Innovative Digital Therapeutic for Smoking Cessation

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合作者:

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追踪信息

首次提交日期 ^ICMJE

September 12, 2018

首次发布日期e ^ICMJE

October 3, 2018

最后更新发布日期

October 3, 2018

预计研究开始日期 ^ICMJE

October 2018

预计主要完成日期

May 31, 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

30-Day Sustained Abstinence from Smoking[ Time Frame: Upon completion of 8-week period ]

Self-reported Abstinence from smoking on the 8-Week Outcome Survey

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Feasibility of biochemical verification of smoking cessation[ Time Frame: Upon completion of 8-week period ]
Concordance between self-reported abstinence and measurement of exhaled carbon monoxide (CO) of <7ppm at study outcome will be assessed.
NRT and Smoking Cessation Pharmacotherapy use[ Time Frame: Upon completion of 8-week period ]
Self-reported NRT and smoking cessation pharmacotherapy use will be acquired via the outcome survey. Cessation rates will be compared between those using/not using pharmacotherapy.

描述性信息

简略标题 ^ICMJE

Innovative Digital Therapeutic for Smoking Cessation

正式标题 ^ICMJE

Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification

简要概况

This study is comparing the efficacy of two smoking cessation apps.

详细说明

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.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Device: Treatment A Digital Intervention
Mobile Application
Device: Treatment B Digital Intervention
Mobile Application

研究工具

Experimental: Treatment A Mobile Application
Treatment A Digital Intervention: Smartphone application designed to assist with smoking cessation.
Active Comparator: Treatment B Mobile Application
Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation.

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

195

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

June 30, 2019

预计主要完成日期

May 31, 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - 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 Exclusion Criteria: - Prior use of Treatment A Digital Intervention or Treatment B Digital Intervention - Current use of pharmacotherapy for smoking cessation or nicotine replacement therapy (NRT)

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：65 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

My Digital Study

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Brian M Iacoviello, PhD My Digital Study

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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