Adapt2Quit - A Machine-Learning, Adaptive Motivational System: RCT for Socio-Economically Disadvantaged Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 757
- 试验地点
- 3
- 主要终点
- Number of Participants With Biochemically Verified 7-Day Point Prevalence Tobacco Abstinence at 6 Months
研究概览
简要总结
The goal of this research is to test the Adapt2Quit computer program that uses participant input (message rating on how much the text motivational message might influence one to quit smoking) to select and text motivational messages that are more likely to help a user stop smoking. This Adapt2Quit system will be compared with a quitline facilitation-only control (text messages will be sent to facilitate quitline use). The primary research hypothesis is that the Adapt2Quit recommender-selected messages will be more effective than a texting quitline facilitation-only control for smoking cessation among socioeconomically disadvantaged (SED) smokers.
详细描述
The Adapt2Quit trial (NCT04720625) is a randomized controlled trial testing a machine-learning-driven text messaging system aimed at increasing smoking cessation rates among socioeconomically disadvantaged adults.
The 6-month study compares an adaptive, personalized motivational messaging intervention against standard Quitline facilitation, utilizing AI to select tailored behavioral prompts based on user feedback.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
After completing the screening, informed consent, and baseline data collection, study staff will enter the participant identification number and participant mobile phone number from the survey into an online system, and the system will assign allocation based on the randomization table. Using this technique, both smokers and the staff will be blinded to allocation during the initial session. Then, the research staff will be un-blinded to provide personalized training for intervention and control (note that staff who complete follow-up will be different and blinded to group assignment).
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current smoker
- •Socioeconomically disadvantaged (SED) (using the following criteria: unemployed or underemployed, low income as defined by the federal poverty level guidelines, uninsured or underinsured, and/or have less than a high school education)
- •English-speaking
- •Active in care (at least two clinical visits in the last year)
- •Have a texting-enabled cell phone
排除标准
- •Not a current smoker
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Prisoners
- •Pregnant women
- •Pilot study participants
研究组 & 干预措施
Control
These participants will receive quitline facilitation-only messaging for 6 months.
干预措施: Control (Behavioral)
Adapt2Quit
These participants will receive Adapt2Quit motivational messaging and quitline facilitation messaging for 6 months.
干预措施: Adapt2Quit (Behavioral)
结局指标
主要结局
Number of Participants With Biochemically Verified 7-Day Point Prevalence Tobacco Abstinence at 6 Months
时间窗: 6-months post-randomization
Participants who self-reported no tobacco use in the past 7 days at the 6-month follow-up underwent biochemical verification using the CoVita Smokerlyzer breath carbon monoxide (CO) monitor. Participants with a CO measurement of ≤6 ppm were classified as abstinent; those with a CO measurement of \>6 ppm were classified as tobacco users.
次要结局
- Number of Participants With Self-Reported 7-Day Point Prevalence Cigarette Abstinence at 6 Months(6-months post-randomization)
研究者
Rajani Sadasivam
Associate Professor
University of Massachusetts, Worcester