Enhanced Usual Care plus Financial Incentives plus Mobile Health Application for Smoking Cessation
N/A
Recruiting
Led By Scott D Halpern, MD PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Current smoker (≥ 1 cigarettes per day, not including e-cigarettes)
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up2 weeks, 3 months, 6 months,12 months
Awards & highlights
No Placebo-Only Group
Study Summary
This trial will compare the effectiveness of four interventions to help smokers quit smoking for at least six months.
Eligible Conditions
- Smoking Cessation
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You smoke at least one regular cigarette per day (excluding e-cigarettes).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks, 3 months, 6 months,12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks, 3 months, 6 months,12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Biochemically confirmed smoking abstinence sustained for 6 months
Secondary outcome measures
Health-related quality of life
Motivation to quit
Perceived barriers to cessation
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Active Control
Group I: Enhanced Usual Care plus Financial Incentives plus Mobile Health ApplicationActive Control3 Interventions
Participants receive all aspects of Arm 3 plus an intervention to promote episodic future thinking (EFT), called FutureMe. EFT has been shown to reliably reduce discounting of the future. Patients will practice using EFT cues to envision the "future is now" between the time of enrollment and the quit date, and will then receive cues from the quit date through the end of the intervention period, 6 months later, unless they ask to stop receiving cues sooner.
Group II: Enhanced Usual Care plus Financial IncentivesActive Control2 Interventions
Participants receive all aspects of enhanced usual care plus an incentive plan in which they will be informed of their eligibility to earn $100, $200, and $300 if they submit negative tests for nicotine metabolites at 2 weeks, 3 month and 6 months following their quit date, respectively.
Group III: Basic Usual CareActive Control1 Intervention
Participants receive the usual care approach, Ask-Advise-Refer (AAR), which is a standard approach in which non-study clinicians ask smokers about their desire to quit smoking, advise them to quit, and provide informational resources such as hotlines, specialized clinics, or smoking cessation classes.
Group IV: Enhanced Usual CareActive Control1 Intervention
Participants receive the basic usual care of Ask-Advise-Refer as well as free access to nicotine replacement therapy (NRT) and/or reimbursement of up to $300 for any smoking cessation medications (varenicline/Chantix or bupropion/Zyban) prescribed by non-study clinicians.
Find a site
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
1,934 Previous Clinical Trials
42,431,899 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
524 Previous Clinical Trials
29,916,524 Total Patients Enrolled
Scott D Halpern, MD PhDPrincipal Investigator
University of Pennsylvania1 Previous Clinical Trials
1,917 Total Patients Enrolled
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is the trial population involved in this research?
"To successfully complete this clinical trial, a total of 3200 participants are required to meet the prerequisites. Notably, Kaiser Permanente Southern California in Oakland and Henry Ford Health System in Detroit have both opened their doors for recruitment."
Answered by AI
How many healthcare institutions are administering this clinical trial?
"This clinical trial is available at Kaiser Permanente Southern California in Oakland, Henry Ford Health System in Detroit, and University of Pennsylvania in Philadelphia. There are 4 other locations offering this study as well."
Answered by AI
Are there still openings available for the participants of this clinical trial?
"Indeed, the information from clinicaltrials.gov reveals this investigation is still in search of participants. The trial was launched on May 17th 2021 and has been updated as recently as October 24th 2022. 3200 individuals have to be enrolled across 4 sites for completion of the study."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Henry Ford Health System
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
What questions have other patients asked about this trial?
I am low income and cannot afford to travel and pay for things involved with the trial is this a paid trial?
Patient
Why did patients apply to this trial?
I have lung nodules that leave me with only 40 percent of lung capacity I was going to the pulmonary specialist every 6 months to see if they mastasized. I have chronic bronchitis and I have smoked since I was 14. A pack a pay. Menthol.
Patient
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