Smartband/Smartphone-based Automatic Smoking Detection and Real Time Mindfulness Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- Fidelity of Detecting Smoking Episodes
研究概览
简要总结
To determine treatment fidelity for a smartband/smartphone-based smoking monitoring, notification and brief mindfulness intervention.
详细描述
This study will test the feasibility of using a smartband to detect and track smoking and deliver brief smoking cessation interventions by smartphone app in real time. Smokers will wear a smartband to detect and notify them of smoking for 21 days and obtain individual smoking profiles; detected smoking will then trigger a "mindful smoking" exercise for the next 7 days leading up to their quit date at 30 days; after which another mindfulness exercise ("RAIN": recognize, accept, investigate and note cravings rather than smoke) will be delivered prior to each predicted smoking episode according to their individual smoking profile for 30 days post-quit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •At least 18 years of age
- •Daily smokers (≥ 5 cigarettes per day)
- •Daily smoker for at least 2 years
- •Own an Android phone or iPhone
- •Fluent in English as study content is currently only available in English
- •>18 of 20 on the Action subscale of the Readiness to Change Questionnaire
排除标准
- •E-cigarette use (some days/every day)
结局指标
主要结局
Fidelity of Detecting Smoking Episodes
时间窗: 60 days
Percent of smoking episodes detected and the rate of false alarms in the first 60 days of the study during which smokers are wearing the smartband to monitor, detect and notify them of smoking episodes.
Acceptability of Intervention - User Experiences Survey
时间窗: up to 60 days
Feedback on user experiences survey (e.g., whether there were too many or not enough interventions) by theme- One survey with feasibility determined by 75% of participants rating the question as moderate or higher. Below are percentage of participants with ratings of moderate or higher for each question.
Adherence to Answering Smartband Notifications of Smoking Events
时间窗: 60 days
Percent of smoking notifications answered
Fidelity of Delivering Mindful Smoking Exercises Triggered by Smoking
时间窗: 39 days
Percent of mindful smoking exercises correctly triggered by detected smoking episodes and the rate of false alarms during which any detected and confirmed smoking event triggers the mindful smoking exercise.
Timeliness of Delivering RAIN Exercise
时间窗: 30 days
Percent of participants and score range (very low, low, moderate, high, very high), with feasibility determined by 75% of participants rating timeliness of RAIN exercise as moderate or higher (via real-time ecological momentary assessment). Moderate or higher indicates a better (more timely) outcome.
Adherence to Wearing the Smartband
时间窗: 60 days
Percent of days spent wearing the smartband.
Adherence to Answering Ecological Momentary Assessment Items
时间窗: 60 days
Percentage of ecological momentary assessment (EMA) ratings (e.g., timeliness, helpfulness, craving, affect) answered when participants completed mindfulness exercises. That is, did the participant complete the EMA when they completed the mindfulness exercise. Measured separately for percentage of EMA answered when participants completed RAIN exercises, and percentage of EMA answered when participants completed mindful smoking exercises. Reported is the percentage of EMA answered out of the number of completed mindfulness exercises, separately for RAIN and mindful smoking.
Adherence to Completing Mindfulness Exercises
时间窗: 60 days
Percent of mindfulness exercises (RAIN, mindful smoking) completed
Acceptability of Intervention - Helpfulness of Mindfulness Exercises
时间窗: 60 days
Percent of participants and score range (very low, low, moderate, high, very high), with feasibility determined by 75% of participants rating helpfulness as moderate or higher of participants that completed at least one mindful smoking or RAIN exercise.
次要结局
- Number of Participants With Self-reported Abstinence From Smoking(7 days)