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临床试验/NCT03048786
NCT03048786已完成不适用

Mobile-based Peer Mentoring for Smoking Cessation: A Pilot Study

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年2月6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
200
试验地点
1
主要终点
Saliva test for cotinine

研究概览

简要总结

Despite the availability of a variety of effective treatments for smoking cessation, uptake of treatments is low. The increasing use of smartphone technology presents an exceptional opportunity to expand access to low-cost smoking cessation services. In this pilot study, the investigators will use a text-messaging platform to test peer mentoring for smoking cessation, delivered by former smokers. While peer mentoring is a common approach to health behavior change, it has rarely been used to maximum effect by smoking cessation programs. The text-messaging platform serves as the basis for a randomized controlled trial to test the effectiveness of peer mentoring for smoking cessation.

This pilot will include approximately 200 U.S. adult smokers who will be randomly assigned to a peer mentor or not. Participants in the control group will receive automated text messages used in SmokefreeTXT, a nationwide text-messaging service sponsored by the National Cancer Institute (NCI) in which users receive one to five automated messages per day for up to eight weeks. Smokers in the intervention group will receive a modified version of the same automated messages from SmokefreeTXT, but with additional personalized messages from an assigned peer mentor. Mentors will provide responses to specific questions or comments a smoker may have after receiving the automated messages.

The intervention will last 8 weeks. The study includes primary outcomes to measure the acceptability, engagement, user experience, and early efficacy of the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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
是

入选标准

  • •At least 18 years old
  • •Current resident of the U.S.
  • •Smoked 100 or more cigarettes in lifetime
  • •Current cigarette smoker
  • •Access to a device that can take pictures to be uploaded to a website
  • •Willing to complete a salivary cotinine test

排除标准

  • •Not a current user of nicotine replacement therapy
  • •Not a current user of electronic cigarettes

研究组 & 干预措施

Control Arm

Active Comparator

Participants will receive automated text messages drawn from the script used by SmokefreeTXT.

干预措施: Control (Behavioral)

Peer Mentoring Arm

Experimental

Participants will receive a modified version of the automated text messages sent to the control arm plus random assignment to a peer mentor.

干预措施: Peer Mentoring (Behavioral)

结局指标

主要结局

Saliva test for cotinine

时间窗: 3 months after quit day

The primary measure of early efficacy is the 7-day point prevalence of abstinence measured 3 months after the quit day, using a saliva cotinine test. The saliva test results will be recorded through a series of photographs and shared with the study team via email or online upload. Participants who self-report having smoked in the last 7 days, as part of the follow-up survey, will be considered to be continuing smokers.

次要结局

  • Duration of engagement(Up to 8 weeks)
  • Number of participant messages sent(Throughout the 6-8 week intervention)
  • Proportion who unsubscribe(Throughout the 6-8 week intervention)
  • Satisfaction with the program(3 months after quit day)
  • Self-reported smoking status(3 months after quit day)
  • Accuracy of beliefs about personal content(Throughout the 6-8 week intervention)
  • Proportion of participants who correctly self-report their message type(3 months after quit day)
  • Change in average cigarettes per day(3 months after quit day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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