<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/NCT02991391</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00059852</org_study_id>
    <nct_id>NCT02991391</nct_id>
  </id_info>
  <brief_title>Expansion of the COPD At-risk Module in 4 States BRFSS Telephone Health Surveys</brief_title>
  <official_title>Expansion of the COPD At-risk Module in 4 States BRFSS Telephone Health Surveys</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Kentucky</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This cross-sectional survey study is intended to describe the characteristics of adults in 4&#xD;
      US states with regards to respiratory symptoms and tobacco exposure, utilizing an existing&#xD;
      state-administered, CDC overseen Behavioral Risk Factor Surveillance System telephone health&#xD;
      survey. The primary goal of study is to describe the sociodemographics, health behaviors, and&#xD;
      presence of chronic diseases in persons with or at risk of having chronic obstructive&#xD;
      pulmonary disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives: The primary objective of this study is to determine the prevalence and&#xD;
      health-related characteristics of adults who are at high risk for COPD, but have never been&#xD;
      diagnosed. The second objective of this study is to determine the frequency and type of&#xD;
      respiratory symptoms in the general adult population among 4 states. The third objective is&#xD;
      to describe respiratory symptoms in the adult population in relationship to other chronic&#xD;
      diseases such as COPD, asthma, obesity and others. The fourth objective is to engage other&#xD;
      states to add the Module into their BRFSS as early as 2017 to aid in efforts to decrease the&#xD;
      burden of COPD.&#xD;
&#xD;
      Procedures: The COPD At-risk Module will be incorporated into 4 state's 2015 BRFSS telephone&#xD;
      health survey (SC, TX, FL, and KY). The COPD At-Risk Module was derived from previously&#xD;
      published COPD case-finding and population screening questionnaires. The 4 questions&#xD;
      contained in the Module are: 1) How many years have you smoked tobacco products? (asked of&#xD;
      those that say they smoked &gt; 100 cigarettes/lifetime, which is part of core survey), 2) In&#xD;
      the last 30 days, how often are you short of breath? 3) How often do you cough up mucus or&#xD;
      phlegm? and 4) In the last 12 months, to what extent would you say your physical activities&#xD;
      are limited by shortness of breath? One additional question, age in years, is already&#xD;
      contained in the BRFSS, and when combined with the other 4 questions, will allow estimation&#xD;
      of survey participant's risk of COPD. The COPD risk categories are: 1) diagnosed COPD&#xD;
      (self-report of provider diagnosis of COPD), 2) high risk for COPD (self-report of frequent&#xD;
      respiratory symptoms based on participant responses plus at least 10 years of tobacco product&#xD;
      use), and 3) low risk (neither diagnosed COPD or in high-risk group).&#xD;
&#xD;
      Each state's BRFSS group (state government epidemiology departments) will undertake the BRFSS&#xD;
      telephone survey beginning January 2015 as part its normal annual state-based health&#xD;
      surveillance. The core BRFSS survey has been developed by the CDC and minor changes in the&#xD;
      core survey may occur each year. Individual states often have additional state-specific&#xD;
      questions such as those requested by outside organizations or individuals, such as done with&#xD;
      this study. The study investigators have requested and received approval to add the &quot;COPD&#xD;
      at-risk Module&quot; that consists of 4 questions will be added to the 70-plus sociodemographic&#xD;
      and health characteristic questions already included in the BRFSS.&#xD;
&#xD;
      Per CDC guidelines, potential survey respondents may refuse to participate or answer any&#xD;
      question in the survey. Using a scripted BRFSS, trained interviewers will collect data using&#xD;
      an independent prob¬ability sample of households through landline and cellular telephones of&#xD;
      non-institutionalized persons. Based on past BRFSS surveys, the participant response rates&#xD;
      have declined from ~ 60% to ~ 50% due to inclusion of cell phones along with landlines&#xD;
      beginning in 2011. According to the CDC, the inclusion of cell phones and landline phones&#xD;
      better represents the general adult population, especially in younger adults. A detailed&#xD;
      description of the survey's design and random sampling procedures is available in the BRFSS&#xD;
      Policies, Procedures, and Protocol Document, 2013 . The BRFSS has been approved as exempt&#xD;
      research by the CDC's institutional review board.&#xD;
&#xD;
      Study Population It is projected that there will be ~ 45,000 non-institutionalized adults (&gt;&#xD;
      18 years) who will complete the 2015 BRFSS telephone health survey among the 4 participating&#xD;
      states - KY, SC, TX, and FL. These 4 states represent a significant segment of the COPD&#xD;
      population in the US based upon prior COPD prevalence estimates and COPD-related&#xD;
      hospitalizations among Medicare recipients. Of note, Kentucky has the highest prevalence of&#xD;
      COPD in the US. For each state, cell phone and landline phones are randomly selected based on&#xD;
      pre-determined goals for geographics and socio-demographics per state and CDC procedures.&#xD;
      Hispanics can also participate in the telephone survey through interpreters. Only one adult&#xD;
      in each household that is contacted can complete the survey. Of all potential survey&#xD;
      respondents, about one-half will provide complete data for the telephone survey.&#xD;
&#xD;
      Data Collection and Confidentiality Collection of survey data from participants will start&#xD;
      January 2, 2015 and be completed by the end of 2015. Prior to states analyzing and releasing&#xD;
      survey data in 2016, the CDC will undertake an internal review of each state's survey data by&#xD;
      May 2016.&#xD;
&#xD;
      Data files from the states and CDC that are shared with outside investigators contain no PHI.&#xD;
      After states review and analyze their survey data, it is then available to be released to the&#xD;
      public upon request, this includes investigators of this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of persons with or at high-risk of COPD</measure>
    <time_frame>1 year</time_frame>
    <description>COPD defined by respondent self-report; high-risk for COPD defined by frequency of respiratory symptoms and tobacco exposure history</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of respiratory symptoms in general adult population</measure>
    <time_frame>1 year</time_frame>
    <description>Telephone health survey using the Behavioral Risk factor Surveillance System to define the frequency of dyspnea</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship between racial and socioeconomic disparities with respiratory symptoms</measure>
    <time_frame>1 year</time_frame>
    <description>Telephone health survey using the Behavioral Risk Factor Surveillance System to define the frequency of respiratory symptoms (%) based upon respondent's race, ethnicity (Hispanic, non-Hispanic), annual income ($), educational status (&lt; high school, HS, some college, college graduate) with frequency (%) and severity of respiratory symptoms</description>
  </secondary_outcome>
  <enrollment type="Actual">40690</enrollment>
  <condition>COPD</condition>
  <condition>Respiratory Symptoms</condition>
  <condition>Tobacco Use</condition>
  <condition>Asthma</condition>
  <condition>Disparities</condition>
  <condition>Air Quality</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>None, use of a questionnaire</intervention_name>
    <description>Telephone health survey using 2015 Behavioral Risk Factor Surveillance Survey in Texas, Florida, South Carolina, and Kentucky that includes questions regarding tobacco exposure and respiratory symptoms</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        It is projected that there will be ~ 50,000 non-institutionalized adults (&gt; 18 years) who&#xD;
        will complete the 2015 BRFSS telephone health survey among the 4 participating states - KY,&#xD;
        SC, TX, and FL. These 4 states represent a significant segment of the COPD population in&#xD;
        the US based upon prior COPD prevalence estimates and COPD-related hospitalizations among&#xD;
        Medicare recipients. Of note, Kentucky has the highest prevalence of COPD in the US. For&#xD;
        each state, cell phone and landline phones are randomly selected based on pre-determined&#xD;
        goals for geographics and socio-demographics per state and CDC procedures. Hispanics can&#xD;
        also participate in the telephone survey through interpretors. Only one adult in each&#xD;
        household that is contacted can complete the survey. Of all potential survey respondents,&#xD;
        about one-half will provide complete data for the telephone survey.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  willingness to complete telephone health survey&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unwillingness to compete telephone health survey&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Njira Lugogo, MD</last_name>
    <role>Study Director</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>October 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>December 9, 2016</last_update_submitted>
  <last_update_submitted_qc>December 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Signs and Symptoms, Respiratory</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Through respective state's BRFSS</ipd_description>
  </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/NCT02991391
org study id: Pro00059852
nct id: NCT02991391
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This cross-sectional survey study is intended to describe the characteristics of adults in 4
      US states with regards to respiratory symptoms and tobacco exposure, utilizing an existing
      state-administered, CDC overseen Behavioral Risk Factor Surveillance System telephone health
      survey. The primary goal of study is to describe the sociodemographics, health behaviors, and
      presence of chronic diseases in persons with or at risk of having chronic obstructive
      pulmonary disease.
Objectives: The primary objective of this study is to determine the prevalence and
      health-related characteristics of adults who are at high risk for COPD, but have never been
      diagnosed. The second objective of this study is to determine the frequency and type of
      respiratory symptoms in the general adult population among 4 states. The third objective is
      to describe respiratory symptoms in the adult population in relationship to other chronic
      diseases such as COPD, asthma, obesity and others. The fourth objective is to engage other
      states to add the Module into their BRFSS as early as 2017 to aid in efforts to decrease the
      burden of COPD.

      Procedures: The COPD At-risk Module will be incorporated into 4 state's 2015 BRFSS telephone
      health survey (SC, TX, FL, and KY). The COPD At-Risk Module was derived from previously
      published COPD case-finding and population screening questionnaires. The 4 questions
      contained in the Module are: 1) How many years have you smoked tobacco products? (asked of
      those that say they smoked > 100 cigarettes/lifetime, which is part of core survey), 2) In
      the last 30 days, how often are you short of breath? 3) How often do you cough up mucus or
      phlegm? and 4) In the last 12 months, to what extent would you say your physical activities
      are limited by shortness of breath? One additional question, age in years, is already
      contained in the BRFSS, and when combined with the other 4 questions, will allow estimation
      of survey participant's risk of COPD. The COPD risk categories are: 1) diagnosed COPD
      (self-report of provider diagnosis of COPD), 2) high risk for COPD (self-report of frequent
      respiratory symptoms based on participant responses plus at least 10 years of tobacco product
      use), and 3) low risk (neither diagnosed COPD or in high-risk group).

      Each state's BRFSS group (state government epidemiology departments) will undertake the BRFSS
      telephone survey beginning January 2015 as part its normal annual state-based health
      surveillance. The core BRFSS survey has been developed by the CDC and minor changes in the
      core survey may occur each year. Individual states often have additional state-specific
      questions such as those requested by outside organizations or individuals, such as done with
      this study. The study investigators have requested and received approval to add the "COPD
      at-risk Module" that consists of 4 questions will be added to the 70-plus sociodemographic
      and health characteristic questions already included in the BRFSS.

      Per CDC guidelines, potential survey respondents may refuse to participate or answer any
      question in the survey. Using a scripted BRFSS, trained interviewers will collect data using
      an independent prob¬ability sample of households through landline and cellular telephones of
      non-institutionalized persons. Based on past BRFSS surveys, the participant response rates
      have declined from ~ 60% to ~ 50% due to inclusion of cell phones along with landlines
      beginning in 2011. According to the CDC, the inclusion of cell phones and landline phones
      better represents the general adult population, especially in younger adults. A detailed
      description of the survey's design and random sampling procedures is available in the BRFSS
      Policies, Procedures, and Protocol Document, 2013 . The BRFSS has been approved as exempt
      research by the CDC's institutional review board.

      Study Population It is projected that there will be ~ 45,000 non-institutionalized adults (>
      18 years) who will complete the 2015 BRFSS telephone health survey among the 4 participating
      states - KY, SC, TX, and FL. These 4 states represent a significant segment of the COPD
      population in the US based upon prior COPD prevalence estimates and COPD-related
      hospitalizations among Medicare recipients. Of note, Kentucky has the highest prevalence of
      COPD in the US. For each state, cell phone and landline phones are randomly selected based on
      pre-determined goals for geographics and socio-demographics per state and CDC procedures.
      Hispanics can also participate in the telephone survey through interpreters. Only one adult
      in each household that is contacted can complete the survey. Of all potential survey
      respondents, about one-half will provide complete data for the telephone survey.

      Data Collection and Confidentiality Collection of survey data from participants will start
      January 2, 2015 and be completed by the end of 2015. Prior to states analyzing and releasing
      survey data in 2016, the CDC will undertake an internal review of each state's survey data by
      May 2016.

      Data files from the states and CDC that are shared with outside investigators contain no PHI.
      After states review and analyze their survey data, it is then available to be released to the
      public upon request, this includes investigators of this study.
observational model: Cohort
time perspective: Prospective
measure: Percentage of persons with or at high-risk of COPD
time frame: 1 year
description: COPD defined by respondent self-report; high-risk for COPD defined by frequency of respiratory symptoms and tobacco exposure history
measure: Prevalence of respiratory symptoms in general adult population
time frame: 1 year
description: Telephone health survey using the Behavioral Risk factor Surveillance System to define the frequency of dyspnea
measure: Relationship between racial and socioeconomic disparities with respiratory symptoms
time frame: 1 year
description: Telephone health survey using the Behavioral Risk Factor Surveillance System to define the frequency of respiratory symptoms (%) based upon respondent's race, ethnicity (Hispanic, non-Hispanic), annual income ($), educational status (< high school, HS, some college, college graduate) with frequency (%) and severity of respiratory symptoms
intervention type: Other
intervention name: None, use of a questionnaire
description: Telephone health survey using 2015 Behavioral Risk Factor Surveillance Survey in Texas, Florida, South Carolina, and Kentucky that includes questions regarding tobacco exposure and respiratory symptoms
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Njira Lugogo, MD
role: Study Director
affiliation: Duke University
responsible party type: Sponsor
mesh term: Signs and Symptoms, Respiratory
sharing ipd: Yes
ipd description: Through respective state's BRFSS