Randomized Clinical Trial Evaluating the Impact of E-cigarette Device Warnings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,369
- 试验地点
- 2
- 主要终点
- Mean Vaping Quit Intentions Score
研究概览
简要总结
The purpose of this randomized clinical trial is to determine whether e-cigarette warnings increase intentions to quit vaping without the unintended consequence of pushing users toward smoking. This trial addresses these issues by evaluating the impact of e-cigarette warnings by randomly assigning vapers to have their devices and refills labeled with control messages, text warnings, or pictorial warnings. Participants will be US adult (ages 21+) vapers. The trial expects ~1,200 participants to complete Visits 1, 3, and 5.
详细描述
This trial will assess the impact of e-cigarette warnings on vapers' devices and refills in a randomized clinical trial.
Recruitment: Vapers will first undergo screening online or call the study center to complete the screening survey over the phone. Trial staff will schedule eligible vapers for 2 in-person visits. For each of the 2 visits, vapers will be asked to bring the vapes and refill materials they plan to use over the next 2 weeks.
Informed Consent: Prior to consenting vapers, trial staff will visually inspect photo identification of vapers to confirm that they are 21 years or older. At the beginning of the first appointment, trial staff will explain the consent form and ask the vaper to read the form. Once the participant has finished reading the form, the trial staff member will ask the participant if he or she has any questions. Then both parties will sign the consent form and the participant will receive a copy of the consent form.
Randomization: At the first visit, trial staff will randomly assign participants to one of the three trial arms by using Qualtrics software. Vapers have an equal chance of being randomized to have labels with control, text, or pictorial warnings.
Assessment: Participants will attend 2 in-person appointments at the study office (at Visit 1 and Visit 3 that are spaced 2 weeks apart). The visits will last about 45-60 minutes. At Visit 1 participants will take a survey, have their vape device and refills labeled based on their trial arm, and take another survey. At Visit 3, participants take a survey and have their vape device and refills labeled based on their trial arm. Participants will also be e-mailed 3 more surveys to complete online at home (taken at Visit 2, 4, and 5). Thus participants will take 5 weekly surveys overall.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Be 21 years or older
- •Currently vape every day or some days
- •Use an e-cigarette that contains nicotine
- •Be able to attend 2 in-person appointments
- •Be able to bring in e-cigarette device and 2 weeks' worth or refills to 2 in-person appointments
- •Be willing to let us apply a sticker to the device and refill materials
- •Be willing to use only the labeled e-cigarette during the study
- •Be able to complete 3 surveys online at home
- •Be able to read and speak English
- •Be able to complete a survey on a computer without help
排除标准
- •Pregnant people
- •If e-cigarette device cannot be labeled
- •Vapers concurrently enrolled in any research studies about vaping or using other tobacco products
- •Vapers who live in the same household as someone who has enrolled in the study
结局指标
主要结局
Mean Vaping Quit Intentions Score
时间窗: Up to 4 weeks
The primary outcome is vaping quit intentions measured by 3 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating higher quit intentions.
次要结局
- Mean Knowledge Score(Up to 4 weeks)
- Mean Cognitive Elaboration Score(Up to 4 weeks)
- Mean Perceived Likelihood of Illness Score(Up to 4 weeks)
- Mean Negative Affect Score(Up to 4 weeks)
- Mean Attention Score(Up to 4 weeks)
- Mean Information Seeking Score(Up to 4 weeks)
- Mean Number of Conversations in Past Week(Up to 4 weeks)
- Mean Vaping Reinforcement Attitudes Score(Up to 4 weeks)
- Mean Uncontrolled Vaping Score(Up to 4 weeks)
- Mean Number of Times Forgoing a Vape in Past Week(Up to 4 weeks)
- Percent of Participants Who Made a Vaping Quit Attempt in Past 4 Weeks(Up to 4 weeks)
- Percent of Participants Who Successfully Quit Vaping(At 4 weeks)
- Mean Inaccurate Risk Perception Score(Up to 4 weeks)
- Mean Stigma Score(Up to 4 weeks)
- Mean Smoking Quit Intentions Score(Up to 4 weeks)
- Percent of Participants Who Made a Smoking Quit Attempt in Past 4 Weeks(Up to 4 weeks)