Pivot Breath Sensor Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04133064|
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Smoking Reduction Smoking Behaviors Smoking, Tobacco Smoking Cessation||Device: Pivot Breath Sensor||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pivot Breath Sensor Study to Evaluate the Effect of the Pivot Breath Sensor on a User's Attitudes Towards Quitting Smoking and Smoking Behavior.|
|Actual Study Start Date :||September 25, 2019|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||May 2020|
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.
- Stage of Change [ Time Frame: 3 months ]
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.
- Confidence to Quit [ Time Frame: 3 months ]
Assessment of participant's attitudes towards quitting by measuring Confidence 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
- Difficulty to Quit [ Time Frame: 3 months ]
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
- Quit attempts [ Time Frame: 3 months ]Assess participant's smoking behavior by measuring Quit attempts. Participant will be asked: Since you began using the Pivot Breath Sensor, how many times have you tried to quit smoking? Answer choice: Yes/No
- Cigarettes Per Day (CPD) [ Time Frame: 3 months ]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.
- Point Prevalence Abstinence (PPA) [ Time Frame: 3 months ]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 Data obtained via questionnaires completed by the participants.
- Feedback on breath sensor setup, experience and use [ Time Frame: 3 months ]
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?
- - 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.
- Feeback on impact [ Time Frame: 3 months ]
Gather participant feedback on impact of breath sensor:
Participant will be asked:
- How has using the breath sensor affected your motivation to quit smoking?
- How has using the breath sensor affected the number of cigarettes you smoke per day?
- 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
- Feeback on commercialization [ Time Frame: 3 months ]
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
- What is a reasonable price you would expect to pay for the Pivot Breath Sensor that you have been using (nearest dollar)?
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133064
|Contact: Kristine Wongfirstname.lastname@example.org|
|Contact: Craig Fujiiemail@example.com|
|United States, California|
|Redwood City, California, United States, 94063|
|Contact: Kristine Wong 415-577-0592 firstname.lastname@example.org|
|Contact: Craig Fujii 6509064255 email@example.com|
|Principal Investigator: Jen Marler|
|Principal Investigator:||Jen Marler||Carrot Sense|