- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03575468
Enhanced E-cigarette Coaching Intervention for Dual Users of Cigarettes and E-cigarettes
October 2, 2023 updated by: Consumer Wellness Solutions
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The specific aims of this research are to:
- Develop an Enhanced ENDS Coaching (EEC) intervention to improve standard quitline treatment for dual users who contact the quitline for help quitting smoking and are using ENDS, and train tobacco cessation coaches to deliver the intervention.
- Phase 1 (n=10): Assess preliminary EEC acceptability and feasibility, and refine the intervention with 10 dual users. Hypothesis 1: ENDS users will rate the helpfulness and usability of EEC positively and will exhibit increased knowledge about ENDS and cessation aids.
- Phase 2 (n=100): Evaluate the feasibility and acceptability of EEC compared to quitline treatment as usual (TAU) in a randomized pilot study of 100 smokers who use ENDS and are seeking help with quitting smoking. Hypothesis 2a (engagement): EEC participants will complete as many or more coaching calls than TAU. Hypothesis 2b (acceptability, satisfaction; assessed via 3-month survey): EEC will have satisfaction at least as high as the TAU group and rate their quit plan development experience more positively. Hypothesis 2c (beliefs; assessed at 3-month survey): EEC participants will report more accurate knowledge and beliefs about ENDS, smoking, and FDA-approved cessation medications.
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Washington
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Seattle, Washington, United States, 98104
- Optum
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Enhanced E-cigarette Coaching (EEC)
The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call.
In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
|
The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call.
In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
Other Names:
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Active Comparator: Quitline treatment as usual (TAU)
The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence.
All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
|
The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence.
All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Satisfaction and Acceptability Measured on a Scale From 1-6 (Very Satisfied to Very Dissatisfied)
Time Frame: 3 months after baseline
|
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
|
Treatment Engagement: Call Completion
Time Frame: Phase 2 time frame: 3 months after baseline
|
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quit Plan Development Experience
Time Frame: 3 months after baseline
|
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.
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3 months after baseline
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Knowledge and Beliefs- Relative Risk of ENDS and Cigarettes
Time Frame: Phase 2 time frame: 3 months after baseline
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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.
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Phase 2 time frame: 3 months after baseline
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Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and Cigarettes
Time Frame: Phase 2 time frame: 3 months after baseline
|
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.
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Phase 2 time frame: 3 months after baseline
|
Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and ENDS
Time Frame: Phase 2 time frame: 3 months after baseline
|
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.
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Phase 2 time frame: 3 months after baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
7-Day Point Prevalence Smoking Cessation Rates
Time Frame: Phase 2 time frame: 3 months after baseline
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In Phase 2 participants will report their quit status during their outcome survey.
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Phase 2 time frame: 3 months after baseline
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Changes in Use of ENDS, Nicotine Replacement Therapy (NRT), and Cigarettes
Time Frame: Up to 12 weeks
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A descriptive analysis of how ENDS, NRT, and cigarettes are used during a participant's quit process through diary procedures.
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Up to 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Katrina Vickerman, PHD, Optum, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 7, 2018
Primary Completion (Actual)
August 31, 2020
Study Completion (Actual)
October 1, 2020
Study Registration Dates
First Submitted
May 31, 2018
First Submitted That Met QC Criteria
June 28, 2018
First Posted (Actual)
July 2, 2018
Study Record Updates
Last Update Posted (Actual)
October 16, 2023
Last Update Submitted That Met QC Criteria
October 2, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 1R21DA042960-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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