<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/NCT03007485</url>
  </required_header>
  <id_info>
    <org_study_id>AD-1511-33066</org_study_id>
    <nct_id>NCT03007485</nct_id>
  </id_info>
  <brief_title>Telehealth Pulmonary Rehabilitation for Hispanic and African-American Patients Admitted With Exacerbation of COPD</brief_title>
  <official_title>A Comprehensive Disease Management Program to Improve Quality of Life in Disparity Hispanic and African-American Patients Admitted With Exacerbation of Chronic Pulmonary Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwell Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic Obstructive Pulmonary Disease (COPD), also known as emphysema, is the leading cause&#xD;
      of hospitalization for older adults in the U.S., and a leading cause of death. Although there&#xD;
      is no cure for COPD, a program called pulmonary rehabilitation (PR), which combines exercise&#xD;
      and education, can help decrease re-hospitalizations and improve patients' quality of life.&#xD;
      Unfortunately, very few COPD Latino and African-American patients actually get PR. These&#xD;
      patients are unlikely to get referrals or to be able to attend PR due to lack of insurance,&#xD;
      lack of transportation, or lack of a PR center in their area. Telehealth is a way of using&#xD;
      computers to deliver healthcare long-distance, eliminating the need for a patient to travel&#xD;
      to receive care. By using telehealth for PR, the patient can exercise on a stationary bike in&#xD;
      his or her home, while being supervised by videoconference by a respiratory therapist (RT).&#xD;
      The RT can &quot;see&quot; the patient, and deliver education by videoconference, and the patient can&#xD;
      &quot;see&quot; the RT, so the patient does not need to leave home to get PR.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Telehealth-delivered PR has been shown to be as effective as standard PR (patients go to an&#xD;
      outpatient setting) at improving quality of life, and patients' exercise capacity. However,&#xD;
      this has not been studied in the Latino and African-American population and it is not known&#xD;
      how effective telehealth PR will be among this population.&#xD;
&#xD;
      For this study, the investigators hope to see if they can help COPD Latino and&#xD;
      African-American patients with access to this needed resource through telehealth PR. They&#xD;
      will compare standard PR and telehealth PR to determine if telehealth results in better&#xD;
      outcomes for patients with moderate to severe COPD who were recently discharged from the&#xD;
      hospital for COPD. The primary outcome the investigators will assess will be change in&#xD;
      re-hospitalization rates. The secondary outcomes will include: change in quality of life,&#xD;
      preparation to make decisions about clinical care, improved functional capacity, decreased&#xD;
      dyspnea, anxiety, and depression.&#xD;
&#xD;
      The study will involve randomly assigning participants to make sure that they are just as&#xD;
      likely to be in one group as the other to receive either: 1) referral for&#xD;
      telehealth-delivered PR, or 2) referral to standard (outpatient) PR. Both PR programs consist&#xD;
      of exercise and education twice a week for 8 weeks. The investigators will give the patients&#xD;
      surveys to complete before they start the program and at the end of the program, to see if PR&#xD;
      had any effect on the outcomes that are being measured. Patients will also be asked to&#xD;
      participate in a qualitative interview and focus group to learn about the barriers they&#xD;
      encountered even after receiving a referral to PR. These qualitative interviews will be&#xD;
      conducted among a sample of participants representing those who withdrew, were&#xD;
      lost-to-follow-up, completed PR and decided to only complete the surveys (i.e. not&#xD;
      participate in PR).The investigators will enroll about 276 patients - with 138 patients in&#xD;
      each group (telehealth PR or standard PR), so they can compare outcomes to see if telehealth&#xD;
      PR was more, less, or equally effective as standard PR.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">November 15, 2020</completion_date>
  <primary_completion_date type="Actual">November 15, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge</measure>
    <time_frame>6 months post-discharge from hospitalization following COPD exacerbation</time_frame>
    <description>The investigators will analyze the change in the rate of patients' rehospitalizations following completion of pulmonary rehabilitation (PR). COPD Hospital Readmission were measured for Intention to Treat (ITT), medically cleared, and those who sat on the bike at least once. Composite of COPD hospital readmission or death within 6 months of discharge using all available (complete) data, and no imputation of missing data. Without adherence added, offset term omitted in the logistic regression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional Capacity Before and After Pulmonary Rehabilitation 6-minute Walk Test (SPR) Tested in Meters) Between Day 1 and 8-weeks</measure>
    <time_frame>Prior to beginning PR (Day 1) and after completion of PR ( 8-weeks)</time_frame>
    <description>The investigators will analyze the change in patients' functional capacity, as measured prior to beginning PR (Day 1), immediately following completion of PR (8 weeks). This measures the length the study participant walked/step (i.e. 2-minute step test (2MST)= how many steps the participant took, 6-minute walk test (6MWT)= the length the participant walked for in meters). Due to the limited space in TelePR participants home, they were only able to complete the 2MST, while SPR participants completed the 6MWT because the center had more space.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program</measure>
    <time_frame>Prior to beginning PR, after completion of PR, and 6 months and12 months post-discharge from hospitalizations following COPD exacerbation</time_frame>
    <description>The investigators will analyze the change in patients' quality of life based on self-reported outcome measurements, as measured prior to beginning PR (Day 1), immediately following completion of PR (8 weeks), 6 months post-hospital discharge, 12 months post-hospital discharge.&#xD;
COPD Assessment Test (CAT): Maximal Score: 40, Minimal Score: 0; lower score denotes improvement&#xD;
Modified Medical Research Council Scale (MMRC): Maximal Score: 4, Minimal Score: 0; lower score denotes improvement&#xD;
All PROMIS scales have a maximal score of 20 and minimal score for all scales is 4; lower score denotes improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Capacity Before and After Pulmonary Rehabilitation (2-minute Step Test (TelePR) Tested in Steps</measure>
    <time_frame>Prior to beginning PR (Day 1) and after completion of PR ( 8-weeks)</time_frame>
    <description>The investigators will analyze the change in patients' functional capacity, as measured prior to beginning PR (Day 1), immediately following completion of PR (8 weeks). This measures the length the study participant walked/step (i.e. 2-minute step test (2MST)= how many steps the participant took, 6-minute walk test (6MWT)= the length the participant walked for in meters). Due to the limited space in TelePR participants home, they were only able to complete the 2MST, while SPR participants completed the 6MWT because the center had more space.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Measure of Patients' Uptake of PR i.e., Number of Referred Patients Who Participated in at Least One PR Session</measure>
    <time_frame>8 weeks post-discharge from hospitalization following COPD exacerbation</time_frame>
    <description>Given the improved convenience and access to PR, the investigators are looking to measure the degree to which patients adhere to their pulmonologists' referrals for pulmonary rehabilitation.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">266</enrollment>
  <condition>COPD Exacerbation</condition>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard pulmonary rehabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telehealth delivered pulmonary rehabilitation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Telehealth Pulmonary Rehabilitation</intervention_name>
    <description>Exercise bikes equipped with software that enables a respiratory therapist to remotely conduct a pulmonary rehabilitation session with a patient while he or she is at home (or at a local community center). The patient's vital signs are continually monitored and the RT is able to remotely alert 911 if a patient is in distress. Educational videos and stretching exercises are also incorporated into this session to mimic what a standard pulmonary rehabilitation session offers.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients with a diagnosis of COPD (defined by one pulmonary function tests (PFT)&#xD;
             and who have not done pulmonary rehabilitation within the past 1 year and&#xD;
&#xD;
          -  Hispanic or African-American (as defined by the patient him/herself).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  individuals who completed PR in the past year or&#xD;
&#xD;
          -  those unable to exercise or follow directions as determined by their outpatient&#xD;
             pulmonologist/cardiologist or&#xD;
&#xD;
          -  A diagnosis of dementia listed in the patient's electronic medical record&#xD;
&#xD;
          -  Patients who weigh more than 300 pounds&#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>Negin Hajizadeh, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hofstra Northwell School of Medicine, Northwell Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwell Health</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <results_first_submitted>February 18, 2021</results_first_submitted>
  <results_first_submitted_qc>December 31, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 10, 2022</results_first_posted>
  <last_update_submitted>December 31, 2021</last_update_submitted>
  <last_update_submitted_qc>December 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwell Health</investigator_affiliation>
    <investigator_full_name>Negin Hajizadeh</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </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>July 9, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/85/NCT03007485/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>In total 266 participants signed the informed consent and were randomized (131 to the TelePR arm and 135 to the SPR arm). Of the 131 randomized to TelePR, 20 were subsequently excluded after randomization because they no longer met inclusion criteria. Of the 135 randomized to SPR, 37 were excluded after randomization because they also no longer met inclusion criteria. Therefore, in total 209 participants were randomized and were included in the intention to treat analysis.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Standard of Care</title>
          <description>Standard pulmonary rehabilitation</description>
        </group>
        <group group_id="P2">
          <title>Telehealth-delivered Pulmonary Rehabilitation</title>
          <description>Telehealth delivered pulmonary rehabilitation- Intervention&#xD;
Telehealth Pulmonary Rehabilitation: Exercise bikes equipped with software that enables a respiratory therapist to remotely conduct a pulmonary rehabilitation session with a patient while he or she is at home (or at a local community center). The patient's vital signs are continually monitored and the RT is able to remotely alert 911 if a patient is in distress. Educational videos and stretching exercises are also incorporated into this session to mimic what a standard pulmonary rehabilitation session offers.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="98"/>
                <participants group_id="P2" count="111"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="54"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Standard of Care</title>
          <description>Standard pulmonary rehabilitation</description>
        </group>
        <group group_id="B2">
          <title>Intervention</title>
          <description>Telehealth delivered pulmonary rehabilitation&#xD;
Telehealth Pulmonary Rehabilitation: Exercise bikes equipped with software that enables a respiratory therapist to remotely conduct a pulmonary rehabilitation session with a patient while he or she is at home (or at a local community center). The patient's vital signs are continually monitored and the RT is able to remotely alert 911 if a patient is in distress. Educational videos and stretching exercises are also incorporated into this session to mimic what a standard pulmonary rehabilitation session offers.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="98"/>
            <count group_id="B2" value="111"/>
            <count group_id="B3" value="209"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="91"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="65.96" spread="10.68"/>
                    <measurement group_id="B2" value="66.89" spread="10.80"/>
                    <measurement group_id="B3" value="66.42" spread="10.70"/>
                  </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="57"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="124"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African-American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="120"/>
                  </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="98"/>
                    <measurement group_id="B2" value="111"/>
                    <measurement group_id="B3" value="209"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge</title>
        <description>The investigators will analyze the change in the rate of patients' rehospitalizations following completion of pulmonary rehabilitation (PR). COPD Hospital Readmission were measured for Intention to Treat (ITT), medically cleared, and those who sat on the bike at least once. Composite of COPD hospital readmission or death within 6 months of discharge using all available (complete) data, and no imputation of missing data. Without adherence added, offset term omitted in the logistic regression.</description>
        <time_frame>6 months post-discharge from hospitalization following COPD exacerbation</time_frame>
        <population>TelePR and SPR arms were combined as pre-specified in the study protocol and explained below:&#xD;
The primary outcome was a composite of COPD-related hospital readmissions or death within 6 months of discharge. Logistic regression was used to compare the primary outcome in terms of the OR of event rates between arms, in 2 sets of models:&#xD;
1: Treatment arm only with no other covariates added to the model&#xD;
2: Treatment arm, adjusted for race and clinical site (stratification variables)</population>
        <group_list>
          <group group_id="O1">
            <title>Intention to Treat (ITT)</title>
            <description>ITT: Total number of participants: 209 TelePR: 111 participants SPR: 98 participants</description>
          </group>
          <group group_id="O2">
            <title>Medically Cleared</title>
            <description>Participants that were medically cleared by their pulmonologist and cardiologist (if needed) to participate in pulmonary rehab.</description>
          </group>
          <group group_id="O3">
            <title>Bike</title>
            <description>Participants that agreed to participate, received medical clearance, and sat on the bike at least once.</description>
          </group>
        </group_list>
        <measure>
          <title>Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge</title>
          <description>The investigators will analyze the change in the rate of patients' rehospitalizations following completion of pulmonary rehabilitation (PR). COPD Hospital Readmission were measured for Intention to Treat (ITT), medically cleared, and those who sat on the bike at least once. Composite of COPD hospital readmission or death within 6 months of discharge using all available (complete) data, and no imputation of missing data. Without adherence added, offset term omitted in the logistic regression.</description>
          <population>TelePR and SPR arms were combined as pre-specified in the study protocol and explained below:&#xD;
The primary outcome was a composite of COPD-related hospital readmissions or death within 6 months of discharge. Logistic regression was used to compare the primary outcome in terms of the OR of event rates between arms, in 2 sets of models:&#xD;
1: Treatment arm only with no other covariates added to the model&#xD;
2: Treatment arm, adjusted for race and clinical site (stratification variables)</population>
          <units>Hospitalizations/death</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
                <count group_id="O2" value="138"/>
                <count group_id="O3" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Unadjusted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.34" lower_limit="0.69" upper_limit="2.59"/>
                    <measurement group_id="O2" value="1.06" lower_limit="0.43" upper_limit="2.58"/>
                    <measurement group_id="O3" value="0.88" lower_limit="0.29" upper_limit="2.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adjusted (race, hospital)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.35" lower_limit="0.69" upper_limit="2.66"/>
                    <measurement group_id="O2" value="1.09" lower_limit="0.43" upper_limit="2.73"/>
                    <measurement group_id="O3" value="0.86" lower_limit="0.27" upper_limit="2.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Sample size and power calculation was a composite of COPD-related hospital readmissions or death within 6 months of discharge. First level of analysis was the ITT, which included all the patients randomly assigned to an arm at the beginning of the study (excluding those who were found to not meet inclusion criteria for referral). The second included all the patients medically cleared and third included all the patients who were medically cleared and who had participated in at least 1 PR session.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.05</p_value>
            <p_value_desc>Reported p-value was calculated</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <other_analysis_desc>The primary outcome was a composite of COPD-related hospital readmissions or death within 6 months of discharge (binary: yes/no). Logistic regression was used to compare the primary outcome in terms of the OR of event rates between the 2 arms, in 3 sets of models (per each of the 3 aforementioned level of analyses):&#xD;
Model 1: Treatment arm only with no other covariates added to the model&#xD;
Model 2: Treatment arm, adjusted for race and clinical site (stratification variables)&#xD;
Model 3: Treatment arm, adjusted for race, clinical site, and risk factors reported in the literature to be associated with the primary outcome, for explanatory purposes To examine the role of adherence on the primary outcome, we included adherence as a binary variable and as a continuous variable (percentage of sessions attended) in the 3 models.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Functional Capacity Before and After Pulmonary Rehabilitation 6-minute Walk Test (SPR) Tested in Meters) Between Day 1 and 8-weeks</title>
        <description>The investigators will analyze the change in patients' functional capacity, as measured prior to beginning PR (Day 1), immediately following completion of PR (8 weeks). This measures the length the study participant walked/step (i.e. 2-minute step test (2MST)= how many steps the participant took, 6-minute walk test (6MWT)= the length the participant walked for in meters). Due to the limited space in TelePR participants home, they were only able to complete the 2MST, while SPR participants completed the 6MWT because the center had more space.</description>
        <time_frame>Prior to beginning PR (Day 1) and after completion of PR ( 8-weeks)</time_frame>
        <population>Data in SPR arm reported in Outcome Measures in meters due to space.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>Standard pulmonary rehabilitation</description>
          </group>
        </group_list>
        <measure>
          <title>Functional Capacity Before and After Pulmonary Rehabilitation 6-minute Walk Test (SPR) Tested in Meters) Between Day 1 and 8-weeks</title>
          <description>The investigators will analyze the change in patients' functional capacity, as measured prior to beginning PR (Day 1), immediately following completion of PR (8 weeks). This measures the length the study participant walked/step (i.e. 2-minute step test (2MST)= how many steps the participant took, 6-minute walk test (6MWT)= the length the participant walked for in meters). Due to the limited space in TelePR participants home, they were only able to complete the 2MST, while SPR participants completed the 6MWT because the center had more space.</description>
          <population>Data in SPR arm reported in Outcome Measures in meters due to space.</population>
          <units>Meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="261.92" spread="125.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="275.29" spread="137.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program</title>
        <description>The investigators will analyze the change in patients' quality of life based on self-reported outcome measurements, as measured prior to beginning PR (Day 1), immediately following completion of PR (8 weeks), 6 months post-hospital discharge, 12 months post-hospital discharge.&#xD;
COPD Assessment Test (CAT): Maximal Score: 40, Minimal Score: 0; lower score denotes improvement&#xD;
Modified Medical Research Council Scale (MMRC): Maximal Score: 4, Minimal Score: 0; lower score denotes improvement&#xD;
All PROMIS scales have a maximal score of 20 and minimal score for all scales is 4; lower score denotes improvement.</description>
        <time_frame>Prior to beginning PR, after completion of PR, and 6 months and12 months post-discharge from hospitalizations following COPD exacerbation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>Standard pulmonary rehabilitation</description>
          </group>
          <group group_id="O2">
            <title>Telehealth-delivered Pulmonary Rehabilitation</title>
            <description>Telehealth delivered pulmonary rehabilitation&#xD;
Telehealth Pulmonary Rehabilitation: Exercise bikes equipped with software that enables a respiratory therapist to remotely conduct a pulmonary rehabilitation session with a patient while he or she is at home (or at a local community center). The patient's vital signs are continually monitored and the RT is able to remotely alert 911 if a patient is in distress. Educational videos and stretching exercises are also incorporated into this session to mimic what a standard pulmonary rehabilitation session offers.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program</title>
          <description>The investigators will analyze the change in patients' quality of life based on self-reported outcome measurements, as measured prior to beginning PR (Day 1), immediately following completion of PR (8 weeks), 6 months post-hospital discharge, 12 months post-hospital discharge.&#xD;
COPD Assessment Test (CAT): Maximal Score: 40, Minimal Score: 0; lower score denotes improvement&#xD;
Modified Medical Research Council Scale (MMRC): Maximal Score: 4, Minimal Score: 0; lower score denotes improvement&#xD;
All PROMIS scales have a maximal score of 20 and minimal score for all scales is 4; lower score denotes improvement.</description>
          <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="37"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>COPD Assessment Test (CAT) Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.89" spread="8.53"/>
                    <measurement group_id="O2" value="22.37" spread="8.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CAT 8-weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.18" spread="8.41"/>
                    <measurement group_id="O2" value="19.91" spread="7.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CAT 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.07" spread="7.54"/>
                    <measurement group_id="O2" value="21.12" spread="9.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CAT 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.09" spread="7.70"/>
                    <measurement group_id="O2" value="23.00" spread="8.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Modified Medical Research Council Scale (MMRC) Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.24" spread="1.04"/>
                    <measurement group_id="O2" value="2.46" spread="1.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MMRC 8-weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.24" spread="1.28"/>
                    <measurement group_id="O2" value="2.28" spread="1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MMRC 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.48" spread="1.18"/>
                    <measurement group_id="O2" value="2.15" spread="1.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MMRC 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.45" spread="0.91"/>
                    <measurement group_id="O2" value="2.42" spread="1.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PROMIS: Depression Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.38" spread="4.24"/>
                    <measurement group_id="O2" value="8.35" spread="4.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PROMIS: Depression 8-weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.85" spread="3.78"/>
                    <measurement group_id="O2" value="7.97" spread="4.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PROMIS: Depression 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.25" spread="4.20"/>
                    <measurement group_id="O2" value="8.60" spread="4.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PROMIS: Depression 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.47" spread="4.25"/>
                    <measurement group_id="O2" value="8.29" spread="4.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PROMIS: Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.70" spread="4.47"/>
                    <measurement group_id="O2" value="11.77" spread="4.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PROMIS: Fatigue 8-weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.88" spread="4.21"/>
                    <measurement group_id="O2" value="10.43" spread="4.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PROMIS: Fatigue 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.43" spread="3.99"/>
                    <measurement group_id="O2" value="11.38" spread="4.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PROMIS: Fatigue 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.50" spread="4.68"/>
                    <measurement group_id="O2" value="10.92" spread="4.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Functional Capacity Before and After Pulmonary Rehabilitation (2-minute Step Test (TelePR) Tested in Steps</title>
        <description>The investigators will analyze the change in patients' functional capacity, as measured prior to beginning PR (Day 1), immediately following completion of PR (8 weeks). This measures the length the study participant walked/step (i.e. 2-minute step test (2MST)= how many steps the participant took, 6-minute walk test (6MWT)= the length the participant walked for in meters). Due to the limited space in TelePR participants home, they were only able to complete the 2MST, while SPR participants completed the 6MWT because the center had more space.</description>
        <time_frame>Prior to beginning PR (Day 1) and after completion of PR ( 8-weeks)</time_frame>
        <population>Data in TelePR arm reported in Outcome Measures in steps due to space limitation.</population>
        <group_list>
          <group group_id="O1">
            <title>Telehealth-delivered Pulmonary Rehabilitation</title>
            <description>Telehealth-delivered Pulmonary Rehabilitation</description>
          </group>
        </group_list>
        <measure>
          <title>Functional Capacity Before and After Pulmonary Rehabilitation (2-minute Step Test (TelePR) Tested in Steps</title>
          <description>The investigators will analyze the change in patients' functional capacity, as measured prior to beginning PR (Day 1), immediately following completion of PR (8 weeks). This measures the length the study participant walked/step (i.e. 2-minute step test (2MST)= how many steps the participant took, 6-minute walk test (6MWT)= the length the participant walked for in meters). Due to the limited space in TelePR participants home, they were only able to complete the 2MST, while SPR participants completed the 6MWT because the center had more space.</description>
          <population>Data in TelePR arm reported in Outcome Measures in steps due to space limitation.</population>
          <units>Steps</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.87" spread="17.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.12" spread="23.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Measure of Patients' Uptake of PR i.e., Number of Referred Patients Who Participated in at Least One PR Session</title>
        <description>Given the improved convenience and access to PR, the investigators are looking to measure the degree to which patients adhere to their pulmonologists' referrals for pulmonary rehabilitation.</description>
        <time_frame>8 weeks post-discharge from hospitalization following COPD exacerbation</time_frame>
        <population>The denominator here is all patients who received a referral to PR.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>Standard pulmonary rehabilitation</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>Telehealth delivered pulmonary rehabilitation&#xD;
Telehealth Pulmonary Rehabilitation: Exercise bikes equipped with software that enables a respiratory therapist to remotely conduct a pulmonary rehabilitation session with a patient while he or she is at home (or at a local community center). The patient's vital signs are continually monitored and the RT is able to remotely alert 911 if a patient is in distress. Educational videos and stretching exercises are also incorporated into this session to mimic what a standard pulmonary rehabilitation session offers.</description>
          </group>
        </group_list>
        <measure>
          <title>Measure of Patients' Uptake of PR i.e., Number of Referred Patients Who Participated in at Least One PR Session</title>
          <description>Given the improved convenience and access to PR, the investigators are looking to measure the degree to which patients adhere to their pulmonologists' referrals for pulmonary rehabilitation.</description>
          <population>The denominator here is all patients who received a referral to PR.</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="98"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events was collected during the duration of the PR program - Day 1 to 8-weeks (completion of PR). The duration of time over which both, All-cause mortality and serious and other (non-serious) adverse events were assessed during Day 1 to 8 weeks (during PR) and until 6 months after enrollment into PR.</time_frame>
      <desc>Hospital readmission/death were monitored/assess within 6 month of discharged which includes the duration of PR 8 weeks. Adverse events were only collected during the duration of the PR program (Day1 to 8 weeks). Deaths were not assessed for a different duration of time than Serious and Other adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Standard of Care</title>
          <description>Standard pulmonary rehabilitation</description>
        </group>
        <group group_id="E2">
          <title>Telehealth-delivered Pulmonary Rehabilitation</title>
          <description>Telehealth delivered pulmonary rehabilitation&#xD;
Telehealth Pulmonary Rehabilitation: Exercise bikes equipped with software that enables a respiratory therapist to remotely conduct a pulmonary rehabilitation session with a patient while he or she is at home (or at a local community center). The patient's vital signs are continually monitored and the RT is able to remotely alert 911 if a patient is in distress. Educational videos and stretching exercises are also incorporated into this session to mimic what a standard pulmonary rehabilitation session offers.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Serious Adverse Event</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Serious Adverse Event</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Other (Not Including Serious) Adverse Events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Other (Not Including Serious) Adverse Events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Other (Not Including Serious) Adverse Events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Other (Not Including Serious) Adervse Events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="111"/>
              </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. Negin Hajizadeh</name_or_title>
      <organization>Northwell Health</organization>
      <phone>516-600-1401</phone>
      <email>Nhajizadeh@northwell.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/NCT03007485
org study id: AD-1511-33066
nct id: NCT03007485
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic Obstructive Pulmonary Disease (COPD), also known as emphysema, is the leading cause
      of hospitalization for older adults in the U.S., and a leading cause of death. Although there
      is no cure for COPD, a program called pulmonary rehabilitation (PR), which combines exercise
      and education, can help decrease re-hospitalizations and improve patients' quality of life.
      Unfortunately, very few COPD Latino and African-American patients actually get PR. These
      patients are unlikely to get referrals or to be able to attend PR due to lack of insurance,
      lack of transportation, or lack of a PR center in their area. Telehealth is a way of using
      computers to deliver healthcare long-distance, eliminating the need for a patient to travel
      to receive care. By using telehealth for PR, the patient can exercise on a stationary bike in
      his or her home, while being supervised by videoconference by a respiratory therapist (RT).
      The RT can "see" the patient, and deliver education by videoconference, and the patient can
      "see" the RT, so the patient does not need to leave home to get PR.
Telehealth-delivered PR has been shown to be as effective as standard PR (patients go to an
      outpatient setting) at improving quality of life, and patients' exercise capacity. However,
      this has not been studied in the Latino and African-American population and it is not known
      how effective telehealth PR will be among this population.

      For this study, the investigators hope to see if they can help COPD Latino and
      African-American patients with access to this needed resource through telehealth PR. They
      will compare standard PR and telehealth PR to determine if telehealth results in better
      outcomes for patients with moderate to severe COPD who were recently discharged from the
      hospital for COPD. The primary outcome the investigators will assess will be change in
      re-hospitalization rates. The secondary outcomes will include: change in quality of life,
      preparation to make decisions about clinical care, improved functional capacity, decreased
      dyspnea, anxiety, and depression.

      The study will involve randomly assigning participants to make sure that they are just as
      likely to be in one group as the other to receive either: 1) referral for
      telehealth-delivered PR, or 2) referral to standard (outpatient) PR. Both PR programs consist
      of exercise and education twice a week for 8 weeks. The investigators will give the patients
      surveys to complete before they start the program and at the end of the program, to see if PR
      had any effect on the outcomes that are being measured. Patients will also be asked to
      participate in a qualitative interview and focus group to learn about the barriers they
      encountered even after receiving a referral to PR. These qualitative interviews will be
      conducted among a sample of participants representing those who withdrew, were
      lost-to-follow-up, completed PR and decided to only complete the surveys (i.e. not
      participate in PR).The investigators will enroll about 276 patients - with 138 patients in
      each group (telehealth PR or standard PR), so they can compare outcomes to see if telehealth
      PR was more, less, or equally effective as standard PR.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
measure: Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge
time frame: 6 months post-discharge from hospitalization following COPD exacerbation
description: The investigators will analyze the change in the rate of patients' rehospitalizations following completion of pulmonary rehabilitation (PR). COPD Hospital Readmission were measured for Intention to Treat (ITT), medically cleared, and those who sat on the bike at least once. Composite of COPD hospital readmission or death within 6 months of discharge using all available (complete) data, and no imputation of missing data. Without adherence added, offset term omitted in the logistic regression.
measure: Functional Capacity Before and After Pulmonary Rehabilitation 6-minute Walk Test (SPR) Tested in Meters) Between Day 1 and 8-weeks
time frame: Prior to beginning PR (Day 1) and after completion of PR ( 8-weeks)
description: The investigators will analyze the change in patients' functional capacity, as measured prior to beginning PR (Day 1), immediately following completion of PR (8 weeks). This measures the length the study participant walked/step (i.e. 2-minute step test (2MST)= how many steps the participant took, 6-minute walk test (6MWT)= the length the participant walked for in meters). Due to the limited space in TelePR participants home, they were only able to complete the 2MST, while SPR participants completed the 6MWT because the center had more space.
measure: Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program
time frame: Prior to beginning PR, after completion of PR, and 6 months and12 months post-discharge from hospitalizations following COPD exacerbation
description: The investigators will analyze the change in patients' quality of life based on self-reported outcome measurements, as measured prior to beginning PR (Day 1), immediately following completion of PR (8 weeks), 6 months post-hospital discharge, 12 months post-hospital discharge.
COPD Assessment Test (CAT): Maximal Score: 40, Minimal Score: 0; lower score denotes improvement
Modified Medical Research Council Scale (MMRC): Maximal Score: 4, Minimal Score: 0; lower score denotes improvement
All PROMIS scales have a maximal score of 20 and minimal score for all scales is 4; lower score denotes improvement.
measure: Functional Capacity Before and After Pulmonary Rehabilitation (2-minute Step Test (TelePR) Tested in Steps
time frame: Prior to beginning PR (Day 1) and after completion of PR ( 8-weeks)
description: The investigators will analyze the change in patients' functional capacity, as measured prior to beginning PR (Day 1), immediately following completion of PR (8 weeks). This measures the length the study participant walked/step (i.e. 2-minute step test (2MST)= how many steps the participant took, 6-minute walk test (6MWT)= the length the participant walked for in meters). Due to the limited space in TelePR participants home, they were only able to complete the 2MST, while SPR participants completed the 6MWT because the center had more space.
measure: Measure of Patients' Uptake of PR i.e., Number of Referred Patients Who Participated in at Least One PR Session
time frame: 8 weeks post-discharge from hospitalization following COPD exacerbation
description: Given the improved convenience and access to PR, the investigators are looking to measure the degree to which patients adhere to their pulmonologists' referrals for pulmonary rehabilitation.
arm group label: Standard of Care
arm group type: No Intervention
description: Standard pulmonary rehabilitation
arm group label: Intervention
arm group type: Experimental
description: Telehealth delivered pulmonary rehabilitation
intervention type: Other
intervention name: Telehealth Pulmonary Rehabilitation
description: Exercise bikes equipped with software that enables a respiratory therapist to remotely conduct a pulmonary rehabilitation session with a patient while he or she is at home (or at a local community center). The patient's vital signs are continually monitored and the RT is able to remotely alert 911 if a patient is in distress. Educational videos and stretching exercises are also incorporated into this session to mimic what a standard pulmonary rehabilitation session offers.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Negin Hajizadeh, MD, MPH
role: Principal Investigator
affiliation: Hofstra Northwell School of Medicine, Northwell Health
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwell Health
investigator full name: Negin Hajizadeh
investigator title: Associate Professor of Medicine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 