Clinical Trial of Mobile-Based Intervention for Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 416
- 试验地点
- 1
- 主要终点
- Number of Participants Who Remain Active Users of the Program
研究概览
简要总结
The Sponsor is doing a research study to assess the effects of a smartphone program designed to help users smoke less and eventually quit. When participants join, their involvement in the core study will last 8 weeks. After 8 weeks, they will have the option to continue using the program to guide their quit journey or participate in follow-up research.
详细描述
The overarching study aim is to recruit and enroll a population of current smokers who are motivated to quit with the assistance of a mobile solution.
The core study period will consist of 8 weeks of iPhone program usage. Comprehensive questionnaires will be given to the user during the course of their application usage. Users will receive notifications to link them to these online surveys, which will record their responses in a secure database. Following the 8-week core study, participants may continue usage of the program.
During the course of their use of the program, participants will be asked to provide information regarding three general areas on a regular basis as part of their use of the app: smoking status, adherence to self or physician-directed quit plans (including but not limited to medications for smoking cessation and over-the-counter quit aids), and overall user satisfaction. One way that the program assesses these areas involves asking users to answer questions addressing whether or not the user used nicotine in the last 24 hours. At the end of each week, users will also be asked to report their cigarette count for each of the past 7 days, using the standardized reporting technique called the Timeline Followback (TLFB) Method Assessment (Sobell, 1992).
At the 16-week mark and at the 24-week mark after enrollment, users will receive a brief questionnaire retrospectively looking at their cigarette usage, adherence to quit aids, and physical symptoms of nicotine withdrawal.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65
- •Smokes at least 5 cigarettes daily
- •Is interested in quitting in the next 30 days
- •Owns an iPhone with iOS 8 or higher capabilities
- •Willing and able to receive SMS text messages
- •Able to comprehend the English-language and the informed consent form
- •Lives in the United States
- •Provides informed consent to participate in the study
- •Able and willing to comply with study procedures as outlined in the protocol and informed consent form
排除标准
- •Unable or unwilling to provide informed consent
- •Responds appropriately to any item in the Eligibility Questionnaire:
- •Do you smoke at least 5 cigarettes a day? - must say YES
- •Are you interested in quitting in the next 30 days? - must say YES
- •Do you have access to an Apple iPhone with iOS 8 (or higher) capabilities and internet access? - must say YES
- •Are you between 18-65 years old? - must say YES
- •Do you currently live in the United States? - must say YES
- •Are you currently using a mobile phone-based smoking cessation intervention? - must say NO
- •Are you willing and able to receive SMS messages throughout the study? - must say YES
研究组 & 干预措施
Mobile Smoking Cessation Solution
Subjects download & use the mobile application.
干预措施: Mobile Smoking Cessation Solution (Device)
结局指标
主要结局
Number of Participants Who Remain Active Users of the Program
时间窗: 8 week core study
The primary objective is to assess the proportion of the Intent to Treat population who remain active users of the program at the end of the 8 week primary study period. Active use is defined as the manipulation of at least one component of the application per week.
次要结局
- Number of Participants With Treatment-related Adverse Events(8 week core study)
- Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence](8 week core study)