<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/NCT03793192</url>
  </required_header>
  <id_info>
    <org_study_id>2018-1526</org_study_id>
    <secondary_id>5K23HL130524-03</secondary_id>
    <nct_id>NCT03793192</nct_id>
  </id_info>
  <brief_title>Promoting Activity After COPD Exacerbations, Aim 2</brief_title>
  <acronym>PACE2</acronym>
  <official_title>Promoting Activity After COPD Exacerbations, Aim 2 (PACE2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at 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 Illinois at Chicago</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This randomized controlled pilot study involving patients with chronic obstructive pulmonary&#xD;
      disease (COPD) recently discharged from the hospital will evaluate the feasibility and&#xD;
      efficacy of a home-based mobile-health supported physical activity promotion program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Deconditioning is common in patients with chronic obstructive pulmonary disease (COPD) and&#xD;
      has been associated with poor outcomes (e.g. difficulty breathing). Pulmonary rehabilitation&#xD;
      (PR) initiated shortly after hospital discharge following a COPD exacerbation has been shown&#xD;
      to improve some of these outcomes. However, for many patients, access to PR programs is&#xD;
      limited due to environmental, physical, and psycho-social reasons. Home-based physical&#xD;
      activity promotion, combined with education and social support, could help to overcome some&#xD;
      barriers to access and have been shown to be effective in populations with mild to moderate&#xD;
      COPD. However, home-based interventions have not been tested in patients recovering from COPD&#xD;
      exacerbations, a group for whom solutions to safely promote physical activity are urgently&#xD;
      needed. In PACE2 up to 64 adult participants with a physician diagnosis of COPD will be&#xD;
      enrolled and randomized to one of two groups: physical activity promotion intervention or&#xD;
      enhanced usual care. Participants will be enrolled while hospitalized and randomization will&#xD;
      occur approximately 7 days after hospital discharge. All participants will be provided&#xD;
      self-management educational materials and community resources both prior to hospital&#xD;
      discharge and during a home visit shortly after hospital discharge. For the participants&#xD;
      randomized to the intervention group, physical activity promotion will start following&#xD;
      randomization and continue for 12 weeks. These participants will also receive a personalized&#xD;
      plan to attend pulmonary rehabilitation, a guideline-recommended program for patients with&#xD;
      COPD recovering from exacerbations. The primary endpoint will be the change in physical&#xD;
      activity (mean daily step counts over 1 week) over time using repeated measures over the 12&#xD;
      weeks of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 18, 2019</start_date>
  <completion_date type="Anticipated">May 2022</completion_date>
  <primary_completion_date type="Anticipated">January 2022</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>
    <intervention_model_description>Intervention versus Enhanced Usual Care</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Allocation sequence will be concealed</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in mean daily step counts</measure>
    <time_frame>12 weeks</time_frame>
    <description>change in mean daily step counts (averaged over 1 week) over time using repeated measures over the 12 weeks of the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in T-score from baseline to week 12 (A negative change in score indicates less emotional distress - depression).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Emotional Distress - Anxiety</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in T-score from baseline to week 12 (A negative change in score indicates less emotional distress - anxiety).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Fatigue</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in T-score from baseline to week 12 (A negative change in score indicates less fatigue).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Physical function</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in T-score from baseline to week 12 (A negative change in score indicates lower physical function).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>PACE2 Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will receive usual healthcare as per their treating medical team and carry a pedometer for recording of physical activity. In addition, participants randomized to the PACE2 intervention will receive written educational materials regarding physical activity, telephone-based coaching to integrate physical activity in daily life activities and address barriers to attending pulmonary rehabilitation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All participants will receive usual healthcare as per their treating medical team and carry a pedometer for recording of physical activity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PACE2 Intervention</intervention_name>
    <description>Written educational materials regarding physical activity, telephone-based coaching to integrate physical activity in daily life activities and address barriers to attending pulmonary rehabilitation.</description>
    <arm_group_label>PACE2 Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 years or older;&#xD;
&#xD;
          2. Physician diagnosis of COPD;&#xD;
&#xD;
          3. Hospitalized as an inpatient, 23-hour observation, or clinical decision unit&#xD;
&#xD;
          4. Admitting respiratory conditions sensitive to the Centers for Medicare and Medicaid&#xD;
             Services Hospital Readmission Reduction Program as listed below:&#xD;
&#xD;
               -  COPD exacerbation&#xD;
&#xD;
               -  Asthma/COPD overlap&#xD;
&#xD;
               -  Decompensated heart failure&#xD;
&#xD;
               -  Pneumonia&#xD;
&#xD;
               -  Chronic Airway Disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Physical inability to participate in a walking program;&#xD;
&#xD;
          2. Oxygen saturation &lt;90% by pulse oximetry refractory to supplemental oxygen, or in a&#xD;
             patient unable or unwilling to use supplemental oxygen;&#xD;
&#xD;
          3. Fall in the previous 6 months;&#xD;
&#xD;
          4. Resting electrocardiogram (ECG) with new ST changes or tachyarrhythmia;&#xD;
&#xD;
          5. Planned discharge home to hospice or to long term care facility/skilled nursing&#xD;
             facility;&#xD;
&#xD;
          6. Life expectancy &lt;3 months;&#xD;
&#xD;
          7. Medical contraindication to participating in a physical activity promotion program as&#xD;
             determined by the inpatient treating clinician;&#xD;
&#xD;
          8. Unable to communicate in English;&#xD;
&#xD;
          9. Unable or declines to provide informed 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>Jerry Krishnan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois at Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Illinois at Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Illinois at Chicago</investigator_affiliation>
    <investigator_full_name>Jerry Krishnan</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <!-- 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/NCT03793192
org study id: 2018-1526
secondary id: 5K23HL130524-03
nct id: NCT03793192
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This randomized controlled pilot study involving patients with chronic obstructive pulmonary
      disease (COPD) recently discharged from the hospital will evaluate the feasibility and
      efficacy of a home-based mobile-health supported physical activity promotion program.
Deconditioning is common in patients with chronic obstructive pulmonary disease (COPD) and
      has been associated with poor outcomes (e.g. difficulty breathing). Pulmonary rehabilitation
      (PR) initiated shortly after hospital discharge following a COPD exacerbation has been shown
      to improve some of these outcomes. However, for many patients, access to PR programs is
      limited due to environmental, physical, and psycho-social reasons. Home-based physical
      activity promotion, combined with education and social support, could help to overcome some
      barriers to access and have been shown to be effective in populations with mild to moderate
      COPD. However, home-based interventions have not been tested in patients recovering from COPD
      exacerbations, a group for whom solutions to safely promote physical activity are urgently
      needed. In PACE2 up to 64 adult participants with a physician diagnosis of COPD will be
      enrolled and randomized to one of two groups: physical activity promotion intervention or
      enhanced usual care. Participants will be enrolled while hospitalized and randomization will
      occur approximately 7 days after hospital discharge. All participants will be provided
      self-management educational materials and community resources both prior to hospital
      discharge and during a home visit shortly after hospital discharge. For the participants
      randomized to the intervention group, physical activity promotion will start following
      randomization and continue for 12 weeks. These participants will also receive a personalized
      plan to attend pulmonary rehabilitation, a guideline-recommended program for patients with
      COPD recovering from exacerbations. The primary endpoint will be the change in physical
      activity (mean daily step counts over 1 week) over time using repeated measures over the 12
      weeks of the study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Intervention versus Enhanced Usual Care
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: Allocation sequence will be concealed
measure: Change in mean daily step counts
time frame: 12 weeks
description: change in mean daily step counts (averaged over 1 week) over time using repeated measures over the 12 weeks of the study.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression
time frame: 12 weeks
description: Change in T-score from baseline to week 12 (A negative change in score indicates less emotional distress - depression).
measure: PROMIS Emotional Distress - Anxiety
time frame: 12 weeks
description: Change in T-score from baseline to week 12 (A negative change in score indicates less emotional distress - anxiety).
measure: PROMIS Fatigue
time frame: 12 weeks
description: Change in T-score from baseline to week 12 (A negative change in score indicates less fatigue).
measure: PROMIS Physical function
time frame: 12 weeks
description: Change in T-score from baseline to week 12 (A negative change in score indicates lower physical function).
arm group label: PACE2 Intervention
arm group type: Experimental
description: All participants will receive usual healthcare as per their treating medical team and carry a pedometer for recording of physical activity. In addition, participants randomized to the PACE2 intervention will receive written educational materials regarding physical activity, telephone-based coaching to integrate physical activity in daily life activities and address barriers to attending pulmonary rehabilitation.
arm group label: Enhanced Usual Care
arm group type: No Intervention
description: All participants will receive usual healthcare as per their treating medical team and carry a pedometer for recording of physical activity.
intervention type: Other
intervention name: PACE2 Intervention
description: Written educational materials regarding physical activity, telephone-based coaching to integrate physical activity in daily life activities and address barriers to attending pulmonary rehabilitation.
arm group label: PACE2 Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jerry Krishnan, MD
role: Principal Investigator
affiliation: University of Illinois at Chicago
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Illinois at Chicago
investigator full name: Jerry Krishnan
investigator title: Professor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive