Development of a mHealth Intervention for Ambivalent Smokers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Program Engagement
研究概览
简要总结
The current pilot study will assess the feasibility and acceptability of a novel mHealth app designed for people who are ambivalent about quitting smoking. Results will be used to refine the intervention and plan for a future randomized effectiveness trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •18 years or older;
- •Can speak/read English;
- •Current smoker;
- •Own and regularly use an eligible smartphone;
- •No vision impairments;
- •Willing to install and use the study program;
- •Willing to use birth control if elect to use nicotine replacement during the study (females);
- •Meet definition for ambivalence
- •Not actively using treatment
排除标准
- •Smoke less than 10 cigarettes per day
- •Self-report a lifetime history of dementia, manic depression, bipolar disorder, or schizophrenia;
- •Have medical contraindications for nicotine replacement therapy;
- •Another household member is enrolled in the study
- •Unable to verify contact information
- •Fail to install app
研究组 & 干预措施
Control
干预措施: Control mHealth program (Device)
Control
干预措施: Nicotine patch (Drug)
Experimental
干预措施: Experimental mHealth program (Device)
Experimental
干预措施: Nicotine patch (Drug)
结局指标
主要结局
Program Engagement
时间窗: Assessed at 3-month follow-up
Number of unique app user-sessions
Quit Attempt Lasting at Least 24 Hours
时间窗: Assessed at 3-month follow-up
At least one intentional smoking quit attempt lasting at least 24 hours. Missing outcomes imputed as not making a quit attempt.
Not Smoking (Even a Puff) in the Last 7 Days
时间窗: Assessed at 3-month follow-up
7-day point prevalent abstinence: self-report of not smoking, even a puff, in the last 7 days. Missing values were imputed as smoking.
次要结局
- Earned and Requested Free Nicotine Replacement Therapy(Assessed at 3-month follow-up)
- Program Engagement - Earned Badges(Assessed at 3-month follow-up)
- Self-efficacy to Quit Smoking(Assessed at 3 months)
- Quit Attempt Lasting at Least 24 Hours(Assessed at 1 month follow-up)
- Satisfaction With Assigned App(Assessed at 3 months)
- Self-efficacy to Stay Quit(Assessed at 3 months)
- Change in Cigarettes/Day(Assessed at baseline and 3 months)
- Refrain From Smoking (Even a Puff) in the Last 7 Days(Assessed at 1-month follow-up)
- Helpfulness of Assigned App(Assessed at 3 months)