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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Smoking Cessation

Intervention / Treatment
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* Device: Mobile smoking cessation program and CO breath sensor device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years of age English speaking Smokes daily Smokes 5 or more cigarettes per day Owns and uses a smartphone (iPhone 5 and above, operating system iOS 9.0 and above, or, Android 4.4 and above, operating system Android 4.4 and above) Employed at least 20 hours per week Lives in the USA Understands and willing to sign the Informed Consent Form

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects experience same program
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Mobile smoking cessation program<br>Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. | Device: Mobile smoking cessation program and CO breath sensor device<br>* Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. |