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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.
Study to collect the following data during and after use of a personal carbon monoxide breath sensor (Pivot Breath Sensor):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pivot Breath Sensor (user group) | Other | Self-reported daily smokers of 10 or more cigarettes per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pivot Breath Sensor | Device | The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user. |
|
| 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:
| 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? |
| Measure | Description | Time Frame |
|---|---|---|
| Feedback on Breath Sensor Setup, Experience and Use | Gather participant feedback on breath sensor setup: Participant is asked:
Select one:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jen Marler | Pivot Health Technologies Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carrot Inc. | Redwood City | California | 94063 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32894829 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants that enrolled in the study and completed the baseline questionnaire.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 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:
| Participants that completed the 12-week questionnaire | Posted | Count of Participants | Participants | 3 months (12 weeks) compared to baseline |
|
Adverse events were assessed for over 12 weeks
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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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP of Clinical and Medical Affairs | Pivot Health Technologies Inc. | 415-757-7696 | marler@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 12, 2019 | Oct 14, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000074264 | Smoking Reduction |
| D012907 | Smoking |
| D000073869 | Tobacco Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| 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) |
| 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:
| 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:
| 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 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
| Years smoking | Mean | Standard Deviation | years |
|
| Cigarettes per day (CPD) | Mean | Standard Deviation | cigarettes smoked per day |
|
| Would you like to stop smoking? | Count of Participants | Participants |
|
| Motivation to Quit (Stage of Change) - Are you seriously thinking of quitting smoking? | Count of Participants | Participants |
|
| Readiness to Quit (RTQ) | How ready are you to quit smoking? Answered on a 1-10 scale: 1 = Not at all ready; 10 = Completely ready | Mean | Standard Deviation | units on a scale |
|
| Success to quit (STQ) | If you were to quit smoking right now, how successful would you be? Answered on a scale: 1 = Not at all successful; 10 = Completely successful | Mean | Standard Deviation | units on a scale |
|
| Difficulty to quit (DTQ) | If you were to quit smoking right now, how difficult do you think it would be to stay smoke free? Answered on a scale: 1 = Really hard to stay quit; 10 = Really easy to stay quit | Mean | Standard Deviation | units on a scale |
|
| 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. |
|
|
| 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. | Participants that completed the 12 week questionnaire | Posted | Mean | Standard Deviation | units on a scale | 3 months (12 weeks) |
|
|
|
| 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. | Participants that completed the 12 week questionnaire | Posted | Mean | Standard Deviation | units on a scale | 3 months (12 weeks) |
|
|
|
| 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? | Participants that completed the 12 week questionnaire | Posted | Mean | Standard Deviation | quit attempts made | 3 months (12 weeks) |
|
|
|
| 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. | Participants that completed the 12 week questionnaire | Posted | Count of Participants | Participants | 3 months (12 weeks) |
|
|
|
| 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. | Participants that completed the 12 week questionnaire | Posted | Count of Participants | Participants | 3 months (12 weeks) |
|
|
|
| Secondary | Feedback on Breath Sensor Setup, Experience and Use | Gather participant feedback on breath sensor setup: Participant is asked:
Select one:
| 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" | Posted | Count of Participants | Participants | 1 week |
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| 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:
| Participants that completed the 1 week questionnaire | Posted | Count of Participants | Participants | 1 week |
|
|
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| 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:
| Participants that completed the 1 week questionnaire | Posted | Count of Participants | Participants | 1 week |
|
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| 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 | Participants that completed the 4 week questionnaire | Posted | Count of Participants | Participants | 4 weeks |
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| 234 |
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| 234 |
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| 234 |
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| Title | Measurements |
|---|---|
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| 4 - Easy |
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| 5 - Very easy |
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| Other |
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| How would you rate the ease or difficulty of following the directions on the breath sensor screen? |
|
| If you ever got an error ... how easy or difficult was it to understand the issue and correct it? |
|
| I haven't used the breath sensor |
|
| I haven't used the breath sensor |
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