Tobacco Tactics Website for Operating Engineers (BCBSM-OE)
2014年11月17日 更新者:Sonia Duffy、University of Michigan
This is a clustered randomized control trial to test the Tobacco Tactics intervention among Operating Engineers (heavy equipment workers).
The intervention group will be directed to the Tobacco Tactics website, and the control group will be directed to the state supported 1-800 quit-now telephone hotline during routine annual safety training that all Operating Engineers are required to attend.
The web-based quitting intervention includes provision of over-the-counter nicotine replacement therapy and will be followed by nurse email and/or telephone counseling.
It is expected that Operating Engineers who are randomized to the Tobacco Tactics website intervention will have at least equal or greater decreases in smoking at 30-day and 6-month follow-up compared to those randomized to the 1-800-QUIT-NOW quit line.
In addition, the investigators expect to find that Operating Engineers randomized to the Tobacco Tactics website intervention will: a) be able to accomplish tasks; b) be able to accomplish goals with skill and speed; c) be able to operate the system; d) be satisfied with the website; e) access the site repeatedly; and f) spend time on the site during the intervention period.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
232
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Michigan
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Ann Arbor、Michigan、美国、48109
- University of Michigan, School of Nursing
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- attending a training session provided by the Operating Engineers Local 324 Education Center
- greater than 18 years of age
- smoked cigarettes in the past month
- interested in participating in a program to quit smoking
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他:1-800-QUIT-NOW Telephone Hotline
The control group receives efficacious smoking cessation treatment via the 1-800-QUIT-NOW telephone hotline.
The 1-800-QUIT-NOW hotline is a national program.
The first time smokers call the hotline, they receive a personal coach who assists them in setting a quit date and making an individualized quit plan.
The personal coach also provides on-going support with up to five telephone coaching sessions around the caller's quit date.
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The control group receives efficacious smoking cessation treatment via the 1-800-QUIT-NOW telephone hotline.
The 1-800-QUIT-NOW hotline is a national program.
The first time smokers call the hotline, they receive a personal coach who assists them in setting a quit date and making an individualized quit plan.
The personal coach also provides on-going support with up to five telephone coaching sessions around the caller's quit date.
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|
实验性的:Tobacco Tactics Intervention
This intervention contains a website, medications, and nurse counseling.
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The Tobacco Tactics Web-Based Intervention contains website, medications, and nurse counseling.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quit Rate
大体时间:30-day Follow-Up
|
The investigators will measure 7-day point prevalence abstinence by asking the well validated question, "Have you used any tobacco products (even one puff) in the past 7 days?"
The investigators will also assess harm reduction (ability to quit at all, number of quit attempts, and number of cigarettes smoked per day).
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30-day Follow-Up
|
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Quit Rate
大体时间:6-Month Follow-Up
|
The investigators will measure 7-day point prevalence abstinence by asking the well validated question, "Have you used any tobacco products (even one puff) in the past 7 days?"
Smoking status will be confirmed by biochemical verification in the form of urinary cotinine test strips.
The investigators will also assess harm reduction (ability to quit at all, number of quit attempts, and number of cigarettes smoked per day).
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6-Month Follow-Up
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Sonia A Duffy, PhD, RN、University of Michigan
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Rice VH, Stead LF. Nursing interventions for smoking cessation. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD001188. doi: 10.1002/14651858.CD001188.pub3.
- Lichtenstein E, Glasgow RE, Lando HA, Ossip-Klein DJ, Boles SM. Telephone counseling for smoking cessation: rationales and meta-analytic review of evidence. Health Educ Res. 1996 Jun;11(2):243-57. doi: 10.1093/her/11.2.243.
- Fiore MC. US public health service clinical practice guideline: treating tobacco use and dependence. Respir Care. 2000 Oct;45(10):1200-62.
- Solomon LJ, Scharoun GM, Flynn BS, Secker-Walker RH, Sepinwall D. Free nicotine patches plus proactive telephone peer support to help low-income women stop smoking. Prev Med. 2000 Jul;31(1):68-74. doi: 10.1006/pmed.2000.0683.
- Stern F, Haring-Sweeney M. Proportionate mortality among unionized construction operating engineers. Am J Ind Med. 1997 Jul;32(1):51-65. doi: 10.1002/(sici)1097-0274(199707)32:13.0.co;2-u.
- Lee DJ, Fleming LE, McCollister KE, Caban AJ, Arheart KL, LeBlanc WG, Chung-Bridges K, Christ SL, Dietz N, Clark JD 3rd. Healthcare provider smoking cessation advice among US worker groups. Tob Control. 2007 Oct;16(5):325-8. doi: 10.1136/tc.2006.019117.
- Moher M, Hey K, Lancaster T. Workplace interventions for smoking cessation. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003440. doi: 10.1002/14651858.CD003440.pub2.
- Lenert L, Munoz RF, Stoddard J, Delucchi K, Bansod A, Skoczen S, Perez-Stable EJ. Design and pilot evaluation of an internet smoking cessation program. J Am Med Inform Assoc. 2003 Jan-Feb;10(1):16-20. doi: 10.1197/jamia.m1128.
- Choi SH, Waltje AH, Ronis DL, Noonan D, Hong O, Richardson CR, Meeker JD, Duffy SA. Web-enhanced tobacco tactics with telephone support versus 1-800-QUIT-NOW telephone line intervention for operating engineers: randomized controlled trial. J Med Internet Res. 2014 Nov 20;16(11):e255. doi: 10.2196/jmir.3375.
- Duffy SA, Ronis DL, Richardson C, Waltje AH, Ewing LA, Noonan D, Hong O, Meeker JD. Protocol of a randomized controlled trial of the Tobacco Tactics website for operating engineers. BMC Public Health. 2012 May 17;12:335. doi: 10.1186/1471-2458-12-335.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年1月1日
初级完成 (实际的)
2013年3月1日
研究完成 (实际的)
2014年8月1日
研究注册日期
首次提交
2010年5月13日
首先提交符合 QC 标准的
2010年5月13日
首次发布 (估计)
2010年5月14日
研究记录更新
最后更新发布 (估计)
2014年11月18日
上次提交的符合 QC 标准的更新
2014年11月17日
最后验证
2014年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.