Smartphone Based Smoking Cessation Intervention
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 454
- 试验地点
- 1
- 主要终点
- Biochemically-Verified Smoking Cessation
研究概览
简要总结
Smoking is becoming increasingly concentrated among individuals with the lowest levels of income, education, and occupational status. In fact, smoking rates in the United States among people living below the poverty line is nearly twice as high as those above the poverty threshold. Highly flexible and low burden technology-based treatment approaches may overcome many of the barriers that have limited the use and effectiveness of traditional smoking cessation treatments among low socioeconomic status (SES) adults. Ecological momentary assessment (EMA), in which mobile devices are used to capture moment-to-moment experiences, allows for the measurement of phenomena in real-time within natural settings. Smartphone-based smoking cessation apps could offer easily accessible, highly tailored, and intensive interventions at a fraction of the cost of traditional smoking cessation counseling. The Smart-T app uses a lapse risk estimator to identify moments of heightened risk for lapse, and the algorithm tailors treatment messages in real-time based upon level of imminent smoking lapse risk and currently present lapse triggers. This study will compare smoking cessation rates for those randomized to the Smart-T app or the NCI QuitGuide app.
详细描述
Smoking is becoming increasingly concentrated among individuals with the lowest levels of income, education, and occupational status. In fact, smoking rates in the United States among people living below the poverty line is nearly twice as high as those above the poverty threshold. Highly flexible and low burden technology-based treatment approaches may overcome many of the barriers that have limited the use and effectiveness of traditional smoking cessation treatments among low SES adults. Ecological momentary assessment (EMA), in which mobile devices are used to capture moment-to-moment experiences, allows for the measurement of phenomena in real-time within natural settings. Smartphone-based smoking cessation apps could offer easily accessible, highly tailored, and intensive interventions at a fraction of the cost of traditional smoking cessation counseling. The Smart-T app uses a lapse risk estimator to identify moments of heightened risk for lapse, and the algorithm tailors treatment messages in real-time based upon level of imminent smoking lapse risk and currently present lapse triggers.
The study aims are to:
Determine the impact of treatment condition (i.e., Smart-T vs. QuitGuide app; n=225 per group) on biochemically verified smoking abstinence. Hypothesis 1: Participants randomly assigned to Smart-T will have significantly higher rates of biochemically-verified abstinence than those assigned to QuitGuide at 26 weeks post-quit.
Determine the effect of Smart-T treatment messages on key lapse risk factors. Hypothesis 2: Smoking urge, stress, and cigarette availability will decline more and cessation motivation will increase more following tailored messages that target these lapse triggers in real-time (Smart-T condition) compared with similar situations wherein no messages are provided (QuitGuide condition).
EXPERIMENTAL DESIGN:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •earn a score ≥ 4 on the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF) indicating > 6th grade English literacy level
- •are willing to quit smoking 7 days after the baseline visit
- •are ≥ 18 years of age
- •have an expired CO level ≥ 8 ppm suggestive of current smoking
- •are currently smoking ≥ 5 cigarettes per day
- •have no contraindications to using nicotine replacement therapy (NRT)
- •agree to complete EMAs and CO tests on a study provided or personal smartphone
- •have household income < 200% of the federal poverty guideline
- •agree to complete the 26 week post-quit follow-up assessment over the phone and via EMA
排除标准
- •cannot read, speak, and understand English
- •are < 18 years of age
研究组 & 干预措施
Smart-T + NRT
Smart-T provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. The Smart-T app contains multiple components including an EMA delivery and data transfer system, automated messages based upon EMA responses, and on-demand content. All participants will receive free nicotine replacement therapy (NRT).
干预措施: Smart-T + NRT (Combination Product)
NCI QuitGuide + NRT
The National Cancer Institute's QuitGuide app is a free smartphone app and is one of few apps that includes many of the recommendations detailed in the Clinical Practice Guideline. The QuitGuide app aims to help smokers understand their smoking patterns and develop the skills needed to quit smoking. QuitGuide provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. All participants will receive free nicotine replacement therapy (NRT).
干预措施: QuitGuide + NRT (Combination Product)
结局指标
主要结局
Biochemically-Verified Smoking Cessation
时间窗: 27 Weeks
Biochemically confirmed 7-day point prevalence abstinence using the CO criteria cutoff of ≤ 6 ppm
Biochemically-Verified Smoking Cessation
时间窗: 27 Weeks
Biochemically confirmed 7-day point prevalence abstinence using the CO criteria cutoff of ≤ 6 ppm
次要结局
- Change in Urge to Quit Smoking(27 weeks)
- Change in Stress(27 weeks)
- Change in Perceived Cigarette Availability(27 weeks)
- Change in Motivation to Quit Smoking(27 weeks)