Pilot Study of a Smartphone-Based Vaping Cessation Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Vaping cessation rate: 30-day PPA
研究概览
简要总结
Prospective, open label, single center clinical study enrolling up to 100 participants to evaluate the effect of the Pivot vaping cessation program.
详细描述
This is a prospective, open label, single center clinical study conducted with IRB approval enrolling up to 100 adult participants who report daily vaping. The study will be performed remotely on an ambulatory basis.
Participants will be asked to set up and use the "Pivot for Vape" program. The program includes an app, moderated online community, and SMS-based coaching with a tobacco treatment specialist. The study duration is 52 weeks, with the estimated active time using the program of up to 6 months and the time thereafter as follow-up. Participants will receive online questionnaires at intervals throughout the study.
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 complete the electronic informed consent form and baseline questionnaire prior to downloading the app on their smartphone.
The investigators aim to assess the performance of the "Pivot for Vape" program, with a focus on assessing use and engagement, changes in attitudes towards quitting vaping and changes in vaping behavior over the course of the 1-year study, as well as participant feedback on the set-up, design, use experience, and impact of the program.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current daily nicotine vape/e-cigarette user for at least the past 30 days
- •Plans to quit vaping in the next 6 months
- •Reports average VSPD ≥ 5
- •Interested in working with a vape cessation coach via SMS text
- •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 12 and above, or, Android 7.0 and above with operating system Android 7.0 and above)
- •Has daily internet access on smartphone
- •Comfortable downloading and using smartphone apps
- •Willing to sign the Informed Consent Form (ICF)
排除标准
- •Using other vaping cessation apps, coaching, classes, or quit programs at entry
- •Currently using cigarettes
- •If previous cigarette smoker, need to have quit smoking at least 3 months ago (self-report)
- •Failure to provide contact or collateral information, and/or failure to verify email address
- •Participation in a previous study sponsored by Pivot Health Technologies Inc. (formerly Carrot Inc.)
结局指标
主要结局
Vaping cessation rate: 30-day PPA
时间窗: 6 months (26 weeks)
30-day point prevalence abstinence (PPA) is defined as a participant self-report of no vaping for the past 30 days
次要结局
- Change in expected difficulty in staying quit(6 months (26 weeks))
- Change in confidence levels toward quitting vaping (expected success in quitting)(6 months (26 weeks))
- Vaping cessation rate: 7-day PPA(6 months (26 weeks))
- Desire to quit vaping(4 weeks)
- The proportion of participants who reduced their vaping sessions per day (VSPD) by ≥ 50% compared to baseline(6, 12, 26, and 52 weeks)
- Percent change in vape sessions per day (VSPD) compared to baseline(6 months (26 weeks))
- Self-reported continuous abstinence at 26 weeks(6 months (26 weeks))
- Self-reported continuous abstinence at 52 weeks(1 year (52 weeks))
- Self-reported serial abstinence(1 year (52 weeks))
- Self-reported abstinence from all tobacco products(6 months (26 weeks))
- The proportion of participants who reduced the amount of vape juice / e-liquid consumed by ≥ 50% compared to baseline(6, 12, 26, and 52 weeks)
- The proportion of participants who reduced their vape juice / e-liquid nicotine concentration by ≥ 50% compared to baseline(6, 12, 26, and 52 weeks)
- The proportion of participants who report decreased/unchanged/increased vaping compared to baseline(6, 12, 26, and 52 weeks)
- Change in vaping / e-cig dependence(12, 26, and 52 weeks)
- Percent change in the amount of vape juice / e-liquid consumed compared to baseline(6 months (26 weeks))
- Number of quit attempts(4, 12, 26, and 52 weeks)
- User satisfaction - Net Promoter Score(4, 12, and 26 weeks)
- User feedback - starting the vaping cessation program(2 weeks)
- User satisfaction - helpful for quitting(8 and 12 weeks)
- Engagement with program - app openings(6 months (26 weeks))
- Engagement with program - number of days with app openings(6 months (26 weeks))
- Average number of weeks with coach engagement(6 months (26 weeks))
- Change in participant self-reported health(6 months (26 weeks))
- Engagement with program - number of weeks with app openings(6 months (26 weeks))
- Engagement with program - average duration of app sessions(6 months (26 weeks))
- Engagement with program - use of app features(6 months (26 weeks))
- Engagement with coach(6 months (26 weeks))
- Presence of depressive symptoms(12, 26, and 52 weeks)
- Living environment relating to vaping and cigarette smoking(12, 26, and 52 weeks)
- Alcohol use behavior(12, 26, and 52 weeks)
- Use of other vaping cessation tools(6 months (26 weeks))
- Social environment relating to vaping and cigarette smoking(12, 26, and 52 weeks)
- Living/relationship environment relating to vaping and cigarette smoking(12, 26, and 52 weeks)
研究者
Jennifer Marler, MD
VP of Clinical and Medical Affairs
Pivot Health Technologies Inc.