Electronic Cigarette UseNCT04135404
Factors That Impact the Relationship Between Pulmonary Status and Actual Electronic Cigarette Use
An observational study of Electronic Cigarette Use and Pulmonary Disease, run by University of Alabama at Birmingham.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Electronic Cigarette Use, Pulmonary Disease
- What is being tested?
- health-related telephone surveys
- How many people
- 400,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 30 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- 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/annualdata/annual2017.html)
About this study
Official title: Factors That Impact the Relationship Between Pulmonary Status and Actual Electronic Cigarette Use (Secondary Data Analysis)
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.
Read the 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.
- Conditions
- Electronic Cigarette Use, Pulmonary Disease
- Being tested
- health-related telephone surveys
- Medical subject headings
- Vaping, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health-related telephone surveysOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: health-related telephone surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 1 year
Secondary outcomes (3)
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).
Measured: 1 year
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.
Measured: 1 year
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start1 Jan 2017
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Electronic Cigarette UseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 400,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Alqahtani, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135404
- Sponsor's protocol ID
- IRB 300003376
- Status last verified
- Oct 2019
- First submitted
- 18 Oct 2019
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 33688091
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors That Impact the Relationship Between Pulmonary Status and Actual Electronic Cigarette Use (Secondary Data Analysis)
- ClinicalTrials.gov ID
- NCT04135404
- Acronym / sponsor ID
- IRB 300003376
- Conditions
- Electronic Cigarette Use, Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400,000 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 22 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Group | – | Other: health-related telephone surveysThis 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. |
| Control Group | – | Other: health-related telephone surveysThis 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| health-related telephone surveysThe 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). | Other | Control Group, Pulmonary Group |
Primary outcome
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).
3 secondary outcomes
Marijuana use moderate the relationship between pulmonary status (pulmonary vs. healthy) and e-cigarette use.
Time frame: 1 year
Severity of COPD symptoms (COPD group) moderate the relationship between pulmonary status (COPD, asthma) and e-cigarette use
Time frame: 1 year
asthma symptoms (asthmatic group) moderate the relationship between pulmonary status (COPD, asthma) and e-cigarette use.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- BackgroundCenters 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].
- BackgroundCenters 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]
- Derived from this study: PubMed 33688091Alqahtani 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Electronic Cigarette Use and Pulmonary Disease, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Poor mental health mediate the relationship between pulmonary status (pulmonary vs. non-pulmonary) and e-cigarette use. (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04135404, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.