Outcomes From a Mobile Smoking Cessation Program During a Monitoring Period of 6 Months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 319
- 试验地点
- 2
- 主要终点
- Number of Participants Who Completed the Secure Stage
研究概览
简要总结
Prospective, open label, single center clinical study enrolling 260 subjects in a mobile smoking cessation program using a smartphone app and a handheld breath sensor with coaching support over a six month period.
详细描述
This is a prospective, open label, single center clinical study enrolling 260 subjects in a mobile smoking cessation program using a smartphone app and handheld breath sensor with coaching support over a six month period. Measurements include user engagement and retention in the program, attitude towards smoking and smoking behavior, quit rates, relapse rates, and quality of life over the study period, as well as user feedback on the program.
Potential participants will complete an online screening form. Eligible participants will be called to confirm eligibility, discuss the study, and have their questions about the study answered. Interested eligible participants will then be emailed the registration link, which includes the electronic informed consent. After providing electronic informed consent, subjects register online and receive the hand held device which measures carbon monoxide (CO) which correlates to smoking behavior.
Baseline questionnaires (demographics, smoking history, and attitude towards smoking) are completed, and subjects then self-train to use the breath sensor and smartphone app and allows viewing of CO sample values. The app also provides the user with ability to log cigarettes, view cigarette consumption trends, view instructional videos, complete educational activities and challenges, and engage with a coach.
Participants will experience the program in 5 phases and then complete the study at approximately six months after enrolling,activating device and app.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-65 years of age
- •English speaking
- •Smokes daily
- •Smokes 5 or more cigarettes per day
- •Owns and uses a smartphone (iPhone 5 and above, operating system iOS 9.0 and above, or, Android 4.4 and above, operating system Android 4.4 and above)
- •Employed at least 20 hours per week
- •Lives in the USA
- •Understands and willing to sign the Informed Consent Form
排除标准
- 未提供
结局指标
主要结局
Number of Participants Who Completed the Secure Stage
时间窗: Assessment at the end of the Secure Stage; between 101 and 128 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days. Quit = 7 days. Secure = 11 weeks.
For the number of participants who started the Secure Stage, the proportion who completed the Secure Stage.
Number of Participants Who Completed the Build Stage
时间窗: Assessment at the end of the Build stage; between 10 and 37 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.
For the number of participants who started the Build Stage, the proportion who completed the Build Stage.
Number of Participants Who Completed the Mobilize Stage
时间窗: Assessment at the end of the Mobilize stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.
For the number of participants who started the Mobilize Stage, the proportion who completed the Mobilize Stage.
Number of Participants Who Completed the Explore Stage
时间窗: Assessment at the end of the Explore stage; 9 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.
For the number of participants who started the Explore Stage, the proportion who completed the Explore Stage.
Number of Participants Who Completed the Quit Stage
时间窗: Assessment at the end of the Quit Stage; between 24 and 51 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days. Quit = 7 days.
For the number of participants who started the Quit Stage, the proportion who completed the Quit Stage.
次要结局
- Number of Participants Who Reported Pivot Increased Their Motivation to Stop Smoking(6 months)
- Quit Rate 30-day Point Prevalence(6 months)
- Readiness to Quit and Goals Related to Smoking Behavior(Assessment at the end of the Explore stage; 9 days after activating app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.)
- Weeks of Active Engagement(6 months)
- Number of Participants Who Completed the Program(6 months)
- Average Percentage Change in Cigarettes Per Day (CPD) by the Pre-Quit Stage(Assessment at the end of the Mobilize stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.)
- Quit Rate 7-day Point Prevalence(6 months)
- Quit Attempts(6 months)
- Difficulty Maintaining Quit(Assessment at the end of the Mobilize stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.)
- Confidence to Quit(Assessment at the end of the Mobilize Stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.)
研究者
Jennifer Marler, MD
Senior Director, Clinical and Medical Affairs
Pivot Health Technologies Inc.