Smoking Behaviors, Smoking Cessation, Smoking Reduction, Smoking, Tobacco
Conditions
Brief summary
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
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
Interventions
DEVICEPivot Breath Sensor
The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.
Sponsors
Jennifer Marler, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Point Prevalence Abstinence (PPA) | 3 months (12 weeks) | 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. |
| Success to Quit (STQ) | 3 months (12 weeks) | 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. |
| Difficulty to Quit (DTQ) | 3 months (12 weeks) | 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. |
| Average Quit Attempts Made Since Using the Pivot Breath Sensor | 3 months (12 weeks) | 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? |
| Change in Cigarettes Per Day (CPD) From Baseline | 3 months (12 weeks) | 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. |
| Number of Participants With Different Stages of Change in Desire to Quit Smoking | 3 months (12 weeks) compared to baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feedback on Impact on Motivation to Quit Smoking | 1 week | 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 |
| Feedback on Impact on Number of Cigarettes Smoked Per Day | 1 week | 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 |
| Feedback on Commercialization | 4 weeks | 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 |
| Feedback on Breath Sensor Setup, Experience and Use | 1 week | Gather participant feedback on breath sensor setup: Participant is asked: 1. How would you rate the ease or difficulty of getting started with the breath sensor? 2. How would you rate the ease or difficulty of following the directions on the breath sensor screen? 3. 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: 1. \- Very difficult 2. \- Difficult 3. \- Neither easy nor difficult 4. \- Easy 5. \- Very Easy I did not set up my breath sensor All data obtained via questionnaires completed by the participants. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pivot Breath Sensor (User Group) Self-reported daily smokers of 10 or more cigarettes per day
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. | 234 |
| Total | 234 |
Baseline characteristics
| Characteristic | Pivot Breath Sensor (User Group) |
|---|---|
| Age, Customized 18-29 years | 37 Participants |
| Age, Customized 30-60 years | 185 Participants |
| Age, Customized 61-80 years | 12 Participants |
| Cigarettes per day (CPD) | 20.3 cigarettes smoked per day STANDARD_DEVIATION 8 |
| Difficulty to quit (DTQ) | 2.8 units on a scale STANDARD_DEVIATION 2.4 |
| Education Associate's (2-year) degree | 37 Participants |
| Education Bachelor's (4-year) degree | 25 Participants |
| Education High school/General educational development | 50 Participants |
| Education Less than 8th grade | 0 Participants |
| Education Master's degree | 7 Participants |
| Education Professional or doctorate degree | 1 Participants |
| Education Some college | 107 Participants |
| Education Some high school | 7 Participants |
| Employment Employed <20 hours/week | 29 Participants |
| Employment Employed ≥ 20 hours/week | 194 Participants |
| Employment Unemployed | 11 Participants |
| Motivation to Quit (Stage of Change) - Are you seriously thinking of quitting smoking? No, not thinking of quitting | 18 Participants |
| Motivation to Quit (Stage of Change) - Are you seriously thinking of quitting smoking? Yes, within the next 30 days | 36 Participants |
| Motivation to Quit (Stage of Change) - Are you seriously thinking of quitting smoking? Yes, within the next 6 months | 180 Participants |
| Race/Ethnicity, Customized Race/Ethnicity American Indian or Alaska Native | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black or African American | 9 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic, Latinx, or Spanish Origin | 5 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Middle Eastern or North African | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Prefer not to answer | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Some other race, ethnicity, or origin | 5 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 209 Participants |
| Readiness to Quit (RTQ) | 5.6 units on a scale STANDARD_DEVIATION 2.7 |
| Region of Enrollment United States | 234 participants |
| Sex: Female, Male Female | 123 Participants |
| Sex: Female, Male Male | 111 Participants |
| Success to quit (STQ) | 3.3 units on a scale STANDARD_DEVIATION 2.3 |
| Would you like to stop smoking? no | 17 Participants |
| Would you like to stop smoking? yes | 217 Participants |
| Years smoking | 21.7 years STANDARD_DEVIATION 11.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 234 |
| other Total, other adverse events | 0 / 234 |
| serious Total, serious adverse events | 0 / 234 |
Outcome results
Primary
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?
Time frame: 3 months (12 weeks)
Population: Participants that completed the 12 week questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pivot Breath Sensor (User Group) | Average Quit Attempts Made Since Using the Pivot Breath Sensor | 2.4 quit attempts made | Standard Deviation 9.1 |
Primary
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.
Time frame: 3 months (12 weeks)
Population: Participants that completed the 12 week questionnaire
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pivot Breath Sensor (User Group) | Change in Cigarettes Per Day (CPD) From Baseline | Reduced CPD from baseline | 178 Participants |
| Pivot Breath Sensor (User Group) | Change in Cigarettes Per Day (CPD) From Baseline | No change in CPD from baseline | 25 Participants |
| Pivot Breath Sensor (User Group) | Change in Cigarettes Per Day (CPD) From Baseline | Increased CPD from baseline | 12 Participants |
Primary
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.
Time frame: 3 months (12 weeks)
Population: Participants that completed the 12 week questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pivot Breath Sensor (User Group) | Difficulty to Quit (DTQ) | 4.3 units on a scale | Standard Deviation 3 |
Primary
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.
Time frame: 3 months (12 weeks) compared to baseline
Population: Participants that completed the 12-week questionnaire
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pivot Breath Sensor (User Group) | Number of Participants With Different Stages of Change in Desire to Quit Smoking | Increased motivation to quit | 84 Participants |
| Pivot Breath Sensor (User Group) | Number of Participants With Different Stages of Change in Desire to Quit Smoking | Unchanged motivation to quit | 118 Participants |
| Pivot Breath Sensor (User Group) | Number of Participants With Different Stages of Change in Desire to Quit Smoking | Decreased motivation to quit | 13 Participants |
Primary
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.
Time frame: 3 months (12 weeks)
Population: Participants that completed the 12 week questionnaire
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pivot Breath Sensor (User Group) | Point Prevalence Abstinence (PPA) | 7-day PPA | 28 Participants |
| Pivot Breath Sensor (User Group) | Point Prevalence Abstinence (PPA) | 30-day PPA | 14 Participants |
| Pivot Breath Sensor (User Group) - Completer | Point Prevalence Abstinence (PPA) | 7-day PPA | 28 Participants |
| Pivot Breath Sensor (User Group) - Completer | Point Prevalence Abstinence (PPA) | 30-day PPA | 14 Participants |
Primary
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.
Time frame: 3 months (12 weeks)
Population: Participants that completed the 12 week questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pivot Breath Sensor (User Group) | Success to Quit (STQ) | 5 units on a scale | Standard Deviation 3.1 |
Secondary
Feedback on Breath Sensor Setup, Experience and Use
Gather participant feedback on breath sensor setup: Participant is asked: 1. How would you rate the ease or difficulty of getting started with the breath sensor? 2. How would you rate the ease or difficulty of following the directions on the breath sensor screen? 3. 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: 1. \- Very difficult 2. \- Difficult 3. \- Neither easy nor difficult 4. \- Easy 5. \- Very Easy I did not set up my breath sensor All data obtained via questionnaires completed by the participants.
Time frame: 1 week
Population: Participants that completed the 1 week questionnaire. For question 3: If you ever got an error on the breath sensor screen, how easy or difficult was it to understand the issue and correct it? Other category = I set up my breath sensor but have not gotten an error on the breath sensor screen
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Pivot Breath Sensor (User Group) | Feedback on Breath Sensor Setup, Experience and Use | How would you rate the ease or difficulty of getting started with the breath sensor? | 2 - Difficult | 9 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Breath Sensor Setup, Experience and Use | How would you rate the ease or difficulty of getting started with the breath sensor? | 3 - Neither easy nor difficult | 10 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Breath Sensor Setup, Experience and Use | How would you rate the ease or difficulty of getting started with the breath sensor? | 4 - Easy | 42 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Breath Sensor Setup, Experience and Use | How would you rate the ease or difficulty of getting started with the breath sensor? | 5 - Very easy | 165 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Breath Sensor Setup, Experience and Use | How would you rate the ease or difficulty of following the directions on the breath sensor screen? | 2 - Difficult | 0 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Breath Sensor Setup, Experience and Use | How would you rate the ease or difficulty of following the directions on the breath sensor screen? | 3 - Neither easy nor difficult | 7 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Breath Sensor Setup, Experience and Use | How would you rate the ease or difficulty of following the directions on the breath sensor screen? | 4 - Easy | 36 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Breath Sensor Setup, Experience and Use | How would you rate the ease or difficulty of following the directions on the breath sensor screen? | 5 - Very easy | 183 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Breath Sensor Setup, Experience and Use | How would you rate the ease or difficulty of following the directions on the breath sensor screen? | Other | 0 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Breath Sensor Setup, Experience and Use | If you ever got an error ... how easy or difficult was it to understand the issue and correct it? | 1 - Very Difficult | 0 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Breath Sensor Setup, Experience and Use | If you ever got an error ... how easy or difficult was it to understand the issue and correct it? | 2 - Difficult | 5 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Breath Sensor Setup, Experience and Use | If you ever got an error ... how easy or difficult was it to understand the issue and correct it? | 3 - Neither easy nor difficult | 8 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Breath Sensor Setup, Experience and Use | If you ever got an error ... how easy or difficult was it to understand the issue and correct it? | 4 - Easy | 37 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Breath Sensor Setup, Experience and Use | If you ever got an error ... how easy or difficult was it to understand the issue and correct it? | 5 - Very easy | 92 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Breath Sensor Setup, Experience and Use | If you ever got an error ... how easy or difficult was it to understand the issue and correct it? | Other | 85 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Breath Sensor Setup, Experience and Use | How would you rate the ease or difficulty of getting started with the breath sensor? | 1 - Very Difficult | 1 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Breath Sensor Setup, Experience and Use | How would you rate the ease or difficulty of getting started with the breath sensor? | Other | 0 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Breath Sensor Setup, Experience and Use | How would you rate the ease or difficulty of following the directions on the breath sensor screen? | 1 - Very Difficult | 1 Participants |
Secondary
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
Time frame: 4 weeks
Population: Participants that completed the 4 week questionnaire
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pivot Breath Sensor (User Group) | Feedback on Commercialization | yes | 153 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Commercialization | no | 63 Participants |
Secondary
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
Time frame: 1 week
Population: Participants that completed the 1 week questionnaire
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pivot Breath Sensor (User Group) | Feedback on Impact on Motivation to Quit Smoking | Using the breath sensor has not affected my motivation to quit smoking | 55 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Impact on Motivation to Quit Smoking | Using the breath sensor has decreased my motivation to quit smoking | 0 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Impact on Motivation to Quit Smoking | I haven't used the breath sensor | 1 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Impact on Motivation to Quit Smoking | Using the breath sensor has increased my motivation to quit smoking | 171 Participants |
Secondary
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
Time frame: 1 week
Population: Participants that completed the 1 week questionnaire
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pivot Breath Sensor (User Group) | Feedback on Impact on Number of Cigarettes Smoked Per Day | Using the breath sensor has increased the number of cigarettes I smoke per day | 2 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Impact on Number of Cigarettes Smoked Per Day | Using the breath sensor has not affected the number of cigarettes I smoke per day | 119 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Impact on Number of Cigarettes Smoked Per Day | Using the breath sensor has decreased the number of cigarettes I smoke per day | 105 Participants |
| Pivot Breath Sensor (User Group) | Feedback on Impact on Number of Cigarettes Smoked Per Day | I haven't used the breath sensor | 1 Participants |