Trial Outcomes & Findings for Pilot Randomized Controlled Trial of a Smart Phone-Based Smoking Cessation Program (NCT NCT04955639)

NCT ID: NCT04955639

Last Updated: 2024-07-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 188 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2024-07-01

Participant Flow

Participant milestones

Measure	Control A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Overall Study STARTED	94	94
Overall Study Completed Week 12 Survey	91	92
Overall Study COMPLETED	90	90
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Measure	Control A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Overall Study Withdrawal by Subject	2	2
Overall Study Week 26 survey not completed	2	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Control n=94 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=94 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program	Total n=188 Participants Total of all reporting groups
Age, Continuous	46.1 years STANDARD_DEVIATION 8.2 • n=5 Participants	46.6 years STANDARD_DEVIATION 10.1 • n=7 Participants	46.4 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	50 Participants n=7 Participants	104 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	44 Participants n=7 Participants	84 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	62 Participants n=5 Participants	66 Participants n=7 Participants	128 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black	21 Participants n=5 Participants	15 Participants n=7 Participants	36 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · American Indian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic, Latino, or Spanish Origin	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Native Hawaiian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Some other race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Prefer not to answer	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	94 participants n=5 Participants	94 participants n=7 Participants	188 participants n=5 Participants
Self-reported health Excellent health	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Self-reported health Very good health	33 Participants n=5 Participants	24 Participants n=7 Participants	57 Participants n=5 Participants
Self-reported health Good health	48 Participants n=5 Participants	51 Participants n=7 Participants	99 Participants n=5 Participants
Self-reported health Fair health	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Self-reported health Poor health	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Cigarettes per day	17.2 Cigarettes per day STANDARD_DEVIATION 8.5 • n=5 Participants	18.0 Cigarettes per day STANDARD_DEVIATION 9.6 • n=7 Participants	17.6 Cigarettes per day STANDARD_DEVIATION 9.0 • n=5 Participants
Years smoking	25.8 years STANDARD_DEVIATION 10.1 • n=5 Participants	27.7 years STANDARD_DEVIATION 10.4 • n=7 Participants	26.8 years STANDARD_DEVIATION 10.3 • n=5 Participants
Tobacco products used Cigarettes only	83 Participants n=5 Participants	79 Participants n=7 Participants	162 Participants n=5 Participants
Tobacco products used Cigarettes + E-cigarettes/vaping	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Tobacco products used Cigarettes + Cigars	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Tobacco products used Cigarettes + E-cigarettes/vaping + Cigars	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Tobacco products used Cigarettes + Chew/snuff	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Tobacco products used Cigarettes + E-cigarettes/vaping + Chew/snuff	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Tobacco products used Cigarettes + E-cigarettes/vaping + Pipe	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Tobacco products used Cigarettes + Hookah + Cigars	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Tobacco products used Cigarettes + Hookah	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Difficulty to Quit (DTQ)	3.6 score on a scale STANDARD_DEVIATION 2.6 • n=5 Participants	3.5 score on a scale STANDARD_DEVIATION 2.3 • n=7 Participants	3.5 score on a scale STANDARD_DEVIATION 2.5 • n=5 Participants
Success to Quit (STQ)	4.3 score on a scale STANDARD_DEVIATION 2.3 • n=5 Participants	4.6 score on a scale STANDARD_DEVIATION 2.4 • n=7 Participants	4.5 score on a scale STANDARD_DEVIATION 2.4 • n=5 Participants
Smoking Abstinence Self-Efficacy Questionnaire (SASEQ)	11.5 score on a scale STANDARD_DEVIATION 4.9 • n=5 Participants	11.8 score on a scale STANDARD_DEVIATION 4.7 • n=7 Participants	11.7 score on a scale STANDARD_DEVIATION 4.8 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=91 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=92 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Average Total App Openings at 12 Weeks	86.5 app openings Standard Deviation 66.3	157.9 app openings Standard Deviation 210.6

SECONDARY outcome

Timeframe: 4 weeks

desire to quit smoking, participant self-report, yes/no

Outcome measures

Measure	Control n=88 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=91 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Desire to Quit (Yes/no) Participants who answered "yes" to having a desire to quit smoking	88 Participants	91 Participants
Desire to Quit (Yes/no) Participants who answered "no" to having a desire to quit smoking	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Control n=91 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=92 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Change in Expected Difficulty in Staying Quit Difficulty to quit 12 weeks	5.2 score on a scale Standard Deviation 3.0	5.7 score on a scale Standard Deviation 3.1
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	2.2 score on a scale Standard Deviation 3.7

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Control n=91 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=92 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Change in Confidence Levels Towards Quitting Smoking Success to quit 12 weeks	5.8 score on a scale Standard Deviation 3.1	6.6 score on a scale Standard Deviation 3.0
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	2.0 score on a scale Standard Deviation 3.6

SECONDARY outcome

Timeframe: 12 weeks

participant self-report of 7-day and 30-day point prevalence abstinence (PPA) from smoking cigarettes

Outcome measures

Measure	Control n=91 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=92 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Self-Reported Smoking Abstinence 7-day PPA at 12 weeks	26 Participants	33 Participants
Self-Reported Smoking Abstinence 30-day PPA at 12 weeks	21 Participants	27 Participants

SECONDARY outcome

Timeframe: 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.

participant self-report of 7-day and 30-day point prevalence abstinence (PPA) from smoking cigarettes

Outcome measures

Measure	Control n=94 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=94 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Self-Reported Smoking Abstinence 7-day PPA at 26 weeks ITT	25 Participants	34 Participants
Self-Reported Smoking Abstinence 7-day PPA at 26 weeks Responder	25 Participants	34 Participants
Self-Reported Smoking Abstinence 30-day PPA at 26 weeks ITT	21 Participants	30 Participants
Self-Reported Smoking Abstinence 30-day PPA at 26 weeks Responder	21 Participants	30 Participants

SECONDARY outcome

Timeframe: 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.

participant self-report of 7-day and 30-day point prevalence abstinence (PPA) from smoking cigarettes

Outcome measures

Measure	Control n=94 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=94 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Self-Reported Smoking Abstinence 7-day PPA at 52 weeks ITT	29 Participants	39 Participants
Self-Reported Smoking Abstinence 7-day PPA at 52 weeks Responder	29 Participants	39 Participants
Self-Reported Smoking Abstinence 30-day PPA at 52 weeks ITT	28 Participants	34 Participants
Self-Reported Smoking Abstinence 30-day PPA at 52 weeks Responder	28 Participants	34 Participants

SECONDARY outcome

Timeframe: 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.

participant self report of no tobacco product use including: cigarettes, e-cigarettes/vaping, cigars, chew/snuff, pipe, and hookah

Outcome measures

Measure	Control n=94 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=94 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Self-Reported Abstinence From All Tobacco Products Self-report no tobacco use ITT	25 Participants	31 Participants
Self-Reported Abstinence From All Tobacco Products Self-report no tobacco use Responder	25 Participants	31 Participants

SECONDARY outcome

Timeframe: 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.

Participant self report of no tobacco product use including: cigarettes, e-cigarettes/vaping, cigars, chew/snuff, pipe, and hookah.

Outcome measures

Measure	Control n=94 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=94 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Self-Reported Abstinence From All Tobacco Products Self-report no tobacco use ITT	23 Participants	32 Participants
Self-Reported Abstinence From All Tobacco Products Self-report no tobacco use Responder	23 Participants	32 Participants

SECONDARY outcome

Timeframe: 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.

Participant self report of no tobacco product use including: cigarettes, e-cigarettes/vaping, cigars, chew/snuff, pipe, and hookah.

Outcome measures

Measure	Control n=94 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=94 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Self-Reported Abstinence From All Tobacco Products Self-report no tobacco use ITT	27 Participants	33 Participants
Self-Reported Abstinence From All Tobacco Products Self-report no tobacco use Responder	27 Participants	33 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Control n=94 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=94 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Biochemically Confirmed Abstinence Biovalidated abstinence ITT	12 Participants	27 Participants
Biochemically Confirmed Abstinence Biovalidated abstinence Responder	12 Participants	27 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Control n=94 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=94 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Biochemically Confirmed Abstinence Biovalidated abstinence ITT	14 Participants	26 Participants
Biochemically Confirmed Abstinence Biovalidated abstinence Responder	14 Participants	26 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Control n=94 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=94 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Biochemically Confirmed Abstinence Biovalidated abstinence ITT	17 Participants	29 Participants
Biochemically Confirmed Abstinence Biovalidated abstinence Responder	17 Participants	29 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Control n=94 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=94 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Self-Reported Continuous Abstinence Self-reported continuous abstinence ITT	15 Participants	24 Participants
Self-Reported Continuous Abstinence Self-reported continuous abstinence Responder	15 Participants	24 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Control n=94 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=94 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Self-Reported Continuous Abstinence Self-reported continuous abstinence ITT	8 Participants	19 Participants
Self-Reported Continuous Abstinence Self-reported continuous abstinence Responder	8 Participants	19 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Control n=94 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=94 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Biochemically Confirmed Continuous Abstinence Biochemically confirmed continuous abstinence ITT	9 Participants	20 Participants
Biochemically Confirmed Continuous Abstinence Biochemically confirmed continuous abstinence Responder	9 Participants	20 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Control n=94 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=94 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Biochemically Confirmed Continuous Abstinence Biochemically confirmed continuous abstinence ITT	8 Participants	18 Participants
Biochemically Confirmed Continuous Abstinence Biochemically confirmed continuous abstinence Responder	8 Participants	18 Participants

SECONDARY outcome

Timeframe: 26 weeks

The proportion of participants who reduced their cigarettes per day (CPD) by ≥ 50% compared to baseline

Outcome measures

Measure	Control n=90 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=90 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Proportion With ≥ 50% CPD Reduction	59 Participants	56 Participants

SECONDARY outcome

Timeframe: 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".

Outcome measures

Measure	Control n=92 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=92 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
User Satisfaction - User Feedback How has using your assigned program affected your motivation to quit smoking? · increased	54 Participants	72 Participants
User Satisfaction - User Feedback How has using your assigned program affected your motivation to quit smoking? · not affected	35 Participants	19 Participants
User Satisfaction - User Feedback How has using your assigned program affected your motivation to quit smoking? · decreased	3 Participants	1 Participants
User Satisfaction - User Feedback How has using your assigned program affected the number of cigarettes you smoke per day? · increased	2 Participants	2 Participants
User Satisfaction - User Feedback How has using your assigned program affected the number of cigarettes you smoke per day? · not affected	34 Participants	25 Participants
User Satisfaction - User Feedback How has using your assigned program affected the number of cigarettes you smoke per day? · decreased	56 Participants	65 Participants

SECONDARY outcome

Timeframe: 3 weeks

Population: Participants that completed the 3 week questionnaire

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".

Outcome measures

Measure	Control n=90 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=89 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Additional User Feedback I've learned some really unique/key insights into my smoking behavior	51 Participants	72 Participants
Additional User Feedback I've learned some things but nothing that impactful	26 Participants	16 Participants
Additional User Feedback I have not learned anything from the program	12 Participants	1 Participants
Additional User Feedback I am more confused after using the program	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Control n=91 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=92 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
User Feedback - Setup and Starting the Program	7.1 score on a scale Standard Deviation 3.0	8.2 score on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Control n=91 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=92 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
User Feedback Study program helped them with their goals related to smoking - answered "true"	69 Participants	79 Participants
User Feedback Among participants reporting 7-day PPA: study program helped them quit smoking - answered "true"	22 Participants	34 Participants

SECONDARY outcome

Timeframe: 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.

User feedback with the smoking cessation program, specifically whether the program helped them quit smoking (true/false).

Outcome measures

Measure	Control n=29 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=39 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
User Feedback: Number of Participants Who Agreed That Their Program Helped Them Quit Smoking	26 Participants	35 Participants

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Control n=91 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=92 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
User Satisfaction - Net Promoter Score (NPS) NPS score at 4 weeks	1.1 score on a scale	50.6 score on a scale
User Satisfaction - Net Promoter Score (NPS) NPS score at 12 weeks	11.0 score on a scale	44.6 score on a scale
User Satisfaction - Net Promoter Score (NPS) NPS score at 26 weeks	23.6 score on a scale	57.8 score on a scale

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=91 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=92 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Engagement With Program - Number of Times App Was Opened	86.5 number of app openings Standard Deviation 66.3	157.9 number of app openings Standard Deviation 210.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=91 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=92 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Engagement With Program - Number of Days App Was Opened	50.4 days Standard Deviation 25.2	49.6 days Standard Deviation 24.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=91 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=92 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Engagement With Program - Number of Weeks App Was Opened	11.0 weeks Standard Deviation 2.3	11.0 weeks Standard Deviation 2.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=91 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=92 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Participant Changes in Self-Efficacy SASEQ 12 weeks	14.1 score on a scale Standard Deviation 6.2	14.5 score on a scale Standard Deviation 6.9
Participant Changes in Self-Efficacy Change in SASEQ from baseline to 12 weeks	2.7 score on a scale Standard Deviation 7.9	2.6 score on a scale Standard Deviation 6.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=90 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=89 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Participant Changes in Self-Efficacy SASEQ 52 weeks	12.6 score on a scale Standard Deviation 8.1	14.9 score on a scale Standard Deviation 7.9
Participant Changes in Self-Efficacy Change in SASEQ from baseline to 52 weeks	1.0 score on a scale Standard Deviation 8.5	3.2 score on a scale Standard Deviation 7.8

SECONDARY outcome

Timeframe: 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

participant self-report, choices for reporting health: excellent, very good, good, fair, or poor

Outcome measures

Measure	Control n=94 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=94 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Participant Changes in Self-reported Health and Wellbeing Self-reported health at baseline · Excellent	1 Participants	4 Participants
Participant Changes in Self-reported Health and Wellbeing Self-reported health at baseline · Very good	33 Participants	24 Participants
Participant Changes in Self-reported Health and Wellbeing Self-reported health at baseline · Good	48 Participants	51 Participants
Participant Changes in Self-reported Health and Wellbeing Self-reported health at baseline · Fair	12 Participants	14 Participants
Participant Changes in Self-reported Health and Wellbeing Self-reported health at baseline · Poor	0 Participants	1 Participants
Participant Changes in Self-reported Health and Wellbeing Self-reported health at 12 weeks · Excellent	6 Participants	4 Participants
Participant Changes in Self-reported Health and Wellbeing Self-reported health at 12 weeks · Very good	27 Participants	25 Participants
Participant Changes in Self-reported Health and Wellbeing Self-reported health at 12 weeks · Good	37 Participants	42 Participants
Participant Changes in Self-reported Health and Wellbeing Self-reported health at 12 weeks · Fair	18 Participants	18 Participants
Participant Changes in Self-reported Health and Wellbeing Self-reported health at 12 weeks · Poor	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 26 weeks

Nicotine replacement therapy (NRT) use assessed with participant orders of NRT

Outcome measures

Measure	Control n=94 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=94 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Self-Reported Nicotine Replacement Therapy (NRT) Use ≥1 NRT single-therapy order	8 Participants	23 Participants
Self-Reported Nicotine Replacement Therapy (NRT) Use ≥1 NRT combination-therapy order	57 Participants	44 Participants
Self-Reported Nicotine Replacement Therapy (NRT) Use ≥1 NRT single-therapy order + ≥1 NRT combination-therapy order	12 Participants	26 Participants
Self-Reported Nicotine Replacement Therapy (NRT) Use No orders	17 Participants	1 Participants

SECONDARY outcome

Timeframe: 52 weeks

Nicotine replacement therapy (NRT) use assessed with participant orders of NRT

Outcome measures

Measure	Control n=94 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=94 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Self-Reported Nicotine Replacement Therapy (NRT) Use ≥1 NRT single therapy order	9 Participants	22 Participants
Self-Reported Nicotine Replacement Therapy (NRT) Use ≥1 NRT combination therapy order	57 Participants	42 Participants
Self-Reported Nicotine Replacement Therapy (NRT) Use ≥1 NRT single therapy + ≥1 NRT combination therapy order	14 Participants	29 Participants
Self-Reported Nicotine Replacement Therapy (NRT) Use None	14 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=94 Participants A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=94 Participants Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Adverse Events Participants who experienced adverse events/issues with their assigned study program	0 Participants	0 Participants
Adverse Events Participants who experienced adverse events/issues with nicotine replacement therapy	17 Participants	19 Participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Pivot

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Control n=94 participants at risk A commercially available mobile phone app and program Control: Standard of Care - Control Smoking Cessation Program	Pivot n=94 participants at risk Pivot mobile phone app and program Pivot: Pivot Program Smoking Cessation Program
Gastrointestinal disorders GI upset due to NRT lozenge or gum use	1.1% 1/94 • Number of events 1 • Participants self-report adverse event experienced due to their assigned program and/or the NRT that they ordered during the study. Participants were asked at 12 weeks and 26 weeks if they had any issues with their assigned program and/or with their use of nicotine replacement therapy.	6.4% 6/94 • Number of events 6 • Participants self-report adverse event experienced due to their assigned program and/or the NRT that they ordered during the study. Participants were asked at 12 weeks and 26 weeks if they had any issues with their assigned program and/or with their use of nicotine replacement therapy.
Skin and subcutaneous tissue disorders Skin irritation due to NRT patch use	7.4% 7/94 • Number of events 7 • Participants self-report adverse event experienced due to their assigned program and/or the NRT that they ordered during the study. Participants were asked at 12 weeks and 26 weeks if they had any issues with their assigned program and/or with their use of nicotine replacement therapy.	7.4% 7/94 • Number of events 7 • Participants self-report adverse event experienced due to their assigned program and/or the NRT that they ordered during the study. Participants were asked at 12 weeks and 26 weeks if they had any issues with their assigned program and/or with their use of nicotine replacement therapy.
Gastrointestinal disorders Heartburn due to NRT lozenge or gum use	3.2% 3/94 • Number of events 3 • Participants self-report adverse event experienced due to their assigned program and/or the NRT that they ordered during the study. Participants were asked at 12 weeks and 26 weeks if they had any issues with their assigned program and/or with their use of nicotine replacement therapy.	0.00% 0/94 • Participants self-report adverse event experienced due to their assigned program and/or the NRT that they ordered during the study. Participants were asked at 12 weeks and 26 weeks if they had any issues with their assigned program and/or with their use of nicotine replacement therapy.
General disorders Sleep issues - wild dreams, insomnia	3.2% 3/94 • Number of events 3 • Participants self-report adverse event experienced due to their assigned program and/or the NRT that they ordered during the study. Participants were asked at 12 weeks and 26 weeks if they had any issues with their assigned program and/or with their use of nicotine replacement therapy.	3.2% 3/94 • Number of events 3 • Participants self-report adverse event experienced due to their assigned program and/or the NRT that they ordered during the study. Participants were asked at 12 weeks and 26 weeks if they had any issues with their assigned program and/or with their use of nicotine replacement therapy.
General disorders Headache due to NRT use	1.1% 1/94 • Number of events 1 • Participants self-report adverse event experienced due to their assigned program and/or the NRT that they ordered during the study. Participants were asked at 12 weeks and 26 weeks if they had any issues with their assigned program and/or with their use of nicotine replacement therapy.	1.1% 1/94 • Number of events 1 • Participants self-report adverse event experienced due to their assigned program and/or the NRT that they ordered during the study. Participants were asked at 12 weeks and 26 weeks if they had any issues with their assigned program and/or with their use of nicotine replacement therapy.
Gastrointestinal disorders Hiccups due to NRT lozenge or gum use	0.00% 0/94 • Participants self-report adverse event experienced due to their assigned program and/or the NRT that they ordered during the study. Participants were asked at 12 weeks and 26 weeks if they had any issues with their assigned program and/or with their use of nicotine replacement therapy.	2.1% 2/94 • Number of events 2 • Participants self-report adverse event experienced due to their assigned program and/or the NRT that they ordered during the study. Participants were asked at 12 weeks and 26 weeks if they had any issues with their assigned program and/or with their use of nicotine replacement therapy.
General disorders Jittery, racing heart, or lightheaded feeling due to NRT use	1.1% 1/94 • Number of events 1 • Participants self-report adverse event experienced due to their assigned program and/or the NRT that they ordered during the study. Participants were asked at 12 weeks and 26 weeks if they had any issues with their assigned program and/or with their use of nicotine replacement therapy.	2.1% 2/94 • Number of events 2 • Participants self-report adverse event experienced due to their assigned program and/or the NRT that they ordered during the study. Participants were asked at 12 weeks and 26 weeks if they had any issues with their assigned program and/or with their use of nicotine replacement therapy.
Gastrointestinal disorders Mouth irritation or sore throat due to NRT lozenge or gum use	1.1% 1/94 • Number of events 1 • Participants self-report adverse event experienced due to their assigned program and/or the NRT that they ordered during the study. Participants were asked at 12 weeks and 26 weeks if they had any issues with their assigned program and/or with their use of nicotine replacement therapy.	1.1% 1/94 • Number of events 1 • Participants self-report adverse event experienced due to their assigned program and/or the NRT that they ordered during the study. Participants were asked at 12 weeks and 26 weeks if they had any issues with their assigned program and/or with their use of nicotine replacement therapy.

Additional Information

Craig Fujii, Sr. Director of Clinical Affairs and Data Science

Pivot Health Technologies Inc.

Phone: 650-906-4255

Email: craig@pivot.co

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place