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临床试验/NCT03152253
NCT03152253已完成不适用

Live Inspired: Individually Tailored and Integrated Social Support Network for Tobacco Cessation

The Miriam Hospital2 个研究点 分布在 1 个国家目标入组 284 人开始时间: 2017年5月30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
284
试验地点
2
主要终点
Smoking Abstinence

研究概览

简要总结

This study will continue development of a quit smoking program delivered through text messaging. Upon completion of programming we will enroll 280 participants and randomize them to a control condition or the intervention condition. Assessments will occur at enrollment, and both 3 and 6 month follow ups.

详细描述

This study builds on pilot work in which Live Inspired LLC and research partners developed T2Q (formerly "Text-2-Quit") a smoking cessation intervention delivered through text messaging. T2Q is a unique program with a number of features that provide superior support and service compared to existing text message quit smoking products. T2Q is 100% accessible through text messaging provides medication support for quitting smoking, an integrated social support network and live counseling. This phase II project will add functionality to accommodate use of multiple forms of quit smoking medications, and then conduct a rigorous test of the efficacy of T2Q among 280 adult smokers and examine smoking outcomes compared to controls at 3 and 6 months follow up. The study will also examine changes in smoking-related attitudes and behaviors among T2Q users to identify strengths and any potential weaknesses that may affect T2Q's impact on smoking outcomes. Analyses will examine the quality of social interactions within the T2Q integrated social support network and their role in promoting smoking abstinence. We will also conduct interviews with study participants in the T2Q arm to enable understanding of the user's experience with T2Q. Results of this trial will demonstrate the efficacy of T2Q - providing important credibility needed for successful commercialization. This research will also provide important data for possible enhancements to improve consumer appeal prior to commercialization.

This proposal finalizes development and testing of a unique, highly scalable intervention that can reach a U.S. market comprised of over 34 million adult smokers who use text messaging, and provide them with effective, evidence-based treatment. Text messaging enjoys near-market saturation and is a widely preferred method of communication with deep penetration across diverse groups. Wide availability of an attractive and effective smoking cessation program such as T2Q, may exert a powerful, sustained impact on public health

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

  • current daily cigarette smoker
  • use of text messaging at least once per week
  • interested in quitting smoking within the next 30 days
  • has access to a physician or healthcare provider
  • no current drug/alcohol abuse.

排除标准

  • Non-English Speaking
  • Currently using quit-smoking medications or therapies

研究组 & 干预措施

Text Message for Smoking Cessation

Experimental

smoking cessation promotion messages and medication reminders sent via text messages for up to 30 days before quit day and 8 weeks following quit day, along with access to a social support chat room

干预措施: Text My Quit (TMQ) (Behavioral)

Text Message for Smoking Cessation

Experimental

smoking cessation promotion messages and medication reminders sent via text messages for up to 30 days before quit day and 8 weeks following quit day, along with access to a social support chat room

干预措施: Peer Support (Behavioral)

Non-Interventional Text Messages

Placebo Comparator

General motivational text messages sent on the same schedule at TMQ arm of the study with access to a social support chat room.

干预措施: Peer Support (Behavioral)

Non-Interventional Text Messages

Placebo Comparator

General motivational text messages sent on the same schedule at TMQ arm of the study with access to a social support chat room.

干预措施: Motivational Messages (Other)

结局指标

主要结局

Smoking Abstinence

时间窗: 6 month follow up

Self-report of no smoking for the past 7 days

次要结局

  • Social support network use(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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