Pilot Randomized Controlled Trial of a Smart Phone-Based Smoking Cessation Program

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Randomized Controlled Trial of a Smart Phone-Based Smoking Cessation Program

Conditions
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Smoking Cessation

Intervention / Treatment
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* Other: Control
* Other: Pivot


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 randomization
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>A commercially available mobile phone app and program | Other: Control<br>* Standard of Care - Control Smoking Cessation Program<br>* Other names: Standard of Care;|
| Active Comparator: Pivot<br>Pivot mobile phone app and program | Other: Pivot<br>* Pivot Program Smoking Cessation Program<br>* Other names: Pivot Program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total app opens at 12 weeks | Number of time the app is opened | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in expected difficulty in staying quit | participant self-report, scale 1-10 | 3 months | 
| Change in confidence levels towards quitting smoking | expected success in quitting, participant self-report, scale 1-10 | 3 months | 
| Desire to quit (yes/no) |  | 3 months | 
| Self-reported abstinence | 7-day and 30-day point prevalence abstinence | 3 months | 
| Self-reported abstinence from all tobacco products |  | 3 months | 
| Biochemically confirmed abstinence | Participants who report they have achieved at least 7-day point prevalence abstinence at 3 months will undergo a videoconference visit with study staff in which they provide a witnessed breath sample using a provided personal mobile carbon monoxide breath sensor. Breath sample values less than 10 ppm (parts per million) will be considered consistent with biochemical abstinence. | 3 months | 
| Self-reported continuous abstinence |  | 3 months | 
| Biochemically confirmed continuous abstinence | Defined as self-report of smoking no more than five cigarettes from 12 weeks after enrollment, and biochemical confirmation of abstinence on all previous and present biovalidation tests, with biochemical confirmation defined as: Participants who report they have achieved at least 7-day point prevalence abstinence at 3 months, 6 months and/or one year will undergo a videoconference visit with study staff in which they provide a witnessed breath sample using a provided personal mobile carbon monoxide breath sensor. Breath sample values less than 10 ppm (parts per million) will be considered consistent with biochemical abstinence. | 6 months, one year | 
| Proportion with >=50% CPD reduction | The proportion of participants who reduced their cigarettes per day (CPD) by ≥ 50% compared to baseline | 3 months | 
| User satisfaction | User satisfaction with the smoking cessation program (set-up and getting started with program, recommend to friend, program design, program was useful for quitting, program helped me quit, program helped me stay quit) | 3 months | 
| Engagement with program | collected weekly during the first 12 weeks after enrollment: Number of times app opened Number of days in which app was opened Number of weeks in which app was opened | 3 months | 
| Participant changes in self-efficacy | 6-item Smoking Abstinence Self-efficacy Questionnaire (SASEQ) (Spek V, et al. Int.J. Behav. Med. (2013) 20:444-449). | 3 months | 
| Participant changes in self-reported health and wellbeing |  | 3 months | 
| Self-reported nicotine replacement therapy (NRT) use |  | 3 months | 
| Use of other smoking cessation tools (apps, counseling, medications, etc.) |  | 3 months | 
| Adverse events |  | 3 months |