Electronic Cigarette UseNCT04151784
Factors That Impact the Relationship Between Pulmonary Status and Susceptibility to Electronic Cigarette Use
An observational study of Electronic Cigarette Use and Pulmonary Disease, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of the study is to explores various psycho-social, physiological, cognitive, behavioral, and environmental factors that may affect the association between pulmonary status and Susceptibility to Electronic Cigarette Use Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Electronic Cigarette Use, Pulmonary Disease
- What is being tested?
- Pulmonary Group
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 20 May 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The cohort will be divided into two groups according to their pulmonary status: subjects who are diagnosed with any pulmonary disease (pulmonary group) and those without any pulmonary disease (control group).
Who may be able to join
- Pulmonary Are 18 years of age or older. Attend outpatient Pulmonary clinic at UAB Diagnosed with a pulmonary disease Speak English as primary language Are medically stable and without psychiatric disorders. Signed Informed consent Healthy Are 18 years of age or older. Free from any pulmonary disease Report good to excellent general health Speak English as primary language Signed Informed consent
Who cannot join
- Pulmonary Are younger than 18 years of age Do not attend the outpatient pulmonary clinic at UAB (pulmonary group) Report current e-cigarette use Are non-English speakers Have unstable medical or psychiatric disorders as determined by the assigned medical doctor (pulmonary group) Refuse to sign the informed consent
- Healthy Are younger than 18 years of age Report any pulmonary diseases (control group) Report fair to poor general health (control group) Report current e-cigarette use Are non-English speakers Refuse to sign the informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294-1212
About this study
The purpose of the study is to explores various psycho-social, physiological, cognitive, behavioral, and environmental factors that may affect the association between pulmonary status and Susceptibility to Electronic Cigarette Use
Read the detailed description
In this study self-report questionnaires will be distributed and it should take between 20-25 minutes. Participants will be be asked questions related to smoking history, e-cigarette use, psychosocial factors, behavioral factors, environmental factors, and cognitive factors.
There is also an option of taking a web-based survey, Qualtrics® (Qualtrics, Provo, UT), if they do not have enough time to complete the surveys at this time. The online version of the questionnaires will be sent to the one week from now.
There is also a follow-up 5 minutes call with 6 months after today to follow-up with any change regarding to e-cigarette use.
- Conditions
- Electronic Cigarette Use, Pulmonary Disease
- Being tested
- Pulmonary Group, Healthy Control
- Keywords
- Susceptibility to Electronic Cigarette Use
- 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.
Pulmonary GroupOther
Data collection will be obtained on the day an individual has an appointment at the pulmonary clinic. After patients meet with their pulmonary physicians, the physicians will inform them about the study and explain that participation is voluntary. If a patient agrees, the researcher will provide copies of the questionnaires and again clarify that participation is voluntary. The workflow of the clinic will not be interrupted while the researcher conducts the study, and he will only ask participants to fill out the questionnaires if they have enough time to participate.
Healthy ControlOther
The second group will be recruited as a control group consisting of healthy adult participants through purposive convenience sampling at other collaborating UAB sites. The principal investigator will collect self-report responses through a questionnaire packet given to anyone willing to participate in the study
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Group | Pulmonary Group who have evidence of pulmonary diseases Receives: Other: Pulmonary Group | |
| Healthy Control | Health Group who have no evidence of pulmonary diseases Receives: Other: Healthy Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine psychosocial (stress, depression, anxiety) as mediators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
The DASS-21 is a clinical assessment that measures the state of depression, It has 21 questions. The internal consistency of the DASS-21 scales was acceptable (depression: alpha = .829). The scale range is from 0 to 28 + with 0 being closest to normal and 28+ being extremely severe. The DASS-21 is a clinical assessment that measures the state of anxiety, It has 21 questions. The internal consistency of the DASS-21 scales was acceptable (anxiety : alpha = .778). The scale range is from 0 to 20 + with 0 being closest to normal and 20+ being extremely severe. The DASS-21 is a clinical assessment that measures the state of stress, It has 21 questions. The internal consistency of the DASS-21 scales was acceptable (stress : alpha = .871). The scale range is from 0 to 37 + with 0 being closest to normal and 37+ being extremely severe
Measured: Through study completion, an average of 1 year
To examine physiological variables (quality of life) as mediators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
The Health Survey SF-12 questionnaire will be used to assess the quality of life (Ware, Kosinski, \& Keller, 1996). The SF-12 is a reliable and valid instrument. Internal consistency, test-retest reliability, construct (convergent and discriminant) validity, and criterion (concurrent and predictive) validity have been shown to be adequate (continuous variable). The minimum score is 0 and maximum score is 100, and higher scores mean a better quality of life and lower score mean worse outcome.
Measured: Through study completion, an average of 1 year
To examine physiological variables (Respiratory Symptoms) as mediators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
Questions that was developed by (Leidy, 2003) will be used to assess Breathlessness, Cough, Sputum, and chest tightness. Each symptom will be tested individually for its mediating effect, and they will be combined as one composite score to test the total mediating effect. The minimum score is 0 and maximum score is 25, and higher scores mean a worse respiratory symptoms and lower score mean better respiratory symptoms.
Measured: Through study completion, an average of 1 year
To examine physiological variables (Eating Disorder Questionnaire) as mediators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
12 questions adopted from Gideon et al. (2016) will be used to discover which participants believe that they suffer from eating disorders. This measure showed high internal consistency (Cronbach's α = .913) and temporal stability (ICC = .93; p < .001) (continuous variable). These range from a score of zero ("no symptoms") to three ("extreme symptoms").
Measured: Through study completion, an average of 1 year
To examine cognitive variables (Belief) as mediators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
A short form of the e-cigarette consequence questionnaire will be used to assess the e-cigarette expectancy questionnaire. This questionnaire was developed and validated by Peter S. Hendricks et al. (2014). Cronbach's alpha reliabilities of the e-cigarette-specific range from .67 to .88 (ordinal variable). This questionnaire has 25 statements. Each statement contains a possible consequence of smoking an e-cigarette. For each of the statements, participants should rate how LIKELY or UNLIKELY that they believe each consequence is for them when they use an e-cigarette. If the consequence seems LIKELY to them, they should circle a number from 5-9. That is, if they believe that a consequence would never happen, circle 0; if they believe a consequence would happen every time they smoke, circle 9. If it seems a little unlikely to them, they would circle 4
Measured: Through study completion, an average of 1 year
To examine cognitive variables (Risk Perception) as mediators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
Questions that have been successfully used in previous studies (Adkison et al., 2013; Choi \& Forster, 2013; Nicksic et al., 2017; Stein et al., 2015) will be used to assess the participants' risk perception of e-cigarettes (ordinal variable). There are six statements that assess the participants' perception toward e-cigarette, and the participants should choose between 1 to 5 where 1 means "strongly disagree" and 5 means "strongly agree".
Measured: Through study completion, an average of 1 year
To examine cognitive variables (attitudes toward e-cigarettes) as mediators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
The Comparing E-cigarettes and Cigarettes Questionnaire (CEAC) will be used to assess attitudes towards e-cigarettes compared to cigarettes. The CEAC is a 17-item self-report measure with three factors: (1) General Benefits (seven items; α = 0.85), (2) Addiction/Cessation Benefits (five items; α = 0.89), and (3) Improve Health (five items; α = 0.92) (Hershberger, Karyadi, VanderVeen, \& Cyders, 2017). The CEAC has been shown to be positively related to e-cig use (b 0.41-1.24, p < .01) and has demonstrated good psychometric properties (α 0.83-0.93) (ordinal variable). There are ten statements that assess the participants' perception toward e-cigarette, and the participants should choose between 1 to 5 where 1 means "strongly disagree" and 5 means "strongly agree".
Measured: Through study completion, an average of 1 year
To examine cognitive variables (intention to quit) as mediators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
A scale of 1 to 10 has been used before by Peter S. Hendricks et al. (2014) will be used to assess the desire to quit smoking and the success of quitting among smokers (continuous variable). (Scale of 1 to 10 with 1 = No desire to quit and 10 = full desire to quit).
Measured: Through study completion, an average of 1 year
To examine behavioral variables (Alcohol And Drug Use) as moderators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
They will be assessed using a previously used questionnaire (P. S. Hendricks, Delucchi, Humfleet, \& Hall, 2012) (categorical variable). Participants should choose "Yes" or "No" based to see if they drink alcohol or use any of the addictive substance.
Measured: Through study completion, an average of 1 year
To examine environmental variables (Advertisement) as moderators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
To assess different areas related to some environmental factors, the following questions will be asked: "When you are using the Internet, how often do you see ads or promotions for e-cigarettes," "When you read newspapers or magazines, how often do you see ads or promotions for e-cigarettes," "When you go to a convenience store, supermarket, or gas station, how often do you see ads or promotions for e-cigarettes," and "When you watch TV, how often do you see ads or promotions for e-cigarettes." Participants can choose from a Likert scale with responses range from 1 to 6 where 1 means ("No use/watch/see/go") and 6 means "always". This question has been successfully used in previous Centers for Disease Control and Prevention (CDC) studies (ordinal variable).
Measured: Through study completion, an average of 1 year
To examine environmental variables (Warning Labels) as moderators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
To assess awareness of warning labels on e-cigarettes and associated paraphernalia, we will use the following question: "During the past 30 days, how often did you see a warning label on an e-cigarette package?" Participants can choose from 6 Likert scale categories in order for them to answer the preceding questions. 1 indicates "I did not see an e-cigarette package during the past 30 days" and 6 indicates always. This question has been successfully used in previous Centers for Disease Control and Prevention (CDC) studies (ordinal variable).
Measured: Through study completion, an average of 1 year
To examine environmental variables (Exposure to Special Prices ) as moderators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
Exposure to special price offers for e-cigarettes will be assessed by asking: "In the last 30 days, have you noticed any special price offers, such as discounts or coupons, for e-cigarettes/vaping devices or e-liquid?" Response options include "Yes" and "No". This question has been successfully used in previous Centers for Disease Control and Prevention (CDC) studies (categorical variable).
Measured: Through study completion, an average of 1 year
To examine environmental variables (Exposure to E-cigarette Vapors from Some in An indoor or Outdoor Public Place ) as moderators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
A question will be asked regarding number of days that someone breathes vapor from someone who was using an e-cigarette in an indoor or outdoor public place. This question has been successfully used in previous Centers for Disease Control and Prevention (CDC) studies (continuous variable).
Measured: Through study completion, an average of 1 year
To examine environmental variables (Using E-cigarettes in Home) as moderators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
The following question will be asked regarding using e-cigarettes in home "Does anyone who lives with you use e-cigarette?" (yes/no). This question has been successfully used in previous Centers for Disease Control and Prevention (CDC) studies (categorical variable).
Measured: Through study completion, an average of 1 year
To examine environmental variables (suggestion to Use E-cigarettes by Healthcare Provider) as moderators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
A question will be asked to see if e-cigarette use was suggested by a healthcare provider. This question has been successfully used by Harrington et al. (2014) in previous studies (yes/no) (categorical variable).
Measured: Through study completion, an average of 1 year
Susceptibility to e-cigarette use
The questionnaire that will be used in our study was adopted from a study performed by Nicksic, Snell, Rudy, Cobb and Barnes (44). Nicksic, Snell, Rudy, Cobb and Barnes (44) adapted a validated measure on susceptibility to smoking. The adapted survey scale for measuring susceptibility to using e-cigarette showed a high degree of internal consistency (Cronbach's alpha = 0.97). The susceptibility to e-cigarette use score is constructed based on participants' responses to the following questions: (1) Do you think that you will use an e- cigarette soon? (2) Do you think that in the future you might experiment with e-cigarettes? (3) Do you think you will use an e-cigarette in the next year? and (4) If one of your best friends were to offer you an e-cigarette, would you smoke it? After each question, participants could endorse "Definitely not," "Probably not," "Probably yes," and "Definitely yes." (Continuous variables).
Measured: Through study completion, an average of 1 year
Nicotine addiction as a moderating variable between pulmonary status and the e-cigarette use.
The Penn State Cigarette Dependence Index (PS-CDI) to assess cigarette dependence. The PS-CDI (α = .72) both have fair to good internal consistency (Foulds et al., 2015). The PS-CDI also appears to be a valid measure of the dependence construct, capturing self-perceived addiction, heavy use, early use after overnight deprivation, and continued use over time (continuous variable). The Penn State Cigarette Dependence Index (PS-CDI) to assess cigarette dependence. The PS-CDI (α = .72) both have fair to good internal consistency (Foulds et al., 2015). The PS-CDI also appears to be a valid measure of the dependence construct, capturing self-perceived addiction, heavy use, early use after overnight deprivation, and continued use over time (continuous variable). Scoring: 0-3= not dependent, 4-8 low dependence, 9-12 medium dependence, 13+ = high dependence
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Demographic variables
Demographic information will be collected from participants by using questions adopted from the National Adult Tobacco Survey Questionnaire. Different question will be used about gender, age, income, and education.
Measured: Through study completion, an average of 1 year
Health information
The following question will be used to assess participants' health status: "In general, how is your health?" (Excellent, very good, good, fair, poor). This question has been successfully used in previous studies
Measured: Through study completion, an average of 1 year
Pulmonary Status
ICD-10-CM (International Classification of pulmonary diseases) will be used to determine if the healthy adults have a history of pulmonary disease.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Jan 2020
- Primary completion5 May 2021
- Study completion20 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 200 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
- NCT04151784
- Sponsor's protocol ID
- IRB-300003376
- Status last verified
- May 2021
- First submitted
- 30 Oct 2019
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To be determined
Publications
Alqahtani MM Jr, Alanazi AMM, Aljohani H, Ismaeil TT, Algarni SS, Alotaibi TF, Alotaibi MM, Kalan ME, Lein DH, Alqahtani MK, Alwadeai KS, Almutairi AB, Hendricks PS. The relationship between chronic lung disease diagnosis and the susceptibility to e-cigarette use in adults: The mediation effects of psychosocial, cognitive influences, and the moderation effect of physiological factors. Tob Induc Dis. 2023 Sep 22;21:116. doi: 10.18332/tid/169741. eCollection 2023.
PubMed 37745030
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors That Impact the Relationship Between Pulmonary Status and Susceptibility to Electronic Cigarette Use
- ClinicalTrials.gov ID
- NCT04151784
- Acronym / sponsor ID
- IRB-300003376
- Conditions
- Electronic Cigarette Use, Pulmonary Disease
- Keywords
- Susceptibility to Electronic Cigarette Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 5 May 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 5 Nov 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.
The purpose of the study is to explores various psycho-social, physiological, cognitive, behavioral, and environmental factors that may affect the association between pulmonary status and Susceptibility to Electronic Cigarette Use
Detailed description
In this study self-report questionnaires will be distributed and it should take between 20-25 minutes. Participants will be be asked questions related to smoking history, e-cigarette use, psychosocial factors, behavioral factors, environmental factors, and cognitive factors.
There is also an option of taking a web-based survey, Qualtrics® (Qualtrics, Provo, UT), if they do not have enough time to complete the surveys at this time. The online version of the questionnaires will be sent to the one week from now.
There is also a follow-up 5 minutes call with 6 months after today to follow-up with any change regarding to e-cigarette use.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Group | – | Other: Pulmonary GroupPulmonary Group who have evidence of pulmonary diseases |
| Healthy Control | – | Other: Healthy ControlHealth Group who have no evidence of pulmonary diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort will be divided into two groups according to their pulmonary status: subjects who are diagnosed with any pulmonary disease (pulmonary group) and those without any pulmonary disease (control group).
Key inclusion criteria (1 listed)
- Pulmonary Are 18 years of age or older. Attend outpatient Pulmonary clinic at UAB Diagnosed with a pulmonary disease Speak English as primary language Are medically stable and without psychiatric disorders. Signed Informed consent Healthy Are 18 years of age or older. Free from any pulmonary disease Report good to excellent general health Speak English as primary language Signed Informed consent
Key exclusion criteria (2 listed)
- Pulmonary Are younger than 18 years of age Do not attend the outpatient pulmonary clinic at UAB (pulmonary group) Report current e-cigarette use Are non-English speakers Have unstable medical or psychiatric disorders as determined by the assigned medical doctor (pulmonary group) Refuse to sign the informed consent
- Healthy Are younger than 18 years of age Report any pulmonary diseases (control group) Report fair to poor general health (control group) Report current e-cigarette use Are non-English speakers Refuse to sign the informed consent
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 |
|---|---|---|
| Pulmonary GroupData collection will be obtained on the day an individual has an appointment at the pulmonary clinic. After patients meet with their pulmonary physicians, the physicians will inform them about the study and explain that participation is voluntary. If a patient agrees, the researcher will provide copies of the questionnaires and again clarify that participation is voluntary. The workflow of the clinic will not be interrupted while the researcher conducts the study, and he will only ask participants to fill out the questionnaires if they have enough time to participate. | Other | Pulmonary Group |
| Healthy ControlThe second group will be recruited as a control group consisting of healthy adult participants through purposive convenience sampling at other collaborating UAB sites. The principal investigator will collect self-report responses through a questionnaire packet given to anyone willing to participate in the study | Other | Healthy Control |
Primary outcome
To examine psychosocial (stress, depression, anxiety) as mediators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
Time frame: Through study completion, an average of 1 year
The DASS-21 is a clinical assessment that measures the state of depression, It has 21 questions. The internal consistency of the DASS-21 scales was acceptable (depression: alpha = .829). The scale range is from 0 to 28 + with 0 being closest to normal and 28+ being extremely severe. The DASS-21 is a clinical assessment that measures the state of anxiety, It has 21 questions. The internal consistency of the DASS-21 scales was acceptable (anxiety : alpha = .778). The scale range is from 0 to 20 + with 0 being closest to normal and 20+ being extremely severe. The DASS-21 is a clinical assessment that measures the state of stress, It has 21 questions. The internal consistency of the DASS-21 scales was acceptable (stress : alpha = .871). The scale range is from 0 to 37 + with 0 being closest to normal and 37+ being extremely severe
To examine physiological variables (quality of life) as mediators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
Time frame: Through study completion, an average of 1 year
The Health Survey SF-12 questionnaire will be used to assess the quality of life (Ware, Kosinski, \& Keller, 1996). The SF-12 is a reliable and valid instrument. Internal consistency, test-retest reliability, construct (convergent and discriminant) validity, and criterion (concurrent and predictive) validity have been shown to be adequate (continuous variable). The minimum score is 0 and maximum score is 100, and higher scores mean a better quality of life and lower score mean worse outcome.
To examine physiological variables (Respiratory Symptoms) as mediators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
Time frame: Through study completion, an average of 1 year
Questions that was developed by (Leidy, 2003) will be used to assess Breathlessness, Cough, Sputum, and chest tightness. Each symptom will be tested individually for its mediating effect, and they will be combined as one composite score to test the total mediating effect. The minimum score is 0 and maximum score is 25, and higher scores mean a worse respiratory symptoms and lower score mean better respiratory symptoms.
To examine physiological variables (Eating Disorder Questionnaire) as mediators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
Time frame: Through study completion, an average of 1 year
12 questions adopted from Gideon et al. (2016) will be used to discover which participants believe that they suffer from eating disorders. This measure showed high internal consistency (Cronbach's α = .913) and temporal stability (ICC = .93; p < .001) (continuous variable). These range from a score of zero ("no symptoms") to three ("extreme symptoms").
To examine cognitive variables (Belief) as mediators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
Time frame: Through study completion, an average of 1 year
A short form of the e-cigarette consequence questionnaire will be used to assess the e-cigarette expectancy questionnaire. This questionnaire was developed and validated by Peter S. Hendricks et al. (2014). Cronbach's alpha reliabilities of the e-cigarette-specific range from .67 to .88 (ordinal variable). This questionnaire has 25 statements. Each statement contains a possible consequence of smoking an e-cigarette. For each of the statements, participants should rate how LIKELY or UNLIKELY that they believe each consequence is for them when they use an e-cigarette. If the consequence seems LIKELY to them, they should circle a number from 5-9. That is, if they believe that a consequence would never happen, circle 0; if they believe a consequence would happen every time they smoke, circle 9. If it seems a little unlikely to them, they would circle 4
To examine cognitive variables (Risk Perception) as mediators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
Time frame: Through study completion, an average of 1 year
Questions that have been successfully used in previous studies (Adkison et al., 2013; Choi \& Forster, 2013; Nicksic et al., 2017; Stein et al., 2015) will be used to assess the participants' risk perception of e-cigarettes (ordinal variable). There are six statements that assess the participants' perception toward e-cigarette, and the participants should choose between 1 to 5 where 1 means "strongly disagree" and 5 means "strongly agree".
To examine cognitive variables (attitudes toward e-cigarettes) as mediators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
Time frame: Through study completion, an average of 1 year
The Comparing E-cigarettes and Cigarettes Questionnaire (CEAC) will be used to assess attitudes towards e-cigarettes compared to cigarettes. The CEAC is a 17-item self-report measure with three factors: (1) General Benefits (seven items; α = 0.85), (2) Addiction/Cessation Benefits (five items; α = 0.89), and (3) Improve Health (five items; α = 0.92) (Hershberger, Karyadi, VanderVeen, \& Cyders, 2017). The CEAC has been shown to be positively related to e-cig use (b 0.41-1.24, p < .01) and has demonstrated good psychometric properties (α 0.83-0.93) (ordinal variable). There are ten statements that assess the participants' perception toward e-cigarette, and the participants should choose between 1 to 5 where 1 means "strongly disagree" and 5 means "strongly agree".
To examine cognitive variables (intention to quit) as mediators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
Time frame: Through study completion, an average of 1 year
A scale of 1 to 10 has been used before by Peter S. Hendricks et al. (2014) will be used to assess the desire to quit smoking and the success of quitting among smokers (continuous variable). (Scale of 1 to 10 with 1 = No desire to quit and 10 = full desire to quit).
To examine behavioral variables (Alcohol And Drug Use) as moderators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
Time frame: Through study completion, an average of 1 year
They will be assessed using a previously used questionnaire (P. S. Hendricks, Delucchi, Humfleet, \& Hall, 2012) (categorical variable). Participants should choose "Yes" or "No" based to see if they drink alcohol or use any of the addictive substance.
To examine environmental variables (Advertisement) as moderators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
Time frame: Through study completion, an average of 1 year
To assess different areas related to some environmental factors, the following questions will be asked: "When you are using the Internet, how often do you see ads or promotions for e-cigarettes," "When you read newspapers or magazines, how often do you see ads or promotions for e-cigarettes," "When you go to a convenience store, supermarket, or gas station, how often do you see ads or promotions for e-cigarettes," and "When you watch TV, how often do you see ads or promotions for e-cigarettes." Participants can choose from a Likert scale with responses range from 1 to 6 where 1 means ("No use/watch/see/go") and 6 means "always". This question has been successfully used in previous Centers for Disease Control and Prevention (CDC) studies (ordinal variable).
To examine environmental variables (Warning Labels) as moderators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
Time frame: Through study completion, an average of 1 year
To assess awareness of warning labels on e-cigarettes and associated paraphernalia, we will use the following question: "During the past 30 days, how often did you see a warning label on an e-cigarette package?" Participants can choose from 6 Likert scale categories in order for them to answer the preceding questions. 1 indicates "I did not see an e-cigarette package during the past 30 days" and 6 indicates always. This question has been successfully used in previous Centers for Disease Control and Prevention (CDC) studies (ordinal variable).
To examine environmental variables (Exposure to Special Prices ) as moderators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
Time frame: Through study completion, an average of 1 year
Exposure to special price offers for e-cigarettes will be assessed by asking: "In the last 30 days, have you noticed any special price offers, such as discounts or coupons, for e-cigarettes/vaping devices or e-liquid?" Response options include "Yes" and "No". This question has been successfully used in previous Centers for Disease Control and Prevention (CDC) studies (categorical variable).
To examine environmental variables (Exposure to E-cigarette Vapors from Some in An indoor or Outdoor Public Place ) as moderators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
Time frame: Through study completion, an average of 1 year
A question will be asked regarding number of days that someone breathes vapor from someone who was using an e-cigarette in an indoor or outdoor public place. This question has been successfully used in previous Centers for Disease Control and Prevention (CDC) studies (continuous variable).
To examine environmental variables (Using E-cigarettes in Home) as moderators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
Time frame: Through study completion, an average of 1 year
The following question will be asked regarding using e-cigarettes in home "Does anyone who lives with you use e-cigarette?" (yes/no). This question has been successfully used in previous Centers for Disease Control and Prevention (CDC) studies (categorical variable).
To examine environmental variables (suggestion to Use E-cigarettes by Healthcare Provider) as moderators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes.
Time frame: Through study completion, an average of 1 year
A question will be asked to see if e-cigarette use was suggested by a healthcare provider. This question has been successfully used by Harrington et al. (2014) in previous studies (yes/no) (categorical variable).
Susceptibility to e-cigarette use
Time frame: Through study completion, an average of 1 year
The questionnaire that will be used in our study was adopted from a study performed by Nicksic, Snell, Rudy, Cobb and Barnes (44). Nicksic, Snell, Rudy, Cobb and Barnes (44) adapted a validated measure on susceptibility to smoking. The adapted survey scale for measuring susceptibility to using e-cigarette showed a high degree of internal consistency (Cronbach's alpha = 0.97). The susceptibility to e-cigarette use score is constructed based on participants' responses to the following questions: (1) Do you think that you will use an e- cigarette soon? (2) Do you think that in the future you might experiment with e-cigarettes? (3) Do you think you will use an e-cigarette in the next year? and (4) If one of your best friends were to offer you an e-cigarette, would you smoke it? After each question, participants could endorse "Definitely not," "Probably not," "Probably yes," and "Definitely yes." (Continuous variables).
Nicotine addiction as a moderating variable between pulmonary status and the e-cigarette use.
Time frame: Through study completion, an average of 1 year
The Penn State Cigarette Dependence Index (PS-CDI) to assess cigarette dependence. The PS-CDI (α = .72) both have fair to good internal consistency (Foulds et al., 2015). The PS-CDI also appears to be a valid measure of the dependence construct, capturing self-perceived addiction, heavy use, early use after overnight deprivation, and continued use over time (continuous variable). The Penn State Cigarette Dependence Index (PS-CDI) to assess cigarette dependence. The PS-CDI (α = .72) both have fair to good internal consistency (Foulds et al., 2015). The PS-CDI also appears to be a valid measure of the dependence construct, capturing self-perceived addiction, heavy use, early use after overnight deprivation, and continued use over time (continuous variable). Scoring: 0-3= not dependent, 4-8 low dependence, 9-12 medium dependence, 13+ = high dependence
3 secondary outcomes
Demographic variables
Time frame: Through study completion, an average of 1 year
Health information
Time frame: Through study completion, an average of 1 year
Pulmonary Status
Time frame: Through study completion, an average of 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 25 May 2021.
- Derived from this study: PubMed 37745030Alqahtani MM Jr, Alanazi AMM, Aljohani H, Ismaeil TT, Algarni SS, Alotaibi TF, Alotaibi MM, Kalan ME, Lein DH, Alqahtani MK, Alwadeai KS, Almutairi AB, Hendricks PS. The relationship between chronic lung disease diagnosis and the susceptibility to e-cigarette use in adults: The mediation effects of psychosocial, cognitive influences, and the moderation effect of physiological factors. Tob Induc Dis. 2023 Sep 22;21:116. doi: 10.18332/tid/169741. eCollection 2023.
- Individual participant dataSharing planned: No. To be determined
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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.
1 site in 1 country: see every site and its status.
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 at 1 site in United States.
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 1 inclusion and 2 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 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
To examine psychosocial (stress, depression, anxiety) as mediators of the relationship between pulmonary disease status and susceptibility to using e-cigarettes. (time frame: Through study completion, an average of 1 year). The study lists 17 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 NCT04151784, which also lists 1 linked publication.
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 25 May 2021.