Acceptability and Feasibility of Self Administered Aversive Therapy for Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Participants satisfaction: short customized survey
研究概览
简要总结
The purpose of this research study is to test a new way to help people quit smoking. The PI will test acceptability and feasibility of a new device called Pavlok wearable wrist band. Participants will be smokers who are highly motivated to quit. Participants will be randomized into intervention and control groups.
详细描述
The participants will be evaluated after 1 week and assessed for their ongoing participation and commitment to the study. Those still interested and eligible will be randomized to two groups described below and will continue the study for 3 more weeks. There will be follow up surveys at various time points while wearing the wristband (1 week, 2 week, 3 weeks) and a final survey at T=3 months.
The intervention group will continue to wear the wristband and the wristband will deliver a slight electric stimulus every time it is pressed.
The placebo group will wear continue to press the button on the wristband but it will not give a slight electric stimulus when pressed. Both groups will wear the device for a total of 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current smoker (defined by the Center for Disease Control as an "adult who has smoked 100 cigarettes in his or her lifetime and who currently smokes cigarettes ". This will be determined based on participant baseline survey.
- •Interested in quitting (contemplation stage and beyond, as defined by serious consideration of quitting smoking in the next 30 days
- •Subject is equal to or greater than 19 years old
- •Considers themselves "tech savvy" (based on self reported 5 point likert scale)
- •Must have a smart phone with blue tooth capabilities
- •Willing to receive aversive therapy if assigned to this group.
排除标准
- •Anyone with a diagnosed arrhythmia or with a pacemaker or with a phobia or history of psychosis.
- •Non-English speaking caregivers
- •Lives outside of contiguous United States
结局指标
主要结局
Participants satisfaction: short customized survey
时间窗: T=0 to 3 months
Participants' acceptability/satisfaction will be assessed using a short customized survey. The survey will be a Likert scale and will include 2 questions with options ranging from satisfied to dissatisfied (with 1 indicating satisfaction and 5 indicating dissatisfaction). One other question is a likert scale with options ranging from 1-3 with 1 indicating the device was very useful and 3 indicating the device was not at all useful. A higher score indicates a worse outcome (less satisfaction with the device). Each question will be evaluated individually.
Evaluate the dropout among participants
时间窗: T=0 to 3 months
Number of participants dropped out from time of randomization. Dropout is defined as missing two follow up assessments.
Participants acceptability: short customized survey
时间窗: T=0 to 3 months
Participants' acceptability/satisfaction will be assessed using a short customized survey. The survey will include 8 questions with options ranging from strongly agree to strongly disagree for five questions and ranging from satisfaction to dissatisfaction for the remainder 3 questions. Each question will be evaluated individually.
Percentage of time wristband worn by participants
时间窗: from two week to three weeks
PI will evaluate the percentage of time the wristband is worn. Instructions will be given to wear the wristband all of the waking hours.
Enrollment percentage of eligible participants
时间窗: Baseline to T=0
PI will evaluate the percentage of participants that were enrolled after the 1 week run in period.
次要结局
- Average Degree of smoking reduction(From baseline to 3 months)
- Percentage of participants that made a quit attempt(From T= 2 weeks to 3 weeks)
- Before and after smoking self-efficacy score(Baseline to 3 months)
- Percentage of participants who had cessation of smoking.(T=0 to T= 3 weeks)
- Stage of change(From baseline until 3 months)
研究者
Nipam Shah, MD
Principal Investigator
University of Alabama at Birmingham