Mobile Smoking Cessation Treatment for Underserved Smokers: A Pilot and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Smoking Abstinence: 3-month Assessment Via Smart Phone
研究概览
简要总结
The goal of this research study is to learn about 2 different interactive methods that are designed to help people with HIV/AIDS stop smoking.
详细描述
Baseline Questionnaire:
If you agree to take part in this study, you will complete a questionnaire on a laptop about your feelings, mood, health, thoughts about smoking, thoughts about quitting smoking, smoking history, and some demographic information such as age, education level, and income level. This should take about 15-20 minutes to complete.
Study Groups:
After completing the questionnaire, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being placed in either group.
Both groups will receive smart phones and an 8-week supply of nicotine patches with instructions on how to use them. Each group will receive different methods of advice for quitting smoking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Smoked at least 100 cigarettes in lifetime
- •English speaking
- •HIV-positive patient at Thomas Street Health Center
- •Currently smoking 5 or more cigarettes per day
- •Willing to make a quit attempt within 1 week of enrollment
排除标准
- •Positive history of a medical condition that precludes use of the nicotine patch
- •Current use of nicotine replacement therapy (NRT)
- •Current use of other smoking cessation medications (e.g., Chantix or Zyban)
- •Pregnant or nursing
- •Enrolled in another smoking cessation study
研究组 & 干预措施
Standard Treatment (ST)
Participants supplied with a 8-week supply of nicotine patches, a smart phone and brief advice to quit smoking. Participants also receive proactive phone counseling (8 sessions) over the 8-week period for support in quitting smoking. The call will last about 15 minutes.
Participants receive weekly assessments to complete for the 8-week treatment period via smartphone.
Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months after intervention.
Participants complete saliva cotinine test 3 months after intervention.
干预措施: Nicotine Patch (Drug)
Standard Treatment (ST)
Participants supplied with a 8-week supply of nicotine patches, a smart phone and brief advice to quit smoking. Participants also receive proactive phone counseling (8 sessions) over the 8-week period for support in quitting smoking. The call will last about 15 minutes.
Participants receive weekly assessments to complete for the 8-week treatment period via smartphone.
Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months after intervention.
Participants complete saliva cotinine test 3 months after intervention.
干预措施: Questionnaires (Behavioral)
Standard Treatment (ST)
Participants supplied with a 8-week supply of nicotine patches, a smart phone and brief advice to quit smoking. Participants also receive proactive phone counseling (8 sessions) over the 8-week period for support in quitting smoking. The call will last about 15 minutes.
Participants receive weekly assessments to complete for the 8-week treatment period via smartphone.
Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months after intervention.
Participants complete saliva cotinine test 3 months after intervention.
干预措施: Pamphlet (Other)
Standard Treatment (ST)
Participants supplied with a 8-week supply of nicotine patches, a smart phone and brief advice to quit smoking. Participants also receive proactive phone counseling (8 sessions) over the 8-week period for support in quitting smoking. The call will last about 15 minutes.
Participants receive weekly assessments to complete for the 8-week treatment period via smartphone.
Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months after intervention.
Participants complete saliva cotinine test 3 months after intervention.
干预措施: Phone Counseling Sessions (Behavioral)
Standard Treatment (ST)
Participants supplied with a 8-week supply of nicotine patches, a smart phone and brief advice to quit smoking. Participants also receive proactive phone counseling (8 sessions) over the 8-week period for support in quitting smoking. The call will last about 15 minutes.
Participants receive weekly assessments to complete for the 8-week treatment period via smartphone.
Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months after intervention.
Participants complete saliva cotinine test 3 months after intervention.
干预措施: Saliva Test (Other)
Standard Treatment (ST)
Participants supplied with a 8-week supply of nicotine patches, a smart phone and brief advice to quit smoking. Participants also receive proactive phone counseling (8 sessions) over the 8-week period for support in quitting smoking. The call will last about 15 minutes.
Participants receive weekly assessments to complete for the 8-week treatment period via smartphone.
Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months after intervention.
Participants complete saliva cotinine test 3 months after intervention.
干预措施: Smart phone (Device)
Automated Treatment (AT)
Participants supplied with a 8-week supply of nicotine patches and a smart phone. Participants also receive brief advice to quit smoking (tailored video clips) and an 8-week automated intervention (interactive text messages and graphical messages) for support in quitting smoking via smartphone.
Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months.
Participants complete saliva cotinine test 3 months after intervention.
干预措施: Nicotine Patch (Drug)
Automated Treatment (AT)
Participants supplied with a 8-week supply of nicotine patches and a smart phone. Participants also receive brief advice to quit smoking (tailored video clips) and an 8-week automated intervention (interactive text messages and graphical messages) for support in quitting smoking via smartphone.
Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months.
Participants complete saliva cotinine test 3 months after intervention.
干预措施: Questionnaires (Behavioral)
Automated Treatment (AT)
Participants supplied with a 8-week supply of nicotine patches and a smart phone. Participants also receive brief advice to quit smoking (tailored video clips) and an 8-week automated intervention (interactive text messages and graphical messages) for support in quitting smoking via smartphone.
Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months.
Participants complete saliva cotinine test 3 months after intervention.
干预措施: Phone Counseling Sessions (Behavioral)
Automated Treatment (AT)
Participants supplied with a 8-week supply of nicotine patches and a smart phone. Participants also receive brief advice to quit smoking (tailored video clips) and an 8-week automated intervention (interactive text messages and graphical messages) for support in quitting smoking via smartphone.
Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months.
Participants complete saliva cotinine test 3 months after intervention.
干预措施: Saliva Test (Other)
Automated Treatment (AT)
Participants supplied with a 8-week supply of nicotine patches and a smart phone. Participants also receive brief advice to quit smoking (tailored video clips) and an 8-week automated intervention (interactive text messages and graphical messages) for support in quitting smoking via smartphone.
Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months.
Participants complete saliva cotinine test 3 months after intervention.
干预措施: Smart phone (Device)
结局指标
主要结局
Smoking Abstinence: 3-month Assessment Via Smart Phone
时间窗: 3 months
Smoking abstinence defined as number of participants with biochemically 7-day abstinence confirmed with weekly smart-phone assessments. Saliva cotinine levels, assessed with NicAlert test strips, used to biochemically verify abstinence. Participants will complete the NicAlert saliva cotinine test (supplies given at enrollment) and take a photograph of the test strip results. In primary abstinence analysis for difference in cessation rate between interventions, participants who do not complete follow-up assessments considered to be smokers.
次要结局
未报告次要终点