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Factors That Impact the Relationship Between Pulmonary Status and Actual Electronic Cigarette Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135404
Recruitment Status : Completed
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Mohammed Alqahtani, University of Alabama at Birmingham

Tracking Information
First Submitted Date October 18, 2019
First Posted Date October 22, 2019
Last Update Posted Date October 22, 2019
Actual Study Start Date January 1, 2017
Actual Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 21, 2019)
  • Poor mental health mediate the relationship between pulmonary status (pulmonary vs. non-pulmonary) and e-cigarette use. [ Time Frame: 1 year ]
    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).
  • Smoking mediate the relationship between pulmonary status (pulmonary vs. non-pulmonary) and e-cigarette use. [ Time Frame: 1 year ]
    Smoking: This scale assesses the frequency of smoking cigarettes: 1 = every day, 2 = some days, 3 = not at all.
  • E-cigarette use (Dependent Variable) [ Time Frame: 1 year ]
    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).
  • Alcohol use moderate the relationship between pulmonary status (pulmonary vs. healthy) and e-cigarette use [ Time Frame: 1 year ]
    This question assesses the number of days in the last 30 days that participants have drunk alcohol (continuous variables).
  • (healthy days (health-related quality of life) mediate the relationship between pulmonary status (pulmonary vs. non-pulmonary) and e-cigarette use. [ Time Frame: 1 year ]
    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).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: October 21, 2019)
  • Marijuana use moderate the relationship between pulmonary status (pulmonary vs. healthy) and e-cigarette use. [ Time Frame: 1 year ]
    This question assesses the number of days in the last 30 days that participants have used marijuana or hashish (continuous variables).
  • Severity of COPD symptoms (COPD group) moderate the relationship between pulmonary status (COPD, asthma) and e-cigarette use [ Time Frame: 1 year ]
    Three questions are posed to assess the severity of COPD symptoms. The responses of these questions are combined to form a composite score. The first question will assess coughing, the second question will assess phlegm production, and the third question will assess shortness of breath. Answers for each of the three questions will be in a yes/no format and will be represented on a scale of 1-3, where 1 is less severe and 3 is more severe.
  • asthma symptoms (asthmatic group) moderate the relationship between pulmonary status (COPD, asthma) and e-cigarette use. [ Time Frame: 1 year ]
    Several questions determine the severity of asthma symptoms. The first question will assess the asthma symptoms by asking the participants the number of days they were unable to work or carry out their usual activities because of their asthma symptoms (continuous variables). The second question will assess coughing, wheezing, shortness of breath, chest tightness and phlegm production by asking participants the number of days out of the last 30 that they have any of the previous symptoms (continuous variables). The final question will symptoms of asthma make it difficult for the participants to stay asleep (continuous variables).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Factors That Impact the Relationship Between Pulmonary Status and Actual Electronic Cigarette Use
Official Title Factors That Impact the Relationship Between Pulmonary Status and Actual Electronic Cigarette Use (Secondary Data Analysis)
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.
Detailed Description Secondary data analysis will be performed as our approach to complete the study. A nationally representative dataset (BRFSS, 2017) will be used to answer our research questions. Our rationale is that there is insufficient research assessing the relationship between pulmonary status and e-cigarette use and that some factors, such as behavioral variables or psychosocial variables, might influence this relationship. Our expectation is that this study will deepen the understanding of the relationship between pulmonary status and e-cigarette use among U.S. adults. This study will cast light on different factors that influence the relationship between pulmonary status and e-cigarette use. Also, the following secondary outcomes will be tested: Severity of COPD symptoms (COPD group) moderate the relationship between pulmonary status (COPD status) and e-cigarette use, and Severity of asthma symptoms (asthma group) moderate the relationship between pulmonary status (asthma status) and e-cigarette use.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability 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
Condition
  • Electronic Cigarette Use
  • Pulmonary Disease
Intervention Other: health-related telephone surveys
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).
Study Groups/Cohorts
  • 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.
    Intervention: 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).
    Intervention: Other: health-related telephone surveys
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 21, 2019)
400000
Original Actual Enrollment Same as current
Actual Study Completion Date December 30, 2017
Actual Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

This is secondary data analysis, so there is no control over the data (inclusion criteria, and exclusion criteria).

Inclusion Criteria:

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).

Exclusion Criteria Group 1: Pulmonary

  • 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)

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04135404
Other Study ID Numbers IRB 300003376
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description:

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.

Current Responsible Party Mohammed Alqahtani, University of Alabama at Birmingham
Original Responsible Party Same as current
Current Study Sponsor University of Alabama at Birmingham
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Alabama at Birmingham
Verification Date October 2019