<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/NCT02234284</url>
  </required_header>
  <id_info>
    <org_study_id>PCORI AD-1306-03900</org_study_id>
    <nct_id>NCT02234284</nct_id>
  </id_info>
  <brief_title>Aides in Respiration Health Coaching for COPD</brief_title>
  <acronym>AIR</acronym>
  <official_title>Health Coaching to Reduce Disparities for Patients With Chronic Obstructive Pulmonary Disease (COPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study examined whether health coaches can improve the management of chronic obstructive&#xD;
      pulmonary disease (COPD) in a population of vulnerable patients cared for in 'safety-net'&#xD;
      clinics. The study is designed as a randomized controlled trial for patients with moderate to&#xD;
      severe COPD. Patients were randomized into a health coaching group and a usual care group.&#xD;
      Those in the health coaching group received 9 months of active health coaching. Outcome&#xD;
      variables were measured at baseline and after 9 months&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Health coaching is a promising model for improving evidence-based care for patients with COPD&#xD;
      which had not been evaluated at the time the current study began in 2014. Health coaching by&#xD;
      health workers or peers trained as coaches, has emerged as an effective model to improve&#xD;
      these management domains for children with asthma and adults with diabetes, and hypertension&#xD;
      receiving care in urban safety-net clinics. The role of the health coach includes many of the&#xD;
      activities also provided by patient navigators, patient educators, and community health&#xD;
      workers. Health coaching is a patient-centered model that recognizes that that people living&#xD;
      with chronic disease are the primary decision-makers in their care; it is a tailored approach&#xD;
      that builds on the strengths and expertise of patients and helps to ensure that they have the&#xD;
      knowledge and skills to be active participants within the medical encounter and to&#xD;
      effectively manage their conditions. Incorporating health coaches into care delivery fits&#xD;
      well with the of integrated care model recommended by the American Thoracic Society which is&#xD;
      based on the Chronic Care Mode. Health coaching can work on several components of the Chronic&#xD;
      Care Model as it applies to COPD to enhance the effectiveness of care delivery and promote&#xD;
      patient goals. Health coaches provide decision support by helping execute customized care&#xD;
      plans jointly developed by patients and providers. Coaches track care targets and conduct&#xD;
      'gap analysis' to identify areas which are sub-optimal. Coaches also help patients to get the&#xD;
      support they need by facilitating access to community, clinic, and specialist support,&#xD;
      improving communication between patients and providers, working with patients to set goals&#xD;
      and develop action plans to reach those goals. The goal of our study was to evaluate the&#xD;
      effectiveness of a health coach model for improving outcomes for low-income urban patients&#xD;
      with COPD. We conducted a randomized trial comparing 9 months of health coaching plus usual&#xD;
      care (health coached arm) to usual care (usual care arm) alone for patients with moderate to&#xD;
      severe COPD cared for at 7 federally qualified health centers (FQHCs). The specific aims of&#xD;
      the study were:&#xD;
&#xD;
      Specific Aim 1. To compare disease specific quality of life for patients randomized to&#xD;
      receive 9 months of health coaching plus usual care to those randomized to usual care alone.&#xD;
      Our hypothesis was that mean quality of life, assessed by the Chronic Respiratory Disease&#xD;
      Questionnaire total score and dyspnea domain score at 9 months, would be greater in patients&#xD;
      in the health-coached arm when tested against the null hypothesis of no difference between&#xD;
      health-coached and usual care patients.&#xD;
&#xD;
      Specific Aim 2. To compare the number of exacerbations of COPD experienced by patients in the&#xD;
      health coached arm to those in the usual care arm during the 9 month period starting at&#xD;
      enrollment. COPD exacerbation was defined as an emergency department visit or hospitalization&#xD;
      for COPD-related diagnosis or the outpatient prescription of oral steroids for COPD-related&#xD;
      diagnosis. Our hypothesis was patients in the health-coached arm would experience fewer&#xD;
      exacerbations when tested against the null hypothesis of no difference between health-coached&#xD;
      and usual care patients.&#xD;
&#xD;
      Specific Aim 3. To compare exercise capacity at 9 months for patients in the health-coached&#xD;
      arm to those in the usual care arm. Our hypothesis was that patients in the health-coached&#xD;
      arm would have greater exercises capacity as measured by the 6-minute Walk Test when tested&#xD;
      against the null hypothesis of no difference between health-coached and usual care patients.&#xD;
&#xD;
      Specific Aim 4. To compare self-efficacy for management of their COPD for health-coached&#xD;
      versus usual care patients at 9 months. Our hypothesis was that mean self-efficacy, as&#xD;
      measured by Stanford Chronic Disease Self-Efficacy Scale would be greater in patients in the&#xD;
      health coached arm when tested against the null hypothesis of no difference in self-efficacy&#xD;
      between health-coached and usual care patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 12, 2014</start_date>
  <completion_date type="Actual">May 4, 2017</completion_date>
  <primary_completion_date type="Actual">May 4, 2017</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>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score</measure>
    <time_frame>9 months</time_frame>
    <description>The Chronic Respiratory Disease Questionnaire assesses disease-related quality of in 4 domains (dyspnea, fatigue, physical function and mastery). The 8-item Short Form version has been validated against the original full version. Each item is answered on a 7-point response scale where a higher score indicates a higher quality of life. The measure is scored as the mean response score (range 1 to 7) for each domain and for the total score, with the higher score indicating higher quality of life.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF)</measure>
    <time_frame>9 months</time_frame>
    <description>The CRQ-SF is the short-form version of the original Chronic Respiratory Disease Questionnaire. The CRQ-SF has a total of 8 items asking about the frequency of COPD-related symptoms in 4 domains (2 questions per domain): Dyspnea, Fatigue, Emotional Function and Mastery. Each item is answered on a 7-point Likert-type scale with 1=none of the time and 7=all of the time. The dyspnea score is reported as the mean of the two items asking about shortness of breath. Mean scores range for 1 to 7, with a higher score indicating a worse quality of life related to dyspnea.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of COPD Exacerbations Per Year</measure>
    <time_frame>Over 9 month study period</time_frame>
    <description>A COPD exacerbation was defined as a COPD-related emergency department visit or hospitalization, or the outpatient prescription of oral steroids and/or antibiotic for COPD-related diagnosis, as documented in the medical record over the 9 month trial period. The rate of COPD exacerbation was calculated as the mean number of exacerbations per participant per year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise Capacity (6-minute Walk Test)</measure>
    <time_frame>9 months</time_frame>
    <description>Distance walked, in meters, over 6 minutes. Higher number indicates greater exercise capacity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy to Manage Chronic Disease Scale</measure>
    <time_frame>9 months</time_frame>
    <description>The Self-efficacy to Manage Chronic Disease Scale is a validated measure of of patient self-efficacy for managing a specific chronic disease (in this case, COPD). The Self-efficacy to Manage Chronic Disease Scale has 6 items asking about patients' self-confidence dealing with 6 aspects off self-management. Each item is answered on a scale of 1 to 10 with 1=&quot;not at all confident&quot; and 10='totally confident&quot;. The score is the mean of all 10-items. Mean scores range for 1 to 10, with a higher score indicating greater self-efficacy for managing COPD.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Short Version of the Patient Assessment of Quality of Care (PACIC)</measure>
    <time_frame>9 months</time_frame>
    <description>Patient Assessment of Chronic Illness Care (PACIC) is a patient reported measure of having received services recommended by Chronic Care Model. The short version of the PACIC has 11 items asking the patient the proportion of time he or she received a specific service. Each item is answered on a 5-point Likert-type scale with 1=None of the time and 5=Always. The total score is the mean of all 11-items. Mean scores range for 1 to 5, with a higher score indicating higher quality of care.</description>
  </other_outcome>
  <other_outcome>
    <measure>COPD Assessment Test</measure>
    <time_frame>9 months</time_frame>
    <description>The COPD Assessment Test (CAT) is an 8-item measure of severity of COPD symptoms, with responses from 1 to 5 . It is scored as the sum of item scores, with a range from 8 to 40, with a higher score indicating greater level of symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Percent of Predicted Force Expiratory Volume at 1 Second (FEV1)</measure>
    <time_frame>9 months</time_frame>
    <description>Volume of air exhaled, using maximal force, over 1 second, divided by the volume expected for health person of same age and gender. Larger volume indicates better lung function.</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion (%) of Participants Reporting Current Cigarette Use</measure>
    <time_frame>9 months</time_frame>
    <description>Current cigarette use is defined as any use in the past 30 days.</description>
  </other_outcome>
  <other_outcome>
    <measure>COPD-related Function (Bed Days Due to Respiratory Problems)</measure>
    <time_frame>9 months</time_frame>
    <description>Number of days in past 4 weeks where COPD keep participant in bed all or most of the day.</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion (%) of Participants Demonstrating Adequate Inhaler Use</measure>
    <time_frame>9 months</time_frame>
    <description>Observational measure using a check list to document mistakes in using inhalers. Adequate use defined as correctly performing all necessary steps for every inhaler used. Definition of necessary steps varies by type of inhaler.</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion (%) of Participants With Correct Answer to Knowledge Question 1</measure>
    <time_frame>9 months</time_frame>
    <description>Okay to get short of breath while exercising</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion (%) of Participants With Correct Answer to Knowledge Question 2</measure>
    <time_frame>9 months</time_frame>
    <description>beneficial to stop smoking</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion (%) of Participants With Correct Answer to Knowledge Question 3</measure>
    <time_frame>9 months</time_frame>
    <description>Okay to be on oxygen for long period</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion (%) of Participants With Correct Answer to Knowledge Question 4</measure>
    <time_frame>9 months</time_frame>
    <description>Smoking does not help breathing</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of Outpatient Visits</measure>
    <time_frame>Over 9 month study period</time_frame>
    <description>Number of outpatient visits per patient per year</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of ED Visits for COPD</measure>
    <time_frame>Over 9 month study period</time_frame>
    <description>Number of ED visits for COPD per patient per year over 9 month study period</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of ED Visits Not for COPD</measure>
    <time_frame>Over 9 month study period</time_frame>
    <description>Number of visits to emergency department other than for COPD related reason per patient per year during 9 month study period</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of Hospitalization for COPD</measure>
    <time_frame>Over 9 month study period</time_frame>
    <description>Number of hospitalizations for COPD per patient per year over 9 month study period</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of Hospitalizations Not for COPD</measure>
    <time_frame>Over 9 month study period</time_frame>
    <description>Number of hospitalizations other than for COPD per patient per year during 9 month study period</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">192</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease (COPD)</condition>
  <arm_group>
    <arm_group_label>Health Coaching</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to the health coaching intervention would work with a trained health coach who would provide patient education self-management support, use action planning to help patient make changes to reach goals, as well as help coordinate patient care between the primary care provider and pulmonary specialist, identify gaps in care, and help patient access needed services</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care was chosen as the comparison group to provide maximum generalizability of the study, as usual care is the practical alternative for the target population. Usual care includes patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health Coaching</intervention_name>
    <description>Patient COPD education; Correct use of inhalers and nebulizers; Red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation; nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Identifying gaps in care, areas where care not in line with care plan; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Access to psychosocial services; Working with pulmonary specialist to provide recommended exercise program; Working with patient family members and caregivers.</description>
    <arm_group_label>Health Coaching</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient at one of the participating primary care clinics (at least 1 visit in past 12&#xD;
             months)&#xD;
&#xD;
          -  Age 40 and older&#xD;
&#xD;
          -  Speaking English or Spanish&#xD;
&#xD;
          -  Plan to continue to be seen at current clinic and to not leave the area for &gt;2 months&#xD;
             anytime in the next 9 months or to be absent at 9 or 15 months&#xD;
&#xD;
          -  COPD defined as ever having had a post-bronchodilator Forced Expiratory Volume in 1&#xD;
             second/Forced Vital Capacity (FEV1/FVC) &lt;.70 of FEV1/FVC of .70 to .74 and diagnosis&#xD;
             of COPD by the study pulmonologist&#xD;
&#xD;
          -  Willingness to attempt spirometry&#xD;
&#xD;
          -  At least moderate COPD, defined as at least one of the following:&#xD;
&#xD;
               -  Ever Forced Expiratory Volume in 1 second (FEV1) &lt; 80% predicted&#xD;
&#xD;
               -  1 or more emergency department (ED) visit for COPD exacerbation in past 12 months&#xD;
&#xD;
               -  1 or more hospital stays for COPD exacerbation in past 12 months&#xD;
&#xD;
               -  1 or more prescriptions for oral prednisone for a COPD exacerbation in past 12&#xD;
                  months&#xD;
&#xD;
               -  Ever on home oxygen therapy&#xD;
&#xD;
               -  Ever outpatient percutaneous oxygen saturation of &lt;/=88%&#xD;
&#xD;
               -  Ever outpatient partial pressure of oxygen (ppO2) by arterial blood gas (ABG) of&#xD;
                  &lt;/=55mm Hg&#xD;
&#xD;
               -  At least 3 outpatient visits for COPD in past 12 months AND (a current COPD&#xD;
                  Assessment Test (CAT) score of &gt;/=10 OR an modified Medical Research Council&#xD;
                  (mMRC) score of &gt;/=2).&#xD;
&#xD;
               -  Currently using tiotropium inhaler or combination inhaled corticosteroid and&#xD;
                  long-acting beta agonist&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to participate in the study due to mental or physical impairment&#xD;
&#xD;
          -  Severe or terminal illness that precludes focus on COPD&#xD;
&#xD;
          -  No phone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David H Thom, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Francisco Departmen of Public Health Community Clinics</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Huang B, Willard-Grace R, De Vore D, Wolf J, Chirinos C, Tsao S, Hessler D, Su G, Thom DH. Health coaching to improve self-management and quality of life for low income patients with chronic obstructive pulmonary disease (COPD): protocol for a randomized controlled trial. BMC Pulm Med. 2017 Jun 9;17(1):90. doi: 10.1186/s12890-017-0433-3. Erratum In: BMC Pulm Med. 2019 May 21;19(1):96.</citation>
    <PMID>28599636</PMID>
  </reference>
  <reference>
    <citation>Huang B, De Vore D, Chirinos C, Wolf J, Low D, Willard-Grace R, Tsao S, Garvey C, Donesky D, Su G, Thom DH. Strategies for recruitment and retention of underrepresented populations with chronic obstructive pulmonary disease for a clinical trial. BMC Med Res Methodol. 2019 Feb 21;19(1):39. doi: 10.1186/s12874-019-0679-y.</citation>
    <PMID>30791871</PMID>
  </reference>
  <results_reference>
    <citation>Thom DH, Willard-Grace R, Tsao S, Hessler D, Huang B, DeVore D, Chirinos C, Wolf J, Donesky D, Garvey C, Su G. Randomized Controlled Trial of Health Coaching for Vulnerable Patients with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2018 Oct;15(10):1159-1168. doi: 10.1513/AnnalsATS.201806-365OC.</citation>
    <PMID>30130430</PMID>
  </results_reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <results_first_submitted>February 20, 2018</results_first_submitted>
  <results_first_submitted_qc>March 8, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 10, 2019</results_first_posted>
  <last_update_submitted>March 8, 2019</last_update_submitted>
  <last_update_submitted_qc>March 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Obstructive Pulmonary Disease</keyword>
  <keyword>Health Coaching</keyword>
  <keyword>Health Disparities</keyword>
  <keyword>Self-management</keyword>
  <keyword>Chronic Disease Model</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 8, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT02234284/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 8, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT02234284/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Health Coaching</title>
          <description>Major health coach activities:&#xD;
Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="92"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="83"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Health Coaching</title>
          <description>Coaching activities: Patient COPD education Correct use of inhalers and nebulizers Red flags and when to seek medical care Dyspnea management Use of oxygen Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations Ensuring appropriate preventive services (pneumovax, flu) Depression screening Reinforcing clinician education and use of treatment guidelines by primary care providers Helping patient obtain prescriptions Identifying gaps in care, areas where care not in line with care plan Helping patients to make and keep appointments and obtain needed testing Facilitating communication between patients, pulmonary specialists and primary care providers Connecting with community resources Access to psychosocial services Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program Working with patient family members and caregivers</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Usual care was chosen as the comparison group to provide maximum generalizability of the study, as usual care is the practical alternative for the target population. Usual care includes patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</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="100"/>
            <count group_id="B2" value="92"/>
            <count group_id="B3" value="192"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="67"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="121"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="71"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.7" spread="8.0"/>
                    <measurement group_id="B2" value="61.9" spread="7.1"/>
                    <measurement group_id="B3" value="61.3" spread="7.6"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="73"/>
                    <measurement group_id="B3" value="160"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="109"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score</title>
          <description>The Chronic Respiratory Disease Questionnaire assesses disease-related quality of in 4 domains (dyspnea, fatigue, physical function and mastery). The 8-item Short Form version has been validated against the original full version. Each item is answered on a 7-point response scale where a higher score indicates a higher quality of life. The measure is scored as the mean response score (range 1 to 7) for each domain and for the total score, with the higher score indicating higher quality of life.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.24" spread="1.22"/>
                    <measurement group_id="B2" value="4.28" spread="1.23"/>
                    <measurement group_id="B3" value="4.26" spread="1.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF)</title>
          <description>The CRQ-SF is the short-form version of the original Chronic Respiratory Disease Questionnaire. The CRQ-SF has a total of 8 items asking about the frequency of COPD-related symptoms in 4 domains (2 questions per domain): Dyspnea, Fatigue, Emotional Function and Mastery. Each item is answered on a 7-point Likert-type scale with 1=none of the time and 7=all of the time. The dyspnea score is reported as the mean of the two items asking about shortness of breath. Mean scores range for 1 to 7, with a higher score indicating a worse quality of life related to dyspnea.</description>
          <population>missing data</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="99"/>
                    <count group_id="B2" value="91"/>
                    <count group_id="B3" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.39" spread="1.46"/>
                    <measurement group_id="B2" value="4.63" spread="1.45"/>
                    <measurement group_id="B3" value="4.51" spread="1.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Rate of COPD exacerbations</title>
          <description>A COPD exacerbation was defined as a COPD-related emergency department visit or hospitalization, or the outpatient prescription of oral steroids and/or antibiotic for COPD-related diagnosis, as documented in the medical record. The rate of COPD exacerbation was calculated as the mean number of exacerbations per participant per year.</description>
          <units>events per person year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.95" spread="1.57"/>
                    <measurement group_id="B2" value="0.92" spread="1.34"/>
                    <measurement group_id="B3" value="0.94" spread="1.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Exercise capacity (6-Minute Walk Test)</title>
          <description>Distance walked, in meters, over 6 minutes. Higher number indicates greater exercise capacity.</description>
          <population>Some participants were unable to do this test</population>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="65"/>
                    <count group_id="B3" value="136"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="305" spread="83.1"/>
                    <measurement group_id="B2" value="292" spread="77.5"/>
                    <measurement group_id="B3" value="299" spread="80.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self-efficacy to Manage Chronic Disease Scale</title>
          <description>The Self-efficacy to Manage Chronic Disease Scale is a validated measure of of patient self-efficacy for managing a specific chronic disease (in this case, COPD). The Self-efficacy to Manage Chronic Disease Scale has 6 items asking about patients' self-confidence dealing with 6 aspects off self-management. Each item is answered on a scale of 1 to 10 with 1=&quot;not at all confident&quot; and 10='totally confident&quot;. The score is the mean of all 10-items. Mean scores range for 1 to 10, with a higher score indicating greater self-efficacy for managing COPD.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.36" spread="2.23"/>
                    <measurement group_id="B2" value="6.45" spread="2.11"/>
                    <measurement group_id="B3" value="6.40" spread="2.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Short version of the Patient Assessment of Quality of Care (PACIC)</title>
          <description>Patient Assessment of Chronic Illness Care (PACIC) is a patient reported measure of having received services recommended by Chronic Care Model. The short version of the PACIC has 11 items asking the patient the proportion of time he or she received a specific service. Each item is answered on a 5-point Likert-type scale with 1=None of the time and 5=Always. The total score is the mean of all 11-items. Mean scores range for 1 to 5, with a higher score indicating higher quality of care.</description>
          <population>missing data</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="93"/>
                    <count group_id="B2" value="85"/>
                    <count group_id="B3" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.58" spread=".98"/>
                    <measurement group_id="B2" value="3.29" spread="1.20"/>
                    <measurement group_id="B3" value="3.45" spread="1.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>COPD Symptoms (COPD Assessment Test)</title>
          <description>The COPD Assessment Test (CAT) is an 8-item measure of severity of COPD symptoms, with responses from 1 to 5 . It is scored as the sum of item scores, with a range from 8 to 40, with a higher score indicating greater level of symptoms.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.6" spread="8.34"/>
                    <measurement group_id="B2" value="20.9" spread="7.41"/>
                    <measurement group_id="B3" value="20.7" spread="7.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lung Function (FEV1 % predicted)</title>
          <description>Volume of air exhaled, using maximal force, over 1 second, divided by the volume expected for health person of same age and gender. Larger volume indicates better lung function.</description>
          <population>We were not able to obtain spirometry on all patients due to contraindications or technical limitations</population>
          <units>percent of predicted</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="79"/>
                    <count group_id="B2" value="73"/>
                    <count group_id="B3" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.55" spread="0.19"/>
                    <measurement group_id="B2" value="0.60" spread="0.20"/>
                    <measurement group_id="B3" value="0.58" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Proportion (%) of Participants reporting Current Cigarette Use</title>
          <description>Current cigarette use is defined as any use in the past 30 days.</description>
          <population>missing data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="99"/>
                    <count group_id="B2" value="85"/>
                    <count group_id="B3" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Proportion (%) of Participants Demonstrating Adequate Inhaler Use</title>
          <description>Observational measure using a check list to document mistakes in using inhalers. Adequate use defined as correctly performing all necessary steps for every inhaler used. Definition of necessary steps varies by type of inhaler.</description>
          <population>Some participants did not have inhalers prescribed at baseline</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="95"/>
                    <count group_id="B2" value="83"/>
                    <count group_id="B3" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>COPD-related function (Bed days in past 4 weeks due to respiratory problems)</title>
          <description>Number of days in past 4 weeks where COPD keep participant in bed all or most of the day.</description>
          <population>missing data</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="99"/>
                    <count group_id="B2" value="90"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.75" spread="6.44"/>
                    <measurement group_id="B2" value="3.86" spread="6.86"/>
                    <measurement group_id="B3" value="3.28" spread="6.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Proportion (%) of Participants With Correct Answer to Knowledge Question 1</title>
          <description>Okay to get short of breath while exercising (correct answer is yes)</description>
          <population>question not answered by 2 participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="90"/>
                    <count group_id="B3" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Proportion (%) of Participants With Correct Answer to Knowledge Question 2</title>
          <description>Beneficial to stop smoking (correct answer is yes)</description>
          <population>question not answered by 2 participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="90"/>
                    <count group_id="B3" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Proportion (%) of Participants With Correct Answer to Knowledge Question 3</title>
          <description>Okay to be on oxygen long term (correct answer)</description>
          <population>not answered by 3 participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="99"/>
                    <count group_id="B2" value="89"/>
                    <count group_id="B3" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Proportion (%) of Participants With Correct Answer to Knowledge Question 4</title>
          <description>Smoking does not help breathing (correct answer)</description>
          <population>Question not answered by 3 participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="99"/>
                    <count group_id="B2" value="90"/>
                    <count group_id="B3" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="96"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="181"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Rate of all outpatient visits</title>
          <description>Number of visits to primary care provider, pulmonary specialist or urgent care, per patient per year, over 12 months prior to enrollment</description>
          <units>visits per patient per year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.62" spread="5.43"/>
                    <measurement group_id="B2" value="6.53" spread="4.08"/>
                    <measurement group_id="B3" value="6.58" spread="4.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Rate of emergency department (ED) visits for COPD</title>
          <description>Number of visits to emergency department for COPD exacerbation, per patient per year, over 12 months prior to enrollment</description>
          <units>visits per patient per year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.54" spread="1.26"/>
                    <measurement group_id="B2" value="0.62" spread="1.19"/>
                    <measurement group_id="B3" value="0.58" spread="1.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Rate of all ED visits not for COPD</title>
          <description>Number of visits to emergency department not for a COPD exacerbation, per patient per year, over 12 months prior to enrollment</description>
          <units>visits per patient per year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.12" spread="2.52"/>
                    <measurement group_id="B2" value="0.62" spread="1.29"/>
                    <measurement group_id="B3" value="0.88" spread="2.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Rate of hospitalizations for COPD</title>
          <description>Number of hospital admissions for COPD exacerbation, per patient per year, over 12 months prior to enrollment</description>
          <units>hospitalizations per patient per year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.13" spread="0.39"/>
                    <measurement group_id="B2" value="0.34" spread="0.77"/>
                    <measurement group_id="B3" value="0.23" spread="0.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Rate of hospitalizations not for COPD</title>
          <description>Number of hospital admissions not for a COPD exacerbation, per patient per year, over 12 months prior to enrollment</description>
          <units>hospitalizations per patient per year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="92"/>
                    <count group_id="B3" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.21" spread="0.57"/>
                    <measurement group_id="B2" value="0.18" spread="0.44"/>
                    <measurement group_id="B3" value="0.20" spread="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Proportion (%) of participants receiving guideline-concordant medications for COPD</title>
          <description>Prescription of medications for COPD in concordance with the recommendations from the Global Initiative for Obstructive Lung Disease (GOLD) Guideline, based on classification categories of A, B C or D.</description>
          <population>unable to determine GOLD classification for 2 patients (1 in each study arm)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="99"/>
                    <count group_id="B2" value="91"/>
                    <count group_id="B3" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Proportion (%) of Patients with a score of &gt;/= 15 on the Patient Health Questionnaire 8 item version</title>
          <description>Patient Health Questionnaire (PHQ) 8 item version (without suicidality item) of the PHQ-9. The 8 items, which ask about the frequency of symptoms of depression, are answered on a likert-type scale from 0 to 3, with 0= 'not at all' and 3='nearly every day'. The total score ranges from 0 to 24, with a higher score indication more more severe depression symptoms. A score of &gt;/= 15 indicates symptoms of at least moderate depression.</description>
          <population>missing data on 1 participant</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="91"/>
                    <count group_id="B3" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score</title>
        <description>The Chronic Respiratory Disease Questionnaire assesses disease-related quality of in 4 domains (dyspnea, fatigue, physical function and mastery). The 8-item Short Form version has been validated against the original full version. Each item is answered on a 7-point response scale where a higher score indicates a higher quality of life. The measure is scored as the mean response score (range 1 to 7) for each domain and for the total score, with the higher score indicating higher quality of life.</description>
        <time_frame>9 months</time_frame>
        <population>All participants who completed the CRQ-SF at 9 months</population>
        <group_list>
          <group group_id="O1">
            <title>Health Coaching</title>
            <description>Health coaching included the following activities Patient COPD education; Correct use of inhalers and nebulizers; Red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions Identifying gaps in care, areas where care not in line with care plan;Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services ; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program ; Working with patient family members and caregivers</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Patients the usual care arm could be referred to a specialist by their primary care clinician and had access to education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score</title>
          <description>The Chronic Respiratory Disease Questionnaire assesses disease-related quality of in 4 domains (dyspnea, fatigue, physical function and mastery). The 8-item Short Form version has been validated against the original full version. Each item is answered on a 7-point response scale where a higher score indicates a higher quality of life. The measure is scored as the mean response score (range 1 to 7) for each domain and for the total score, with the higher score indicating higher quality of life.</description>
          <population>All participants who completed the CRQ-SF at 9 months</population>
          <units>units 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="75"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.58" spread="1.25"/>
                    <measurement group_id="O2" value="4.43" spread="1.28"/>
                  </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_list>
            <groups_desc>Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.35</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-.15</ci_lower_limit>
            <ci_upper_limit>.43</ci_upper_limit>
            <estimate_desc>Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF)</title>
        <description>The CRQ-SF is the short-form version of the original Chronic Respiratory Disease Questionnaire. The CRQ-SF has a total of 8 items asking about the frequency of COPD-related symptoms in 4 domains (2 questions per domain): Dyspnea, Fatigue, Emotional Function and Mastery. Each item is answered on a 7-point Likert-type scale with 1=none of the time and 7=all of the time. The dyspnea score is reported as the mean of the two items asking about shortness of breath. Mean scores range for 1 to 7, with a higher score indicating a worse quality of life related to dyspnea.</description>
        <time_frame>9 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Health Coaching</title>
            <description>Major health coach activities:&#xD;
Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF)</title>
          <description>The CRQ-SF is the short-form version of the original Chronic Respiratory Disease Questionnaire. The CRQ-SF has a total of 8 items asking about the frequency of COPD-related symptoms in 4 domains (2 questions per domain): Dyspnea, Fatigue, Emotional Function and Mastery. Each item is answered on a 7-point Likert-type scale with 1=none of the time and 7=all of the time. The dyspnea score is reported as the mean of the two items asking about shortness of breath. Mean scores range for 1 to 7, with a higher score indicating a worse quality of life related to dyspnea.</description>
          <units>units 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="75"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.98" spread="1.39"/>
                    <measurement group_id="O2" value="4.78" spread="1.49"/>
                  </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_list>
            <groups_desc>Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.20</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-.13</ci_lower_limit>
            <ci_upper_limit>.65</ci_upper_limit>
            <estimate_desc>Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of COPD Exacerbations Per Year</title>
        <description>A COPD exacerbation was defined as a COPD-related emergency department visit or hospitalization, or the outpatient prescription of oral steroids and/or antibiotic for COPD-related diagnosis, as documented in the medical record over the 9 month trial period. The rate of COPD exacerbation was calculated as the mean number of exacerbations per participant per year.</description>
        <time_frame>Over 9 month study period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Health Coaching</title>
            <description>Major health coach activities:&#xD;
Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of COPD Exacerbations Per Year</title>
          <description>A COPD exacerbation was defined as a COPD-related emergency department visit or hospitalization, or the outpatient prescription of oral steroids and/or antibiotic for COPD-related diagnosis, as documented in the medical record over the 9 month trial period. The rate of COPD exacerbation was calculated as the mean number of exacerbations per participant per year.</description>
          <units>events</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.17" spread="1.87"/>
                    <measurement group_id="O2" value="1.44" spread="2.16"/>
                  </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_list>
            <groups_desc>Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.13</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.49</ci_lower_limit>
            <ci_upper_limit>0.07</ci_upper_limit>
            <estimate_desc>Value is for rate of exacerbations for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Exercise Capacity (6-minute Walk Test)</title>
        <description>Distance walked, in meters, over 6 minutes. Higher number indicates greater exercise capacity.</description>
        <time_frame>9 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Health Coaching</title>
            <description>Major health coach activities:&#xD;
Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Exercise Capacity (6-minute Walk Test)</title>
          <description>Distance walked, in meters, over 6 minutes. Higher number indicates greater exercise capacity.</description>
          <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 group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="326" spread="68.3"/>
                    <measurement group_id="O2" value="311" spread="73.8"/>
                  </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_list>
            <groups_desc>Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.32</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>8.53</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.18</ci_lower_limit>
            <ci_upper_limit>25.26</ci_upper_limit>
            <other_analysis_desc>Value is for mean distance (in meters) of participants in Health Coached arm minus mean distance in Usual Care, adjusted for baseline values and for clustering.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-efficacy to Manage Chronic Disease Scale</title>
        <description>The Self-efficacy to Manage Chronic Disease Scale is a validated measure of of patient self-efficacy for managing a specific chronic disease (in this case, COPD). The Self-efficacy to Manage Chronic Disease Scale has 6 items asking about patients' self-confidence dealing with 6 aspects off self-management. Each item is answered on a scale of 1 to 10 with 1=&quot;not at all confident&quot; and 10='totally confident&quot;. The score is the mean of all 10-items. Mean scores range for 1 to 10, with a higher score indicating greater self-efficacy for managing COPD.</description>
        <time_frame>9 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Health Coaching</title>
            <description>Major health coach activities:&#xD;
Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-efficacy to Manage Chronic Disease Scale</title>
          <description>The Self-efficacy to Manage Chronic Disease Scale is a validated measure of of patient self-efficacy for managing a specific chronic disease (in this case, COPD). The Self-efficacy to Manage Chronic Disease Scale has 6 items asking about patients' self-confidence dealing with 6 aspects off self-management. Each item is answered on a scale of 1 to 10 with 1=&quot;not at all confident&quot; and 10='totally confident&quot;. The score is the mean of all 10-items. Mean scores range for 1 to 10, with a higher score indicating greater self-efficacy for managing COPD.</description>
          <units>units 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="73"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.84" spread="2.01"/>
                    <measurement group_id="O2" value="6.50" spread="2.00"/>
                  </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_list>
            <groups_desc>Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.27</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-.23</ci_lower_limit>
            <ci_upper_limit>.83</ci_upper_limit>
            <estimate_desc>Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Short Version of the Patient Assessment of Quality of Care (PACIC)</title>
        <description>Patient Assessment of Chronic Illness Care (PACIC) is a patient reported measure of having received services recommended by Chronic Care Model. The short version of the PACIC has 11 items asking the patient the proportion of time he or she received a specific service. Each item is answered on a 5-point Likert-type scale with 1=None of the time and 5=Always. The total score is the mean of all 11-items. Mean scores range for 1 to 5, with a higher score indicating higher quality of care.</description>
        <time_frame>9 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Health Coaching</title>
            <description>Major health coach activities:&#xD;
Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Short Version of the Patient Assessment of Quality of Care (PACIC)</title>
          <description>Patient Assessment of Chronic Illness Care (PACIC) is a patient reported measure of having received services recommended by Chronic Care Model. The short version of the PACIC has 11 items asking the patient the proportion of time he or she received a specific service. Each item is answered on a 5-point Likert-type scale with 1=None of the time and 5=Always. The total score is the mean of all 11-items. Mean scores range for 1 to 5, with a higher score indicating higher quality of care.</description>
          <units>units 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="72"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.91" spread="0.95"/>
                    <measurement group_id="O2" value="3.44" spread="1.17"/>
                  </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_list>
            <groups_desc>Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.02</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>.07</ci_lower_limit>
            <ci_upper_limit>.68</ci_upper_limit>
            <estimate_desc>Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>COPD Assessment Test</title>
        <description>The COPD Assessment Test (CAT) is an 8-item measure of severity of COPD symptoms, with responses from 1 to 5 . It is scored as the sum of item scores, with a range from 8 to 40, with a higher score indicating greater level of symptoms.</description>
        <time_frame>9 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Health Coaching</title>
            <description>Health coaching included the following activities Patient COPD education; Correct use of inhalers and nebulizers; Red flags and when to seek medic al care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions Identifying gaps in care, areas where care not in line with care plan;Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services ; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program ; Working with patient family members and caregivers</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care was chosen as the comparison group to provide maximum generalizability of the study, as usual care is the practical alternative for the target population. Usual care includes patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>COPD Assessment Test</title>
          <description>The COPD Assessment Test (CAT) is an 8-item measure of severity of COPD symptoms, with responses from 1 to 5 . It is scored as the sum of item scores, with a range from 8 to 40, with a higher score indicating greater level of symptoms.</description>
          <units>units 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="74"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.1" spread="8.80"/>
                    <measurement group_id="O2" value="20.2" spread="9.25"/>
                  </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_list>
            <groups_desc>Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.40</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.78</ci_lower_limit>
            <ci_upper_limit>1.12</ci_upper_limit>
            <estimate_desc>Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percent of Predicted Force Expiratory Volume at 1 Second (FEV1)</title>
        <description>Volume of air exhaled, using maximal force, over 1 second, divided by the volume expected for health person of same age and gender. Larger volume indicates better lung function.</description>
        <time_frame>9 months</time_frame>
        <population>Participants completing measurement of FEV1 % Predicted at 9 months</population>
        <group_list>
          <group group_id="O1">
            <title>Health Coaching</title>
            <description>Major health coach activities:&#xD;
Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Predicted Force Expiratory Volume at 1 Second (FEV1)</title>
          <description>Volume of air exhaled, using maximal force, over 1 second, divided by the volume expected for health person of same age and gender. Larger volume indicates better lung function.</description>
          <population>Participants completing measurement of FEV1 % Predicted at 9 months</population>
          <units>Percent of predicted value</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.55" spread="0.20"/>
                    <measurement group_id="O2" value=".59" spread=".21"/>
                  </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_list>
            <groups_desc>Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.98</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3</ci_lower_limit>
            <ci_upper_limit>3</ci_upper_limit>
            <estimate_desc>Value is for mean percent predicted of participants in Health Coached arm minus mean percent predicted in Usual Care, adjusted for baseline values and for clustering.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Proportion (%) of Participants Reporting Current Cigarette Use</title>
        <description>Current cigarette use is defined as any use in the past 30 days.</description>
        <time_frame>9 months</time_frame>
        <population>Participants reporting smoking status at 9 months</population>
        <group_list>
          <group group_id="O1">
            <title>Health Coaching</title>
            <description>Major health coach activities:&#xD;
Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion (%) of Participants Reporting Current Cigarette Use</title>
          <description>Current cigarette use is defined as any use in the past 30 days.</description>
          <population>Participants reporting smoking status at 9 months</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="77"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="34"/>
                  </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_list>
            <groups_desc>Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.30</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-11.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.3</ci_lower_limit>
            <ci_upper_limit>10.2</ci_upper_limit>
            <estimate_desc>Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>COPD-related Function (Bed Days Due to Respiratory Problems)</title>
        <description>Number of days in past 4 weeks where COPD keep participant in bed all or most of the day.</description>
        <time_frame>9 months</time_frame>
        <population>Participants reporting bed days at 9 monhts</population>
        <group_list>
          <group group_id="O1">
            <title>Health Coaching</title>
            <description>Major health coach activities:&#xD;
Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>COPD-related Function (Bed Days Due to Respiratory Problems)</title>
          <description>Number of days in past 4 weeks where COPD keep participant in bed all or most of the day.</description>
          <population>Participants reporting bed days at 9 monhts</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.15" spread="5.76"/>
                    <measurement group_id="O2" value="3.64" spread="6.81"/>
                  </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_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.29</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.07</ci_lower_limit>
            <ci_upper_limit>0.62</ci_upper_limit>
            <estimate_desc>Value is for mean number of days for participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Proportion (%) of Participants Demonstrating Adequate Inhaler Use</title>
        <description>Observational measure using a check list to document mistakes in using inhalers. Adequate use defined as correctly performing all necessary steps for every inhaler used. Definition of necessary steps varies by type of inhaler.</description>
        <time_frame>9 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Health Coaching</title>
            <description>Major health coach activities:&#xD;
Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion (%) of Participants Demonstrating Adequate Inhaler Use</title>
          <description>Observational measure using a check list to document mistakes in using inhalers. Adequate use defined as correctly performing all necessary steps for every inhaler used. Definition of necessary steps varies by type of inhaler.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="9"/>
                  </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_list>
            <groups_desc>Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>39.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>19.6</ci_lower_limit>
            <ci_upper_limit>59.8</ci_upper_limit>
            <estimate_desc>Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Proportion (%) of Participants With Correct Answer to Knowledge Question 1</title>
        <description>Okay to get short of breath while exercising</description>
        <time_frame>9 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Health Coaching</title>
            <description>Major health coach activities:&#xD;
Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion (%) of Participants With Correct Answer to Knowledge Question 1</title>
          <description>Okay to get short of breath while exercising</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="56"/>
                  </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_list>
            <groups_desc>Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.38</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.5</ci_lower_limit>
            <ci_upper_limit>25.2</ci_upper_limit>
            <estimate_desc>Value is for proportion of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Proportion (%) of Participants With Correct Answer to Knowledge Question 2</title>
        <description>beneficial to stop smoking</description>
        <time_frame>9 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Health Coaching</title>
            <description>Major health coach activities:&#xD;
Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion (%) of Participants With Correct Answer to Knowledge Question 2</title>
          <description>beneficial to stop smoking</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                    <measurement group_id="O2" value="73"/>
                  </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_list>
            <groups_desc>Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.73</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.</method_desc>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>2.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.4</ci_lower_limit>
            <ci_upper_limit>13.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Proportion (%) of Participants With Correct Answer to Knowledge Question 3</title>
        <description>Okay to be on oxygen for long period</description>
        <time_frame>9 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Health Coaching</title>
            <description>Major health coach activities:&#xD;
Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion (%) of Participants With Correct Answer to Knowledge Question 3</title>
          <description>Okay to be on oxygen for long period</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="52"/>
                  </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_list>
            <groups_desc>Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.70</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.0</ci_lower_limit>
            <ci_upper_limit>20.8</ci_upper_limit>
            <estimate_desc>Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Proportion (%) of Participants With Correct Answer to Knowledge Question 4</title>
        <description>Smoking does not help breathing</description>
        <time_frame>9 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Health Coaching</title>
            <description>Major health coach activities:&#xD;
Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion (%) of Participants With Correct Answer to Knowledge Question 4</title>
          <description>Smoking does not help breathing</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="80"/>
                  </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_list>
            <groups_desc>Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.97</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.5</ci_lower_limit>
            <ci_upper_limit>5.3</ci_upper_limit>
            <estimate_desc>Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Rate of Outpatient Visits</title>
        <description>Number of outpatient visits per patient per year</description>
        <time_frame>Over 9 month study period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Health Coaching</title>
            <description>Major health coach activities:&#xD;
Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Outpatient Visits</title>
          <description>Number of outpatient visits per patient per year</description>
          <units>visits per patient per year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.51" spread="5.64"/>
                    <measurement group_id="O2" value="6.83" spread="4.73"/>
                  </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_list>
            <groups_desc>Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.52</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.32</ci_lower_limit>
            <ci_upper_limit>1.28</ci_upper_limit>
            <estimate_desc>Value is for rate of outpatient visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Rate of ED Visits for COPD</title>
        <description>Number of ED visits for COPD per patient per year over 9 month study period</description>
        <time_frame>Over 9 month study period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Health Coaching</title>
            <description>Major health coach activities:&#xD;
Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of ED Visits for COPD</title>
          <description>Number of ED visits for COPD per patient per year over 9 month study period</description>
          <units>Visits per patient per year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.80" spread="1.63"/>
                    <measurement group_id="O2" value="0.89" spread="1.99"/>
                  </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_list>
            <groups_desc>Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.78</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.32</ci_lower_limit>
            <ci_upper_limit>0.22</ci_upper_limit>
            <estimate_desc>Value is for rate of COPD-related ED visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Rate of ED Visits Not for COPD</title>
        <description>Number of visits to emergency department other than for COPD related reason per patient per year during 9 month study period</description>
        <time_frame>Over 9 month study period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Health Coaching</title>
            <description>Major health coach activities:&#xD;
Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of ED Visits Not for COPD</title>
          <description>Number of visits to emergency department other than for COPD related reason per patient per year during 9 month study period</description>
          <units>Visits per patient per year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" spread="1.89"/>
                    <measurement group_id="O2" value="0.83" spread="2.33"/>
                  </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_list>
            <groups_desc>Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.80</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.56</ci_lower_limit>
            <ci_upper_limit>0.40</ci_upper_limit>
            <estimate_desc>Value is for rate of non-COPD-related ED visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Rate of Hospitalization for COPD</title>
        <description>Number of hospitalizations for COPD per patient per year over 9 month study period</description>
        <time_frame>Over 9 month study period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Health Coaching</title>
            <description>Major health coach activities:&#xD;
Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Hospitalization for COPD</title>
          <description>Number of hospitalizations for COPD per patient per year over 9 month study period</description>
          <units>Hospitalizations per patient per year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.27" spread="0.77"/>
                    <measurement group_id="O2" value="0.52" spread="1.25"/>
                  </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_list>
            <groups_desc>Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.35</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.32</ci_lower_limit>
            <ci_upper_limit>0.06</ci_upper_limit>
            <estimate_desc>Value is for rate of COPD-related hospital visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Rate of Hospitalizations Not for COPD</title>
        <description>Number of hospitalizations other than for COPD per patient per year during 9 month study period</description>
        <time_frame>Over 9 month study period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Health Coaching</title>
            <description>Major health coach activities:&#xD;
Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Hospitalizations Not for COPD</title>
          <description>Number of hospitalizations other than for COPD per patient per year during 9 month study period</description>
          <units>Hospitalizations per patient per year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.16" spread="0.58"/>
                    <measurement group_id="O2" value="0.21" spread="0.81"/>
                  </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_list>
            <groups_desc>Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.37</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.20</ci_lower_limit>
            <ci_upper_limit>0.04</ci_upper_limit>
            <estimate_desc>Value is for rate of non-COPD-related hospitalizations for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Proportion (%) of Patients With a Score of &gt;/= 15 on the Patient Health Questionnaire 8 Item Version</title>
        <description>Patient Health Questionnaire (PHQ) 8 item version (without suicidality item) of the PHQ-9. The 8 items, which ask about the frequency of symptoms of depression, are answered on a likert-type scale from 0 to 3, with 0= 'not at all' and 3='nearly every day'. The total score ranges from 0 to 24, with a higher score indication more more severe depression symptoms. A score of &gt;/= 15 indicates symptoms of at least moderate depression.</description>
        <time_frame>9 month study period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Health Coaching</title>
            <description>Major health coach activities:&#xD;
Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion (%) of Patients With a Score of &gt;/= 15 on the Patient Health Questionnaire 8 Item Version</title>
          <description>Patient Health Questionnaire (PHQ) 8 item version (without suicidality item) of the PHQ-9. The 8 items, which ask about the frequency of symptoms of depression, are answered on a likert-type scale from 0 to 3, with 0= 'not at all' and 3='nearly every day'. The total score ranges from 0 to 24, with a higher score indication more more severe depression symptoms. A score of &gt;/= 15 indicates symptoms of at least moderate depression.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="16"/>
                  </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_list>
            <groups_desc>Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.01</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.</method_desc>
            <param_type>difference in proportion</param_type>
            <param_value>-18.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.1</ci_lower_limit>
            <ci_upper_limit>-4.8</ci_upper_limit>
            <estimate_desc>Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Proportion (%) of Participants Receiving Guideline-concordant Medications for COPD.</title>
        <description>Prescription of medications for COPD in concordance with the recommendations from the Global Initiative for Obstructive Lung Disease (GOLD) Guideline, based on classification categories of A, B C or D.</description>
        <time_frame>9 month study period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Health Coaching</title>
            <description>Major health coach activities:&#xD;
Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion (%) of Participants Receiving Guideline-concordant Medications for COPD.</title>
          <description>Prescription of medications for COPD in concordance with the recommendations from the Global Initiative for Obstructive Lung Disease (GOLD) Guideline, based on classification categories of A, B C or D.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                    <measurement group_id="O2" value="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_list>
            <groups_desc>Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.01</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>14.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.3</ci_lower_limit>
            <ci_upper_limit>25.9</ci_upper_limit>
            <estimate_desc>Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>9 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Health Coaching</title>
          <description>Health coaching included the following activities Patient COPD education; Correct use of inhalers and nebulizers; Red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions Identifying gaps in care, areas where care not in line with care plan;Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members and caregivers</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Patients the usual care arm could be referred to a specialist by their primary care clinician and had access to education classes, smoking cessation classes, psychosocial medicine and nutritional counseling</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="4" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization for other than COPD related diagnosis</sub_title>
                <counts group_id="E1" events="12" subjects_affected="9" subjects_at_risk="100"/>
                <counts group_id="E2" events="14" subjects_affected="8" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization for COPD related diagnosis</sub_title>
                <counts group_id="E1" events="20" subjects_affected="14" subjects_at_risk="100"/>
                <counts group_id="E2" events="35" subjects_affected="20" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="48" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="43" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ED visit for non-COPD related diagnosis</sub_title>
                <counts group_id="E1" events="73" subjects_affected="33" subjects_at_risk="100"/>
                <counts group_id="E2" events="57" subjects_affected="25" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>ED visit for COPD related diagnosis</sub_title>
                <counts group_id="E1" events="59" subjects_affected="29" subjects_at_risk="100"/>
                <counts group_id="E2" events="57" subjects_affected="28" subjects_at_risk="92"/>
              </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>
    <limitations_and_caveats>Target sample size was reduced from 250 to 190 due difficulties with recruitment.&#xD;
The outcome of medication adherence, measured by the Morisky Medication Adherence Scale, was deleted because we did not realized it required a license.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. David Thom</name_or_title>
      <organization>University of California San Francisco</organization>
      <phone>415-206-2278</phone>
      <email>David.Thom@UCSF.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/NCT02234284
org study id: PCORI AD-1306-03900
nct id: NCT02234284
lead sponsor: 
collaborator: 
has dmc: Yes
This study examined whether health coaches can improve the management of chronic obstructive
      pulmonary disease (COPD) in a population of vulnerable patients cared for in 'safety-net'
      clinics. The study is designed as a randomized controlled trial for patients with moderate to
      severe COPD. Patients were randomized into a health coaching group and a usual care group.
      Those in the health coaching group received 9 months of active health coaching. Outcome
      variables were measured at baseline and after 9 months
Health coaching is a promising model for improving evidence-based care for patients with COPD
      which had not been evaluated at the time the current study began in 2014. Health coaching by
      health workers or peers trained as coaches, has emerged as an effective model to improve
      these management domains for children with asthma and adults with diabetes, and hypertension
      receiving care in urban safety-net clinics. The role of the health coach includes many of the
      activities also provided by patient navigators, patient educators, and community health
      workers. Health coaching is a patient-centered model that recognizes that that people living
      with chronic disease are the primary decision-makers in their care; it is a tailored approach
      that builds on the strengths and expertise of patients and helps to ensure that they have the
      knowledge and skills to be active participants within the medical encounter and to
      effectively manage their conditions. Incorporating health coaches into care delivery fits
      well with the of integrated care model recommended by the American Thoracic Society which is
      based on the Chronic Care Mode. Health coaching can work on several components of the Chronic
      Care Model as it applies to COPD to enhance the effectiveness of care delivery and promote
      patient goals. Health coaches provide decision support by helping execute customized care
      plans jointly developed by patients and providers. Coaches track care targets and conduct
      'gap analysis' to identify areas which are sub-optimal. Coaches also help patients to get the
      support they need by facilitating access to community, clinic, and specialist support,
      improving communication between patients and providers, working with patients to set goals
      and develop action plans to reach those goals. The goal of our study was to evaluate the
      effectiveness of a health coach model for improving outcomes for low-income urban patients
      with COPD. We conducted a randomized trial comparing 9 months of health coaching plus usual
      care (health coached arm) to usual care (usual care arm) alone for patients with moderate to
      severe COPD cared for at 7 federally qualified health centers (FQHCs). The specific aims of
      the study were:

      Specific Aim 1. To compare disease specific quality of life for patients randomized to
      receive 9 months of health coaching plus usual care to those randomized to usual care alone.
      Our hypothesis was that mean quality of life, assessed by the Chronic Respiratory Disease
      Questionnaire total score and dyspnea domain score at 9 months, would be greater in patients
      in the health-coached arm when tested against the null hypothesis of no difference between
      health-coached and usual care patients.

      Specific Aim 2. To compare the number of exacerbations of COPD experienced by patients in the
      health coached arm to those in the usual care arm during the 9 month period starting at
      enrollment. COPD exacerbation was defined as an emergency department visit or hospitalization
      for COPD-related diagnosis or the outpatient prescription of oral steroids for COPD-related
      diagnosis. Our hypothesis was patients in the health-coached arm would experience fewer
      exacerbations when tested against the null hypothesis of no difference between health-coached
      and usual care patients.

      Specific Aim 3. To compare exercise capacity at 9 months for patients in the health-coached
      arm to those in the usual care arm. Our hypothesis was that patients in the health-coached
      arm would have greater exercises capacity as measured by the 6-minute Walk Test when tested
      against the null hypothesis of no difference between health-coached and usual care patients.

      Specific Aim 4. To compare self-efficacy for management of their COPD for health-coached
      versus usual care patients at 9 months. Our hypothesis was that mean self-efficacy, as
      measured by Stanford Chronic Disease Self-Efficacy Scale would be greater in patients in the
      health coached arm when tested against the null hypothesis of no difference in self-efficacy
      between health-coached and usual care patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score
time frame: 9 months
description: The Chronic Respiratory Disease Questionnaire assesses disease-related quality of in 4 domains (dyspnea, fatigue, physical function and mastery). The 8-item Short Form version has been validated against the original full version. Each item is answered on a 7-point response scale where a higher score indicates a higher quality of life. The measure is scored as the mean response score (range 1 to 7) for each domain and for the total score, with the higher score indicating higher quality of life.
measure: Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF)
time frame: 9 months
description: The CRQ-SF is the short-form version of the original Chronic Respiratory Disease Questionnaire. The CRQ-SF has a total of 8 items asking about the frequency of COPD-related symptoms in 4 domains (2 questions per domain): Dyspnea, Fatigue, Emotional Function and Mastery. Each item is answered on a 7-point Likert-type scale with 1=none of the time and 7=all of the time. The dyspnea score is reported as the mean of the two items asking about shortness of breath. Mean scores range for 1 to 7, with a higher score indicating a worse quality of life related to dyspnea.
measure: Rate of COPD Exacerbations Per Year
time frame: Over 9 month study period
description: A COPD exacerbation was defined as a COPD-related emergency department visit or hospitalization, or the outpatient prescription of oral steroids and/or antibiotic for COPD-related diagnosis, as documented in the medical record over the 9 month trial period. The rate of COPD exacerbation was calculated as the mean number of exacerbations per participant per year.
measure: Exercise Capacity (6-minute Walk Test)
time frame: 9 months
description: Distance walked, in meters, over 6 minutes. Higher number indicates greater exercise capacity.
measure: Self-efficacy to Manage Chronic Disease Scale
time frame: 9 months
description: The Self-efficacy to Manage Chronic Disease Scale is a validated measure of of patient self-efficacy for managing a specific chronic disease (in this case, COPD). The Self-efficacy to Manage Chronic Disease Scale has 6 items asking about patients' self-confidence dealing with 6 aspects off self-management. Each item is answered on a scale of 1 to 10 with 1="not at all confident" and 10='totally confident". The score is the mean of all 10-items. Mean scores range for 1 to 10, with a higher score indicating greater self-efficacy for managing COPD.
measure: Short Version of the Patient Assessment of Quality of Care (PACIC)
time frame: 9 months
description: Patient Assessment of Chronic Illness Care (PACIC) is a patient reported measure of having received services recommended by Chronic Care Model. The short version of the PACIC has 11 items asking the patient the proportion of time he or she received a specific service. Each item is answered on a 5-point Likert-type scale with 1=None of the time and 5=Always. The total score is the mean of all 11-items. Mean scores range for 1 to 5, with a higher score indicating higher quality of care.
measure: COPD Assessment Test
time frame: 9 months
description: The COPD Assessment Test (CAT) is an 8-item measure of severity of COPD symptoms, with responses from 1 to 5 . It is scored as the sum of item scores, with a range from 8 to 40, with a higher score indicating greater level of symptoms.
measure: Percent of Predicted Force Expiratory Volume at 1 Second (FEV1)
time frame: 9 months
description: Volume of air exhaled, using maximal force, over 1 second, divided by the volume expected for health person of same age and gender. Larger volume indicates better lung function.
measure: Proportion (%) of Participants Reporting Current Cigarette Use
time frame: 9 months
description: Current cigarette use is defined as any use in the past 30 days.
measure: COPD-related Function (Bed Days Due to Respiratory Problems)
time frame: 9 months
description: Number of days in past 4 weeks where COPD keep participant in bed all or most of the day.
measure: Proportion (%) of Participants Demonstrating Adequate Inhaler Use
time frame: 9 months
description: Observational measure using a check list to document mistakes in using inhalers. Adequate use defined as correctly performing all necessary steps for every inhaler used. Definition of necessary steps varies by type of inhaler.
measure: Proportion (%) of Participants With Correct Answer to Knowledge Question 1
time frame: 9 months
description: Okay to get short of breath while exercising
measure: Proportion (%) of Participants With Correct Answer to Knowledge Question 2
time frame: 9 months
description: beneficial to stop smoking
measure: Proportion (%) of Participants With Correct Answer to Knowledge Question 3
time frame: 9 months
description: Okay to be on oxygen for long period
measure: Proportion (%) of Participants With Correct Answer to Knowledge Question 4
time frame: 9 months
description: Smoking does not help breathing
measure: Rate of Outpatient Visits
time frame: Over 9 month study period
description: Number of outpatient visits per patient per year
measure: Rate of ED Visits for COPD
time frame: Over 9 month study period
description: Number of ED visits for COPD per patient per year over 9 month study period
measure: Rate of ED Visits Not for COPD
time frame: Over 9 month study period
description: Number of visits to emergency department other than for COPD related reason per patient per year during 9 month study period
measure: Rate of Hospitalization for COPD
time frame: Over 9 month study period
description: Number of hospitalizations for COPD per patient per year over 9 month study period
measure: Rate of Hospitalizations Not for COPD
time frame: Over 9 month study period
description: Number of hospitalizations other than for COPD per patient per year during 9 month study period
arm group label: Health Coaching
arm group type: Experimental
description: Patients randomized to the health coaching intervention would work with a trained health coach who would provide patient education self-management support, use action planning to help patient make changes to reach goals, as well as help coordinate patient care between the primary care provider and pulmonary specialist, identify gaps in care, and help patient access needed services
arm group label: Usual care
arm group type: No Intervention
description: Usual care was chosen as the comparison group to provide maximum generalizability of the study, as usual care is the practical alternative for the target population. Usual care includes patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling.
intervention type: Behavioral
intervention name: Health Coaching
description: Patient COPD education; Correct use of inhalers and nebulizers; Red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation; nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Identifying gaps in care, areas where care not in line with care plan; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Access to psychosocial services; Working with pulmonary specialist to provide recommended exercise program; Working with patient family members and caregivers.
arm group label: Health Coaching
criteria: 
gender: All
minimum age: 40 Years
maximum age: 95 Years
healthy volunteers: No
last name: David H Thom, MD, PhD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
citation: Huang B, Willard-Grace R, De Vore D, Wolf J, Chirinos C, Tsao S, Hessler D, Su G, Thom DH. Health coaching to improve self-management and quality of life for low income patients with chronic obstructive pulmonary disease (COPD): protocol for a randomized controlled trial. BMC Pulm Med. 2017 Jun 9;17(1):90. doi: 10.1186/s12890-017-0433-3. Erratum In: BMC Pulm Med. 2019 May 21;19(1):96.
PMID: 28599636
citation: Huang B, De Vore D, Chirinos C, Wolf J, Low D, Willard-Grace R, Tsao S, Garvey C, Donesky D, Su G, Thom DH. Strategies for recruitment and retention of underrepresented populations with chronic obstructive pulmonary disease for a clinical trial. BMC Med Res Methodol. 2019 Feb 21;19(1):39. doi: 10.1186/s12874-019-0679-y.
PMID: 30791871
citation: Thom DH, Willard-Grace R, Tsao S, Hessler D, Huang B, DeVore D, Chirinos C, Wolf J, Donesky D, Garvey C, Su G. Randomized Controlled Trial of Health Coaching for Vulnerable Patients with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2018 Oct;15(10):1159-1168. doi: 10.1513/AnnalsATS.201806-365OC.
PMID: 30130430
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Target sample size was reduced from 250 to 190 due difficulties with recruitment.
The outcome of medication adherence, measured by the Morisky Medication Adherence Scale, was deleted because we did not realized it required a license.
point of contact: 