ACT on Vaping: Digital Therapeutic for Young Adult Vaping Cessation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Overall Treatment Satisfaction Rating
研究概览
简要总结
Almost one in ten young adults report current e-cigarette use, putting them at risk of developing nicotine addiction and long-term health effects of exposure to inhaled toxicants. Despite the need for effective treatments to help these young users quit, very few treatments targeting any type of tobacco use among young adults have been evaluated, particularly for young adults who vape and have unique treatment needs. To address these needs, this trial will evaluate a digital program for young adult e-cigarette users at all stages of readiness to quit called ACT on Vaping.
详细描述
OUTLINE:
Participants are randomized to 1 of 2 arms.
ARM I: Participants use the ACT on Vaping smartphone app and text messaging program and receive incentivized text messages assessing their vaping status.
ARM II: Participants receive incentivized text messages check-ins assessing their vaping status.
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
- Single (Outcomes Assessor)
盲法说明
Any outcome evaluator who has direct contact with participants will be blinded to treatment assignment.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current weekly user of e-cigarette product(s).
- •Owns an Android phone or iPhone.
- •Has an email address.
- •United States (US) resident, with a US mailing address.
- •Willing to complete all study procedures.
排除标准
- •Currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (note: use of these treatments is allowable during trial participation).
- •Member of the same household as another research participant.
结局指标
主要结局
Overall Treatment Satisfaction Rating
时间窗: At 3 months post-randomization
We calculated descriptive statistics (mean, standard deviation) for the primary acceptability benchmark of overall satisfaction averaging at least 3.5 on a 1-5 Likert-type scale within the ACT on Vaping arm only. Overall satisfaction was assessed with a 5-point Likert-type item on the 3-month follow-up survey, with response options ranging from (1) "not at all" to (5) "very much." The ACT on Vaping benchmark average of 3.5 falls between ratings of 3="somewhat" and 4="mostly." Higher values are associated with a higher level of satisfaction.
Change in Readiness to Quit
时间窗: From baseline to 3 months post-randomization
Will evaluate differences of Contemplation Ladder scores. The 1-item Contemplation Ladder, scores range from 0-10, was used to assess readiness to quit using e-cigarettes. The higher the score, the more ready the person is to make a change. The anchor for the cut-off score of 5, indicating high vs. low quit readiness, is "Think I should quit but not quite ready."
Percentage of Participants With a 24-hour Quit Attempt
时间窗: At 3 months post-randomization
Making a 24-hour quit attempt between baseline and 3-month follow-up was assessed via self-report at the 3-month follow-up survey. The percentage of participants with self-reported 24-hour quit attempts is evaluated descriptively.
Cotinine-confirmed 30-day Point Prevalence Abstinence From All Nicotine and Tobacco
时间窗: At 3 months post-randomization
Complete case, self-reported 30-day abstinence from all nicotine and tobacco products at 3 months, confirmed via saliva cotinine testing. Differences were evaluated descriptively.
次要结局
未报告次要终点
研究者
Jaimee Heffner
Associate Professor
Fred Hutchinson Cancer Center