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

NCT04151784 | Completed

• 1 other identifier: IRB-300003376
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Electronic Cigarette Use; Pulmonary Disease

Keywords

Susceptibility to Electronic Cigarette Use

Outcome Measures

Primary Outcomes (17)

• 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

  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.

  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.

  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").

  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

  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".

  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".

  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).

  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.

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• Demographic variables

  Through study completion, an average of 1 year

• Health information

  Through study completion, an average of 1 year

• Pulmonary Status

  Through study completion, an average of 1 year

Study Arms (2)

Pulmonary Group

Pulmonary Group who have evidence of pulmonary diseases

Other: Pulmonary Group

Healthy Control

Health Group who have no evidence of pulmonary diseases

Other: Healthy Control

Interventions

Pulmonary Group OTHER

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.

Pulmonary Group

Healthy Control OTHER

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

Healthy Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-1212, United States

Location

Related Publications (1)

• 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.

  PMID: 37745030 DERIVED

MeSH Terms

Conditions

Vaping; Lung Diseases

Condition Hierarchy (Ancestors)

Smoking; Behavior; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 5, 2019
• Study Start: January 1, 2020
• Primary Completion: May 5, 2021
• Study Completion: May 20, 2021
• Last Updated: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)