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COPDNCT02991391

Expansion of the COPD At-risk Module in 4 States BRFSS Telephone Health Surveys

An observational study of COPD and Respiratory Symptoms, run by Duke University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COPD, Respiratory Symptoms, Tobacco Use
What is being tested?
None, use of a questionnaire
How many people
40,690 participants
Where
No sites listed yet
Study dates
Jan 2015to Dec 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: It is projected that there will be ~ 50,000 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 interpretors. 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.

Who may be able to join

  • willingness to complete telephone health survey

Who cannot join

  • unwillingness to compete telephone health survey

About this study

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.

Read the detailed description

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.

Being tested
None, use of a questionnaire
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Signs and Symptoms, Respiratory, Tobacco Use, Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • None, use of a questionnaireOther

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of persons with or at high-risk of COPD

    COPD defined by respondent self-report; high-risk for COPD defined by frequency of respiratory symptoms and tobacco exposure history

    Measured: 1 year

Secondary outcomes (2)
  1. Prevalence of respiratory symptoms in general adult population

    Telephone health survey using the Behavioral Risk factor Surveillance System to define the frequency of dyspnea

    Measured: 1 year

  2. Relationship between racial and socioeconomic disparities with respiratory symptoms

    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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2016 (estimated)
  2. Study startJan 2015
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40,690 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02991391
Sponsor's protocol ID
Pro00059852
Status last verified
Oct 2016
First submitted
6 Oct 2016
Last updated
13 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Through respective state's BRFSS

Questions about this trial

What is this clinical trial studying?

An observational study of COPD and Respiratory Symptoms, run by Duke University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of persons with or at high-risk of COPD (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2016.

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