Take a Break (TAB): mHealth-assisted Skills Building Challenge for Unmotivated Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 433
- 试验地点
- 8
- 主要终点
- Time to First Quit Attempt
研究概览
简要总结
Take a Break (TAB) is a randomized trial designed to evaluate Nicotine Replacement Therapy (NRT)-sampling and a mHealth suite of apps. TAB is a time-limited self-efficacy and skills building experience for Motivation Phase smokers. TAB is designed to create a timeline within which motivation smokers will be encouraged to try a brief period of abstinence. Smokers in this Motivation Phase are relatively untapped in research available information. This project offers these smokers point-of-need technology support in the many components of the intervention..
详细描述
The Take a Break intervention is designed to increase self-efficacy and support new skills for Motivation Phase smokers. We hypothesize that, compared with the NRT-only group, the Take a Break group will have a greater number of days abstinent during the 'break' period, a greater increase in self-efficacy at the end of the 'break' period, a lower time to first quit attempt, and a higher rate of quit at 6 months. This research study will also provide valuable insight into this population of smokers and increase our understanding of which tools may be effective in helping them quit smoking Our Specific Aims are
- AIM 1: Refine the Take a Break mHealth tool and implementation program.
- AIM 2: Conduct a randomized trial of the effectiveness of Take a Break.
- AIM 3: Follow participants in the AIM 2 randomized clinical trial for 6 months to evaluate time to quit attempts, number of quit attempts, and 6-month biochemically verified point prevalent cessation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For all Aims, investigators will include individuals 18 years and older who are identified as current smokers who are not preparing to quit, and are active in care within the UMMHC system, Northwell Health in Long Island, NY, Reliant Medical Group (RMG) in Worcester, MA and Central Western Massachusetts VA (VACWM) in Worcester, MA. Active in care is defined as having at least two clinical visits in the past year. If an eligible participant does not already have a smart phone, one will be provided to them, free of charge, for the duration of their participation in the study.
排除标准
- •Exclusion Criteria: Those unwilling to sample nicotine lozenges or participate in the game will be excluded. All patients already on NRT will be excluded. All participants who have a FDA contraindication or cautions for nicotine lozenge use (pregnancy, breastfeeding, recent cardiovascular distress, or phenylketonuria) will be excluded. We have chosen to exclude patients with a diagnosis of depression, due to confounding factors.
- •Adults unable to consent, individuals who are not yet adults (infants, children, teenagers), and prisoners will be excluded from this study. The Food and Drug Administration (FDA) advises caution for nicotine lozenge use among women who are pregnant. Thus, women who are pregnant at the time of baseline will be excluded from the study.
结局指标
主要结局
Time to First Quit Attempt
时间窗: 6 months
Time to first quit attempt is measured by participant self-report of number of days from baseline to first quit attempt within a 6 month period. At the 6-month follow-up visit, the dates of all quit attempts were assessed using the Timeline Follow-Back Method and used to calculate time to first quit attempt.
次要结局
- Change in Self-Efficacy at the End of the 6 Months(6 months)
- Point Prevalent Cessation as Measured by Carbon Monoxide Levels(6 months)
- Number of Participants Abstinent During the First 3 Weeks(3 Weeks)
- Mean Number of Days Abstinent During the First 3 Weeks(3 Weeks)
研究者
Rajani Sadasivam
Principal Investigator
University of Massachusetts, Worcester