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

• ClinicalTrials.gov Identifier: NCT04135404
• Recruitment Status: Completed
• First Posted: October 22, 2019
• Last Update Posted: October 22, 2019
• Sponsor: University of Alabama at Birmingham
• 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 *

• 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].
• 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]
• 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.

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

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