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临床试验/NCT00749151
NCT00749151已完成不适用

A Randomized Controlled Trial on the Effectiveness of the American Lung Association Reactive Anti-Smoking Telephone Help Line in Illinois

Southern Illinois University2 个研究点 分布在 1 个国家目标入组 990 人开始时间: 2002年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
990
试验地点
2
主要终点
point prevalence abstinence rate

研究概览

简要总结

An estimated 47 million adult Americans smoke. The American Lung Association has launched a reactive telephone help line to assist in smoking cessation. The proposed study will evaluate its effectiveness in a randomized controlled trial design involving active smokers who call this helpline. Eligible callers will be randomized into two groups: those who receive self-help literature only (i.e. control group) and those who receive additional reactive telephone counseling (i.e. study group). Detailed information will be collected proactively by an independent research calling specialist from all subjects who enroll into the study, by way of follow-up telephone calls, at one, three, six and twelve months following the screen date. The outcome measures to be compared are abstinence rates, quit attempts, changes in extent of smoking and behavioral stage, and cost-effectiveness. A thousand subjects will be enrolled in the two study arms in equal numbers over a period of fifteen months. Intent to treat analysis will be used after adjustment for covariates. The significance of this study lies in establishing the public health importance of such a reactive telephone helpline as a low intensity and low cost interventional smoking cessation tool.

详细描述

An estimated 47 million adult Americans smoke. Telephone counseling is considered a promising mode of intervention for smoking cessation. While pro-active (acting in anticipation of future change) telephone counseling has been shown to be efficacious in randomized trials, evaluation of reactive (occurring as a result of a stimulus) phone lines has been criticized by the lack of randomization and adequate controls for comparison. The American Lung Association has launched a reactive telephone help line to assist in smoking cessation. The proposed study will evaluate its effectiveness in a randomized controlled trial design involving active smokers who call this helpline. Eligible callers will be randomized into two groups: those who receive self-help literature only (i.e. control group) and those who receive additional reactive telephone counseling (i.e. study group). Detailed information will be collected proactively by an independent research calling specialist from all subjects who enroll into the study, by way of follow-up telephone calls, at one, three, six and twelve months following the screen date. The outcome measures to be compared are abstinence rates, quit attempts, changes in extent of smoking and behavioral stage, and cost-effectiveness. A thousand subjects will be enrolled in the two study arms in equal numbers over a period of fifteen months. Intent to treat analysis will be used after adjustment for covariates. The significance of this study lies in establishing the public health importance of such a reactive telephone helpline as a low intensity and low cost interventional smoking cessation tool.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be an active nicotine user at the time of initial contact with the Tobacco
  • Quitline, and interested in quitting nicotine
  • Establish contact, by himself or herself, with the ALA, seeking help in quitting nicotine;
  • Be contactable by telephone, and
  • Be agreeable to consenting for the study and for follow-up by telephone interviews for a total period of six months

排除标准

  • Pregnant subjects,
  • Minors (under 18 years of age),
  • People with current psychiatric conditions other than anxiety or depression,
  • Refusal or inability to consent

结局指标

主要结局

point prevalence abstinence rate

时间窗: not a single puff for 7 day minimum

continuous abstinence rate

时间窗: calculated at 1, 3, and 6 months

change in behavioral stage with respect to smoking (transtheoretical model)

时间窗: baseline, 1, 3, 6, and 12 months

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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