NCT03694327已完成不适用
Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification
My Digital Study1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2018年10月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- 30-Day Sustained Abstinence From Smoking
研究概览
简要总结
This study is comparing the efficacy of two smoking cessation apps.
详细描述
Given that tobacco smoking is the leading cause of preventable death in the US, the development of effective cessation programs is critical; mobile phone applications represent a novel, accessible platform for helping smokers quit. This research project seeks to compare the efficacy of two smoking cessation apps. In a blinded, randomized, controlled study, current smokers motivated to quit will use a smoking cessation app for 8 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 18 to 65
- •Fluent in written and spoken English (confirmed by ability to read and comprehend Informed Consent Form)
- •Lives in the United States
- •Smokes at least 5 cigarettes daily
- •Is interested in quitting in the next 30 days
- •The participant owns and has access to an iPhone with iOS 9 or greater capabilities, or an Android with OS 7 or greater capabilities
- •The participant is willing and able to receive SMS text messages on their smartphone
- •The participant is willing and able to receive email messages.
- •Ability to confirm download of installed treatment arm app via telephone on randomization date.
- •One half of the study sample will be recruited from the general population of smokers via social media advertisements
- •One half of the study sample will be recruited via mail form a Magellan Behavioral Health value-based care network
排除标准
- •Prior use of Treatment A Digital Intervention or Treatment B Digital Intervention
- •Current use of pharmacotherapy for smoking cessation or nicotine replacement therapy (NRT)
结局指标
主要结局
30-Day Sustained Abstinence From Smoking
时间窗: Upon completion of 8-week period
Self-reported abstinence from smoking was assessed in the 8-Week Outcome Survey.
次要结局
- Feasibility of Biochemical Verification of Smoking Cessation(Upon completion of 8-week period)
- NRT and Smoking Cessation Pharmacotherapy Use(Upon completion of 8-week period)
研究者
研究点 (1)
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