Smoking Cessation
Conditions
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.
Interventions
OTHERControl
Standard of Care - Control Smoking Cessation Program
OTHERPivot
Pivot Program Smoking Cessation Program
Sponsors
Jennifer Marler, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Participant blinded to arm assignment but not to the smoking cessation program he/she is using.
Intervention model description
1:1 randomization
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 Smoking Abstinence | 12 weeks | participant self-report of 7-day and 30-day point prevalence abstinence (PPA) from smoking cigarettes |
| Self-Reported Abstinence From All Tobacco Products | 12 weeks | participant self report of no tobacco product use including: cigarettes, e-cigarettes/vaping, cigars, chew/snuff, pipe, and hookah |
| Biochemically Confirmed Abstinence | 12 weeks | 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. |
| Self-Reported Continuous Abstinence | 26 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. |
| Biochemically Confirmed Continuous Abstinence | 26 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 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. |
| Proportion With ≥ 50% CPD Reduction | 26 weeks | The proportion of participants who reduced their cigarettes per day (CPD) by ≥ 50% compared to baseline |
| 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. |
| Desire to Quit (Yes/no) | 4 weeks | desire to quit smoking, participant self-report, yes/no |
| 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 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). |
| 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 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 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. |
| 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 | 12 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 |
| Self-Reported Nicotine Replacement Therapy (NRT) Use | 26 weeks | Nicotine replacement therapy (NRT) use assessed with participant orders of NRT |
| 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. |
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control A commercially available mobile phone app and program
Control: Standard of Care - Control Smoking Cessation Program | 94 |
| Pivot Pivot mobile phone app and program
Pivot: Pivot Program Smoking Cessation Program | 94 |
| Total | 188 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Week 26 survey not completed | 2 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Pivot | Control | Total |
|---|---|---|---|
| Age, Continuous | 46.6 years STANDARD_DEVIATION 10.1 | 46.1 years STANDARD_DEVIATION 8.2 | 46.4 years STANDARD_DEVIATION 9.2 |
| Cigarettes per day | 18.0 Cigarettes per day STANDARD_DEVIATION 9.6 | 17.2 Cigarettes per day STANDARD_DEVIATION 8.5 | 17.6 Cigarettes per day STANDARD_DEVIATION 9 |
| Difficulty to Quit (DTQ) | 3.5 score on a scale STANDARD_DEVIATION 2.3 | 3.6 score on a scale STANDARD_DEVIATION 2.6 | 3.5 score on a scale STANDARD_DEVIATION 2.5 |
| Race/Ethnicity, Customized Race/Ethnicity American Indian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 15 Participants | 21 Participants | 36 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic, Latino, or Spanish Origin | 8 Participants | 5 Participants | 13 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Native Hawaiian | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Prefer not to answer | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Some other race | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 66 Participants | 62 Participants | 128 Participants |
| Region of Enrollment United States | 94 participants | 94 participants | 188 participants |
| Self-reported health Excellent health | 4 Participants | 1 Participants | 5 Participants |
| Self-reported health Fair health | 14 Participants | 12 Participants | 26 Participants |
| Self-reported health Good health | 51 Participants | 48 Participants | 99 Participants |
| Self-reported health Poor health | 1 Participants | 0 Participants | 1 Participants |
| Self-reported health Very good health | 24 Participants | 33 Participants | 57 Participants |
| Sex: Female, Male Female | 50 Participants | 54 Participants | 104 Participants |
| Sex: Female, Male Male | 44 Participants | 40 Participants | 84 Participants |
| Smoking Abstinence Self-Efficacy Questionnaire (SASEQ) | 11.8 score on a scale STANDARD_DEVIATION 4.7 | 11.5 score on a scale STANDARD_DEVIATION 4.9 | 11.7 score on a scale STANDARD_DEVIATION 4.8 |
| Success to Quit (STQ) | 4.6 score on a scale STANDARD_DEVIATION 2.4 | 4.3 score on a scale STANDARD_DEVIATION 2.3 | 4.5 score on a scale STANDARD_DEVIATION 2.4 |
| Tobacco products used Cigarettes + Chew/snuff | 2 Participants | 0 Participants | 2 Participants |
| Tobacco products used Cigarettes + Cigars | 1 Participants | 2 Participants | 3 Participants |
| Tobacco products used Cigarettes + E-cigarettes/vaping | 10 Participants | 5 Participants | 15 Participants |
| Tobacco products used Cigarettes + E-cigarettes/vaping + Chew/snuff | 0 Participants | 1 Participants | 1 Participants |
| Tobacco products used Cigarettes + E-cigarettes/vaping + Cigars | 1 Participants | 1 Participants | 2 Participants |
| Tobacco products used Cigarettes + E-cigarettes/vaping + Pipe | 0 Participants | 1 Participants | 1 Participants |
| Tobacco products used Cigarettes + Hookah | 1 Participants | 0 Participants | 1 Participants |
| Tobacco products used Cigarettes + Hookah + Cigars | 0 Participants | 1 Participants | 1 Participants |
| Tobacco products used Cigarettes only | 79 Participants | 83 Participants | 162 Participants |
| Years smoking | 27.7 years STANDARD_DEVIATION 10.4 | 25.8 years STANDARD_DEVIATION 10.1 | 26.8 years STANDARD_DEVIATION 10.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 94 | 0 / 94 |
| other Total, other adverse events | 17 / 94 | 19 / 94 |
| serious Total, serious adverse events | 0 / 94 | 0 / 94 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Average Total App Openings at 12 Weeks | 86.5 app openings | Standard Deviation 66.3 |
| Pivot | Average Total App Openings at 12 Weeks | 157.9 app openings | Standard Deviation 210.6 |
Secondary
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
Population: Participants that completed the 3 week questionnaire
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Additional User Feedback | I've learned some really unique/key insights into my smoking behavior | 51 Participants |
| Control | Additional User Feedback | I have not learned anything from the program | 12 Participants |
| Control | Additional User Feedback | I've learned some things but nothing that impactful | 26 Participants |
| Control | Additional User Feedback | I am more confused after using the program | 1 Participants |
| Pivot | Additional User Feedback | I've learned some things but nothing that impactful | 16 Participants |
| Pivot | Additional User Feedback | I've learned some really unique/key insights into my smoking behavior | 72 Participants |
| Pivot | Additional User Feedback | I am more confused after using the program | 0 Participants |
| Pivot | Additional User Feedback | I have not learned anything from the program | 1 Participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Adverse Events | Participants who experienced adverse events/issues with their assigned study program | 0 Participants |
| Control | Adverse Events | Participants who experienced adverse events/issues with nicotine replacement therapy | 17 Participants |
| Pivot | Adverse Events | Participants who experienced adverse events/issues with their assigned study program | 0 Participants |
| Pivot | Adverse Events | Participants who experienced adverse events/issues with nicotine replacement therapy | 19 Participants |
Secondary
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
Population: Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses.~ITT includes entire study population from the study arm, while responder only includes participants who completed the 12 week questionnaire.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Biochemically Confirmed Abstinence | Biovalidated abstinence ITT | 12 Participants |
| Control | Biochemically Confirmed Abstinence | Biovalidated abstinence Responder | 12 Participants |
| Pivot | Biochemically Confirmed Abstinence | Biovalidated abstinence ITT | 27 Participants |
| Pivot | Biochemically Confirmed Abstinence | Biovalidated abstinence Responder | 27 Participants |
Secondary
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
Population: Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses.~ITT includes entire study population from the study arm, while responder only includes participants who completed the 52 week questionnaire.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Biochemically Confirmed Abstinence | Biovalidated abstinence ITT | 17 Participants |
| Control | Biochemically Confirmed Abstinence | Biovalidated abstinence Responder | 17 Participants |
| Pivot | Biochemically Confirmed Abstinence | Biovalidated abstinence ITT | 29 Participants |
| Pivot | Biochemically Confirmed Abstinence | Biovalidated abstinence Responder | 29 Participants |
Secondary
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
Population: Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses.~ITT includes entire study population from the study arm, while responder only includes participants who completed the 26 week questionnaire.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Biochemically Confirmed Abstinence | Biovalidated abstinence Responder | 14 Participants |
| Control | Biochemically Confirmed Abstinence | Biovalidated abstinence ITT | 14 Participants |
| Pivot | Biochemically Confirmed Abstinence | Biovalidated abstinence ITT | 26 Participants |
| Pivot | Biochemically Confirmed Abstinence | Biovalidated abstinence Responder | 26 Participants |
Secondary
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
Population: Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses.~ITT includes entire study population from the study arm, while responder only includes participants who completed the 52 week questionnaire.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Biochemically Confirmed Continuous Abstinence | Biochemically confirmed continuous abstinence ITT | 8 Participants |
| Control | Biochemically Confirmed Continuous Abstinence | Biochemically confirmed continuous abstinence Responder | 8 Participants |
| Pivot | Biochemically Confirmed Continuous Abstinence | Biochemically confirmed continuous abstinence ITT | 18 Participants |
| Pivot | Biochemically Confirmed Continuous Abstinence | Biochemically confirmed continuous abstinence Responder | 18 Participants |
Secondary
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
Population: Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses.~ITT includes entire study population from the study arm, while responder only includes participants who completed the 26 week questionnaire.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Biochemically Confirmed Continuous Abstinence | Biochemically confirmed continuous abstinence ITT | 9 Participants |
| Control | Biochemically Confirmed Continuous Abstinence | Biochemically confirmed continuous abstinence Responder | 9 Participants |
| Pivot | Biochemically Confirmed Continuous Abstinence | Biochemically confirmed continuous abstinence ITT | 20 Participants |
| Pivot | Biochemically Confirmed Continuous Abstinence | Biochemically confirmed continuous abstinence Responder | 20 Participants |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Confidence Levels Towards Quitting Smoking | Success to quit 12 weeks | 5.8 score on a scale | Standard Deviation 3.1 |
| Control | Change in Confidence Levels Towards Quitting Smoking | Change in Success to quit from baseline to 12 weeks | 1.6 score on a scale | Standard Deviation 3.6 |
| Pivot | Change in Confidence Levels Towards Quitting Smoking | Success to quit 12 weeks | 6.6 score on a scale | Standard Deviation 3 |
| Pivot | Change in Confidence Levels Towards Quitting Smoking | Change in Success to quit from baseline to 12 weeks | 2.0 score on a scale | Standard Deviation 3.6 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Expected Difficulty in Staying Quit | Difficulty to quit 12 weeks | 5.2 score on a scale | Standard Deviation 3 |
| Control | Change in Expected Difficulty in Staying Quit | Change in Difficulty to quit from baseline to 12 weeks | 1.7 score on a scale | Standard Deviation 3.4 |
| Pivot | Change in Expected Difficulty in Staying Quit | Difficulty to quit 12 weeks | 5.7 score on a scale | Standard Deviation 3.1 |
| Pivot | Change in Expected Difficulty in Staying Quit | Change in Difficulty to quit from baseline to 12 weeks | 2.2 score on a scale | Standard Deviation 3.7 |
Secondary
Desire to Quit (Yes/no)
desire to quit smoking, participant self-report, yes/no
Time frame: 4 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Desire to Quit (Yes/no) | Participants who answered yes to having a desire to quit smoking | 88 Participants |
| Control | Desire to Quit (Yes/no) | Participants who answered no to having a desire to quit smoking | 0 Participants |
| Pivot | Desire to Quit (Yes/no) | Participants who answered yes to having a desire to quit smoking | 91 Participants |
| Pivot | Desire to Quit (Yes/no) | Participants who answered no to having a desire to quit smoking | 0 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Engagement With Program - Number of Days App Was Opened | 50.4 days | Standard Deviation 25.2 |
| Pivot | Engagement With Program - Number of Days App Was Opened | 49.6 days | Standard Deviation 24.1 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Engagement With Program - Number of Times App Was Opened | 86.5 number of app openings | Standard Deviation 66.3 |
| Pivot | Engagement With Program - Number of Times App Was Opened | 157.9 number of app openings | Standard Deviation 210.6 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Engagement With Program - Number of Weeks App Was Opened | 11.0 weeks | Standard Deviation 2.3 |
| Pivot | Engagement With Program - Number of Weeks App Was Opened | 11.0 weeks | Standard Deviation 2.2 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Participant Changes in Self-Efficacy | SASEQ 12 weeks | 14.1 score on a scale | Standard Deviation 6.2 |
| Control | Participant Changes in Self-Efficacy | Change in SASEQ from baseline to 12 weeks | 2.7 score on a scale | Standard Deviation 7.9 |
| Pivot | Participant Changes in Self-Efficacy | SASEQ 12 weeks | 14.5 score on a scale | Standard Deviation 6.9 |
| Pivot | Participant Changes in Self-Efficacy | Change in SASEQ from baseline to 12 weeks | 2.6 score on a scale | Standard Deviation 6.7 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Participant Changes in Self-Efficacy | SASEQ 52 weeks | 12.6 score on a scale | Standard Deviation 8.1 |
| Control | Participant Changes in Self-Efficacy | Change in SASEQ from baseline to 52 weeks | 1.0 score on a scale | Standard Deviation 8.5 |
| Pivot | Participant Changes in Self-Efficacy | SASEQ 52 weeks | 14.9 score on a scale | Standard Deviation 7.9 |
| Pivot | Participant Changes in Self-Efficacy | Change in SASEQ from baseline to 52 weeks | 3.2 score on a scale | Standard Deviation 7.8 |
Secondary
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
Population: Participant numbers are different from baseline to week 26 due to 4 participants from each arm not completing the week 16 questionnaire
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Control | Participant Changes in Self-reported Health and Wellbeing | Self-reported health at baseline | Excellent | 1 Participants |
| Control | Participant Changes in Self-reported Health and Wellbeing | Self-reported health at baseline | Very good | 33 Participants |
| Control | Participant Changes in Self-reported Health and Wellbeing | Self-reported health at baseline | Good | 48 Participants |
| Control | Participant Changes in Self-reported Health and Wellbeing | Self-reported health at baseline | Fair | 12 Participants |
| Control | Participant Changes in Self-reported Health and Wellbeing | Self-reported health at baseline | Poor | 0 Participants |
| Control | Participant Changes in Self-reported Health and Wellbeing | Self-reported health at 12 weeks | Excellent | 6 Participants |
| Control | Participant Changes in Self-reported Health and Wellbeing | Self-reported health at 12 weeks | Very good | 27 Participants |
| Control | Participant Changes in Self-reported Health and Wellbeing | Self-reported health at 12 weeks | Good | 37 Participants |
| Control | Participant Changes in Self-reported Health and Wellbeing | Self-reported health at 12 weeks | Fair | 18 Participants |
| Control | Participant Changes in Self-reported Health and Wellbeing | Self-reported health at 12 weeks | Poor | 2 Participants |
| Pivot | Participant Changes in Self-reported Health and Wellbeing | Self-reported health at 12 weeks | Good | 42 Participants |
| Pivot | Participant Changes in Self-reported Health and Wellbeing | Self-reported health at baseline | Excellent | 4 Participants |
| Pivot | Participant Changes in Self-reported Health and Wellbeing | Self-reported health at 12 weeks | Excellent | 4 Participants |
| Pivot | Participant Changes in Self-reported Health and Wellbeing | Self-reported health at baseline | Very good | 24 Participants |
| Pivot | Participant Changes in Self-reported Health and Wellbeing | Self-reported health at 12 weeks | Poor | 1 Participants |
| Pivot | Participant Changes in Self-reported Health and Wellbeing | Self-reported health at baseline | Good | 51 Participants |
| Pivot | Participant Changes in Self-reported Health and Wellbeing | Self-reported health at 12 weeks | Very good | 25 Participants |
| Pivot | Participant Changes in Self-reported Health and Wellbeing | Self-reported health at baseline | Fair | 14 Participants |
| Pivot | Participant Changes in Self-reported Health and Wellbeing | Self-reported health at 12 weeks | Fair | 18 Participants |
| Pivot | Participant Changes in Self-reported Health and Wellbeing | Self-reported health at baseline | Poor | 1 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Proportion With ≥ 50% CPD Reduction | 59 Participants |
| Pivot | Proportion With ≥ 50% CPD Reduction | 56 Participants |
Secondary
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
Population: Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses.~ITT includes entire study population from the study arm, while responder only includes participants who completed the 26 week questionnaire.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Self-Reported Abstinence From All Tobacco Products | Self-report no tobacco use ITT | 23 Participants |
| Control | Self-Reported Abstinence From All Tobacco Products | Self-report no tobacco use Responder | 23 Participants |
| Pivot | Self-Reported Abstinence From All Tobacco Products | Self-report no tobacco use ITT | 32 Participants |
| Pivot | Self-Reported Abstinence From All Tobacco Products | Self-report no tobacco use Responder | 32 Participants |
Secondary
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
Population: Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses.~ITT includes entire study population from the study arm, while responder only includes participants who completed the 52 week questionnaire.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Self-Reported Abstinence From All Tobacco Products | Self-report no tobacco use ITT | 27 Participants |
| Control | Self-Reported Abstinence From All Tobacco Products | Self-report no tobacco use Responder | 27 Participants |
| Pivot | Self-Reported Abstinence From All Tobacco Products | Self-report no tobacco use ITT | 33 Participants |
| Pivot | Self-Reported Abstinence From All Tobacco Products | Self-report no tobacco use Responder | 33 Participants |
Secondary
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
Population: Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses.~ITT includes entire study population from the study arm, while responder only includes participants who completed the 12 week questionnaire.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Self-Reported Abstinence From All Tobacco Products | Self-report no tobacco use ITT | 25 Participants |
| Control | Self-Reported Abstinence From All Tobacco Products | Self-report no tobacco use Responder | 25 Participants |
| Pivot | Self-Reported Abstinence From All Tobacco Products | Self-report no tobacco use ITT | 31 Participants |
| Pivot | Self-Reported Abstinence From All Tobacco Products | Self-report no tobacco use Responder | 31 Participants |
Secondary
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
Population: Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses.~ITT includes entire study population from the study arm, while responder only includes participants who completed the 52 week questionnaire.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Self-Reported Continuous Abstinence | Self-reported continuous abstinence ITT | 8 Participants |
| Control | Self-Reported Continuous Abstinence | Self-reported continuous abstinence Responder | 8 Participants |
| Pivot | Self-Reported Continuous Abstinence | Self-reported continuous abstinence ITT | 19 Participants |
| Pivot | Self-Reported Continuous Abstinence | Self-reported continuous abstinence Responder | 19 Participants |
Secondary
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
Population: Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses.~ITT includes entire study population from the study arm, while responder only includes participants who completed the 26 week questionnaire.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Self-Reported Continuous Abstinence | Self-reported continuous abstinence ITT | 15 Participants |
| Control | Self-Reported Continuous Abstinence | Self-reported continuous abstinence Responder | 15 Participants |
| Pivot | Self-Reported Continuous Abstinence | Self-reported continuous abstinence ITT | 24 Participants |
| Pivot | Self-Reported Continuous Abstinence | Self-reported continuous abstinence Responder | 24 Participants |
Secondary
Self-Reported Nicotine Replacement Therapy (NRT) Use
Nicotine replacement therapy (NRT) use assessed with participant orders of NRT
Time frame: 26 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Self-Reported Nicotine Replacement Therapy (NRT) Use | ≥1 NRT combination-therapy order | 57 Participants |
| Control | Self-Reported Nicotine Replacement Therapy (NRT) Use | ≥1 NRT single-therapy order | 8 Participants |
| Control | Self-Reported Nicotine Replacement Therapy (NRT) Use | ≥1 NRT single-therapy order + ≥1 NRT combination-therapy order | 12 Participants |
| Control | Self-Reported Nicotine Replacement Therapy (NRT) Use | No orders | 17 Participants |
| Pivot | Self-Reported Nicotine Replacement Therapy (NRT) Use | No orders | 1 Participants |
| Pivot | Self-Reported Nicotine Replacement Therapy (NRT) Use | ≥1 NRT single-therapy order + ≥1 NRT combination-therapy order | 26 Participants |
| Pivot | Self-Reported Nicotine Replacement Therapy (NRT) Use | ≥1 NRT single-therapy order | 23 Participants |
| Pivot | Self-Reported Nicotine Replacement Therapy (NRT) Use | ≥1 NRT combination-therapy order | 44 Participants |
Secondary
Self-Reported Nicotine Replacement Therapy (NRT) Use
Nicotine replacement therapy (NRT) use assessed with participant orders of NRT
Time frame: 52 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Self-Reported Nicotine Replacement Therapy (NRT) Use | ≥1 NRT single therapy order | 9 Participants |
| Control | Self-Reported Nicotine Replacement Therapy (NRT) Use | ≥1 NRT combination therapy order | 57 Participants |
| Control | Self-Reported Nicotine Replacement Therapy (NRT) Use | ≥1 NRT single therapy + ≥1 NRT combination therapy order | 14 Participants |
| Control | Self-Reported Nicotine Replacement Therapy (NRT) Use | None | 14 Participants |
| Pivot | Self-Reported Nicotine Replacement Therapy (NRT) Use | None | 1 Participants |
| Pivot | Self-Reported Nicotine Replacement Therapy (NRT) Use | ≥1 NRT single therapy order | 22 Participants |
| Pivot | Self-Reported Nicotine Replacement Therapy (NRT) Use | ≥1 NRT single therapy + ≥1 NRT combination therapy order | 29 Participants |
| Pivot | Self-Reported Nicotine Replacement Therapy (NRT) Use | ≥1 NRT combination therapy order | 42 Participants |
Secondary
Self-Reported Smoking Abstinence
participant self-report of 7-day and 30-day point prevalence abstinence (PPA) from smoking cigarettes
Time frame: 26 weeks
Population: Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses.~ITT includes entire study population from the study arm, while responder only includes participants who completed the 26 week questionnaire.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Self-Reported Smoking Abstinence | 7-day PPA at 26 weeks ITT | 25 Participants |
| Control | Self-Reported Smoking Abstinence | 7-day PPA at 26 weeks Responder | 25 Participants |
| Control | Self-Reported Smoking Abstinence | 30-day PPA at 26 weeks ITT | 21 Participants |
| Control | Self-Reported Smoking Abstinence | 30-day PPA at 26 weeks Responder | 21 Participants |
| Pivot | Self-Reported Smoking Abstinence | 30-day PPA at 26 weeks Responder | 30 Participants |
| Pivot | Self-Reported Smoking Abstinence | 7-day PPA at 26 weeks ITT | 34 Participants |
| Pivot | Self-Reported Smoking Abstinence | 30-day PPA at 26 weeks ITT | 30 Participants |
| Pivot | Self-Reported Smoking Abstinence | 7-day PPA at 26 weeks Responder | 34 Participants |
Secondary
Self-Reported Smoking Abstinence
participant self-report of 7-day and 30-day point prevalence abstinence (PPA) from smoking cigarettes
Time frame: 12 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Self-Reported Smoking Abstinence | 7-day PPA at 12 weeks | 26 Participants |
| Control | Self-Reported Smoking Abstinence | 30-day PPA at 12 weeks | 21 Participants |
| Pivot | Self-Reported Smoking Abstinence | 7-day PPA at 12 weeks | 33 Participants |
| Pivot | Self-Reported Smoking Abstinence | 30-day PPA at 12 weeks | 27 Participants |
Secondary
Self-Reported Smoking Abstinence
participant self-report of 7-day and 30-day point prevalence abstinence (PPA) from smoking cigarettes
Time frame: 52 weeks
Population: Number of participants analyzed is different due to Intention to Treat (ITT) vs. Responder analyses.~ITT includes entire study population from the study arm, while responder only includes participants who completed the 52 week questionnaire.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Self-Reported Smoking Abstinence | 7-day PPA at 52 weeks ITT | 29 Participants |
| Control | Self-Reported Smoking Abstinence | 7-day PPA at 52 weeks Responder | 29 Participants |
| Control | Self-Reported Smoking Abstinence | 30-day PPA at 52 weeks ITT | 28 Participants |
| Control | Self-Reported Smoking Abstinence | 30-day PPA at 52 weeks Responder | 28 Participants |
| Pivot | Self-Reported Smoking Abstinence | 30-day PPA at 52 weeks Responder | 34 Participants |
| Pivot | Self-Reported Smoking Abstinence | 7-day PPA at 52 weeks ITT | 39 Participants |
| Pivot | Self-Reported Smoking Abstinence | 30-day PPA at 52 weeks ITT | 34 Participants |
| Pivot | Self-Reported Smoking Abstinence | 7-day PPA at 52 weeks Responder | 39 Participants |
Secondary
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
Population: Number of participants differs per question:~Only participants reporting 7-day PPA (n=25 control, n=34 Pivot) were asked if their study program helped them quit smoking.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | User Feedback | Study program helped them with their goals related to smoking - answered true | 69 Participants |
| Control | User Feedback | Among participants reporting 7-day PPA: study program helped them quit smoking - answered true | 22 Participants |
| Pivot | User Feedback | Study program helped them with their goals related to smoking - answered true | 79 Participants |
| Pivot | User Feedback | Among participants reporting 7-day PPA: study program helped them quit smoking - answered true | 34 Participants |
Secondary
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
Population: Only participants reporting 7-day PPA at 52 weeks (n=29 control, n=39 Pivot) were asked if their study program helped them quit smoking.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | User Feedback: Number of Participants Who Agreed That Their Program Helped Them Quit Smoking | 26 Participants |
| Pivot | User Feedback: Number of Participants Who Agreed That Their Program Helped Them Quit Smoking | 35 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | User Feedback - Setup and Starting the Program | 7.1 score on a scale | Standard Deviation 3 |
| Pivot | User Feedback - Setup and Starting the Program | 8.2 score on a scale | Standard Deviation 2.3 |
Secondary
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
Population: Number analyzed differs based on differential completion of the surveys at each of the timepoints: 4 weeks, 12 weeks, and 26 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | User Satisfaction - Net Promoter Score (NPS) | NPS score at 4 weeks | 1.1 score on a scale |
| Control | User Satisfaction - Net Promoter Score (NPS) | NPS score at 12 weeks | 11.0 score on a scale |
| Control | User Satisfaction - Net Promoter Score (NPS) | NPS score at 26 weeks | 23.6 score on a scale |
| Pivot | User Satisfaction - Net Promoter Score (NPS) | NPS score at 4 weeks | 50.6 score on a scale |
| Pivot | User Satisfaction - Net Promoter Score (NPS) | NPS score at 12 weeks | 44.6 score on a scale |
| Pivot | User Satisfaction - Net Promoter Score (NPS) | NPS score at 26 weeks | 57.8 score on a scale |
Secondary
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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Control | User Satisfaction - User Feedback | How has using your assigned program affected your motivation to quit smoking? | increased | 54 Participants |
| Control | User Satisfaction - User Feedback | How has using your assigned program affected your motivation to quit smoking? | not affected | 35 Participants |
| Control | User Satisfaction - User Feedback | How has using your assigned program affected your motivation to quit smoking? | decreased | 3 Participants |
| Control | User Satisfaction - User Feedback | How has using your assigned program affected the number of cigarettes you smoke per day? | increased | 2 Participants |
| Control | User Satisfaction - User Feedback | How has using your assigned program affected the number of cigarettes you smoke per day? | not affected | 34 Participants |
| Control | User Satisfaction - User Feedback | How has using your assigned program affected the number of cigarettes you smoke per day? | decreased | 56 Participants |
| Pivot | User Satisfaction - User Feedback | How has using your assigned program affected the number of cigarettes you smoke per day? | not affected | 25 Participants |
| Pivot | User Satisfaction - User Feedback | How has using your assigned program affected your motivation to quit smoking? | increased | 72 Participants |
| Pivot | User Satisfaction - User Feedback | How has using your assigned program affected the number of cigarettes you smoke per day? | increased | 2 Participants |
| Pivot | User Satisfaction - User Feedback | How has using your assigned program affected your motivation to quit smoking? | not affected | 19 Participants |
| Pivot | User Satisfaction - User Feedback | How has using your assigned program affected the number of cigarettes you smoke per day? | decreased | 65 Participants |
| Pivot | User Satisfaction - User Feedback | How has using your assigned program affected your motivation to quit smoking? | decreased | 1 Participants |