Comparison of Internet Stop Smoking Intervention to Usual Care on Smoking Cessation at 6 Months (TC5Redes)
2018年11月13日 更新者:University of California, San Francisco
Smoking Cessation Through the Web: Latino Smokers Follow-Up Study
The primary goal of this project is to carry out a randomized controlled trial (RCT) comparing quit rates of a Spanish/English stop smoking Web site to those of a no-intervention or "quit on your own" control.
The investigators have not included a no-intervention condition in previous Web studies and although 20% of participants quit smoking at one year are 20%, obtaining evidence that the investigators interventions yield higher abstinence rates than a no-intervention control is the next logical step.
Furthermore, although the investigators Web site was designed in English and Spanish, the investigators success in attracting the U.S. Hispanic/Latino (HL) population in either language has been limited, so this project only will only conduct intensive telephone follow-up of HL smokers and add new recruitment methods to do so.
研究概览
详细说明
The main study will randomize participants to one of two conditions, an intervention condition ("immediate") and a no-intervention control ("delayed").
For the control "quit on your own" condition, we will offer a 6-month "Delayed" treatment condition (DC) and will inform participants that we are testing whether smokers who are motivated enough to seek Internet information on smoking cessation can quit on their own at the same rate as smokers who are given access to an interactive stop smoking Web site.
For our intervention, the "Immediate" treatment condition (IC) is the UCSF Spanish/English Stop Smoking research Web site (www.stopsmoking.ucsf.edu)
that provides smokers their preference of all elements tested in earlier trials: 1) a Web version of a National Cancer Institute-designated evidence-based intervention with updated content, the Guía para Dejar de Fumar; 2) A document summarizing pharmacological treatment to aide smoking cessation available over the counter such as nicotine gum or patch or by prescriptions from a clinician; 3) e-mail reminders to return to the site timed to individually set quit dates; 4) a mood management smoking cessation intervention; and 5) a virtual group (an asynchronous bulletin board designed to let participants provide mutual support).
We will recruit study participants until we have randomized 1200 HL smokers in English or Spanish stratified by gender within language group.
Participants will be followed at 1, 3, 6, and 12 months after randomization to obtain self-reported prolonged abstinence and 7- and 30-day time point prevalence rates.
E-mail reminders will be sent to remind participants to return to the site to complete follow-up surveys online.
Only HL smokers from the US will be followed up by telephone calls at 1 and 6 months.
The main comparison measure will be cessation at 6 and 12 months from original randomization.
DC participants will be able to access the interactive site after finishing the 6-month follow-up.
We plan to attract Spanish-speaking HL participants to our Web site using Spanish-language TV and radio interviews and public service announcements (PSA), Spanish-language Google ads and networking with U.S. cessation groups.
研究类型
介入性
注册 (实际的)
146
阶段
- 不适用
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
-
-
California
-
San Francisco、California、美国、94143-0320
- University of California, San Francisco
-
-
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 至 90年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- age 18 or older
- daily (smoking one or more cigarettes per day) or non-daily (smoke some days) smoker
- planning to quit within the next month
- have a valid e-mail address so to send a password required to consent online.
- speak English or Spanish
- consent to participate
Exclusion Criteria:
- does not speak English or Spanish
- age younger than 18 years
- non-smoker
- no valid email address
Note - You do not need to contact anyone to begin this study. Please access the following URLs to participate: English: www.stopsmoking.ucsf.edu Spanish: https://www.stopsmoking.ucsf.edu/es/intro/home.aspx
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:治疗
- 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 |
|---|---|
|
无干预:Usual Care for Smoking
Usual care for smoking cessation with access to the web site after 6 months
|
|
|
实验性的:Internet Smoking Cessation Web Site
Internet Stop Smoking site (TC5) offers a menu of several intervention elements from which the participants may choose as many as they wish. The links (URLs) to register for the study are: English: www.stopsmoking.ucsf.edu Spanish: https://www.stopsmoking.ucsf.edu/es/intro/home.aspx |
Internet Stop Smoking site (TC5) with several intervention elements from which the participants may choose as many as they wish.
The links (URLs) to register for the study are: English: www.stopsmoking.ucsf.edu
Spanish: https://www.stopsmoking.ucsf.edu/es/intro/home.aspx
其他名称:
|
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 |
|---|---|---|
|
smoking abstinence
大体时间:6 months
|
no cigarettes smoked in the week and/or month prior to completion of the follow-up survey
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Smoking fewer cigarettes
大体时间:6 months
|
Reduction in the average number of cigarettes smoked per day
|
6 months
|
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:Ricardo F. Muñoz, PhD、University of California, San Francisco
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
2012年6月1日
初级完成 (实际的)
2016年4月1日
研究完成 (实际的)
2016年4月1日
研究注册日期
首次提交
2012年7月10日
首先提交符合 QC 标准的
2012年7月11日
首次发布 (估计)
2012年7月12日
研究记录更新
最后更新发布 (实际的)
2018年11月15日
上次提交的符合 QC 标准的更新
2018年11月13日
最后验证
2018年11月1日
更多信息
与本研究相关的术语
其他研究编号
- REDES-EPS-LAT-SMK-5
- U01CA086117 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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.