Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study

Study Overview
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Brief Summary
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Prospective open label, single center study enrolling up to 220 participants to evaluate the effect of the Pivot Breath Sensor on a user's attitudes towards quitting smoking and smoking behavior.

Detailed Description
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Study to collect the following data during and after use of a personal carbon monoxide breath sensor (Pivot Breath Sensor): Change in attitudes towards quitting smoking Change in smoking behavior Participant feedback

Official Title
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Pivot Breath Sensor Study to Evaluate the Effect of the Pivot Breath Sensor on a User's Attitudes Towards Quitting Smoking and Smoking Behavior.

Conditions
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Smoking, Tobacco, Smoking Reduction, Smoking Behaviors, Smoking Cessation

Intervention / Treatment
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* Device: Pivot Breath Sensor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 years of age Current daily cigarette smokers (at least 10 cigarettes per day) Resident of the United States Able to read and comprehend English Owns and uses a smartphone compatible with the study app (iPhone 5 and above with operating system iOS 11 and above, or, Android 5.0 and above with operating system Android 5.0 and above) Willing to sign the Informed Consent Form Exclusion Criteria: Pregnancy Participation in a previous study sponsored by Carrot Inc

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pivot Breath Sensor (user group)<br>Self-reported daily smokers of 10 or more cigarettes per day | Device: Pivot Breath Sensor<br>* The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Different Stages of Change in Desire to Quit Smoking | Assessment of participant's desire to quit by measuring Stage of Change. The participant will be asked if they are serious about quitting smoking and they can select from the following options: Yes, within the next 30 days Yes, within the next 6 months No, not thinking of quitting All data obtained via questionnaires completed by the participants. Throughout the course of the study, if the participant moves from No, not thinking of quitting to yes, within the next 6 months to Yes, within the next 30 days - that is a positive outcome for the participant. If they answered in the reverse, that would be a negative outcome for the participant. In short, becoming more ready to quit is a positive outcome, becoming less ready to quit is a less positive outcome. | 3 months (12 weeks) compared to baseline | 
| Success to Quit (STQ) | Assessment of participant's attitudes towards quitting by measuring Success to Quit. The participant will be asked If you were to quit smoking right now, how successful would you be? Rating Scale: 1 = Not at all successful, 10 = Completely successful. Higher score is a better outcome for participants, it indicates a more positive attitude towards quitting smoking. | 3 months (12 weeks) | 
| Difficulty to Quit (DTQ) | Assessment of participant's attitudes towards quitting by measuring Perceived Difficulty to staying Quit. Participant will be asked: If you were to quit smoking right now, how difficult do you think it would be to stay smoke free? Rating scale: 1 = Really hard to stay quit, 10 = Really easy to stay quit. Higher score is a better outcome for participants, it indicates a more positive attitude towards quitting smoking, specifically lower perceived difficulty to quit. | 3 months (12 weeks) | 
| Average Quit Attempts Made Since Using the Pivot Breath Sensor | Assess participant's smoking behavior by measuring Quit attempts. Participant were asked: Since you began using the Pivot Breath Sensor, how many times have you tried to quit smoking? | 3 months (12 weeks) | 
| Change in Cigarettes Per Day (CPD) From Baseline | Assess participant's smoking behavior by measuring CPD. Participant will be asked to enter a number for: How many cigarettes do you now smoke per day, on average? Enter number value. | 3 months (12 weeks) | 
| Point Prevalence Abstinence (PPA) | Assess participant's smoking behavior by measuring 7-Day and 30-Day PPA. Participant will be asked: In the last 7 days and 30 days have you smoked any cigarettes? Answer choice: Yes/No 7-Day PPA is defined as answering No to In the last 7 days have you smoked any cigarettes? 30-Day PPA is defined as answering No to In the last 30 days have you smoked any cigarettes? Data obtained via questionnaires completed by the participants. | 3 months (12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feedback on Breath Sensor Setup, Experience and Use | Gather participant feedback on breath sensor setup: Participant is asked: How would you rate the ease or difficulty of getting started with the breath sensor? How would you rate the ease or difficulty of following the directions on the breath sensor screen? If you ever got an error on the breath sensor screen, how easy or difficult was it to understand the issue and correct it? Select one: - Very difficult - Difficult - Neither easy nor difficult - Easy - Very Easy I did not set up my breath sensor All data obtained via questionnaires completed by the participants. | 1 week | 
| Feedback on Impact on Motivation to Quit Smoking | Gather participant feedback on impact of breath sensor: Participant will be asked: How has using the breath sensor affected your motivation to quit smoking? Select one: Using the breath sensor has increased my motivation to quit smoking Using the breath sensor has not affected my motivation to quit smoking Using the breath sensor has decreased my motivation to quit smoking I haven't used the breath sensor | 1 week | 
| Feedback on Impact on Number of Cigarettes Smoked Per Day | Gather participant feedback on impact of breath sensor: Participant will be asked: How has using the breath sensor affected the number of cigarettes you smoke per day? Select one: Using the breath sensor has increased the number of cigarettes I smoke per day Using the breath sensor has not affected the number of cigarettes I smoke per day Using the breath sensor has decreased the number of cigarettes I smoke per day I haven't used the breath sensor | 1 week | 
| Feedback on Commercialization | Gather participant feedback on commercialization: Participant will be asked: Hypothetical: if it was commercially available, would you be interested in buying the Pivot Breath Sensor? Answer: Yes/No | 4 weeks |