Pilot Randomized Controlled Trial of a Smart Phone-Based Smoking Cessation Program
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 188
- Locations
- 1
- Primary Endpoint
- Average Total App Openings at 12 Weeks
Study Overview
Brief Summary
Two-arm, parallel-group, non-crossover, single-center pilot randomized controlled trial, enrolling up to 180 participants to evaluate the effect of the Pivot smoking cessation program (intervention) compared to usual care (commercially available app smoking cessation program plus optional nicotine replacement therapy, control).
Detailed Description
The present pilot randomized controlled trial compares user engagement and retention, change in attitudes towards quitting smoking, change in smoking behavior and participant feedback in adult smokers randomized either to the Pivot (intervention) or commercially available (control) smoking cessation programs.
We aim to assess participants' use of Pivot program and commercially available program. There will be a focus on assessing use and engagement, changes in attitudes towards quitting smoking and changes in smoking behavior over the course of the 2-year study, as well as participant feedback on the set-up, design, use experience, and impact of each program.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Masking Description
Participant blinded to arm assignment but not to the smoking cessation program he/she is using.
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •21+ years of age
- •Current daily cigarette smokers (at least 5 cigarettes per day) for the past 12 months
- •Plans to quit smoking in the next 30 days
- •Resident of the United States
- •Able to read and comprehend English
- •Owns and uses a smart phone compatible with the study app (iPhone 5 and above with operating system (iOS) 12 and above, or, Android 7.0 and above with operating system Android 7.0 and above)
- •Has daily internet access on smart phone
- •Comfortable downloading and using smart phone apps
- •Willing to sign the Informed Consent Form
Exclusion Criteria
- •Pregnancy (self-reported)
- •Health contraindications to nicotine replacement therapy (NRT) use (irregular heartbeat, high blood pressure not controlled with medication, heart attack or stroke in last 2 months, pregnant or breast feeding, skin allergies to adhesive tape or serious skin problems, stomach ulcers, history of seizures)
- •Using other smoking cessation support, including apps and/or actively taking medication to quit smoking
- •Daily marijuana use
- •Residence with another person who is a participant in this study
- •Immediate family member is a participant in this study
- •Failure to provide contact or collateral information, failure to verify email address, and/or failure to demonstrate videoconference capability
- •Participation in a previous study sponsored by Carrot Inc.
Arms & Interventions
Control
A commercially available mobile phone app and program
Intervention: Control (Other)
Pivot
Pivot mobile phone app and program
Intervention: Pivot (Other)
Outcomes
Primary Outcomes
Average Total App Openings at 12 Weeks
Time Frame: 12 weeks
App/program engagement is assessed with the self-report of total app openings through the first 12 weeks of the program. Calculated by summing the number of weekly app openings reported by participants weekly.
Secondary Outcomes
- Self-Reported Continuous Abstinence(52 weeks)
- User Feedback: Number of Participants Who Agreed That Their Program Helped Them Quit Smoking(52 weeks)
- Desire to Quit (Yes/no)(4 weeks)
- Biochemically Confirmed Abstinence(52 weeks)
- Biochemically Confirmed Continuous Abstinence(52 weeks)
- Change in Confidence Levels Towards Quitting Smoking(12 weeks)
- Self-Reported Nicotine Replacement Therapy (NRT) Use(52 weeks)
- Change in Expected Difficulty in Staying Quit(12 weeks)
- Self-Reported Smoking Abstinence(52 weeks)
- Self-Reported Abstinence From All Tobacco Products(52 weeks)
- Proportion With ≥ 50% CPD Reduction(26 weeks)
- User Feedback - Setup and Starting the Program(12 weeks)
- User Feedback(26 weeks)
- User Satisfaction - User Feedback(2 weeks)
- Additional User Feedback(3 weeks)
- Engagement With Program - Number of Times App Was Opened(12 weeks)
- Engagement With Program - Number of Weeks App Was Opened(12 weeks)
- Participant Changes in Self-Efficacy(52 weeks)
- Participant Changes in Self-reported Health and Wellbeing(12 weeks)
- User Satisfaction - Net Promoter Score (NPS)(4 weeks, 12 weeks, and 26 weeks)
- Engagement With Program - Number of Days App Was Opened(12 weeks)
- Adverse Events(12 weeks)
- Self-Reported Smoking Abstinence(12 weeks)
- Self-Reported Smoking Abstinence(26 weeks)
- Self-Reported Abstinence From All Tobacco Products(12 weeks)
- Self-Reported Abstinence From All Tobacco Products(26 weeks)
- Biochemically Confirmed Abstinence(12 weeks)
- Biochemically Confirmed Abstinence(26 weeks)
- Self-Reported Continuous Abstinence(26 weeks)
- Biochemically Confirmed Continuous Abstinence(26 weeks)
- Participant Changes in Self-Efficacy(12 weeks)
- Self-Reported Nicotine Replacement Therapy (NRT) Use(26 weeks)
Investigators
Jennifer Marler, MD
Sr. Dir., Clinical and Medical Affairs
Pivot Health Technologies Inc.