Pivot Breath Sensor Study to Evaluate the Effect of the Pivot Breath Sensor on a User's Attitudes Towards Quitting Smoking and Smoking Behavior.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Number of Participants With Different Stages of Change in Desire to Quit Smoking
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Pregnancy
- •Participation in a previous study sponsored by Carrot Inc
研究组 & 干预措施
Pivot Breath Sensor (user group)
Self-reported daily smokers of 10 or more cigarettes per day
干预措施: Pivot Breath Sensor (Device)
结局指标
主要结局
Number of Participants With Different Stages of Change in Desire to Quit Smoking
时间窗: 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.
Success to Quit (STQ)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
Point Prevalence Abstinence (PPA)
时间窗: 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.
次要结局
- Feedback on Breath Sensor Setup, Experience and Use(1 week)
- Feedback on Impact on Motivation to Quit Smoking(1 week)
- Feedback on Impact on Number of Cigarettes Smoked Per Day(1 week)
- Feedback on Commercialization(4 weeks)
研究者
Jennifer Marler, MD
Senior Director, Clinical and Medical Affairs
Pivot Health Technologies Inc.