Development and Pilot Testing of a Multimodal Web-based Program to Address Heavy Drinking During Smoking Cessation
2019年9月16日 更新者:Christopher W. Kahler、Brown University
The overall objective of this project is to develop and pilot-test a web-based smoking cessation program that specifically addresses heavy drinking (HD).
The project builds upon a well-established, free evidence-based smoking cessation website, BecomeAnEX.org ("EX"), which is supported by Truth Initiative, a national non-profit public health organization, and its research arm, the Schroeder Institute.
Investigators will develop an alternative version of BecomenAnEX that will include detailed content on alcohol's relation to smoking relapse, health effects of alcohol (including moderate drinking recommendations) along with related worksheets, feedback materials, and links to resources for drinking.
Once a version of BecomeAnEX is developed that specifically addresses HD (called EX-HD), the investigators will conduct a one-arm open pilot of the site with 30 HD smokers recruited from newly registered BecomeAnEX users.
The study will gather participant feedback on the site as well as site use metrics (e.g., number of logins, number of pages viewed, use of interactive components) and will revise EX-HD in response to this feedback in preparation for Stage 1b work.
Stage 1b will use the updated EX-HD version to run a small scale randomized clinical trial where 120 participants will be randomly assigned to the standard version of BecomeAnEX or to EX-HD.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
119
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
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Rhode Island
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Providence、Rhode Island、美国、02912
- Center for Alcohol and Addiction Studies, Brown University
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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:
- current daily smoking of at least one cigarette per day
- meeting NIAAA criteria for past month heavy or at-risk drinking (for women: drinking 8+ drinks per week or consuming 4+ drinks on one occasion at least once in the past month; for men: drinking 15+ drinks per week or consuming 5+ drinks on one occasion at least once in the past month)
- age 18 or older
- willingness to provide contact and mailing information following consent
Exclusion Criteria:
1. history of severe alcohol withdrawal as indicated by past alcohol-induced seizures or delirium tremens;
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:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Standard Web-based Smoking Cessation
A website and text messaging program that is publicly available through BecomeAnEX.com.
Participants have access to the website whenever they wish.
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A website and text messaging program that is publicly available through BecomeAnEX.com.
Participants have access to the website whenever they wish.
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实验性的:Alcohol-focused Web-Based Smoking Cessation
A modified version of the website and text messaging program that is publicly available through BecomeAnEX.com.
This version includes specific information and feedback on alcohol use, allows participants to consider benefits of changing drinking, plans for changing drinking, and strategies.
Participants have access to the website whenever they wish.
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A website and text messaging program that is publicly available through BecomeAnEX.com.
Participants have access to the website whenever they wish.
|
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 |
|---|---|---|
|
Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 1 Month
大体时间:1 month after enrollment
|
Self-report abstinence from smoking
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1 month after enrollment
|
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Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 6 Months
大体时间:6 months after enrollment
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Self-report abstinence from smoking
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6 months after enrollment
|
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Number of Heavy Drinking Days at 1 Month
大体时间:1 month after enrollment
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Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men
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1 month after enrollment
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Number of Heavy Drinking Days at 6 Months
大体时间:6 months after enrollment
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Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men
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6 months after enrollment
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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。
合作者
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。
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 (实际的)
2017年5月11日
初级完成 (实际的)
2018年4月1日
研究完成 (实际的)
2018年4月30日
研究注册日期
首次提交
2017年2月23日
首先提交符合 QC 标准的
2017年2月27日
首次发布 (实际的)
2017年3月3日
研究记录更新
最后更新发布 (实际的)
2019年10月7日
上次提交的符合 QC 标准的更新
2019年9月16日
最后验证
2019年9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.