<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/NCT03834350</url>
  </required_header>
  <id_info>
    <org_study_id>IRB18-1210</org_study_id>
    <secondary_id>R03HL144883</secondary_id>
    <nct_id>NCT03834350</nct_id>
  </id_info>
  <brief_title>At Home Spirometry and Video Module Education for COPD Patients</brief_title>
  <acronym>BREATHES</acronym>
  <official_title>BREATHES: Bringing Respiratory Education for Improved Adherence and Technique Home Through E-interventions for Self-management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The central hypothesis is that patients hospitalized for COPD who subsequently complete the&#xD;
      at-home BREATHES Program with V-TTG skill training and SpiroPD adherence support will retain&#xD;
      increased medication knowledge, skill, self-efficacy, and adherence that otherwise decays&#xD;
      substantially by 30 days post-discharge. To test this hypothesis, this study proposes the&#xD;
      following specific aims:&#xD;
&#xD;
      Aim 1: Determine the feasibility of, adherence to, and efficacy of at-home V-TTG for ongoing&#xD;
      inhaler skill training.&#xD;
&#xD;
      Hypothesis: Participants who complete both in-hospital and at-home V-TTG will have a&#xD;
      significantly increased likelihood of demonstrating effective respiratory inhaler technique&#xD;
      within 30 days after hospital discharge compared to in-hospital technique&#xD;
&#xD;
      Aim 2. Determine the feasibility of, adherence to, and efficacy of at-home SpiroPD for COPD&#xD;
      medication adherence support.&#xD;
&#xD;
      Hypothesis: Participants' use of SpiroPD (PMD Healthcare) will significantly improve their&#xD;
      COPD medication adherence.&#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 30-day hospital readmissions in the United&#xD;
      States.Improving the quality of care for hospitalized COPD patients has recently become a&#xD;
      national priority through the Centers for Medicare and Medicaid Services' Hospital&#xD;
      Readmissions Reduction Program. A key element of improving care quality is translating&#xD;
      existing evidence into improved practice. Extensive evidence exists to support the efficacy&#xD;
      of inhaled medications to control and reduce COPD symptoms and to improve patient outcomes.&#xD;
      However, the real-world effectiveness of these medications is often limited due both to poor&#xD;
      inhaler technique and to insufficient adherence to treatment plans. Most interventions for&#xD;
      hospitalized patients with COPD focus on medication reconciliation, treatment optimization,&#xD;
      and inhaler technique education prior to being discharged home. However, after discharge&#xD;
      home, patients quickly lose inhaler technique skills, have difficulty adhering to complex&#xD;
      regimens, and lack tools to aid adherence, such as lung function response to their treatment&#xD;
      regimen. Interventions to reinforce skills and support adherence are needed across care&#xD;
      transitions to reduce the risk of deleterious health outcomes.&#xD;
&#xD;
      Simple and feasible at-home interventions to provide skills training and adherence support&#xD;
      are needed. This novel idea is to pair at-home inhaler skill training with at-home spirometry&#xD;
      measurements to comprehensively support both medication skill and adherence. The investigator&#xD;
      proposes testing a novel at-home self-management support program called &quot;BREATHES&quot; (Bringing&#xD;
      Respiratory Education for improved Adherence and Technique Home through E-interventions for&#xD;
      Self-management) Program. BREATHES will include two main components: first, self-directed&#xD;
      inhaler skill training sessions through the virtual Teach-To-Goal (V-TTG) intervention the&#xD;
      investigator developed and tested during a K23 grant and, second, a handheld lung function&#xD;
      device to provide physiologic feedback and capture medication adherence called SpiroPD. TTG&#xD;
      is a patient-centered strategy that uses cycles of assessment and demonstration tailored to&#xD;
      patients' self-management needs; the investigator's research shows in-person TTG is effective&#xD;
      for teaching inhaler technique and reduces acute care utilization. Virtual-TTG delivers the&#xD;
      key features of TTG using virtual patient-directed lessons through novel adaptive technology&#xD;
      that provides tailored self-assessment and training. The investigator's studies demonstrate&#xD;
      participants' willingness to use V-TTG at-home for post-discharge booster education and show&#xD;
      that V-TTG is effective and may be non-inferior to in-person TTG in significantly reducing&#xD;
      inhaler misuse among hospitalized patients. However, it remains unknown whether at-home V-TTG&#xD;
      sessions will maintain self-management skills over the longer term and how direct physiologic&#xD;
      lung monitoring support can impact medication adherence. The proposed studies will determine&#xD;
      whether combining at-home skill training with objective measurements of lung function and&#xD;
      adherence monitoring through the BREATHES Program improves self-management skills and&#xD;
      medication adherence in the first 30 days after hospitalization for COPD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 11, 2019</start_date>
  <completion_date type="Actual">June 23, 2021</completion_date>
  <primary_completion_date type="Actual">June 23, 2021</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>Virtual Education Module Adherence</measure>
    <time_frame>30 days</time_frame>
    <description>Number of participants who completed the virtual education module at least once before the 30 day follow-up visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of SpiroPD Device Usage for At-Home COPD Self-Management</measure>
    <time_frame>30 days</time_frame>
    <description>Number of participants who used the SpiroPD device to perform lung function test and keep track of medications post-discharge.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inhaler Technique</measure>
    <time_frame>Baseline; Baseline post-education; 30-day post-discharge</time_frame>
    <description>Percent of participants who misused their inhalers (≤10/12 steps correct) at baseline, post-baseline inhaler education, and at 30-day follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Self-Efficacy for Inhalers: 5 Point Likert Scale</measure>
    <time_frame>Baseline Pre-VTTG (right before the lesson); Baseline Post-VTTG (immediately after baseline lesson - within 30 minutes)</time_frame>
    <description>Patient self-efficacy regarding proper inhaler technique on a 5 point Likert scale, 1 to 5 where 1 is Not Sure at All and 5 is Completely Sure. This outcome was measured at baseline just prior to VTTG inhaler education and again at baseline immediately after VTTG inhaler education. Scores of 3-5 were coded as &quot;confident&quot;; scores of 1-2 were coded as &quot;not confident&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Symptom Burden</measure>
    <time_frame>Baseline; 30 days post-discharge</time_frame>
    <description>Self reported measure using two validated surveys, The Modified Borg Dyspnea Scale (rating of shortness of breath from 0-10 where 0 is not at all and 10 is maximal) and a modified COPD Severity Tool (the possible COPD severity score range is 0 to 26, with higher scores reflecting more severe disease). These measures were assessed at baseline prior to VTTG education and again 30 days post-discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life: The Airway Questionnaire (AQ-20)</measure>
    <time_frame>Baseline; 30 days post-discharge</time_frame>
    <description>Using the validated survey, The Airway Questionnaire (AQ-20), a 20-item survey that assesses effect of current symptoms in everyday life for patients with COPD, to assess the change in quality of life from before the BREATHES program to after. The AQ-20 contains 20 items, with scores ranging from 0 to 20 (total score maximum is 20). High scores indicate poor quality of life. This measure was assessed at Baseline prior to VTTG education and again at 30 days post-discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Acute Care Services</measure>
    <time_frame>30 day</time_frame>
    <description>Using University of Chicago Medical Center data and chart reviews, the investigators will examine the use of acute care services within the 30 day window of participation within the study.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>At-Home Breathes Program</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>BREATHES Program</intervention_name>
    <description>Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital. 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. A small device will be attached to track real-time medication use.</description>
    <arm_group_label>At-Home Breathes Program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BREATHES SpiroPD or Propeller Health</intervention_name>
    <description>At the time of their initial study visit, study participants may 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. A small device will be attached to track real-time medication use.</description>
    <arm_group_label>At-Home Breathes Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 years and older&#xD;
&#xD;
          2. Physician-diagnosed COPD (prior to or during hospitalization)&#xD;
&#xD;
          3. Owns a wifi-enabled device (desktop, laptop, tablet, smart phone, etc.)&#xD;
&#xD;
          4. Discharged with a rescue and/or controller MDI (metered dose inhaler).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Currently in an intensive care unit&#xD;
&#xD;
          2. Physician declines to provide consent&#xD;
&#xD;
          3. Patient unable to provide consent (e.g., history of cognitive impairment, unable to&#xD;
             understand English) 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 G Press, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor</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>July 2022</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <results_first_submitted>April 20, 2022</results_first_submitted>
  <results_first_submitted_qc>July 19, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 22, 2022</results_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>September 27, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT03834350/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study team enrolled hospitalized adults at an academic medical center with COPD between April 2019 and June 2021 who met the following selection criteria: age&gt;18yrs, owned a wifi-enabled device, had or will have a rescue and/or controller meter dose inhaler prescribed upon discharge, had a visual acuity of at least 20/50, and received assent for approach by the treating clinician.</recruitment_details>
      <pre_assignment_details>There were 71 participants who were enrolled and completed informed written consent. 71 participants were also assigned to the arms of this study. However, prior to completion of the baseline visit 1 participant withdrew.70 total participants were included in our final analyses.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Breathes Program</title>
          <description>Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD.&#xD;
BREATHES Program: Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital.&#xD;
BREATHES SpiroPD or Propeller Health: At the time of their initial study visit, study participants may 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. A small device will be attached to track real-time medication use.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Breathes Program</title>
          <description>Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD.&#xD;
BREATHES Program: Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital.&#xD;
BREATHES SpiroPD or Propeller Health: At the time of their initial study visit, study participants may 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. A small device will be attached to track real-time medication use.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="70"/>
          </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="63" spread="8.4"/>
                  </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="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Virtual Education Module Adherence</title>
        <description>Number of participants who completed the virtual education module at least once before the 30 day follow-up visit.</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>At-Home Breathes Program</title>
            <description>Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD.&#xD;
BREATHES Program: Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital. 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. A small device will be attached to track real-time medication use.&#xD;
BREATHES SpiroPD or Propeller Health: At the time of their initial study visit, study participants may 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. A small device will be attached to track real-time medication use.</description>
          </group>
        </group_list>
        <measure>
          <title>Virtual Education Module Adherence</title>
          <description>Number of participants who completed the virtual education module at least once before the 30 day follow-up visit.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Rate of SpiroPD Device Usage for At-Home COPD Self-Management</title>
        <description>Number of participants who used the SpiroPD device to perform lung function test and keep track of medications post-discharge.</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Breathes Program</title>
            <description>Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD.&#xD;
BREATHES Program: Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital.&#xD;
BREATHES SpiroPD or Propeller Health: At the time of their initial study visit, study participants may 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. A small device will be attached to track real-time medication use.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of SpiroPD Device Usage for At-Home COPD Self-Management</title>
          <description>Number of participants who used the SpiroPD device to perform lung function test and keep track of medications post-discharge.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Inhaler Technique</title>
        <description>Percent of participants who misused their inhalers (≤10/12 steps correct) at baseline, post-baseline inhaler education, and at 30-day follow-up</description>
        <time_frame>Baseline; Baseline post-education; 30-day post-discharge</time_frame>
        <population>Due to participant retention, only 24 participants attended their 30-day follow up visit and were able to have their inhaler technique assessed.</population>
        <group_list>
          <group group_id="O1">
            <title>Breathes Program</title>
            <description>Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD.&#xD;
BREATHES Program: Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital.&#xD;
BREATHES SpiroPD or Propeller Health: At the time of their initial study visit, study participants may 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. A small device will be attached to track real-time medication use.</description>
          </group>
        </group_list>
        <measure>
          <title>Inhaler Technique</title>
          <description>Percent of participants who misused their inhalers (≤10/12 steps correct) at baseline, post-baseline inhaler education, and at 30-day follow-up</description>
          <population>Due to participant retention, only 24 participants attended their 30-day follow up visit and were able to have their inhaler technique assessed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Misuse</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Post-education Misuse</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30d post-discharge Misuse</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Self-Efficacy for Inhalers: 5 Point Likert Scale</title>
        <description>Patient self-efficacy regarding proper inhaler technique on a 5 point Likert scale, 1 to 5 where 1 is Not Sure at All and 5 is Completely Sure. This outcome was measured at baseline just prior to VTTG inhaler education and again at baseline immediately after VTTG inhaler education. Scores of 3-5 were coded as &quot;confident&quot;; scores of 1-2 were coded as &quot;not confident&quot;.</description>
        <time_frame>Baseline Pre-VTTG (right before the lesson); Baseline Post-VTTG (immediately after baseline lesson - within 30 minutes)</time_frame>
        <population>Only 69 participants answered this question due to a technology error that occurred that affected only 1 participant.</population>
        <group_list>
          <group group_id="O1">
            <title>Breathes Program</title>
            <description>Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD.&#xD;
BREATHES Program: Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital.&#xD;
BREATHES SpiroPD or Propeller Health: At the time of their initial study visit, study participants may 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. A small device will be attached to track real-time medication use.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Self-Efficacy for Inhalers: 5 Point Likert Scale</title>
          <description>Patient self-efficacy regarding proper inhaler technique on a 5 point Likert scale, 1 to 5 where 1 is Not Sure at All and 5 is Completely Sure. This outcome was measured at baseline just prior to VTTG inhaler education and again at baseline immediately after VTTG inhaler education. Scores of 3-5 were coded as &quot;confident&quot;; scores of 1-2 were coded as &quot;not confident&quot;.</description>
          <population>Only 69 participants answered this question due to a technology error that occurred that affected only 1 participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Pre-VTTG Confident</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Pre-VTTG not confident</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Post-VTTG confident</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Post-VTTG not confident</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Symptom Burden</title>
        <description>Self reported measure using two validated surveys, The Modified Borg Dyspnea Scale (rating of shortness of breath from 0-10 where 0 is not at all and 10 is maximal) and a modified COPD Severity Tool (the possible COPD severity score range is 0 to 26, with higher scores reflecting more severe disease). These measures were assessed at baseline prior to VTTG education and again 30 days post-discharge.</description>
        <time_frame>Baseline; 30 days post-discharge</time_frame>
        <population>Due to retention in the study, only 43 participants were able to be assessed at the 30d follow-up visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Breathes Program</title>
            <description>Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD.&#xD;
BREATHES Program: Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital.&#xD;
BREATHES SpiroPD or Propeller Health: At the time of their initial study visit, study participants may 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. A small device will be attached to track real-time medication use.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Symptom Burden</title>
          <description>Self reported measure using two validated surveys, The Modified Borg Dyspnea Scale (rating of shortness of breath from 0-10 where 0 is not at all and 10 is maximal) and a modified COPD Severity Tool (the possible COPD severity score range is 0 to 26, with higher scores reflecting more severe disease). These measures were assessed at baseline prior to VTTG education and again 30 days post-discharge.</description>
          <population>Due to retention in the study, only 43 participants were able to be assessed at the 30d follow-up visit.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Borg Dyspnea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.97" spread="2.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30d post-discharge Borg Dyspnea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.28" spread="2.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline modified COPD Severity Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.03" spread="6.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30d post-discharge modified COPD Severity Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.72" spread="6.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Quality of Life: The Airway Questionnaire (AQ-20)</title>
        <description>Using the validated survey, The Airway Questionnaire (AQ-20), a 20-item survey that assesses effect of current symptoms in everyday life for patients with COPD, to assess the change in quality of life from before the BREATHES program to after. The AQ-20 contains 20 items, with scores ranging from 0 to 20 (total score maximum is 20). High scores indicate poor quality of life. This measure was assessed at Baseline prior to VTTG education and again at 30 days post-discharge.</description>
        <time_frame>Baseline; 30 days post-discharge</time_frame>
        <population>Due to retention, only 43 participants attended the 30d follow-up visit and completed the AQ-20</population>
        <group_list>
          <group group_id="O1">
            <title>Breathes Program</title>
            <description>Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD.&#xD;
BREATHES Program: Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital.&#xD;
BREATHES SpiroPD or Propeller Health: At the time of their initial study visit, study participants may 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. A small device will be attached to track real-time medication use.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life: The Airway Questionnaire (AQ-20)</title>
          <description>Using the validated survey, The Airway Questionnaire (AQ-20), a 20-item survey that assesses effect of current symptoms in everyday life for patients with COPD, to assess the change in quality of life from before the BREATHES program to after. The AQ-20 contains 20 items, with scores ranging from 0 to 20 (total score maximum is 20). High scores indicate poor quality of life. This measure was assessed at Baseline prior to VTTG education and again at 30 days post-discharge.</description>
          <population>Due to retention, only 43 participants attended the 30d follow-up visit and completed the AQ-20</population>
          <units>score on a scale (0-20)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline AQ-20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.06" spread="4.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30d post-discharge AQ-20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.70" spread="4.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Use of Acute Care Services</title>
        <description>Using University of Chicago Medical Center data and chart reviews, the investigators will examine the use of acute care services within the 30 day window of participation within the study.</description>
        <time_frame>30 day</time_frame>
        <population>Only 69 participants had their charts reviewed because one participant withdrew from the study after the initial study visit and therefore no additional data was pulled.</population>
        <group_list>
          <group group_id="O1">
            <title>Breathes Program</title>
            <description>Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD.&#xD;
BREATHES Program: Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital.&#xD;
BREATHES SpiroPD or Propeller Health: At the time of their initial study visit, study participants may 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. A small device will be attached to track real-time medication use.</description>
          </group>
        </group_list>
        <measure>
          <title>Use of Acute Care Services</title>
          <description>Using University of Chicago Medical Center data and chart reviews, the investigators will examine the use of acute care services within the 30 day window of participation within the study.</description>
          <population>Only 69 participants had their charts reviewed because one participant withdrew from the study after the initial study visit and therefore no additional data was pulled.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>30 day all admissions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 day COPD admissions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 day all ED visits</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 day COPD ED visits</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 day all ICU admissions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 day COPD ICU admissions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Participants were enrolled in the study for a maximum of 30 days and there were two study visits. The initial study visit was during hospitalization and noted as &quot;Baseline&quot;. The follow-up study visit was 30-days post-discharge and the subject returned to the hospital to complete this visit.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Breathes Program</title>
          <description>Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD.&#xD;
BREATHES Program: Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital.&#xD;
BREATHES SpiroPD or Propeller Health: At the time of their initial study visit, study participants may 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. A small device will be attached to track real-time medication use.</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="70"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
              </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="70"/>
              </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>Dr. Valerie Press</name_or_title>
      <organization>University of Chicago</organization>
      <phone>773-702-5170</phone>
      <email>vpress@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/NCT03834350
org study id: IRB18-1210
secondary id: R03HL144883
nct id: NCT03834350
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The central hypothesis is that patients hospitalized for COPD who subsequently complete the
      at-home BREATHES Program with V-TTG skill training and SpiroPD adherence support will retain
      increased medication knowledge, skill, self-efficacy, and adherence that otherwise decays
      substantially by 30 days post-discharge. To test this hypothesis, this study proposes the
      following specific aims:

      Aim 1: Determine the feasibility of, adherence to, and efficacy of at-home V-TTG for ongoing
      inhaler skill training.

      Hypothesis: Participants who complete both in-hospital and at-home V-TTG will have a
      significantly increased likelihood of demonstrating effective respiratory inhaler technique
      within 30 days after hospital discharge compared to in-hospital technique

      Aim 2. Determine the feasibility of, adherence to, and efficacy of at-home SpiroPD for COPD
      medication adherence support.

      Hypothesis: Participants' use of SpiroPD (PMD Healthcare) will significantly improve their
      COPD medication adherence.
Chronic obstructive pulmonary disease (COPD) results in nearly 750,000 hospitalizations
      annually and is the third leading cause of 30-day hospital readmissions in the United
      States.Improving the quality of care for hospitalized COPD patients has recently become a
      national priority through the Centers for Medicare and Medicaid Services' Hospital
      Readmissions Reduction Program. A key element of improving care quality is translating
      existing evidence into improved practice. Extensive evidence exists to support the efficacy
      of inhaled medications to control and reduce COPD symptoms and to improve patient outcomes.
      However, the real-world effectiveness of these medications is often limited due both to poor
      inhaler technique and to insufficient adherence to treatment plans. Most interventions for
      hospitalized patients with COPD focus on medication reconciliation, treatment optimization,
      and inhaler technique education prior to being discharged home. However, after discharge
      home, patients quickly lose inhaler technique skills, have difficulty adhering to complex
      regimens, and lack tools to aid adherence, such as lung function response to their treatment
      regimen. Interventions to reinforce skills and support adherence are needed across care
      transitions to reduce the risk of deleterious health outcomes.

      Simple and feasible at-home interventions to provide skills training and adherence support
      are needed. This novel idea is to pair at-home inhaler skill training with at-home spirometry
      measurements to comprehensively support both medication skill and adherence. The investigator
      proposes testing a novel at-home self-management support program called "BREATHES" (Bringing
      Respiratory Education for improved Adherence and Technique Home through E-interventions for
      Self-management) Program. BREATHES will include two main components: first, self-directed
      inhaler skill training sessions through the virtual Teach-To-Goal (V-TTG) intervention the
      investigator developed and tested during a K23 grant and, second, a handheld lung function
      device to provide physiologic feedback and capture medication adherence called SpiroPD. TTG
      is a patient-centered strategy that uses cycles of assessment and demonstration tailored to
      patients' self-management needs; the investigator's research shows in-person TTG is effective
      for teaching inhaler technique and reduces acute care utilization. Virtual-TTG delivers the
      key features of TTG using virtual patient-directed lessons through novel adaptive technology
      that provides tailored self-assessment and training. The investigator's studies demonstrate
      participants' willingness to use V-TTG at-home for post-discharge booster education and show
      that V-TTG is effective and may be non-inferior to in-person TTG in significantly reducing
      inhaler misuse among hospitalized patients. However, it remains unknown whether at-home V-TTG
      sessions will maintain self-management skills over the longer term and how direct physiologic
      lung monitoring support can impact medication adherence. The proposed studies will determine
      whether combining at-home skill training with objective measurements of lung function and
      adherence monitoring through the BREATHES Program improves self-management skills and
      medication adherence in the first 30 days after hospitalization for COPD.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Virtual Education Module Adherence
time frame: 30 days
description: Number of participants who completed the virtual education module at least once before the 30 day follow-up visit.
measure: Rate of SpiroPD Device Usage for At-Home COPD Self-Management
time frame: 30 days
description: Number of participants who used the SpiroPD device to perform lung function test and keep track of medications post-discharge.
measure: Inhaler Technique
time frame: Baseline; Baseline post-education; 30-day post-discharge
description: Percent of participants who misused their inhalers (≤10/12 steps correct) at baseline, post-baseline inhaler education, and at 30-day follow-up
measure: Change in Self-Efficacy for Inhalers: 5 Point Likert Scale
time frame: Baseline Pre-VTTG (right before the lesson); Baseline Post-VTTG (immediately after baseline lesson - within 30 minutes)
description: Patient self-efficacy regarding proper inhaler technique on a 5 point Likert scale, 1 to 5 where 1 is Not Sure at All and 5 is Completely Sure. This outcome was measured at baseline just prior to VTTG inhaler education and again at baseline immediately after VTTG inhaler education. Scores of 3-5 were coded as "confident"; scores of 1-2 were coded as "not confident".
measure: Change in Symptom Burden
time frame: Baseline; 30 days post-discharge
description: Self reported measure using two validated surveys, The Modified Borg Dyspnea Scale (rating of shortness of breath from 0-10 where 0 is not at all and 10 is maximal) and a modified COPD Severity Tool (the possible COPD severity score range is 0 to 26, with higher scores reflecting more severe disease). These measures were assessed at baseline prior to VTTG education and again 30 days post-discharge.
measure: Change in Quality of Life: The Airway Questionnaire (AQ-20)
time frame: Baseline; 30 days post-discharge
description: Using the validated survey, The Airway Questionnaire (AQ-20), a 20-item survey that assesses effect of current symptoms in everyday life for patients with COPD, to assess the change in quality of life from before the BREATHES program to after. The AQ-20 contains 20 items, with scores ranging from 0 to 20 (total score maximum is 20). High scores indicate poor quality of life. This measure was assessed at Baseline prior to VTTG education and again at 30 days post-discharge.
measure: Use of Acute Care Services
time frame: 30 day
description: Using University of Chicago Medical Center data and chart reviews, the investigators will examine the use of acute care services within the 30 day window of participation within the study.
arm group label: At-Home Breathes Program
arm group type: Other
description: Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD.
intervention type: Other
intervention name: BREATHES Program
description: Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital. 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. A small device will be attached to track real-time medication use.
arm group label: At-Home Breathes Program
intervention type: Device
intervention name: BREATHES SpiroPD or Propeller Health
description: At the time of their initial study visit, study participants may 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. A small device will be attached to track real-time medication use.
arm group label: At-Home Breathes Program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Valerie G Press, MD, MPH
role: Principal Investigator
affiliation: Associate Professor
facility: 
country: United States
responsible party type: Sponsor
provided document: 
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reported events: 
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