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临床试验/NCT01544153
NCT01544153已完成不适用

Improving Adherence to Web-Based Cessation Programs: A Social Network Approach

Truth Initiative1 个研究点 分布在 1 个国家目标入组 5,292 人开始时间: 2012年2月1日最近更新:
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
5,292
试验地点
1
主要终点
Self-reported 30-day Point Prevalence Abstinence

研究概览

简要总结

This study will compare the efficacy of an interactive, evidence-based smoking cessation website (WEB) alone and in conjunction with 1) a theory-driven, empirically-informed social network (SN) protocol designed to integrate participants into the online community, and 2) access to a 4-week supply of free NRT.

详细描述

This study will compare the efficacy of an interactive, evidence-based smoking cessation website (WEB) alone and in conjunction with 1) a theory-driven, empirically-informed social network (SN) protocol designed to integrate participants into the online community, and 2) access to a 4-week supply of free NRT. Using a 2 (SN integration, no SN) x 2 (access to free NRT, no access) randomized, controlled factorial design with repeated measures at baseline, 3, and 9 months, this study will recruit N=5,000 new members of a Web-based smoking cessation program and randomize them to: 1) WEB, 2) WEB+SN, 3) WEB+NRT, or 4) WEB+SN+NRT.

Aim 1: To evaluate the comparative efficacy of WEB+SN, WEB+NRT, and WEB+SN+NRT versus WEB alone with regard to self-reported 30-day point prevalence abstinence at the primary endpoint of 9 months and at secondary endpoint of 3 months. Hypothesis 1a: All three intervention conditions will outperform WEB. Hypothesis 1b: WEB+SN+NRT will outperform WEB+SN and WEB+NRT.

Aim 2: To examine whether the impact of treatment condition on cessation is mediated by greater adherence to problem solving/skills training tools, social support, and pharmacotherapy. Hypothesis 2: WEB+SN+NRT will have the greatest impact on treatment adherence, which will yield higher quit rates than the other treatments.

Exploratory Aim: To advance theory and identify the processes through which social network integration and provision of free NRT influence treatment adherence. Specifically, exploratory analyses will examine whether social support and social norms are active elements in the pathway to adherence, along with other known mediators of abstinence such as self-efficacy.

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

  • Age 18 years and older
  • Current smoker
  • Registered user on BecomeAnEX.org

排除标准

  • Pregnant or breastfeeding
  • Cardiovascular conditions
  • Current use of any stop smoking medication

研究组 & 干预措施

WEB only

Other

Control group receiving no additional intervention

干预措施: WEB (Behavioral)

WEB+SN

Experimental

WEB plus social network intervention.

干预措施: WEB (Behavioral)

WEB+SN

Experimental

WEB plus social network intervention.

干预措施: Social Network (Behavioral)

WEB+NRT

Experimental

WEB plus nicotine replacement therapy product.

干预措施: WEB (Behavioral)

WEB+SN+NRT

Experimental

WEB plus social network intervention and nicotine replacement therapy product.

干预措施: WEB (Behavioral)

WEB+SN+NRT

Experimental

WEB plus social network intervention and nicotine replacement therapy product.

干预措施: Social Network (Behavioral)

WEB+SN+NRT

Experimental

WEB plus social network intervention and nicotine replacement therapy product.

干预措施: Nicotine Replacement Therapy (NRT) (Behavioral)

WEB+NRT

Experimental

WEB plus nicotine replacement therapy product.

干预措施: Nicotine Replacement Therapy (NRT) (Behavioral)

结局指标

主要结局

Self-reported 30-day Point Prevalence Abstinence

时间窗: 9 months post-randomization

In the past 30 days, have you smoked any cigarettes at all, even a puff? Number of participants responding "No", 30day point prevalence abstinence.

次要结局

  • Self-reported 30-day Point Prevalence Abstinence(3 months post-randomization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amanda L. Graham, PhD

Director, Research Development

Truth Initiative

研究点 (1)

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