Trial Outcomes & Findings for Outcomes From a Mobile Smoking Cessation Program During a Monitoring Period of 6 Months (NCT NCT03295643)

NCT ID: NCT03295643

Last Updated: 2024-07-01

Results Overview

For the number of participants who started the Mobilize Stage, the proportion who completed the Mobilize Stage.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 319 participants
• Primary outcome timeframe: Assessment at the end of the Mobilize stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.
• Results posted on: 2024-07-01

Participant Flow

Online recruitment

Phone call to confirm eligibility.

Participant milestones

Measure	Mobile Smoking Cessation Program Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. The mobile smoking cessation program includes 5 phases with the following names and timelines: Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days. Quit = 7 days. Secure = 11 weeks.
Overall Study STARTED	319
Overall Study Completed Explore Stage	283
Overall Study Completed Build Stage	183
Overall Study Completed Mobilize Stage	139
Overall Study Completed Quit Stage	131
Overall Study Completed Secure Stage	126
Overall Study COMPLETED	272
Overall Study NOT COMPLETED	47

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Outcomes From a Mobile Smoking Cessation Program During a Monitoring Period of 6 Months

Baseline characteristics by cohort

Measure	Mobile Smoking Cessation Program n=319 Participants Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
Age, Continuous	42.8 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	184 Participants n=5 Participants
Sex: Female, Male Male	135 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · White	264 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · African American	22 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic	15 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Asian	5 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · American Indian or Alaska Native	4 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Native Hawaiian or other Pacific Islander	2 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Other	7 Participants n=5 Participants
Region of Enrollment United States	319 participants n=5 Participants
Cigarettes smoked per day	17.7 Cigarettes per day STANDARD_DEVIATION 7.6 • n=5 Participants

PRIMARY outcome

Timeframe: Assessment at the end of the Explore stage; 9 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.

For the number of participants who started the Explore Stage, the proportion who completed the Explore Stage.

Outcome measures

Measure	Mobile Smoking Cessation Program n=319 Participants Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
Number of Participants Who Completed the Explore Stage	283 Participants

PRIMARY outcome

Timeframe: Assessment at the end of the Build stage; between 10 and 37 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.

For the number of participants who started the Build Stage, the proportion who completed the Build Stage.

Outcome measures

Measure	Mobile Smoking Cessation Program n=319 Participants Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
Number of Participants Who Completed the Build Stage	183 Participants

PRIMARY outcome

Timeframe: Assessment at the end of the Mobilize stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.

For the number of participants who started the Mobilize Stage, the proportion who completed the Mobilize Stage.

Outcome measures

Measure	Mobile Smoking Cessation Program n=319 Participants Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
Number of Participants Who Completed the Mobilize Stage	139 Participants

PRIMARY outcome

Timeframe: Assessment at the end of the Quit Stage; between 24 and 51 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days. Quit = 7 days.

For the number of participants who started the Quit Stage, the proportion who completed the Quit Stage.

Outcome measures

Measure	Mobile Smoking Cessation Program n=319 Participants Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
Number of Participants Who Completed the Quit Stage	131 Participants

PRIMARY outcome

Timeframe: Assessment at the end of the Secure Stage; between 101 and 128 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days. Quit = 7 days. Secure = 11 weeks.

For the number of participants who started the Secure Stage, the proportion who completed the Secure Stage.

Outcome measures

Measure	Mobile Smoking Cessation Program n=319 Participants Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
Number of Participants Who Completed the Secure Stage	126 Participants

SECONDARY outcome

Timeframe: Assessment at the end of the Explore stage; 9 days after activating app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.

Population: Participants who provided baseline and explore stage results

Are you seriously thinking of quitting smoking? (stage of change) "Yes, within the next 30 days". "Yes, within the next 6 months". "No, not thinking of quitting".

Outcome measures

Measure	Mobile Smoking Cessation Program n=281 Participants Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
Readiness to Quit and Goals Related to Smoking Behavior End of Explore Stage - Stage of Change · No, not thinking of quitting	10 Participants
Readiness to Quit and Goals Related to Smoking Behavior Baseline - Stage of Change · Yes, within the next 30 days	94 Participants
Readiness to Quit and Goals Related to Smoking Behavior Baseline - Stage of Change · Yes, within the next 6 months	176 Participants
Readiness to Quit and Goals Related to Smoking Behavior Baseline - Stage of Change · No, not thinking of quitting	11 Participants
Readiness to Quit and Goals Related to Smoking Behavior End of Explore Stage - Stage of Change · Yes, within the next 30 days	157 Participants
Readiness to Quit and Goals Related to Smoking Behavior End of Explore Stage - Stage of Change · Yes, within the next 6 months	114 Participants

SECONDARY outcome

Timeframe: Assessment at the end of the Mobilize stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.

Average percentage change in cigarettes per day (CPD) by the Pre-Quit Stage using repeated measures linear mixed model analysis.

Model uses all available data on CPD to estimate an average. The Pre-Quit Stage is defined as from the start of the study (activation of the app and device/ Baseline) to the end of the Mobilize Stage.

Outcome measures

Measure	Mobile Smoking Cessation Program n=319 Participants Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
Average Percentage Change in Cigarettes Per Day (CPD) by the Pre-Quit Stage	-44.5 percentage change in cpd Standard Deviation 3

SECONDARY outcome

Timeframe: 6 months

Engagement defined as interaction with the program at least once within app (app open, daily check-in, responds to coach, logs cigarettes, etc)

Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.

Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.

Outcome measures

Measure	Mobile Smoking Cessation Program n=319 Participants Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
Weeks of Active Engagement	12.4 weeks Standard Deviation 7.1

SECONDARY outcome

Timeframe: 6 months

The number of participants who completed the quit-smoking program.

Outcome measures

Measure	Mobile Smoking Cessation Program n=319 Participants Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
Number of Participants Who Completed the Program	272 Participants

SECONDARY outcome

Timeframe: 6 months

Number attempt to quit by participant

Outcome measures

Measure	Mobile Smoking Cessation Program n=272 Participants Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
Quit Attempts	2.4 quit attempts Standard Deviation 3.1

SECONDARY outcome

Timeframe: 6 months

Number of participant who have not smoked in last 7 days

Outcome measures

Measure	Mobile Smoking Cessation Program n=272 Participants Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
Quit Rate 7-day Point Prevalence	102 Participants

SECONDARY outcome

Timeframe: 6 months

Number of participant who have not smoked in last 30 days

Outcome measures

Measure	Mobile Smoking Cessation Program n=272 Participants Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
Quit Rate 30-day Point Prevalence	88 Participants

SECONDARY outcome

Timeframe: 6 months

the number of participants who reported Pivot program (app, breath sensor, and coaching) increased their motivation to stop smoking

Outcome measures

Measure	Mobile Smoking Cessation Program n=272 Participants Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
Number of Participants Who Reported Pivot Increased Their Motivation to Stop Smoking	233 Participants

SECONDARY outcome

Timeframe: Assessment at the end of the Mobilize Stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.

Confidence to quit. Estimate of means and standard errors based on linear mixed model.

Participants were asked: "If you were to quit smoking right now, how successful would you be?" Answered on a scale from 1 to 10 (1=not at all successful, 10=completely successful).

Outcome measures

Measure	Mobile Smoking Cessation Program n=319 Participants Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
Confidence to Quit Baseline Confidence to Quit	4.2 score on a scale Standard Error 0.1443
Confidence to Quit End of Explore Confidence to Quit	5.9 score on a scale Standard Error 0.1508
Confidence to Quit End of Build Confidence to Quit	6.4 score on a scale Standard Error 0.1782
Confidence to Quit End of Mobilize Confidence to Quit	7.4 score on a scale Standard Error 0.1916

SECONDARY outcome

Timeframe: Assessment at the end of the Mobilize stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.

Difficulty maintaining quit. Estimate of means and standard errors based on linear mixed model.

Participants were asked: "If you were to quit smoking right now, how difficult do you think it would be to stay smoke-free?" Answered on a scale from 1 to 10 (1=really hard to stay quit, 10=really easy to stay quit).

Outcome measures

Measure	Mobile Smoking Cessation Program n=319 Participants Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
Difficulty Maintaining Quit Baseline difficulty maintaining quit	3.1 score on a scale Standard Error 0.1449
Difficulty Maintaining Quit End of Explore difficulty maintaining quit	4.9 score on a scale Standard Error 0.1531
Difficulty Maintaining Quit End of Build difficulty maintaining quit	5.7 score on a scale Standard Error 0.1891
Difficulty Maintaining Quit End of Mobilize difficulty maintaining quit	6.8 score on a scale Standard Error 0.2055

Adverse Events

Mobile Smoking Cessation Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior 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