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Prospective, open label, single center clinical study enrolling 260 subjects in a mobile smoking cessation program using a smartphone app and a handheld breath sensor with coaching support over a six month period.
This is a prospective, open label, single center clinical study enrolling 260 subjects in a mobile smoking cessation program using a smartphone app and handheld breath sensor with coaching support over a six month period. Measurements include user engagement and retention in the program, attitude towards smoking and smoking behavior, quit rates, relapse rates, and quality of life over the study period, as well as user feedback on the program.
Potential participants will complete an online screening form. Eligible participants will be called to confirm eligibility, discuss the study, and have their questions about the study answered. Interested eligible participants will then be emailed the registration link, which includes the electronic informed consent. After providing electronic informed consent, subjects register online and receive the hand held device which measures carbon monoxide (CO) which correlates to smoking behavior.
Baseline questionnaires (demographics, smoking history, and attitude towards smoking) are completed, and subjects then self-train to use the breath sensor and smartphone app and allows viewing of CO sample values. The app also provides the user with ability to log cigarettes, view cigarette consumption trends, view instructional videos, complete educational activities and challenges, and engage with a coach.
Participants will experience the program in 5 phases and then complete the study at approximately six months after enrolling,activating device and app.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile smoking cessation program | Other | Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile smoking cessation program and CO breath sensor device | Device | Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Completed the Explore Stage | For the number of participants who started the Explore Stage, the proportion who completed the Explore Stage. | 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. |
| Number of Participants Who Completed the Build Stage | For the number of participants who started the Build Stage, the proportion who completed the Build Stage. | 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. |
| Number of Participants Who Completed the Mobilize Stage | For the number of participants who started the Mobilize Stage, the proportion who completed the Mobilize Stage. | 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. |
| Number of Participants Who Completed the Quit Stage | For the number of participants who started the Quit Stage, the proportion who completed the Quit Stage. | 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. |
| Number of Participants Who Completed the Secure Stage | For the number of participants who started the Secure Stage, the proportion who completed the Secure Stage. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Readiness to Quit and Goals Related to Smoking Behavior | 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". | 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. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Utley, MD | Pivot Health Technologies, Inc (formerly Carrot Sense) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carrot Inc. | Redwood City | California | 94063 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33482628 | Derived | Marler JD, Fujii CA, Galanko JA, Balbierz DJ, Utley DS. Durability of Abstinence After Completing a Comprehensive Digital Smoking Cessation Program Incorporating a Mobile App, Breath Sensor, and Coaching: Cohort Study. J Med Internet Res. 2021 Feb 15;23(2):e25578. doi: 10.2196/25578. | |
| 30670372 | Derived | Marler JD, Fujii CA, Utley DS, Tesfamariam LJ, Galanko JA, Patrick H. Initial Assessment of a Comprehensive Digital Smoking Cessation Program That Incorporates a Mobile App, Breath Sensor, and Coaching: Cohort Study. JMIR Mhealth Uhealth. 2019 Feb 4;7(2):e12609. doi: 10.2196/12609. |
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Phone call to confirm eligibility.
Online recruitment
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Completed the Explore Stage | For the number of participants who started the Explore Stage, the proportion who completed the Explore Stage. | Posted | Count of Participants | Participants | 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. |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director of Clinical Affairs and Data Science | Pivot Health Technologies Inc. | 650-906-4255 | craig@pivot.co |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2017 | Oct 13, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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All subjects experience same program
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| Average Percentage Change in Cigarettes Per Day (CPD) by the Pre-Quit Stage | 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. | 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. |
| Weeks of Active Engagement | 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. | 6 months |
| Number of Participants Who Completed the Program | The number of participants who completed the quit-smoking program. | 6 months |
| Quit Attempts | Number attempt to quit by participant | 6 months |
| Quit Rate 7-day Point Prevalence | Number of participant who have not smoked in last 7 days | 6 months |
| Quit Rate 30-day Point Prevalence | Number of participant who have not smoked in last 30 days | 6 months |
| Number of Participants Who Reported Pivot Increased Their Motivation to Stop Smoking | the number of participants who reported Pivot program (app, breath sensor, and coaching) increased their motivation to stop smoking | 6 months |
| Confidence to Quit | 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). | 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 | 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). | 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. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Cigarettes smoked per day | Mean | Standard Deviation | Cigarettes per day |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Primary | Number of Participants Who Completed the Build Stage | For the number of participants who started the Build Stage, the proportion who completed the Build Stage. | Posted | Count of Participants | Participants | 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. |
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| Primary | Number of Participants Who Completed the Mobilize Stage | For the number of participants who started the Mobilize Stage, the proportion who completed the Mobilize Stage. | Posted | Count of Participants | Participants | 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. |
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| Primary | Number of Participants Who Completed the Quit Stage | For the number of participants who started the Quit Stage, the proportion who completed the Quit Stage. | Posted | Count of Participants | Participants | 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. |
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| Primary | Number of Participants Who Completed the Secure Stage | For the number of participants who started the Secure Stage, the proportion who completed the Secure Stage. | Posted | Count of Participants | Participants | 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. |
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| Secondary | Readiness to Quit and Goals Related to Smoking Behavior | 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". | Participants who provided baseline and explore stage results | Posted | Count of Participants | Participants | 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. |
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| Secondary | Average Percentage Change in Cigarettes Per Day (CPD) by the Pre-Quit Stage | 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. | Posted | Mean | Standard Deviation | percentage change in cpd | 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. |
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| Secondary | Weeks of Active Engagement | 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. | Posted | Mean | Standard Deviation | weeks | 6 months |
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| Secondary | Number of Participants Who Completed the Program | The number of participants who completed the quit-smoking program. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Quit Attempts | Number attempt to quit by participant | Posted | Mean | Standard Deviation | quit attempts | 6 months |
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| Secondary | Quit Rate 7-day Point Prevalence | Number of participant who have not smoked in last 7 days | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Quit Rate 30-day Point Prevalence | Number of participant who have not smoked in last 30 days | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants Who Reported Pivot Increased Their Motivation to Stop Smoking | the number of participants who reported Pivot program (app, breath sensor, and coaching) increased their motivation to stop smoking | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Confidence to Quit | 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). | Posted | Mean | Standard Error | score on a scale | 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. |
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| Secondary | Difficulty Maintaining Quit | 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). | Posted | Mean | Standard Error | score on a scale | 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. |
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| End of Explore Stage - Stage of Change |
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| End of Mobilize Confidence to Quit |
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| End of Mobilize difficulty maintaining quit |
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