<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/NCT02999685</url>
  </required_header>
  <id_info>
    <org_study_id>14-009016</org_study_id>
    <nct_id>NCT02999685</nct_id>
  </id_info>
  <brief_title>Home-based Health Management of Chronic Obstructive Lung Disease (COPD) Patients</brief_title>
  <official_title>Home-based Health Management of COPD Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Minnesota HealthSolutions</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Regular physical activity has been found to be important in maintaining health and well-being&#xD;
      in people with COPD. The purpose of this study is to test new technology and health coaching&#xD;
      aimed to help people with COPD become more physically active in their daily lives.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study consists of a home-based pulmonary rehabilitation system. The system consists of a&#xD;
      tablet computer, pulse oximeter, activity monitor and weekly telephone health coach calls.&#xD;
      The rehabilitation period lasts 8 weeks. This is a randomized trial with two groups. Group A&#xD;
      will complete the study activities during the first 8 weeks of the study followed by a period&#xD;
      of observation. Group B will complete 8 weeks of observation followed by 8 weeks of&#xD;
      rehabilitation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">June 2019</completion_date>
  <primary_completion_date type="Actual">June 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Life: Chronic Respiratory Questionaire</measure>
    <time_frame>8 weeks from the start of the intervention</time_frame>
    <description>To determine the effect of the proposed system on disease specific quality of life. The instrument has 2 summary scores, physical and emotional</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Daily Physical Activity measured by Actigraph</measure>
    <time_frame>8 weeks from the start of the intervention</time_frame>
    <description>To determine the effectiveness of the proposed system, on daily physical activity measured by triaxial accelerometers</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">154</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>Emphysema</condition>
  <condition>Pulmonary Rehabilitation</condition>
  <arm_group>
    <arm_group_label>Home-base Pulm Rehab w/ Health Coaching</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The intervention group starts with 8 weeks of Home-base Pulmonary Rehab with Health Coaching, followed by 8 weeks of observation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control/Wait</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Control/Wait group starts with 8 weeks of observation, followed by 8 weeks of intervention (Home-base Pulm Rehab w/ Health Coaching).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Home-base Pulmonary Rehab with Health Coaching</intervention_name>
    <arm_group_label>Control/Wait</arm_group_label>
    <arm_group_label>Home-base Pulm Rehab w/ Health Coaching</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Men and women age 40 years and older&#xD;
&#xD;
               -  Current or former smoker of at least 10 pack-years&#xD;
&#xD;
               -  Diagnosis of Global Initiative for Chronic Lung Disease (GOLD) stage II, III or&#xD;
                  IV COPD as documented by pulmonary function&#xD;
&#xD;
               -  Are eligible for Pulmonary Rehabilitation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Unable to perform mild exercises&#xD;
&#xD;
               -  Patients with a high likelihood of being lost to follow-up or contact (patients&#xD;
                  with active chemical dependency), are planning to move out of the state, are not&#xD;
                  living in the healthcare area.&#xD;
&#xD;
               -  Patients with an inability to provide good data or follow commands (patients who&#xD;
                  are disoriented, have a severe neurologic or psychiatric condition).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roberto Benzo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>January 3, 2020</last_update_submitted>
  <last_update_submitted_qc>January 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Roberto P. Benzo</investigator_full_name>
    <investigator_title>M.D.</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>
    <mesh_term>Emphysema</mesh_term>
  </condition_browse>
  <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/NCT02999685
org study id: 14-009016
nct id: NCT02999685
lead sponsor: 
collaborator: 
has dmc: No
Regular physical activity has been found to be important in maintaining health and well-being
      in people with COPD. The purpose of this study is to test new technology and health coaching
      aimed to help people with COPD become more physically active in their daily lives.
This study consists of a home-based pulmonary rehabilitation system. The system consists of a
      tablet computer, pulse oximeter, activity monitor and weekly telephone health coach calls.
      The rehabilitation period lasts 8 weeks. This is a randomized trial with two groups. Group A
      will complete the study activities during the first 8 weeks of the study followed by a period
      of observation. Group B will complete 8 weeks of observation followed by 8 weeks of
      rehabilitation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Quality of Life: Chronic Respiratory Questionaire
time frame: 8 weeks from the start of the intervention
description: To determine the effect of the proposed system on disease specific quality of life. The instrument has 2 summary scores, physical and emotional
measure: Daily Physical Activity measured by Actigraph
time frame: 8 weeks from the start of the intervention
description: To determine the effectiveness of the proposed system, on daily physical activity measured by triaxial accelerometers
arm group label: Home-base Pulm Rehab w/ Health Coaching
arm group type: Active Comparator
description: The intervention group starts with 8 weeks of Home-base Pulmonary Rehab with Health Coaching, followed by 8 weeks of observation.
arm group label: Control/Wait
arm group type: Active Comparator
description: The Control/Wait group starts with 8 weeks of observation, followed by 8 weeks of intervention (Home-base Pulm Rehab w/ Health Coaching).
intervention type: Behavioral
intervention name: Home-base Pulmonary Rehab with Health Coaching
arm group label: Control/Wait
arm group label: Home-base Pulm Rehab w/ Health Coaching
criteria: 
gender: All
minimum age: 40 Years
maximum age: 99 Years
healthy volunteers: No
last name: Roberto Benzo, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Roberto P. Benzo
investigator title: M.D.
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Emphysema
sharing ipd: No