- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04135404
Factors That Impact the Relationship Between Pulmonary Status and Actual Electronic Cigarette Use
Factors That Impact the Relationship Between Pulmonary Status and Actual Electronic Cigarette Use (Secondary Data Analysis)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
Description
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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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 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).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
1 year
|
|
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.
|
1 year
|
|
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).
|
1 year
|
|
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).
|
1 year
|
|
(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).
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
1 year
|
|
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.
|
1 year
|
|
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).
|
1 year
|
Collaborators and Investigators
Publications and helpful links
General 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 300003376
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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