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

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Smoking Reduction; Smoking, Tobacco; Smoking Behaviors
• Intervention / Treatment: Device: Pivot Breath Sensor

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 234
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Carrot Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jennifer Marler, MD
• Investigators: Principal Investigator: Jen Marler, Pivot Health Technologies Inc.

Publications and helpful links

General Publications

• Marler JD, Fujii CA, Wong KS, Galanko JA, Balbierz DJ, Utley DS. Assessment of a Personal Interactive Carbon Monoxide Breath Sensor in People Who Smoke Cigarettes: Single-Arm Cohort Study. J Med Internet Res. 2020 Oct 2;22(10):e22811. doi: 10.2196/22811.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2019
• Primary Completion (Actual): March 10, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: c-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No