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

Not Applicable

Completed

Conditions: Smoking Cessation

Interventions: Other: Pivot
Other: Control

Registration Number: NCT04955639

Lead Sponsor: Jennifer Marler, MD

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 188

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pivot	Pivot	Pivot mobile phone app and program
Control	Control	A commercially available mobile phone app and program

Primary Outcome Measures

Name	Time	Method
Average Total App Openings at 12 Weeks	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 Outcome Measures

Name	Time	Method
Self-Reported Continuous Abstinence	52 weeks	Defined as self-report of 7-day PPA or greater at 12 weeks, 30-day PPA at 26 weeks, and no more than 5 cigarettes during the intervening time period.
User Feedback: Number of Participants Who Agreed That Their Program Helped Them Quit Smoking	52 weeks	User feedback with the smoking cessation program, specifically whether the program helped them quit smoking (true/false).
Desire to Quit (Yes/no)	4 weeks	desire to quit smoking, participant self-report, yes/no
Biochemically Confirmed Abstinence	52 weeks	Participants who report they have achieved at least 7-day point prevalence abstinence at 52 weeks 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.
Biochemically Confirmed Continuous Abstinence	52 weeks	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 12 weeks, 26 weeks, and 52 weeks 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.
Change in Confidence Levels Towards Quitting Smoking	12 weeks	Expected success in quitting smoking. Asked: " If you were to quit smoking right now, how successful would you be?". Participant self-report, scale 1-10 (1=Not at all successful, 10=Completely successful).
Self-Reported Nicotine Replacement Therapy (NRT) Use	52 weeks	Nicotine replacement therapy (NRT) use assessed with participant orders of NRT
Change in Expected Difficulty in Staying Quit	12 weeks	Expected difficulty to stay quit from smoking. Participants asked: "How difficult do you think it would be to stay smoke free?". Participant self-report on scale 1-10 (1=Really hard to stay quit, 10=Really easy to stay quit)
Self-Reported Smoking Abstinence	52 weeks	participant self-report of 7-day and 30-day point prevalence abstinence (PPA) from smoking cigarettes
Self-Reported Abstinence From All Tobacco Products	52 weeks	Participant self report of no tobacco product use including: cigarettes, e-cigarettes/vaping, cigars, chew/snuff, pipe, and hookah.
Proportion With ≥ 50% CPD Reduction	26 weeks	The proportion of participants who reduced their cigarettes per day (CPD) by ≥ 50% compared to baseline
User Feedback - Setup and Starting the Program	12 weeks	User feedback with the smoking cessation program, specifically ease of set-up and starting of the program (scale of 1-10, higher value equates to easier time setting up and starting use of the program)
User Feedback	26 weeks	User feedback with the smoking cessation program, specifically whether the program helped with their smoking cessation goals (true/false), and whether the program helped them quit smoking (true/false).
User Satisfaction - User Feedback	2 weeks	User satisfaction with the smoking cessation program, specifically its impact on motivation to quit smoking, and the amount of cigarettes smoked per day. Participants were asked: "How has using your assigned program affected your motivation to quit smoking?" and "How has using your assigned program affected the number of cigarettes you smoke per day?" with the answer choices of "increased", "not affected", and "decreased".
Additional User Feedback	3 weeks	User feedback on what they have learned from using their assigned smoking cessation program. Participants were asked "Which of the following best described what you have learned from using your program?" with the answer choices: "I've learned some really unique/key insights into my smoking behavior", "I've learned some things but nothing that impactful", "I have not learned anything from the program", and "I am more confused after using the program".
Engagement With Program - Number of Times App Was Opened	12 weeks	Collected weekly during the first 12 weeks after enrollment: o Number of times app opened Average number of times the app was opened, cumulative over 12 weeks.
Engagement With Program - Number of Weeks App Was Opened	12 weeks	Collected weekly during the first 12 weeks after enrollment: o Number of weeks in which app was opened Average number of weeks the app was opened, cumulative over 12 weeks.
Participant Changes in Self-Efficacy	52 weeks	6-item Smoking Abstinence Self-efficacy Questionnaire (SASEQ) (Spek V, et al. Int.J. Behav. Med. (2013) 20:444-449). SASEQ score is on a scale of 0-24. Each of the 6 questions is answered on a 5-point Likert scale (0-4). Greater scores indicate greater self-efficacy toward quitting smoking.
Participant Changes in Self-reported Health and Wellbeing	12 weeks	participant self-report, choices for reporting health: excellent, very good, good, fair, or poor
User Satisfaction - Net Promoter Score (NPS)	4 weeks, 12 weeks, and 26 weeks	User satisfaction with the smoking cessation program, specifically the likelihood of recommending the program to a friend. Measured with a net promoter score (NPS). Participants are asked "How likely are you to recommend your study program to a friend or colleague?" and answer on a 10-point (1-10) scale (where 1=Not at all likely and 10=Very likely). NPS was calculated for each study group by subtracting the percentage of respondents who answered ≤6 (detractors) from the percentage of respondents who answered 9 or 10 (promotors). NPS formula = %promotor - %detractor NPS has a score range between -100 and 100 (-100 indicates 100% detractors, 100 indicated 100% promotors of the program). A higher NPS score indicates greater promoters of the program, and thus a greater likelihood of individuals recommending the program to a friend.
Engagement With Program - Number of Days App Was Opened	12 weeks	Collected weekly during the first 12 weeks after enrollment: o Number of days in which app was opened Average number of days the app was opened, cumulative over 12 weeks.
Adverse Events	12 weeks	participant self-report of adverse events and any issues experienced with assigned study app/program as well as the provided nicotine replacement therapy (NRT). For further adverse event details - see adverse event portion of this record.