<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/NCT03284203</url>
  </required_header>
  <id_info>
    <org_study_id>IRB17-0562</org_study_id>
    <nct_id>NCT03284203</nct_id>
  </id_info>
  <brief_title>Feasibility of At-Home Handheld Spirometry</brief_title>
  <official_title>Feasibility of Inpatient and At-Home Use of Handheld Spirometry (SpiroPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators' central hypotheses predict that the handheld spirometry device will be&#xD;
      feasible for inpatient and at-home use, and is equally efficacious at determining lung&#xD;
      function when compared to traditional, bedside spirometry measurements. To test these&#xD;
      hypotheses, the investigators propose the following specific aims:&#xD;
&#xD;
      Specific Aim 1: Determine the correlation of SpiroPD handheld spirometry measurements with&#xD;
      bedside Koko spirometry lung function.&#xD;
&#xD;
      Hypothesis: Correlation between the two lung function tests will be substantial for both&#xD;
      hospitalized and ambulatory patients.&#xD;
&#xD;
      Specific Aim 2: To determine the feasibility, adherence, and preliminary management efficacy&#xD;
      of home SpiroPD testing.&#xD;
&#xD;
      Hypotheses: (1) Patients will demonstrate substantial adherence to daily home spirometry&#xD;
      testing; (2) medication adherence will increase significantly in patients who are adherent to&#xD;
      daily home spirometry testing; (3) acute care utilization will decrease significant in&#xD;
      adherent patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic Obstructive Pulmonary Disease (COPD) results in nearly 750,000 hospitalizations&#xD;
      annually and is the third leading cause of &quot;early&quot; (within 30-day) hospital readmissions in&#xD;
      the United States. Curbing preventable early readmissions for acute exacerbations of COPD&#xD;
      (AECOPD) has become a national priority, as demonstrated by the Medicare Hospital&#xD;
      Readmissions Reduction financial penalty program. One critical barrier in assessing&#xD;
      readmission risk is the lack of an easily-measured 'vital sign' for COPD: accurate, timely&#xD;
      measurements of lung function. Unlike other medical problems that have validated,&#xD;
      easily-obtained measurements of organ function, COPD evaluation often defaults to patient&#xD;
      report and physician evaluation without critical physiologic data. This lack of objective&#xD;
      pulmonary function data during AECOPD in turn leads to critical errors in disease severity&#xD;
      assessment. However, the required, repeated measurements by spirometry that can demonstrate&#xD;
      responses to therapy can be time-consuming and expensive to perform in a laboratory, and both&#xD;
      equipment and staffing infrastructure for bedside testing is cumbersome and often not&#xD;
      prioritized. For these reasons, spirometry frequently is not done for patients with AECOPD.&#xD;
&#xD;
      To monitor patient responses to therapy and to assess risks based on objective measures, the&#xD;
      investigators propose to the study the use of a portable, patient-driven device (&quot;SpiroPD&quot;)&#xD;
      that can be used in both in-patient and outpatient settings, and that reports (via the&#xD;
      internet) values collected in real time. While the device has been used in the lung&#xD;
      transplant community and for patients with cystic fibrosis, no studies have been done to&#xD;
      validate its use in COPD. This protocol involves in-hospital patient training with the device&#xD;
      followed by serial measurements at home in the first 30 days post hospital-discharge.&#xD;
&#xD;
      Demonstration in a pilot, single-center trial of the usefulness of real-time, repeated&#xD;
      hand-held spirometry to provide objective measurements of lung function in AECOPD will have a&#xD;
      substantial impact on both patient health outcomes and on health care utilization and will&#xD;
      set the stage for appropriate next-step studies and NIH grant applications. It is unknown&#xD;
      whether this specific technology will be acceptable in the target population, though previous&#xD;
      research suggests that older patients may be more willing to use home monitoring technology.&#xD;
      This multi-disciplinary research team includes providers from the Department of Medicine and&#xD;
      the UCM COPD Readmissions Program team.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The aims represented in this study are also included in another, larger study of at-home COPD&#xD;
    care. There was insufficient research team support to complete both protocols and the work&#xD;
    would have been duplicative. Thus, we have terminated this study.&#xD;
  </why_stopped>
  <start_date type="Actual">September 30, 2017</start_date>
  <completion_date type="Actual">March 1, 2018</completion_date>
  <primary_completion_date type="Actual">November 20, 2017</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>Comparison of KOKO Spirometry to SpiroPD Use</measure>
    <time_frame>30 days from patient enrollment</time_frame>
    <description>Participants will use the handheld spirometry device every day for 30 days. After use, the device will store spirometry measurements for each patient each day and the data will be synced over wifi to each individual's associated online account. Daily measurements from the SpiroPD device will be collected over the course of 30 days. These measurements will then be compared against spirometry measurements collected using the bedside KoKo machine during baseline and 30-day follow-up visits.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence to Using the SpiroPD Device at Home on a Daily Basis</measure>
    <time_frame>30 days from patient enrollment</time_frame>
    <description>Daily use of the SpiroPD will be measured by way of captured spirometry measurements. If there is no recorded spirometry measurement in the SpiroPD device for certain days, those days will be considered when discussing non-adherence to daily use of the SpiroPD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of Patients to Use the SpiroPD Device at Home Consistently</measure>
    <time_frame>30 days from patient enrollment</time_frame>
    <description>Feasibility, or ease of use, will be measured by tracking the number of inquiries received on the designated SpiroPD help line. Each inquiry will be measured and tracked using an inquiry intake form. The type of inquiry or issue the patient is having and the possible solutions to the issue will be recorded. The patient's study ID and the date and time of their call will be recorded. These metrics along with adherence measurements will be factored in when discussing the feasibility of the SpiroPD device.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>SpiroPD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the intervention arm will be given a handheld spirometry device to take home and use daily for 30 consecutive days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SpiroPD</intervention_name>
    <description>At the time of their initial study visit, study participants will be given a SpiroPD device for use at home following instruction in the hospital or clinic. Patient adherence to daily testing over one-month will be monitored using real-time capture Wi-Fi-data from the SpiroPD data portal.</description>
    <arm_group_label>SpiroPD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18+ years&#xD;
&#xD;
          -  Physician-diagnosed COPD&#xD;
&#xD;
          -  Able to perform spirometry&#xD;
&#xD;
          -  Access to wireless internet at home&#xD;
&#xD;
          -  Visual acuity of at least 20/50 in one eye&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently in ICU&#xD;
&#xD;
          -  Physician declines to provide consent&#xD;
&#xD;
          -  Patient unable to provide consent or declines to provide consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Valerie Press</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <results_first_submitted>May 25, 2021</results_first_submitted>
  <results_first_submitted_qc>May 26, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">May 31, 2023</results_first_posted>
  <last_update_submitted>May 26, 2023</last_update_submitted>
  <last_update_submitted_qc>May 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT03284203/Prot_SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT03284203/ICF_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants enrolled from September to December 2017 at the University of Chicago Medical Center.</recruitment_details>
      <pre_assignment_details>No participants were excluded from the study except those who did not meet the eligibility criteria.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>SpiroPD</title>
          <description>Participants in the intervention arm will be given a handheld spirometry device to take home and use daily for 30 consecutive days.&#xD;
SpiroPD: At the time of their initial study visit, study participants will be given a SpiroPD device for use at home following instruction in the hospital or clinic. Patient adherence to daily testing over one-month will be monitored using real-time capture Wi-Fi-data from the SpiroPD data portal.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>SpiroPD</title>
          <description>Participants in the intervention arm will be given a handheld spirometry device to take home and use daily for 30 consecutive days.&#xD;
SpiroPD: At the time of their initial study visit, study participants will be given a SpiroPD device for use at home following instruction in the hospital or clinic. Patient adherence to daily testing over one-month will be monitored using real-time capture Wi-Fi-data from the SpiroPD data portal.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
          </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="61.85" spread="9.52"/>
                  </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="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Measure of race and ethnicity of participants</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race/Ethnicity</title>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black/African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian/Alaskan Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian/Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic/Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Comparison of KOKO Spirometry to SpiroPD Use</title>
        <description>Participants will use the handheld spirometry device every day for 30 days. After use, the device will store spirometry measurements for each patient each day and the data will be synced over wifi to each individual's associated online account. Daily measurements from the SpiroPD device will be collected over the course of 30 days. These measurements will then be compared against spirometry measurements collected using the bedside KoKo machine during baseline and 30-day follow-up visits.</description>
        <time_frame>30 days from patient enrollment</time_frame>
        <population>We have reported data from baseline KOKO spirometry measurements vs. in-hospital SpiroPD use. However, none of the 8 enrolled participants used the SpiroPD device at home and thus, no data from at-home spirometry exists for this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>SpiroPD</title>
            <description>Participants in the intervention arm will be given a handheld spirometry device to take home and use daily for 30 consecutive days.&#xD;
SpiroPD: At the time of their initial study visit, study participants will be given a SpiroPD device for use at home following instruction in the hospital or clinic. Patient adherence to daily testing over one-month will be monitored using real-time capture Wi-Fi-data from the SpiroPD data portal.</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of KOKO Spirometry to SpiroPD Use</title>
          <description>Participants will use the handheld spirometry device every day for 30 days. After use, the device will store spirometry measurements for each patient each day and the data will be synced over wifi to each individual's associated online account. Daily measurements from the SpiroPD device will be collected over the course of 30 days. These measurements will then be compared against spirometry measurements collected using the bedside KoKo machine during baseline and 30-day follow-up visits.</description>
          <population>We have reported data from baseline KOKO spirometry measurements vs. in-hospital SpiroPD use. However, none of the 8 enrolled participants used the SpiroPD device at home and thus, no data from at-home spirometry exists for this analysis.</population>
          <units>percentage of FVC</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FVC % Predicted KOKO</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.01" spread="22.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FVC % Predicted Baseline SpiroPD</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.33" spread="24.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FVC % Predicted at-home SpiroPD</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adherence to Using the SpiroPD Device at Home on a Daily Basis</title>
        <description>Daily use of the SpiroPD will be measured by way of captured spirometry measurements. If there is no recorded spirometry measurement in the SpiroPD device for certain days, those days will be considered when discussing non-adherence to daily use of the SpiroPD.</description>
        <time_frame>30 days from patient enrollment</time_frame>
        <population>None of the 8 enrolled participants adhered to using the SpiroPD at home. No at-home data was able to be collected during this study; thus, there are no results to report.</population>
        <group_list>
          <group group_id="O1">
            <title>SpiroPD</title>
            <description>Participants in the intervention arm will be given a handheld spirometry device to take home and use daily for 30 consecutive days.&#xD;
SpiroPD: At the time of their initial study visit, study participants will be given a SpiroPD device for use at home following instruction in the hospital or clinic. Patient adherence to daily testing over one-month will be monitored using real-time capture Wi-Fi-data from the SpiroPD data portal.</description>
          </group>
        </group_list>
        <measure>
          <title>Adherence to Using the SpiroPD Device at Home on a Daily Basis</title>
          <description>Daily use of the SpiroPD will be measured by way of captured spirometry measurements. If there is no recorded spirometry measurement in the SpiroPD device for certain days, those days will be considered when discussing non-adherence to daily use of the SpiroPD.</description>
          <population>None of the 8 enrolled participants adhered to using the SpiroPD at home. No at-home data was able to be collected during this study; thus, there are no results to report.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Feasibility of Patients to Use the SpiroPD Device at Home Consistently</title>
        <description>Feasibility, or ease of use, will be measured by tracking the number of inquiries received on the designated SpiroPD help line. Each inquiry will be measured and tracked using an inquiry intake form. The type of inquiry or issue the patient is having and the possible solutions to the issue will be recorded. The patient's study ID and the date and time of their call will be recorded. These metrics along with adherence measurements will be factored in when discussing the feasibility of the SpiroPD device.</description>
        <time_frame>30 days from patient enrollment</time_frame>
        <population>There were no inquiries received on the SpiroPD help line. Thus, there is no data to report regarding the feasibility of SpiroPD.</population>
        <group_list>
          <group group_id="O1">
            <title>SpiroPD</title>
            <description>Participants in the intervention arm will be given a handheld spirometry device to take home and use daily for 30 consecutive days.&#xD;
SpiroPD: At the time of their initial study visit, study participants will be given a SpiroPD device for use at home following instruction in the hospital or clinic. Patient adherence to daily testing over one-month will be monitored using real-time capture Wi-Fi-data from the SpiroPD data portal.</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility of Patients to Use the SpiroPD Device at Home Consistently</title>
          <description>Feasibility, or ease of use, will be measured by tracking the number of inquiries received on the designated SpiroPD help line. Each inquiry will be measured and tracked using an inquiry intake form. The type of inquiry or issue the patient is having and the possible solutions to the issue will be recorded. The patient's study ID and the date and time of their call will be recorded. These metrics along with adherence measurements will be factored in when discussing the feasibility of the SpiroPD device.</description>
          <population>There were no inquiries received on the SpiroPD help line. Thus, there is no data to report regarding the feasibility of SpiroPD.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Participants were assessed over 30 days post hospital discharge after enrollment into this study.</time_frame>
      <desc>Any serious negative health outcome, such as mortality.</desc>
      <group_list>
        <group group_id="E1">
          <title>SpiroPD</title>
          <description>Participants in the intervention arm will be given a handheld spirometry device to take home and use daily for 30 consecutive days.&#xD;
SpiroPD: At the time of their initial study visit, study participants will be given a SpiroPD device for use at home following instruction in the hospital or clinic. Patient adherence to daily testing over one-month will be monitored using real-time capture Wi-Fi-data from the SpiroPD data portal.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
              </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="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Mary Akel</name_or_title>
      <organization>University of Chicago</organization>
      <phone>773-834-4489</phone>
      <email>makel@medicine.bsd.uchicago.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/NCT03284203
org study id: IRB17-0562
nct id: NCT03284203
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
The investigators' central hypotheses predict that the handheld spirometry device will be
      feasible for inpatient and at-home use, and is equally efficacious at determining lung
      function when compared to traditional, bedside spirometry measurements. To test these
      hypotheses, the investigators propose the following specific aims:

      Specific Aim 1: Determine the correlation of SpiroPD handheld spirometry measurements with
      bedside Koko spirometry lung function.

      Hypothesis: Correlation between the two lung function tests will be substantial for both
      hospitalized and ambulatory patients.

      Specific Aim 2: To determine the feasibility, adherence, and preliminary management efficacy
      of home SpiroPD testing.

      Hypotheses: (1) Patients will demonstrate substantial adherence to daily home spirometry
      testing; (2) medication adherence will increase significantly in patients who are adherent to
      daily home spirometry testing; (3) acute care utilization will decrease significant in
      adherent patients.
Chronic Obstructive Pulmonary Disease (COPD) results in nearly 750,000 hospitalizations
      annually and is the third leading cause of "early" (within 30-day) hospital readmissions in
      the United States. Curbing preventable early readmissions for acute exacerbations of COPD
      (AECOPD) has become a national priority, as demonstrated by the Medicare Hospital
      Readmissions Reduction financial penalty program. One critical barrier in assessing
      readmission risk is the lack of an easily-measured 'vital sign' for COPD: accurate, timely
      measurements of lung function. Unlike other medical problems that have validated,
      easily-obtained measurements of organ function, COPD evaluation often defaults to patient
      report and physician evaluation without critical physiologic data. This lack of objective
      pulmonary function data during AECOPD in turn leads to critical errors in disease severity
      assessment. However, the required, repeated measurements by spirometry that can demonstrate
      responses to therapy can be time-consuming and expensive to perform in a laboratory, and both
      equipment and staffing infrastructure for bedside testing is cumbersome and often not
      prioritized. For these reasons, spirometry frequently is not done for patients with AECOPD.

      To monitor patient responses to therapy and to assess risks based on objective measures, the
      investigators propose to the study the use of a portable, patient-driven device ("SpiroPD")
      that can be used in both in-patient and outpatient settings, and that reports (via the
      internet) values collected in real time. While the device has been used in the lung
      transplant community and for patients with cystic fibrosis, no studies have been done to
      validate its use in COPD. This protocol involves in-hospital patient training with the device
      followed by serial measurements at home in the first 30 days post hospital-discharge.

      Demonstration in a pilot, single-center trial of the usefulness of real-time, repeated
      hand-held spirometry to provide objective measurements of lung function in AECOPD will have a
      substantial impact on both patient health outcomes and on health care utilization and will
      set the stage for appropriate next-step studies and NIH grant applications. It is unknown
      whether this specific technology will be acceptable in the target population, though previous
      research suggests that older patients may be more willing to use home monitoring technology.
      This multi-disciplinary research team includes providers from the Department of Medicine and
      the UCM COPD Readmissions Program team.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Comparison of KOKO Spirometry to SpiroPD Use
time frame: 30 days from patient enrollment
description: Participants will use the handheld spirometry device every day for 30 days. After use, the device will store spirometry measurements for each patient each day and the data will be synced over wifi to each individual's associated online account. Daily measurements from the SpiroPD device will be collected over the course of 30 days. These measurements will then be compared against spirometry measurements collected using the bedside KoKo machine during baseline and 30-day follow-up visits.
measure: Adherence to Using the SpiroPD Device at Home on a Daily Basis
time frame: 30 days from patient enrollment
description: Daily use of the SpiroPD will be measured by way of captured spirometry measurements. If there is no recorded spirometry measurement in the SpiroPD device for certain days, those days will be considered when discussing non-adherence to daily use of the SpiroPD.
measure: Feasibility of Patients to Use the SpiroPD Device at Home Consistently
time frame: 30 days from patient enrollment
description: Feasibility, or ease of use, will be measured by tracking the number of inquiries received on the designated SpiroPD help line. Each inquiry will be measured and tracked using an inquiry intake form. The type of inquiry or issue the patient is having and the possible solutions to the issue will be recorded. The patient's study ID and the date and time of their call will be recorded. These metrics along with adherence measurements will be factored in when discussing the feasibility of the SpiroPD device.
arm group label: SpiroPD
arm group type: Experimental
description: Participants in the intervention arm will be given a handheld spirometry device to take home and use daily for 30 consecutive days.
intervention type: Device
intervention name: SpiroPD
description: At the time of their initial study visit, study participants will be given a SpiroPD device for use at home following instruction in the hospital or clinic. Patient adherence to daily testing over one-month will be monitored using real-time capture Wi-Fi-data from the SpiroPD data portal.
arm group label: SpiroPD
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Valerie Press
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 