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

Pulmonary Disease Clinical Trial

Official title:

Factors That Impact the Relationship Between Pulmonary Status and Actual Electronic Cigarette Use (Secondary Data Analysis)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04135404
• Other study ID #: IRB 300003376
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: December 30, 2017

Study information

• Verified date: October 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400000
• Est. completion date: December 30, 2017
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Electronic Cigarette Use
• Lung Diseases
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

References & Publications (2)

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]

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	(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	Marijuana 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 used marijuana or hashish (continuous variables).	1 year
Secondary	Severity of COPD symptoms (COPD group) moderate the relationship between pulmonary status (COPD, asthma) and e-cigarette use	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.	1 year
Secondary	asthma symptoms (asthmatic group) moderate the relationship between pulmonary status (COPD, asthma) and e-cigarette use.	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).	1 year

External Links

•   This a comprehensive description of this data set