<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/NCT03287440</url>
  </required_header>
  <id_info>
    <org_study_id>16-19967</org_study_id>
    <nct_id>NCT03287440</nct_id>
  </id_info>
  <brief_title>Rehabilitation for Patients With COPD</brief_title>
  <acronym>COPD Wellness</acronym>
  <official_title>Pilot Study of Rehabilitation in Safety-net Settings for Patients With COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nina Ireland Program in Lung Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine COPD Wellness, a 10-week low-intensity pulmonary rehabilitation&#xD;
      program consisting of group and home exercise, education, and social support can improve&#xD;
      symptoms and increase physical activity in participants with COPD who receive care within a&#xD;
      'safety-net' healthcare system (e.g. County Hospital). Half of the participants will also&#xD;
      receive an adherence strategy targeted at addressing unmet social needs, while the other half&#xD;
      will undergo the intervention without the adherence strategy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic obstructive pulmonary disease (COPD), one of the leading causes of death in the US,&#xD;
      disproportionately affects low socioeconomic communities. While few interventions effectively&#xD;
      modify the course of COPD and improve outcomes, pulmonary rehabilitation is the one notable&#xD;
      exception. However, implementation of this resource-intensive program in real-life settings,&#xD;
      and in particular, for underserved communities, has proven to be challenging. Safety-net&#xD;
      centers that serve primarily under-insured populations lack financial resources to provide&#xD;
      pulmonary rehabilitation.&#xD;
&#xD;
      COPD Wellness, a 10-week low-intensity pulmonary rehabilitation program consisting of group&#xD;
      and home exercise, education, and social support, was developed to address this gap. This&#xD;
      intervention is targeted at patients with moderate to severe COPD (GOLD Class B-D) who&#xD;
      receive care through a safety-net health system. To be impactful, risk factors for low&#xD;
      adherence include both disease severity and socio-environmental factors, must be addressed.&#xD;
      As merely having a pulmonary rehabilitation program will not automatically lead to improved&#xD;
      outcomes.&#xD;
&#xD;
      As part of this study, an adherence strategy targeted at addressing unmet social needs to&#xD;
      improve health will also be implemented. A Health Advocates program that links social needs&#xD;
      screening with a tiered referral and linkage process to appropriate resources will be tested&#xD;
      to see if adherence to COPD Wellness (exercise intervention) improves by addressing competing&#xD;
      non-medical stressors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">July 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2020</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>Sequential Assignment</intervention_model>
    <intervention_model_description>A step-wedge design will allow all participants to receive the intervention. Participants not immediately enrolled into the intervention will serve as controls. At the time of the intervention, these participants will move over to the treatment arm.&#xD;
The first two groups will be used to refine the COPD Wellness intervention and identify social barriers specific to individuals living with COPD. Starting with group 3, we will alternate the addition of the Health Advocates (HA) program as an adherence strategy in order to determine the HA's effect on participation in COPD Wellness.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>The principal investigator and outcome assessor will be masked to when the participant completes the intervention and to whether or not they received the Health Advocates adherence strategy.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline 6 Minute Walk Test at End of Intervention</measure>
    <time_frame>End of Intervention, an average of 4 months</time_frame>
    <description>Standardized test to measure distance walked in 6 minutes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline COPD Assessment Test (CAT) at End of Intervention</measure>
    <time_frame>End of Intervention, an average of 4 months</time_frame>
    <description>Questionnaire assessing COPD symptoms and quality of life</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline number of exacerbations of COPD at End of Intervention</measure>
    <time_frame>End of Intervention, an average of 4 months</time_frame>
    <description>Exacerbation defined as a visit to an urgent care or emergency department for COPD, a hospitalization for COPD, or a prescription of an oral steroid for worsening COPD symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline number of exacerbations of COPD at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Exacerbation defined as a visit to an urgent care or emergency department for COPD, a hospitalization for COPD, or a prescription of an oral steroid for worsening COPD symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in baseline Smoking status at end of intervention</measure>
    <time_frame>End of Intervention, an average of 4 months</time_frame>
    <description>Have you smoked a cigarette in the past 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in baseline Smoking status at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Have you smoked a cigarette in the past 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline D-12 evaluation at end of intervention</measure>
    <time_frame>End of Intervention, an average of 4 months</time_frame>
    <description>Evaluates dyspnea symptoms and increased ease of activities of daily living as related to COPD symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline D-12 evaluation at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluates dyspnea symptoms and increased ease of activities of daily living as related to COPD symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in baseline Patient Health Questionnaire (PHQ-)8 at End of Intervention</measure>
    <time_frame>End of Intervention, an average of 4 months</time_frame>
    <description>Diagnoses of depressive disorders and depression severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence</measure>
    <time_frame>Assessed during 10-week COPD Wellness Intervention</time_frame>
    <description>Number of classes attended by the participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline 6 Minute Walk Test at 12 months</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Standardized test to measure distance walked in 6 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline COPD Assessment Test (CAT) at 12 months</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Measure of COPD symptoms and quality of life</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>COPD Wellness With Health Advocate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will be given low-intensity pulmonary rehabilitation, COPD Wellness, for individuals with moderate-to-severe COPD with an additional assignment of a health advocate to address unmet social needs as an adherence strategy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COPD Wellness</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will only be given low-intensity pulmonary rehabilitation, COPD Wellness, for individuals with moderate-to-severe COPD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>COPD Wellness</intervention_name>
    <description>This is low-intensity pulmonary rehabilitation that incorporates exercise, nutrition, patient education, and a support group class.</description>
    <arm_group_label>COPD Wellness</arm_group_label>
    <arm_group_label>COPD Wellness With Health Advocate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health Advocate</intervention_name>
    <description>The Zuckerberg San Francisco General (ZSFG) Hospital Health Advocates program links social needs screening with a tiered referral and linkage process to appropriate resources</description>
    <arm_group_label>COPD Wellness With Health Advocate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: Are greater than or equal to 40 years&#xD;
&#xD;
          -  Diagnosis: COPD Gold Stage Class B-D (symptomatic disease), COPD/Asthma overlap with&#xD;
             symptoms&#xD;
&#xD;
          -  Language: English&#xD;
&#xD;
          -  Care Center: ZSFG, Community Health Center clinics, Federally Qualified Health Centers&#xD;
&#xD;
          -  Availability: Able to participate in a 10-week, weekly course at the weekly scheduled&#xD;
             time (can defer x 1)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Planning to move out of the area within the next year&#xD;
&#xD;
          -  Eligible for and desire to go to full intensity pulmonary rehabilitation. Participant&#xD;
             has Medicare Part A and B OR have San Francisco Health Plan. For those that met these&#xD;
             criteria, we will assist with referral to program&#xD;
&#xD;
          -  Resides in any kind of long-term care facilities that is NOT Laguna Honda or the&#xD;
             Mental Health Rehabilitation Facility&#xD;
&#xD;
          -  Has a diagnosis of interstitial lung disease, pulmonary fibrosis, or cystic fibrosis&#xD;
&#xD;
          -  Active, chronic lung infection, such as tuberculosis&#xD;
&#xD;
          -  A history of a pulmonary embolism in the year (12 months) prior to recruitment&#xD;
&#xD;
          -  History of a myocardial infarction in the year (12 months) prior to recruitment&#xD;
&#xD;
          -  In the 12 weeks prior to recruitment, has had history of unstable heart disease&#xD;
             (including valve disease), heart failure, or uncontrolled irregular heart beat&#xD;
&#xD;
        Potential participants who have had the following will be re-assess for eligibility 6 weeks&#xD;
        after the initial assessment:&#xD;
&#xD;
          -  A pulmonary exacerbation or worsening of COPD/Asthma symptoms in the past 6 weeks&#xD;
&#xD;
          -  History of an upper respiratory infection in the past 6 weeks&#xD;
&#xD;
          -  History of an eye, chest, or abdominal surgery within the past 6 weeks&#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>Neeta Thakur, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zuckerberg San Francisco General Hospital and Trauma Center</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>Troosters T, Gosselink R, Decramer M. Short- and long-term effects of outpatient rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. Am J Med. 2000 Aug 15;109(3):207-12. doi: 10.1016/s0002-9343(00)00472-1.</citation>
    <PMID>10974183</PMID>
  </reference>
  <reference>
    <citation>Baumann HJ, Kluge S, Rummel K, Klose H, Hennigs JK, Schmoller T, Meyer A. Low intensity, long-term outpatient rehabilitation in COPD: a randomised controlled trial. Respir Res. 2012 Sep 27;13(1):86. doi: 10.1186/1465-9921-13-86.</citation>
    <PMID>23017153</PMID>
  </reference>
  <reference>
    <citation>Selzler AM, Simmonds L, Rodgers WM, Wong EY, Stickland MK. Pulmonary rehabilitation in chronic obstructive pulmonary disease: predictors of program completion and success. COPD. 2012 Aug;9(5):538-45. doi: 10.3109/15412555.2012.705365.</citation>
    <PMID>23030585</PMID>
  </reference>
  <reference>
    <citation>Fischer MJ, Scharloo M, Abbink JJ, van 't Hul AJ, van Ranst D, Rudolphus A, Weinman J, Rabe KF, Kaptein AA. Drop-out and attendance in pulmonary rehabilitation: the role of clinical and psychosocial variables. Respir Med. 2009 Oct;103(10):1564-71. doi: 10.1016/j.rmed.2008.11.020. Epub 2009 May 29.</citation>
    <PMID>19481919</PMID>
  </reference>
  <reference>
    <citation>Rochester CL, Vogiatzis I, Holland AE, Lareau SC, Marciniuk DD, Puhan MA, Spruit MA, Masefield S, Casaburi R, Clini EM, Crouch R, Garcia-Aymerich J, Garvey C, Goldstein RS, Hill K, Morgan M, Nici L, Pitta F, Ries AL, Singh SJ, Troosters T, Wijkstra PJ, Yawn BP, ZuWallack RL; ATS/ERS Task Force on Policy in Pulmonary Rehabilitation. An Official American Thoracic Society/European Respiratory Society Policy Statement: Enhancing Implementation, Use, and Delivery of Pulmonary Rehabilitation. Am J Respir Crit Care Med. 2015 Dec 1;192(11):1373-86. doi: 10.1164/rccm.201510-1966ST.</citation>
    <PMID>26623686</PMID>
  </reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>June 1, 2022</last_update_submitted>
  <last_update_submitted_qc>June 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Health Disparities</keyword>
  <keyword>Lung Diseases</keyword>
  <keyword>Self-management</keyword>
  <keyword>Chronic Disease</keyword>
  <keyword>Socio-economic status</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03287440
org study id: 16-19967
nct id: NCT03287440
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will examine COPD Wellness, a 10-week low-intensity pulmonary rehabilitation
      program consisting of group and home exercise, education, and social support can improve
      symptoms and increase physical activity in participants with COPD who receive care within a
      'safety-net' healthcare system (e.g. County Hospital). Half of the participants will also
      receive an adherence strategy targeted at addressing unmet social needs, while the other half
      will undergo the intervention without the adherence strategy.
Chronic obstructive pulmonary disease (COPD), one of the leading causes of death in the US,
      disproportionately affects low socioeconomic communities. While few interventions effectively
      modify the course of COPD and improve outcomes, pulmonary rehabilitation is the one notable
      exception. However, implementation of this resource-intensive program in real-life settings,
      and in particular, for underserved communities, has proven to be challenging. Safety-net
      centers that serve primarily under-insured populations lack financial resources to provide
      pulmonary rehabilitation.

      COPD Wellness, a 10-week low-intensity pulmonary rehabilitation program consisting of group
      and home exercise, education, and social support, was developed to address this gap. This
      intervention is targeted at patients with moderate to severe COPD (GOLD Class B-D) who
      receive care through a safety-net health system. To be impactful, risk factors for low
      adherence include both disease severity and socio-environmental factors, must be addressed.
      As merely having a pulmonary rehabilitation program will not automatically lead to improved
      outcomes.

      As part of this study, an adherence strategy targeted at addressing unmet social needs to
      improve health will also be implemented. A Health Advocates program that links social needs
      screening with a tiered referral and linkage process to appropriate resources will be tested
      to see if adherence to COPD Wellness (exercise intervention) improves by addressing competing
      non-medical stressors.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: A step-wedge design will allow all participants to receive the intervention. Participants not immediately enrolled into the intervention will serve as controls. At the time of the intervention, these participants will move over to the treatment arm.
The first two groups will be used to refine the COPD Wellness intervention and identify social barriers specific to individuals living with COPD. Starting with group 3, we will alternate the addition of the Health Advocates (HA) program as an adherence strategy in order to determine the HA's effect on participation in COPD Wellness.
primary purpose: Health Services Research
masking: Double (Investigator, Outcomes Assessor)
masking description: The principal investigator and outcome assessor will be masked to when the participant completes the intervention and to whether or not they received the Health Advocates adherence strategy.
measure: Change from Baseline 6 Minute Walk Test at End of Intervention
time frame: End of Intervention, an average of 4 months
description: Standardized test to measure distance walked in 6 minutes
measure: Change from Baseline COPD Assessment Test (CAT) at End of Intervention
time frame: End of Intervention, an average of 4 months
description: Questionnaire assessing COPD symptoms and quality of life
measure: Change from Baseline number of exacerbations of COPD at End of Intervention
time frame: End of Intervention, an average of 4 months
description: Exacerbation defined as a visit to an urgent care or emergency department for COPD, a hospitalization for COPD, or a prescription of an oral steroid for worsening COPD symptoms
measure: Change from Baseline number of exacerbations of COPD at 12 months
time frame: 12 months
description: Exacerbation defined as a visit to an urgent care or emergency department for COPD, a hospitalization for COPD, or a prescription of an oral steroid for worsening COPD symptoms
measure: Change in baseline Smoking status at end of intervention
time frame: End of Intervention, an average of 4 months
description: Have you smoked a cigarette in the past 30 days
measure: Change in baseline Smoking status at 12 months
time frame: 12 months
description: Have you smoked a cigarette in the past 30 days
measure: Change from baseline D-12 evaluation at end of intervention
time frame: End of Intervention, an average of 4 months
description: Evaluates dyspnea symptoms and increased ease of activities of daily living as related to COPD symptoms
measure: Change from baseline D-12 evaluation at 12 months
time frame: 12 months
description: Evaluates dyspnea symptoms and increased ease of activities of daily living as related to COPD symptoms
measure: Change in baseline Patient Health Questionnaire (PHQ-)8 at End of Intervention
time frame: End of Intervention, an average of 4 months
description: Diagnoses of depressive disorders and depression severity
measure: Adherence
time frame: Assessed during 10-week COPD Wellness Intervention
description: Number of classes attended by the participant
measure: Change from Baseline 6 Minute Walk Test at 12 months
time frame: Baseline and 12 months
description: Standardized test to measure distance walked in 6 minutes
measure: Change from Baseline COPD Assessment Test (CAT) at 12 months
time frame: Baseline, 12 months
description: Measure of COPD symptoms and quality of life
arm group label: COPD Wellness With Health Advocate
arm group type: Active Comparator
description: This arm will be given low-intensity pulmonary rehabilitation, COPD Wellness, for individuals with moderate-to-severe COPD with an additional assignment of a health advocate to address unmet social needs as an adherence strategy.
arm group label: COPD Wellness
arm group type: Active Comparator
description: This arm will only be given low-intensity pulmonary rehabilitation, COPD Wellness, for individuals with moderate-to-severe COPD.
intervention type: Behavioral
intervention name: COPD Wellness
description: This is low-intensity pulmonary rehabilitation that incorporates exercise, nutrition, patient education, and a support group class.
arm group label: COPD Wellness
arm group label: COPD Wellness With Health Advocate
intervention type: Behavioral
intervention name: Health Advocate
description: The Zuckerberg San Francisco General (ZSFG) Hospital Health Advocates program links social needs screening with a tiered referral and linkage process to appropriate resources
arm group label: COPD Wellness With Health Advocate
criteria: 
gender: All
minimum age: 40 Years
maximum age: 95 Years
healthy volunteers: No
last name: Neeta Thakur, MD, MPH
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
citation: Troosters T, Gosselink R, Decramer M. Short- and long-term effects of outpatient rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. Am J Med. 2000 Aug 15;109(3):207-12. doi: 10.1016/s0002-9343(00)00472-1.
PMID: 10974183
citation: Baumann HJ, Kluge S, Rummel K, Klose H, Hennigs JK, Schmoller T, Meyer A. Low intensity, long-term outpatient rehabilitation in COPD: a randomised controlled trial. Respir Res. 2012 Sep 27;13(1):86. doi: 10.1186/1465-9921-13-86.
PMID: 23017153
citation: Selzler AM, Simmonds L, Rodgers WM, Wong EY, Stickland MK. Pulmonary rehabilitation in chronic obstructive pulmonary disease: predictors of program completion and success. COPD. 2012 Aug;9(5):538-45. doi: 10.3109/15412555.2012.705365.
PMID: 23030585
citation: Fischer MJ, Scharloo M, Abbink JJ, van 't Hul AJ, van Ranst D, Rudolphus A, Weinman J, Rabe KF, Kaptein AA. Drop-out and attendance in pulmonary rehabilitation: the role of clinical and psychosocial variables. Respir Med. 2009 Oct;103(10):1564-71. doi: 10.1016/j.rmed.2008.11.020. Epub 2009 May 29.
PMID: 19481919
citation: Rochester CL, Vogiatzis I, Holland AE, Lareau SC, Marciniuk DD, Puhan MA, Spruit MA, Masefield S, Casaburi R, Clini EM, Crouch R, Garcia-Aymerich J, Garvey C, Goldstein RS, Hill K, Morgan M, Nici L, Pitta F, Ries AL, Singh SJ, Troosters T, Wijkstra PJ, Yawn BP, ZuWallack RL; ATS/ERS Task Force on Policy in Pulmonary Rehabilitation. An Official American Thoracic Society/European Respiratory Society Policy Statement: Enhancing Implementation, Use, and Delivery of Pulmonary Rehabilitation. Am J Respir Crit Care Med. 2015 Dec 1;192(11):1373-86. doi: 10.1164/rccm.201510-1966ST.
PMID: 26623686
responsible party type: Sponsor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No