NCT04135404

Brief Summary

Secondary data analysis will be performed as our approach to complete the study. A nationally representative dataset (BRFSS, 2017) will be used to answer the above hypotheses.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
400,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

12 months

First QC Date

October 18, 2019

Last Update Submit

October 21, 2019

Conditions

Outcome Measures

Primary Outcomes (5)

  • Poor mental health mediate the relationship between pulmonary status (pulmonary vs. non-pulmonary) and e-cigarette use.

    This question assesses mental health, including stress, depression, and emotional problems, by asking participants the number of days out of the last 30 days that their mental health was not good (continuous variables).

    1 year

  • Smoking mediate the relationship between pulmonary status (pulmonary vs. non-pulmonary) and e-cigarette use.

    Smoking: This scale assesses the frequency of smoking cigarettes: 1 = every day, 2 = some days, 3 = not at all.

    1 year

  • E-cigarette use (Dependent Variable)

    This survey item asks participants if they ever used an e-cigarette or other electronic "vaping" product, even just one time, in their entire life (Yes/No).

    1 year

  • Alcohol use moderate the relationship between pulmonary status (pulmonary vs. healthy) and e-cigarette use

    This question assesses the number of days in the last 30 days that participants have drunk alcohol (continuous variables).

    1 year

  • (healthy days (health-related quality of life) mediate the relationship between pulmonary status (pulmonary vs. non-pulmonary) and e-cigarette use.

    In reference to healthy days, these questions assess health-related quality of life, which is going to be assessed by asking questions concerning the number of days out of the last 30 days that the participants were physically or mentally ill (continuous variables).

    1 year

Secondary Outcomes (3)

  • Marijuana use moderate the relationship between pulmonary status (pulmonary vs. healthy) and e-cigarette use.

    1 year

  • Severity of COPD symptoms (COPD group) moderate the relationship between pulmonary status (COPD, asthma) and e-cigarette use

    1 year

  • asthma symptoms (asthmatic group) moderate the relationship between pulmonary status (COPD, asthma) and e-cigarette use.

    1 year

Study Arms (2)

Pulmonary Group

This project will be achieved by using a publicly available data set (Behavioral Risk Factor Surveillance System, 2017). The subjects from the data set will be selected on their pulmonary status; pulmonary group are those who have reported any pulmonary diseases and they will be included in this study as pulmonary group.

Other: health-related telephone surveys

Control Group

This project will be achieved by using a publicly available data set (Behavioral Risk Factor Surveillance System, 2017). The subjects from the data set will be selected on their pulmonary status; The control group are subjects without pulmonary diseases and they will be included as (control group).

Other: health-related telephone surveys

Interventions

The Behavioral Risk Factor Surveillance System (BRFSS) is a health-related telephone surveys that collect state data about United States residents regarding their health-related risk behaviors, chronic health conditions, and use of preventive services (Secondary-data analysis).

Control GroupPulmonary Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

* This study will use a quantitative, cross-sectional research design. The project has two phases for completion. * This project will be achieved by using a publicly available dataset (Behavioral Risk Factor Surveillance System, 2017). The subjects from the dataset will be selected on their pulmonary status; subjects without pulmonary diseases and those who have reported any pulmonary diseases will be included in this study

You may not qualify if:

  • Group 1: Pulmonary
  • Are 18 years of age or older.
  • Reported any of the pulmonary disease (Asthma, COPD). Group 2: Control Group
  • Are 18 years of age or older.
  • Free from any pulmonary disease (asthma, COPD).
  • Are younger than 18 years of age.
  • Did not report any of the pulmonary disease (Asthma, COPD). Group 2: Control Group
  • Are younger than 18 years of age.
  • Reported any pulmonary disease (asthma, COPD
  • The Behavioral Risk Factor Surveillance System (BRFSS) is health-related telephone surveys that collect state data about United States residents regarding their health-related risk behaviors, chronic health conditions, and use of preventive services. This database contains data to help determine e-cigarette use in individuals with pulmonary disease in the US which little is known.
  • Note: The Behavioral Risk Factor Surveillance System (BRFSS) is a public dataset, and the data is publicly available online at (https://www.cdc.gov/brfss/annual\_data/annual\_2017.html)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Centers for Disease Control and Prevention (CDC). Behavioral Risk Factor Surveillance System Survey Data. Atlanta, Georgia: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, [2017].

    BACKGROUND
  • Centers for Disease Control and Prevention (CDC). Behavioral Risk Factor Surveillance System Survey Questionnaire. Atlanta, Georgia: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, [2017]

    BACKGROUND
  • Alqahtani MM, Alanazi AM, Pavela G, Dransfield MT, Wells JM, Lein DH Jr, Hendricks PS. Binge Drinking Moderates the Association Between Chronic Lung Disease and E-Cigarette Use. Respir Care. 2021 Jun;66(6):936-942. doi: 10.4187/respcare.08559. Epub 2021 Mar 9.

Related Links

MeSH Terms

Conditions

VapingLung Diseases

Condition Hierarchy (Ancestors)

SmokingBehaviorRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. Candidate, Rehabilitation Science Program

Study Record Dates

First Submitted

October 18, 2019

First Posted

October 22, 2019

Study Start

January 1, 2017

Primary Completion

December 30, 2017

Study Completion

December 30, 2017

Last Updated

October 22, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

This is public data set, it is already published by the CDC and any researchers can use these data. The Behavioral Risk Factor Surveillance System (BRFSS) is a health-related telephone surveys that collect state data about United States residents regarding their health-related risk behaviors, chronic health conditions, and use of preventive services.