<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/NCT03018847</url>
  </required_header>
  <id_info>
    <org_study_id>CPV2-2016-S1</org_study_id>
    <nct_id>NCT03018847</nct_id>
  </id_info>
  <brief_title>Evaluation of COPD Co-Pilot</brief_title>
  <official_title>Evaluation of COPD Co-Pilot</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HGE Health Care Solutions, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PneumRx, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>HGE Health Care Solutions, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of undertaking this study is to examine the use of COPD Co-PilotTM, a COPD&#xD;
      disease management program manufactured and operated by HGE Health Care Solutions, LLC, in&#xD;
      COPD patients outside of the geographic base of HGE's existing patient population&#xD;
      (Philadelphia, PA). The purpose is to demonstrate the feasibility of expanding the program to&#xD;
      additional geographic sites and to examine whether similar outcome measures are achieved in&#xD;
      patients under the supervision of health care providers that are new to the program.&#xD;
&#xD;
      .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Adoption</measure>
    <time_frame>6 months</time_frame>
    <description>Percentage of potential daily symptom reports completed by patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>6 months</time_frame>
    <description>patient satisfaction questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inpatient Admissions</measure>
    <time_frame>6 months</time_frame>
    <description>admission records for period prior to study and during study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency department visits</measure>
    <time_frame>6 months</time_frame>
    <description>emergency department records for period prior to study and during study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinic visits</measure>
    <time_frame>6 months</time_frame>
    <description>clinic visits for period prior to study and during study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported respiratory symptoms</measure>
    <time_frame>6 months</time_frame>
    <description>Daily values for breathlessness, sputum quantity, sputum color, sputum consistency, peak flow, temperature over 100 F, cough, wheeze, sore throat, and nasal congestion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom change detected</measure>
    <time_frame>6 months</time_frame>
    <description>Change index (a numeric value) and the categorical level of change that corresponds to the patient's reported symptoms when compared to their baseline. This is recorded for each daily symptom report submitted after completion of the run-in period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Episode duration</measure>
    <time_frame>6 months</time_frame>
    <description>the date when a mild, moderate or significant level of change is first detected for a patient through the date immediately followed by seven consecutive days in which no level of change is detected. The total number of days in this period, symptoms reported during this period, and clinical responses communicated to the patient (including any treatments or changes) will be reported for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical responses</measure>
    <time_frame>6 months</time_frame>
    <description>the date, medication or instruction, dosage, frequency, duration of clinical responses sent to subjects, and time elapsed between the patient's check-in and the time the response was acknowledged by the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization history</measure>
    <time_frame>6 months</time_frame>
    <description>hospitalization history reported to Health Assistants by patients during scheduled monthly phone calls. This will be reconciled with admissions data from the site and may include utilization at other institutions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medications</measure>
    <time_frame>6 months</time_frame>
    <description>list of medications entered by site coordinator, provider, or reported by subjects to Health Assistants during scheduled monthly phone calls.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient profile information</measure>
    <time_frame>6 months</time_frame>
    <description>This will include, among other variables, medial history, smoking history, spirometry results, oxygen use, and diagnoses of co-morbidities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication compliance</measure>
    <time_frame>6 months</time_frame>
    <description>compliance with newly prescribed treatments as reported by patients during follow up phone calls.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>6 months</time_frame>
    <description>total number of inpatient days and the average length of stay per admission will be reported for analyses. These records will include date of admission, date of discharge, patient name and medical record number, patient date of birth (DOB), location, length of stay, attending physician, admission diagnosis and diagnosis at discharge. Reported for period prior to study and during study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmissions</measure>
    <time_frame>6 months</time_frame>
    <description>The number of inpatient admissions that occurred within 30, 60, and 90 days of discharge from a prior admission will be reported for analyses. These records will include date of admission, date of discharge, patient name and medical record number, patient DOB, location, length of stay, attending physician, admission diagnosis, diagnosis at discharge, and associated costs broken down by category. This will be reported for time prior to study and during study period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission rate</measure>
    <time_frame>6 months</time_frame>
    <description>The rate and percent of inpatient admissions that occurred within 30, 60, and 90 days of discharge from a prior admission will be reported for analyses. These records will include date of admission, date of discharge, patient name and medical record number, patient DOB, location, length of stay, attending physician, admission diagnosis and diagnosis at discharge. These will be reported for the period prior to the start of the study through the study period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Source of inpatient admissions and visits to the Emergency Department (ED)</measure>
    <time_frame>6 months</time_frame>
    <description>The source (e.g. from home, from accident, from outpatient clinical, at direction of physician, from ED, etc.) of each and every inpatient admission an emergency department visit will be reported for analyses. These will be reported for the period prior to the enrollment through the study period.</description>
  </secondary_outcome>
  <enrollment type="Actual">23</enrollment>
  <condition>COPD</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>COPD Co-Pilot</intervention_name>
    <description>The COPD Co-Pilot is a system that guides a patient through a software application (web or mobile app) to collect, track, and trend daily symptoms related to Chronic Obstructive Pulmonary Disease (COPD). The system is intended to be used by patients as a support tool to track COPD symptoms as part of their personal disease management plan. The COPD Co-Pilot allows health care providers to view and triage subject symptoms via the provider web-based application. Health care providers also have the ability to send responses to subjects, like medication recommendations, through preset forms in the system.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects shall be recruited from the pool of patients at the investigative site that have&#xD;
        been diagnosed with moderate to severe COPD.&#xD;
&#xD;
        The study is planned to enroll 100 subjects. The study will be conducted at one&#xD;
        investigative site in the United States, the Medical University of South Carolina Health&#xD;
        System. Recruitment will stop when 100 subjects are enrolled. There will be no replacement&#xD;
        for dropouts. Recruitment is planned to last approximately 6 months.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject has read, understood and signed an informed consent form prior to enrollment.&#xD;
&#xD;
          2. Males or females age ≥35 years old&#xD;
&#xD;
          3. Documented diagnosis of moderate to very severe COPD (GOLD Level II-IV)&#xD;
&#xD;
          4. Must be able to read and understand English and consent for themselves&#xD;
&#xD;
          5. Subject is willing and able to use an iPad mini device.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has a cognitive impairment (determined by physician) that will make it hard to&#xD;
             follow instructions regarding device usage&#xD;
&#xD;
          2. Subject is currently known to suffer from or have a history of significant substance&#xD;
             abuse within the last 2 years&#xD;
&#xD;
          3. Subject has any condition that in the opinion of the provider may adversely affect&#xD;
             their participation&#xD;
&#xD;
          4. Subject is residing in hospice care, Skilled Nursing Facilities or Long Term Acute&#xD;
             Care facilities&#xD;
&#xD;
          5. Subject has a planned procedures at time of enrollment that will occur within&#xD;
             timeframe of study that will require hospitalization or otherwise adversely affect&#xD;
             their ability to participate&#xD;
&#xD;
          6. Subject has no cellular coverage at their primary residence&#xD;
&#xD;
          7. Subject plans to travel to a location with no cellular coverage for a significant&#xD;
             period (&gt;1 week) during their program participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tatsiana Beiko, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Smith HS, Criner AJ, Fehrle D, Grabianowski CL, Jacobs MR, Criner GJ. Use of a SmartPhone/Tablet-Based Bidirectional Telemedicine Disease Management Program Facilitates Early Detection and Treatment of COPD Exacerbation Symptoms. Telemed J E Health. 2016 May;22(5):395-9. doi: 10.1089/tmj.2015.0135. Epub 2015 Oct 9.</citation>
    <PMID>26451903</PMID>
  </reference>
  <reference>
    <citation>Cordova FC, Ciccolella D, Grabianowski C, Gaughan J, Brennan K, Goldstein F, Jacobs MR, Criner GJ. A Telemedicine-Based Intervention Reduces the Frequency and Severity of COPD Exacerbation Symptoms: A Randomized, Controlled Trial. Telemed J E Health. 2016 Feb;22(2):114-122. doi: 10.1089/tmj.2015.0035. Epub 2015 Aug 10.</citation>
    <PMID>26259074</PMID>
  </reference>
  <reference>
    <citation>Kim V, Garfield JL, Grabianowski CL, Krahnke JS, Gaughan JP, Jacobs MR, Criner GJ. The effect of chronic sputum production on respiratory symptoms in severe COPD. COPD. 2011 Apr;8(2):114-20. doi: 10.3109/15412555.2011.558546.</citation>
    <PMID>21495839</PMID>
  </reference>
  <reference>
    <citation>So JY, Lastra AC, Zhao H, Marchetti N, Criner GJ. Daily Peak Expiratory Flow Rate and Disease Instability in Chronic Obstructive Pulmonary Disease. Chronic Obstr Pulm Dis. 2015 Nov 11;3(1):398-405. doi: 10.15326/jcopdf.3.1.2015.0142.</citation>
    <PMID>28848862</PMID>
  </reference>
  <reference>
    <citation>Remakus, Christopher B., et al.</citation>
  </reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>March 12, 2018</last_update_submitted>
  <last_update_submitted_qc>March 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03018847
org study id: CPV2-2016-S1
nct id: NCT03018847
lead sponsor: 
collaborator: 
has dmc: No
The purpose of undertaking this study is to examine the use of COPD Co-PilotTM, a COPD
      disease management program manufactured and operated by HGE Health Care Solutions, LLC, in
      COPD patients outside of the geographic base of HGE's existing patient population
      (Philadelphia, PA). The purpose is to demonstrate the feasibility of expanding the program to
      additional geographic sites and to examine whether similar outcome measures are achieved in
      patients under the supervision of health care providers that are new to the program.

      .
observational model: Case-Only
time perspective: Other
measure: Patient Adoption
time frame: 6 months
description: Percentage of potential daily symptom reports completed by patients
measure: Patient Satisfaction
time frame: 6 months
description: patient satisfaction questionnaire
measure: Inpatient Admissions
time frame: 6 months
description: admission records for period prior to study and during study
measure: Emergency department visits
time frame: 6 months
description: emergency department records for period prior to study and during study
measure: Clinic visits
time frame: 6 months
description: clinic visits for period prior to study and during study
measure: Patient reported respiratory symptoms
time frame: 6 months
description: Daily values for breathlessness, sputum quantity, sputum color, sputum consistency, peak flow, temperature over 100 F, cough, wheeze, sore throat, and nasal congestion.
measure: Symptom change detected
time frame: 6 months
description: Change index (a numeric value) and the categorical level of change that corresponds to the patient's reported symptoms when compared to their baseline. This is recorded for each daily symptom report submitted after completion of the run-in period.
measure: Episode duration
time frame: 6 months
description: the date when a mild, moderate or significant level of change is first detected for a patient through the date immediately followed by seven consecutive days in which no level of change is detected. The total number of days in this period, symptoms reported during this period, and clinical responses communicated to the patient (including any treatments or changes) will be reported for analysis.
measure: Clinical responses
time frame: 6 months
description: the date, medication or instruction, dosage, frequency, duration of clinical responses sent to subjects, and time elapsed between the patient's check-in and the time the response was acknowledged by the patient.
measure: Hospitalization history
time frame: 6 months
description: hospitalization history reported to Health Assistants by patients during scheduled monthly phone calls. This will be reconciled with admissions data from the site and may include utilization at other institutions.
measure: Medications
time frame: 6 months
description: list of medications entered by site coordinator, provider, or reported by subjects to Health Assistants during scheduled monthly phone calls.
measure: Patient profile information
time frame: 6 months
description: This will include, among other variables, medial history, smoking history, spirometry results, oxygen use, and diagnoses of co-morbidities.
measure: Medication compliance
time frame: 6 months
description: compliance with newly prescribed treatments as reported by patients during follow up phone calls.
measure: Length of stay
time frame: 6 months
description: total number of inpatient days and the average length of stay per admission will be reported for analyses. These records will include date of admission, date of discharge, patient name and medical record number, patient date of birth (DOB), location, length of stay, attending physician, admission diagnosis and diagnosis at discharge. Reported for period prior to study and during study period
measure: Readmissions
time frame: 6 months
description: The number of inpatient admissions that occurred within 30, 60, and 90 days of discharge from a prior admission will be reported for analyses. These records will include date of admission, date of discharge, patient name and medical record number, patient DOB, location, length of stay, attending physician, admission diagnosis, diagnosis at discharge, and associated costs broken down by category. This will be reported for time prior to study and during study period.
measure: Readmission rate
time frame: 6 months
description: The rate and percent of inpatient admissions that occurred within 30, 60, and 90 days of discharge from a prior admission will be reported for analyses. These records will include date of admission, date of discharge, patient name and medical record number, patient DOB, location, length of stay, attending physician, admission diagnosis and diagnosis at discharge. These will be reported for the period prior to the start of the study through the study period.
measure: Source of inpatient admissions and visits to the Emergency Department (ED)
time frame: 6 months
description: The source (e.g. from home, from accident, from outpatient clinical, at direction of physician, from ED, etc.) of each and every inpatient admission an emergency department visit will be reported for analyses. These will be reported for the period prior to the enrollment through the study period.
intervention type: Device
intervention name: COPD Co-Pilot
description: The COPD Co-Pilot is a system that guides a patient through a software application (web or mobile app) to collect, track, and trend daily symptoms related to Chronic Obstructive Pulmonary Disease (COPD). The system is intended to be used by patients as a support tool to track COPD symptoms as part of their personal disease management plan. The COPD Co-Pilot allows health care providers to view and triage subject symptoms via the provider web-based application. Health care providers also have the ability to send responses to subjects, like medication recommendations, through preset forms in the system.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: N/A
healthy volunteers: No
last name: Tatsiana Beiko, MD
role: Principal Investigator
affiliation: Medical University of South Carolina
facility: 
country: United States
citation: Smith HS, Criner AJ, Fehrle D, Grabianowski CL, Jacobs MR, Criner GJ. Use of a SmartPhone/Tablet-Based Bidirectional Telemedicine Disease Management Program Facilitates Early Detection and Treatment of COPD Exacerbation Symptoms. Telemed J E Health. 2016 May;22(5):395-9. doi: 10.1089/tmj.2015.0135. Epub 2015 Oct 9.
PMID: 26451903
citation: Cordova FC, Ciccolella D, Grabianowski C, Gaughan J, Brennan K, Goldstein F, Jacobs MR, Criner GJ. A Telemedicine-Based Intervention Reduces the Frequency and Severity of COPD Exacerbation Symptoms: A Randomized, Controlled Trial. Telemed J E Health. 2016 Feb;22(2):114-122. doi: 10.1089/tmj.2015.0035. Epub 2015 Aug 10.
PMID: 26259074
citation: Kim V, Garfield JL, Grabianowski CL, Krahnke JS, Gaughan JP, Jacobs MR, Criner GJ. The effect of chronic sputum production on respiratory symptoms in severe COPD. COPD. 2011 Apr;8(2):114-20. doi: 10.3109/15412555.2011.558546.
PMID: 21495839
citation: So JY, Lastra AC, Zhao H, Marchetti N, Criner GJ. Daily Peak Expiratory Flow Rate and Disease Instability in Chronic Obstructive Pulmonary Disease. Chronic Obstr Pulm Dis. 2015 Nov 11;3(1):398-405. doi: 10.15326/jcopdf.3.1.2015.0142.
PMID: 28848862
citation: Remakus, Christopher B., et al.
responsible party type: Sponsor
sharing ipd: No