Smoking Cessation Clinical Trial
Official title:
Enhanced E-cigarette Coaching Intervention for Dual Users of Cigarettes and E-cigarettes
Verified date | October 2023 |
Source | Consumer Wellness Solutions |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to develop and pilot test an enhanced behavioral coaching intervention for dual users of cigarettes and electronic nicotine delivery systems (ENDS) who call tobacco quitlines for help quitting smoking.
Status | Completed |
Enrollment | 110 |
Est. completion date | October 1, 2020 |
Est. primary completion date | August 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - • Requested quitline coaching services and enrolled in 5 call Oklahoma Tobacco Helpline (OKHL) program - Currently using e-cigarettes - Indicated plan to use e-cigarettes in the next 30 days - English Speaking - 18+ years old - Willing to quit cigarettes in the next 30 days - Consented to receive automated phone outreach via the quitline (TCPA consented) - Has an Android smartphone with an operating system of 6.0 or higher and comfort downloading and using apps on phone - Has regular access to email - Callback best time between the hours of 6:00 am - 3:00 pm Pacific Standard Time Exclusion Criteria: - • Pregnant or Planning pregnancy within 3 months - Reported Schizophrenia diagnosis history during registration - Heart attack past 2 weeks - Stroke/Transient Ischemic Attack past 2 weeks - Rapid Irregular heart beat past 6 months - Angina or heart pain past 6 months - Currently taking Varenicline (also known as Chantix) or Bupropion (also known as Wellbutrin or Zyban) - Previously screened for study - Enrolled via proxy (i.e., did not self-enroll) |
Country | Name | City | State |
---|---|---|---|
United States | Optum | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Consumer Wellness Solutions | H. Lee Moffitt Cancer Center and Research Institute, SRI International, University of Oklahoma |
United States,
Vickerman KA, Carpenter KM, Miles LN, Hsu JM, Watt KA, Brandon TH, Hart JT, Javitz HS, Wagener TL. Treatment development, implementation, and participant baseline characteristics: A randomized pilot study of a tailored quitline intervention for individual — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 7-Day Point Prevalence Smoking Cessation Rates | In Phase 2 participants will report their quit status during their outcome survey. | Phase 2 time frame: 3 months after baseline | |
Other | Changes in Use of ENDS, Nicotine Replacement Therapy (NRT), and Cigarettes | A descriptive analysis of how ENDS, NRT, and cigarettes are used during a participant's quit process through diary procedures. | Up to 12 weeks | |
Primary | Treatment Satisfaction and Acceptability Measured on a Scale From 1-6 (Very Satisfied to Very Dissatisfied) | In Phase 2, average treatment satisfaction and acceptability rating will be compared for EEC and TAU participants. Full 1-6 scale description: 1 - very satisfied; 2 - satisfied; 3 - somewhat satisfied; 4 - somewhat dissatisfied; 5 - dissatisfied; 6 - very dissatisfied. Participants can also respond "I don't know" or "I prefer not to answer". On scale 1-6, 1 is the best outcome. | 3 months after baseline | |
Primary | Treatment Engagement: Call Completion | In Phase 2, call completion (captured via standard quitline data systems) will be compared for EEC and TAU participants. There is no limit to number of calls that can be completed, although participants are called to complete 5 scheduled calls (best outcome). | Phase 2 time frame: 3 months after baseline | |
Secondary | Quit Plan Development Experience | In Phase 2, quit plan development experience will be compared for EEC and TAU participants. Quit plan development experience will be measured with an adapted version of the CollaboRATE (not an abbreviation) shared decision making assessment measure. The adapted CollaboRATE measure included 3 questions (on a 5-point scale from "no effort (0)" to "every effort was made (4)"): "How much effort was made to help you understand your options for quitting smoking?", "How much effort was made to listen to the things that matter most to you about your plan for quitting smoking?", and "How much effort was made to include what matters most to you in creating your plan for quitting smoking?". Higher total scores indicate greater utilization of a shared decision-making approach during quit plan development. Scale minimum equals 0 and maximum equals 12. | 3 months after baseline | |
Secondary | Knowledge and Beliefs- Relative Risk of ENDS and Cigarettes | In Phase 2, Knowledge and Beliefs about ENDS, Smoking, and FDA-approved Cessation Medications was assessed via 3 relative risk questions about ENDS, Smoking, and FDA-approved Cessation Medications designed for this study, and compared for EEC and TAU participants. Responses to individual items will be described. To assess the relative risk of ENDS and cigarettes, the following question was asked, "Compared to cigarettes, how harmful are e-cigarettes to a person's health?" Answer responses included: less harmful, about the same, more harmful, and I prefer not to answer. | Phase 2 time frame: 3 months after baseline | |
Secondary | Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and Cigarettes | In Phase 2, Knowledge and Beliefs about ENDS, Smoking, and FDA-approved Cessation Medications was assessed via 3 relative risk questions about ENDS, Smoking, and FDA-approved Cessation Medications designed for this study, and compared for EEC and TAU participants. Responses to individual items will be described. To assess the relative risk of FDA-approved Cessation Medications and cigarettes, the following question was asked, "Compared to cigarettes, how harmful are quit medications like the nicotine patch to a person's health?" Answer responses included: less harmful, about the same, more harmful, and I prefer not to answer. | Phase 2 time frame: 3 months after baseline | |
Secondary | Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and ENDS | In Phase 2, Knowledge and Beliefs about ENDS, Smoking, and FDA-approved Cessation Medications was assessed via 3 relative risk questions about ENDS, Smoking, and FDA-approved Cessation Medications designed for this study, and compared for EEC and TAU participants. Responses to individual items will be described. To assess the relative risk of FDA-approved Cessation Medications and ENDS, the following question was asked, "Compared to quit medications like the nicotine patch, how harmful are e-cigarettes to a person's health?" Answer responses included: less harmful, about the same, more harmful, and I prefer not to answer. | Phase 2 time frame: 3 months after baseline |
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