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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
188
Pivot Health Technologies, Inc.
San Carlos, California, United States
Average Total App Openings at 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.
Time frame: 12 weeks
Desire to Quit (Yes/no)
desire to quit smoking, participant self-report, yes/no
Time frame: 4 weeks
Change in Expected Difficulty in Staying Quit
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)
Time frame: 12 weeks
Change in Confidence Levels Towards Quitting Smoking
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).
Time frame: 12 weeks
Self-Reported Smoking Abstinence
participant self-report of 7-day and 30-day point prevalence abstinence (PPA) from smoking cigarettes
Time frame: 12 weeks
Self-Reported Smoking Abstinence
participant self-report of 7-day and 30-day point prevalence abstinence (PPA) from smoking cigarettes
Time frame: 26 weeks
Self-Reported Smoking Abstinence
participant self-report of 7-day and 30-day point prevalence abstinence (PPA) from smoking cigarettes
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Time frame: 52 weeks
Self-Reported Abstinence From All Tobacco Products
participant self report of no tobacco product use including: cigarettes, e-cigarettes/vaping, cigars, chew/snuff, pipe, and hookah
Time frame: 12 weeks
Self-Reported Abstinence From All Tobacco Products
Participant self report of no tobacco product use including: cigarettes, e-cigarettes/vaping, cigars, chew/snuff, pipe, and hookah.
Time frame: 26 weeks
Self-Reported Abstinence From All Tobacco Products
Participant self report of no tobacco product use including: cigarettes, e-cigarettes/vaping, cigars, chew/snuff, pipe, and hookah.
Time frame: 52 weeks
Biochemically Confirmed Abstinence
Participants who report they have achieved at least 7-day point prevalence abstinence at 12 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.
Time frame: 12 weeks
Biochemically Confirmed Abstinence
Participants who report they have achieved at least 7-day point prevalence abstinence at 26 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.
Time frame: 26 weeks
Biochemically Confirmed Abstinence
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.
Time frame: 52 weeks
Self-Reported Continuous Abstinence
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.
Time frame: 26 weeks
Self-Reported Continuous Abstinence
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.
Time frame: 52 weeks
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 12 weeks and 26 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.
Time frame: 26 weeks
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 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.
Time frame: 52 weeks
Proportion With ≥ 50% CPD Reduction
The proportion of participants who reduced their cigarettes per day (CPD) by ≥ 50% compared to baseline
Time frame: 26 weeks
User Satisfaction - User Feedback
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".
Time frame: 2 weeks
Additional User Feedback
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".
Time frame: 3 weeks
User Feedback - Setup and Starting the Program
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)
Time frame: 12 weeks
User Feedback
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).
Time frame: 26 weeks
User Feedback: Number of Participants Who Agreed That Their Program Helped Them Quit Smoking
User feedback with the smoking cessation program, specifically whether the program helped them quit smoking (true/false).
Time frame: 52 weeks
User Satisfaction - Net Promoter Score (NPS)
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.
Time frame: 4 weeks, 12 weeks, and 26 weeks
Engagement With Program - Number of Times App Was Opened
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.
Time frame: 12 weeks
Engagement With Program - Number of Days App Was Opened
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.
Time frame: 12 weeks
Engagement With Program - Number of Weeks App Was Opened
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.
Time frame: 12 weeks
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). 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.
Time frame: 12 weeks
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). 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.
Time frame: 52 weeks
Participant Changes in Self-reported Health and Wellbeing
participant self-report, choices for reporting health: excellent, very good, good, fair, or poor
Time frame: 12 weeks
Self-Reported Nicotine Replacement Therapy (NRT) Use
Nicotine replacement therapy (NRT) use assessed with participant orders of NRT
Time frame: 26 weeks
Self-Reported Nicotine Replacement Therapy (NRT) Use
Nicotine replacement therapy (NRT) use assessed with participant orders of NRT
Time frame: 52 weeks
Adverse Events
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.
Time frame: 12 weeks