<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/NCT04479969</url>
  </required_header>
  <id_info>
    <org_study_id>20-003806</org_study_id>
    <secondary_id>1R43HL151461</secondary_id>
    <nct_id>NCT04479969</nct_id>
  </id_info>
  <brief_title>Enabling Independent Living by Expanding Access to Home-Based Pulmonary Rehabilitation</brief_title>
  <official_title>Enabling Independent Living by Expanding Access to Home-Based Pulmonary Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</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>Mayo Clinic</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>
      The purpose of this study is to test an existing home-based pulmonary rehab program with the&#xD;
      addition of video chat and a capability of a Spanish version.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this research is to test video chat on a computer tablet that is used for&#xD;
      Pulmonary Rehabilitation. We are interested in learning patients' thoughts on how easy or&#xD;
      difficult video chat is to use and the translation to Spanish and the feed back from Spanish&#xD;
      speaking patients .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 22, 2021</start_date>
  <completion_date type="Actual">July 30, 2021</completion_date>
  <primary_completion_date type="Actual">July 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Qualitative Interview</measure>
    <time_frame>Week 1</time_frame>
    <description>A Qualitative Interview will be conducted over the phone asking about the video chat experience.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This is a small study to assess the usability of video conferencing. A total of 10 patients will be enrolled, 5 of which will be Spanish speakers. All patients will test the video conferencing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Video Chat</intervention_name>
    <description>Video chat with health coach using a computer tablet.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must be ≥ 40 years old.&#xD;
&#xD;
          -  Patients mist have a diagnosis of GOLD stage II, III, or IV COPD documented by&#xD;
             pulmonary function testing.&#xD;
&#xD;
          -  Patients must be a current or previous smoker with at least 10 pack-years of cigarette&#xD;
             smoking.&#xD;
&#xD;
        Additional Inclusion Criteria to test Spanish version of system:&#xD;
&#xD;
          -  Be a native Spanish speaker.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a high likelihood of being lost to follow-up or contact (patients with&#xD;
             active chemical dependency).&#xD;
&#xD;
          -  Patients planning to move out of the state or who are not living in the healthcare&#xD;
             area.&#xD;
&#xD;
          -  Patients with an inability to provide good data or follow commands (patients who are&#xD;
             disoriented, have a severe neurologic or psychiatric condition).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roberto P Benzo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</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>July 2022</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 7, 2022</last_update_submitted>
  <last_update_submitted_qc>July 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2022</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>Principal Investigator</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>
  <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/NCT04479969
org study id: 20-003806
secondary id: 1R43HL151461
nct id: NCT04479969
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test an existing home-based pulmonary rehab program with the
      addition of video chat and a capability of a Spanish version.
The purpose of this research is to test video chat on a computer tablet that is used for
      Pulmonary Rehabilitation. We are interested in learning patients' thoughts on how easy or
      difficult video chat is to use and the translation to Spanish and the feed back from Spanish
      speaking patients .
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Qualitative Interview
time frame: Week 1
description: A Qualitative Interview will be conducted over the phone asking about the video chat experience.
arm group label: Intervention
arm group type: Other
description: This is a small study to assess the usability of video conferencing. A total of 10 patients will be enrolled, 5 of which will be Spanish speakers. All patients will test the video conferencing.
intervention type: Behavioral
intervention name: Video Chat
description: Video chat with health coach using a computer tablet.
arm group label: Intervention
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Roberto P Benzo
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: Principal Investigator
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No