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临床试验/NCT00992264
NCT00992264已完成不适用

Optimizing an Online Motivational Tobacco Cessation Program

Kaiser Permanente2 个研究点 分布在 1 个国家目标入组 1,865 人开始时间: 2010年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,865
试验地点
2
主要终点
Treatment Utilization for Smoking Cessation

研究概览

简要总结

The current study tested the effectiveness of four potentially important tailoring factors (decisional framework, self-efficacy, navigation autonomy, and proactive outreach) in the context of an online motivational intervention for smoking cessation. A fifth factor was originally planned by dropped during intervention development due to confounds with the other planned factors. Information learned from this study will inform how to best design an online interventions for smoking cessation. Participants were recruited from a large, regional U.S. health plan. Using a full factorial design to screen for important main effects and 2-way interactions, participants were randomized to receive one of 16 different experimental factor combinations and followed for one year to assess program impact on smokers' use of empirically-validated cessation treatment and abstinence.

详细描述

The current study is a factorial screening experiment, consistent with the Multiphase Optimization Strategy. Participants were randomly assigned to one of 16 different combinations of the 4 experimental factors. Each factor was explored on 2 contrasting levels. Each contrasting factor level was then compared to the other, resulting in 4 analytic arms. Within each arm, all participants (n = 1865) were analyzed to determine the relative effect of each contrasting factor level on the primary and secondary outcomes of interest.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

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

  • Member of Group Health Cooperative
  • Currently Smoking at Least 5 Cigarettes/Day
  • Access to Email and the Internet
  • Read and Write English
  • 18 years or older
  • Not currently receiving tobacco cessation treatment
  • Capable of participating in online and phone surveys

排除标准

  • Persons will be excluded if they do not meet above criteria

研究组 & 干预措施

Message Tone

Experimental

Prescriptive or Motivational

Persons are randomized to receive intervention content written in either a prescriptive or motivational tone.

干预措施: Message Tone (Behavioral)

Testimonials

Experimental

Persons are randomized to receive a personally tailored testimonial or not.

干预措施: Testimonials (Behavioral)

Navigation

Experimental

Dictated or Non-Dictated

Persons are randomly assigned to be able to freely navigate the website or to have their navigation of the website pre-determined based on their baseline readiness to quit smoking.

干预措施: Navigation (Behavioral)

Proactive Outreach

Experimental

Email or No-Email communication

Persons are randomized to receive periodic email reminders to return to the intervention website or not.

干预措施: Proactive Outreach (Behavioral)

结局指标

主要结局

Treatment Utilization for Smoking Cessation

时间窗: 12 months

confirmed use of pharmacotherapy or enrollment in health plan-sponsored counseling program

Smoking Abstinence

时间窗: 12 months

7 day point prevalent abstinence

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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