
          -  Asthma diagnosis from a care provider,&#xD;
&#xD;
          -  Prescribed asthma controller medication&#xD;
&#xD;
        Inclusion Criteria: Comparison(Non-asthma)Group&#xD;
&#xD;
          -  Age 13 through 17 years,&#xD;
&#xD;
        Exclusion Criteria: Asthma Group&#xD;
&#xD;
          -  Other health conditions (e.g., heart disease, cystic fibrosis) producing asthma-like&#xD;
             symptoms,&#xD;
&#xD;
          -  Known cognitive, psychological and behavior problems (based on self-report and/or&#xD;
             clinician report) that present challenges in following study procedures&#xD;
&#xD;
          -  Ability to understand spoken and written English.&#xD;
&#xD;
        Exclusion Criteria: Comparison(Non-asthma)Group&#xD;
&#xD;
          -  Other health conditions (e.g., heart disease, cystic fibrosis) producing asthma-like&#xD;
             symptoms,&#xD;
&#xD;
          -  Known cognitive, psychological and behavior problems (based on self-report and/or&#xD;
             clinician report) that present challenges in following study procedures&#xD;
&#xD;
          -  Ability to understand spoken and written English.&#xD;
&#xD;
          -  Asthma diagnosis from a care provider,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyekyun Rhee, PhD, RN, PNP</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester School of Nursing</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mark Bocko, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester Electrical Engineering</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Rhee H, Miner S, Sterling M, Halterman JS, Fairbanks E. The development of an automated device for asthma monitoring for adolescents: methodologic approach and user acceptability. JMIR Mhealth Uhealth. 2014 Jun 19;2(2):e27. doi: 10.2196/mhealth.3118.</citation>
    <PMID>25100184</PMID>
  </reference>
  <results_reference>
    <citation>Rhee H, Fairbanks E, Butz A. Symptoms, feelings, activities and medication use in adolescents with uncontrolled asthma: lessons learned from asthma diaries. J Pediatr Nurs. 2014 Jan-Feb;29(1):39-46. doi: 10.1016/j.pedn.2013.04.009. Epub 2013 May 15.</citation>
    <PMID>23685266</PMID>
  </results_reference>
  <results_reference>
    <citation>Sterling M, Rhee H, Bocko M. Automated Cough Assessment on a Mobile Platform. J Med Eng. 2014;2014:951621. doi: 10.1155/2014/951621.</citation>
    <PMID>25506590</PMID>
  </results_reference>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <results_first_submitted>December 2, 2014</results_first_submitted>
  <results_first_submitted_qc>December 8, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 10, 2014</results_first_posted>
  <last_update_submitted>December 8, 2014</last_update_submitted>
  <last_update_submitted_qc>December 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Hyekyun Rhee</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Asthma</keyword>
  <keyword>Adolescents</keyword>
  <keyword>Self-monitoring</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Biomedical device</keyword>
  <keyword>Symptom monitoring</keyword>
  <keyword>Self-management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Adolescents With Asthma</title>
          <description>Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.&#xD;
Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device.</description>
        </group>
        <group group_id="P2">
          <title>Adolescents Without Asthma</title>
          <description>Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.&#xD;
Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Adolescents With Asthma</title>
          <description>Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.&#xD;
Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device.</description>
        </group>
        <group group_id="B2">
          <title>Adolescents Without Asthma</title>
          <description>Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.&#xD;
Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device.</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="42"/>
            <count group_id="B2" value="42"/>
            <count group_id="B3" value="84"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.2" spread="1.5"/>
                    <measurement group_id="B2" value="14.8" spread="1.3"/>
                    <measurement group_id="B3" value="15.0" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Average Number of Coughs Per Hour</title>
        <description>The device is supposed to detect and count the number of coughs per 24 hours and register the numbers into the device.</description>
        <time_frame>7 days</time_frame>
        <population>One subject in the non-asthma group failed to return the device after the 7-trial. Data from 22 participants (3 from the asthma group, 19 from non-asthma group) were not included in the analysis as no data were recorded (due to a mechanical issue) or data were too extreme (due to cough algorithm failure).</population>
        <group_list>
          <group group_id="O1">
            <title>Adolescents With Asthma</title>
            <description>Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.&#xD;
Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device.</description>
          </group>
          <group group_id="O2">
            <title>Adolescents Without Asthma</title>
            <description>Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.&#xD;
Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Number of Coughs Per Hour</title>
          <description>The device is supposed to detect and count the number of coughs per 24 hours and register the numbers into the device.</description>
          <population>One subject in the non-asthma group failed to return the device after the 7-trial. Data from 22 participants (3 from the asthma group, 19 from non-asthma group) were not included in the analysis as no data were recorded (due to a mechanical issue) or data were too extreme (due to cough algorithm failure).</population>
          <units>average number of coughs per hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.64" spread="111.41"/>
                    <measurement group_id="O2" value=".63" spread=".76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Adolescents With Asthma</title>
          <description>Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.&#xD;
Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device.</description>
        </group>
        <group group_id="E2">
          <title>Adolescents Without Asthma</title>
          <description>Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.&#xD;
Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
              </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>Hyekyun Rhee</name_or_title>
      <organization>University of Rochester Medical Center</organization>
      <phone>5852763775</phone>
      <email>hyekyun_rhee@urmc.rochester.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/NCT01696357
org study id: 5R01NR011169
nct id: NCT01696357
lead sponsor: 
has dmc: Yes
This study will examine an innovative strategy to monitor asthma symptoms by using existing
      technology to develop a non-invasive device for monitoring asthma symptoms in adolescents.
      Using an iPod as a platform, and current sound data analysis techniques, a prototype device
      will be developed that will directly monitor the chosen parameters of asthma symptoms,
      including wheezing, coughing and activity levels. This small non-invasive device will be
      continuously carried by or placed in close proximity to the adolescent on a daily basis. It
      is hypothesized that such a device would be acceptable to adolescents and would lend accuracy
      and objectivity to symptom assessment; something that existing monitoring strategies have yet
      to achieve. It will also stimulate the adolescents' partnership in asthma self-monitoring and
      ultimately lead to effective asthma management.
Prior research has generated compelling evidence that programs promoting self-management can
      reduce morbidity and improve asthma outcomes in children. Successful asthma management
      strategies require patients' active commitment to engage in care processes by establishing
      self-monitoring routines. Adequate self-monitoring of asthma symptoms is considered to be the
      cornerstone of appropriate asthma management leading to fewer cases of asthma exacerbation
      and acute care visits as well as better functional outcomes and higher quality of life in
      children and adolescents. Symptom monitoring informs patient decisions to initiate necessary
      self-management behaviors (e.g., adjust medication, alter activity level, alter the
      surrounding environment or seek medical assistance) as well as the providers' decisions
      related to an appropriate treatment course such as step up, no change or step down therapy.
      Thus, current guidelines by National Heart, Lung, and Blood Institute (NHLBI) Expert Panel
      Review 3 (EPR3) highlight the importance of ongoing symptom monitoring.

      Studies of children have raised concerns about adequacy and effectiveness of current methods
      of asthma self-monitoring including symptom-based and peak expiratory flow (PEF) monitoring.
      Symptom-based monitoring relies on the individual's symptom perception which is subjective
      and influenced by a variety of factors such as the patient's emotional status, social
      influences (e.g, family, peers) and previous experiences with symptoms. Thus, the accuracy
      and objectivity of this monitoring method is uncertain. As an objective approach, PEF
      monitoring has been encouraged, yet the efficacy of this method has also been a subject of
      ongoing debate in the literature. Poor adherence and inadequate technique further diminish
      the clinical usefulness of PEF monitoring. Thus, the uncertainty of current monitoring
      strategies underscores the imperative of an alternative symptom monitoring strategy that
      addresses the issues of accuracy and objectivity of symptom assessment.

      Adolescence is an important period for consolidating and establishing self-management of and
      adjustment to chronic health conditions. Yet an array of developmental challenges including
      the desire for normalcy and peer approval, feelings of invulnerability and emerging
      independence undermine adolescents' motivation and behaviors to engage in self-management and
      present particular difficulties in achieving optimal asthma control in adolescents with
      asthma. Parents become less able to manage asthma as children reach adolescence and many
      researchers and clinicians have reported similar difficulties in managing asthma in
      adolescents primarily due to inadequate adherence and counterproductive behaviors. Thus,
      clinicians face serious challenges in providing optimal management for adolescents with
      asthma primarily due to difficulties in soliciting patients' active partnership in asthma
      management with sustainable and reliable symptom monitoring routines. Accurate symptom
      monitoring by patients is the most fundamental antecedent to effective asthma management, yet
      existing monitoring strategies have not been conducive to adolescents' cooperation or yielded
      accurate or clinically useful information. Having recognized these limitations, this study
      will examine an innovative strategy to monitor asthma symptoms that stimulates adolescents'
      partnership and ultimately leads to effective asthma management.

      The device will directly monitor the chosen parameters of asthma symptoms, including
      wheezing, coughing and activity levels. A mobile phone will be employed as a platform for
      processing, analyzing and storing data transmitted from a microphone and a wireless
      accelerometer. This new approach is developmentally appropriate, given adolescents' affinity
      for technology and its capacity to address adolescents' need for maintaining normalcy while
      allowing continuous asthma monitoring during real-life situations. The device involves
      biomedical engineering techniques enabling automatic sound and activity recording, analysis,
      feedback, and storage function. A mobile phone will be employed as a platform for processing,
      analyzing and storing data transmitted from a microphone and a wireless accelerometer. This
      technology will automate daily symptom monitoring with minimal intrusiveness and maximum
      accuracy, thereby reducing the risk of inappropriate treatment and ameliorating
      asthma-related disability. Due to its foreseen safety, noninvasiveness, objectivity,
      convenience, user-friendliness, and cost containment, the approach can greatly enhance asthma
      management by adolescents and health care providers. This device has the potential to bring
      about patient behavior changes such as avoiding triggers and adjusting medications as the
      device will provide the opportunity for in-time review of symptoms.
observational model: Case-Control
time perspective: Prospective
measure: Average Number of Coughs Per Hour
time frame: 7 days
description: The device is supposed to detect and count the number of coughs per 24 hours and register the numbers into the device.
arm group label: Adolescents with asthma
description: Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.
arm group label: Adolescents without asthma
description: Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.
intervention type: Device
intervention name: Automated Device for Asthma Monitoring (ADAM)
description: Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device.
arm group label: Adolescents with asthma
arm group label: Adolescents without asthma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 13 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hyekyun Rhee, PhD, RN, PNP
role: Principal Investigator
affiliation: University of Rochester School of Nursing
last name: Mark Bocko, PhD
role: Principal Investigator
affiliation: University of Rochester Electrical Engineering
facility: 
country: United States
citation: Rhee H, Miner S, Sterling M, Halterman JS, Fairbanks E. The development of an automated device for asthma monitoring for adolescents: methodologic approach and user acceptability. JMIR Mhealth Uhealth. 2014 Jun 19;2(2):e27. doi: 10.2196/mhealth.3118.
PMID: 25100184
citation: Rhee H, Fairbanks E, Butz A. Symptoms, feelings, activities and medication use in adolescents with uncontrolled asthma: lessons learned from asthma diaries. J Pediatr Nurs. 2014 Jan-Feb;29(1):39-46. doi: 10.1016/j.pedn.2013.04.009. Epub 2013 May 15.
PMID: 23685266
citation: Sterling M, Rhee H, Bocko M. Automated Cough Assessment on a Mobile Platform. J Med Eng. 2014;2014:951621. doi: 10.1155/2014/951621.
PMID: 25506590
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Hyekyun Rhee
investigator title: Associate Professor
mesh term: Asthma
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 