NCT02991391

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40,690

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
Last Updated

December 13, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

October 6, 2016

Last Update Submit

December 9, 2016

Conditions

Outcome Measures

Primary Outcomes (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

    1 year

Secondary Outcomes (2)

  • Prevalence of respiratory symptoms in general adult population

    1 year

  • Relationship between racial and socioeconomic disparities with respiratory symptoms

    1 year

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • willingness to complete telephone health survey

You may not qualify if:

  • unwillingness to compete telephone health survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveSigns and Symptoms, RespiratoryTobacco UseAsthma

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsBehaviorBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Njira Lugogo, MD

    Duke University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2016

First Posted

December 13, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 13, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

Through respective state's BRFSS