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临床试验/NCT01952236
NCT01952236已完成不适用

Web and Mobile Smoking Cessation Interventions

Oregon Research Institute2 个研究点 分布在 1 个国家目标入组 1,266 人开始时间: 2015年2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
1,266
试验地点
2
主要终点
Change in all-tobacco abstinence from enrollment to 3 months and 6 months post enrollment

研究概览

简要总结

This study seeks to develop and then perform a controlled efficacy Randomized Controlled Trial assessing tobacco abstinence of a best-practices Web-based PC-delivered smoking cessation intervention (QuitOnline) compared to a Mobile Smartphone-delivered intervention (MobileQuit). Study participants are randomized to one of two conditions: a Web Only intervention and the Web+Mobile intervention. The hypothesis is that the Web+Mobile approach will yield greater efficacy than the Web Only condition.

详细描述

The primary aims of this project are to:

  1. Use an iterative formative development process to create two separate Web-based smoking cessation programs (Web+Mobile, Web Only).
  2. Compare the efficacy of the two smoking cessation programs in terms of tobacco abstinence. The investigators hypothesize that the Web+Mobile condition will be significantly more efficacious in terms of tobacco abstinence than the Web Only condition.
  3. Evaluate program usage/participant engagement, treatment acceptability, and consumer satisfaction. The investigators hypothesize that both conditions will be acceptable and that the Web+Mobile condition will have significantly greater usage and higher consumer satisfaction than the Web Only condition.

The secondary aims of this proposal are to:

  1. Evaluate the differences between conditions on ancillary tobacco outcomes. The investigators hypothesize that the participants assigned to the Web+Mobile condition who continue to smoke will nonetheless report a greater decline in the smoking rate and more quit attempts.
  2. Evaluate predictors and condition moderators of tobacco abstinence. The investigators will conduct exploratory analyses of the association of treatment outcomes to participant characteristics (e.g., baseline smoking rate, nicotine dependence level, partner's tobacco use, prior quitting attempts, prior use of pharmacological adjuncts, and other demographic factors).
  3. Evaluate putative mechanisms of change. The investigators will test whether change in the putative mechanisms of change (i.e., self-efficacy, program use, use of pharmacological adjuncts) mediate the association between the intervention condition and 3-month sustained abstinence from the 3 month to 6 month assessments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • ≥ 18 years of age
  • Cigarettes are primary tobacco of use
  • Smoke ≥ 5 cigs/day for the previous 6 months
  • Want to quit in next 14 days
  • Use a smartphone and willing to potentially receive/send up to 150 text messages over the six months of the program
  • Access to the Internet
  • Have a valid personal e-mail address
  • Be a U.S. citizen

排除标准

  • 未提供

研究组 & 干预措施

Web+Mobile

Experimental

A best-practices Web-based smoking cessation program integrated with a tailored treatment program delivered using a smartphone application.

干预措施: Web+Mobile (Behavioral)

Web Only

Active Comparator

A best-practices Web-based smoking cessation program.

干预措施: Web Only (Behavioral)

结局指标

主要结局

Change in all-tobacco abstinence from enrollment to 3 months and 6 months post enrollment

时间窗: Change from enrollment to 3 months and 6 months post enrollment

Change in all-tobacco abstinence from enrollment to 3 and 6 months. Measured using 7 day point prevalence.

次要结局

  • Predictors and condition moderators of tobacco abstinence at 6-months follow-up(Baseline to 6-month follow-up)
  • Program usage, treatment acceptability, consumer satisfaction 3 months post enrollment follow-up(3 months post enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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