<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/NCT03837847</url>
  </required_header>
  <id_info>
    <org_study_id>18-000780 (Pilot Study)</org_study_id>
    <secondary_id>1K24HL138150-01A1</secondary_id>
    <nct_id>NCT03837847</nct_id>
  </id_info>
  <brief_title>Mechanistic Effects of Health Coaching to Reduce COPD Hospitalizations</brief_title>
  <official_title>Mechanistic Effects of Health Coaching to Reduce COPD Hospitalizations</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>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 pilot study will explore the benefit of Health Coaching on patients with severe symptoms&#xD;
      of COPD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be randomized to either 12 weeks of weekly telephone health coaching calls&#xD;
      followed by 12 weeks of living a normal life or 12 weeks of living a normal life (in addition&#xD;
      to 6 brief educational guides and 6 non-health related calls), followed by 12 weeks of health&#xD;
      coaching over the phone.&#xD;
&#xD;
      Questionnaires and an activity monitor worn for one week will be used at baseline, 3,6 and 12&#xD;
      months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 5, 2018</start_date>
  <completion_date type="Actual">June 14, 2023</completion_date>
  <primary_completion_date type="Actual">June 14, 2023</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>Randomized Control wait design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>It is not possible to blind the participants or the study team as subjects will know if they are receiving a health coaching call.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Health related Quality of life</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Chronic Respiratory questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health care utilization (hospitalization or ED visits)</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>COPD exacerbations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily Physical activity</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Actigraph monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self Management</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Self Management Ability Scale-30 item questionnaire measuring ability and function. Score range is 0-100, higher score is best.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Meaning in Life</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Meaning in Life MLQ- 10 item questionnaire measures engagement and valued meaning and purpose in life. Scores range from 5-35. The higher the score the more meaning and purpose a person feels in their life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Patient Health Questionnaire 9 item questionnaire that screens for the presence of depression. Scores range from 0-27, a higher score suggests the presence of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>GAD-2 item questionnaire that screens for anxiety. Scores range from 0-6, a higher score suggests that anxiety may be present.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>COPD</condition>
  <condition>Emphysema</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive 12 weekly health coaching calls followed by 12 weeks of living a normal life.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attention Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this group will receive 6 educational guides and 6 calls to remind them to read the educational guides (over a 12 week period). The participants will then move to 12 weeks of weekly health coaching calls.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health Coaching Calls</intervention_name>
    <description>12 weekly health coaching calls</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wait list control</intervention_name>
    <description>after being 12 week in the usual care arm , patient will compassionately be offered the health coaching intervention</description>
    <arm_group_label>Attention Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Men and women 40 years or older with a clinical diagnosis of COPD with&#xD;
        shortness of breath.&#xD;
&#xD;
        Exclusion: terminal illness, inability to communicate by phone&#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 2023</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>July 10, 2023</last_update_submitted>
  <last_update_submitted_qc>July 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2023</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>
  <keyword>Health coaching</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emphysema</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/NCT03837847
org study id: 18-000780 (Pilot Study)
secondary id: 1K24HL138150-01A1
nct id: NCT03837847
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This pilot study will explore the benefit of Health Coaching on patients with severe symptoms
      of COPD.
Participants will be randomized to either 12 weeks of weekly telephone health coaching calls
      followed by 12 weeks of living a normal life or 12 weeks of living a normal life (in addition
      to 6 brief educational guides and 6 non-health related calls), followed by 12 weeks of health
      coaching over the phone.

      Questionnaires and an activity monitor worn for one week will be used at baseline, 3,6 and 12
      months.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Control wait design
primary purpose: Treatment
masking: None (Open Label)
masking description: It is not possible to blind the participants or the study team as subjects will know if they are receiving a health coaching call.
measure: Health related Quality of life
time frame: Baseline and 3 months
description: Chronic Respiratory questionnaire
measure: Health care utilization (hospitalization or ED visits)
time frame: Baseline and 3 months
description: COPD exacerbations
measure: Daily Physical activity
time frame: Baseline and 3 months
description: Actigraph monitor
measure: Self Management
time frame: Baseline and 3 months
description: Self Management Ability Scale-30 item questionnaire measuring ability and function. Score range is 0-100, higher score is best.
measure: Meaning in Life
time frame: Baseline and 3 months
description: Meaning in Life MLQ- 10 item questionnaire measures engagement and valued meaning and purpose in life. Scores range from 5-35. The higher the score the more meaning and purpose a person feels in their life.
measure: Patient Health
time frame: Baseline and 3 months
description: Patient Health Questionnaire 9 item questionnaire that screens for the presence of depression. Scores range from 0-27, a higher score suggests the presence of depression.
measure: Anxiety
time frame: Baseline and 3 months
description: GAD-2 item questionnaire that screens for anxiety. Scores range from 0-6, a higher score suggests that anxiety may be present.
arm group label: Intervention
arm group type: Experimental
description: Participants in this group will receive 12 weekly health coaching calls followed by 12 weeks of living a normal life.
arm group label: Attention Control
arm group type: Active Comparator
description: Participants in this group will receive 6 educational guides and 6 calls to remind them to read the educational guides (over a 12 week period). The participants will then move to 12 weeks of weekly health coaching calls.
intervention type: Behavioral
intervention name: Health Coaching Calls
description: 12 weekly health coaching calls
arm group label: Intervention
intervention type: Behavioral
intervention name: Wait list control
description: after being 12 week in the usual care arm , patient will compassionately be offered the health coaching intervention
arm group label: Attention Control
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: Emphysema