此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Addressing Tobacco Use Disparities Through an Innovative Mobile Phone Intervention

2019年1月15日 更新者:Duke University

Addressing Tobacco Use Disparities Through an Innovative Mobile Phone Intervention: The Text to Forgo Smokeless Tobacco

The purpose of this study is to evaluate the feasibility, acceptability and preliminary efficacy of a Scheduled Gradual Reduction (SGR) intervention via Short Message Service (SMS) text messaging plus SMS Support Messages in decreasing smokeless tobacco use in a rural population.

研究概览

详细说明

Participants will be randomized to either the Scheduled Gradual Reduction (SGR) group or the control group. All participants in both groups will complete surveys at the baseline, end of program, and 6 month time points. All participants in both groups will also receive supportive counseling text messages at various times during the day over a period of 4 weeks.

Participants assigned to the SGR intervention group will receive their intervention, in addition to the supportive counseling messages received by the control group, via text message over a period of four weeks. Participants will initially report their smokeless tobacco use according to their usual habit, and over the course of the intervention be directed via text message precise times to start and stop each instance of smokeless tobacco use, gradually reducing the occurrences of use.

研究类型

介入性

注册 (实际的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • North Carolina
      • Durham、North Carolina、美国、27710
        • Duke University School of Nursing

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Over 18 years of age
  • Have used smokeless tobacco for the last year, currently (past 30 days) uses smokeless tobacco daily, and use of at least one or more tins/cans per week
  • Have an address in a rural census tract defined by a RUCA code of 4-10.
  • Interested in participating in a cessation program
  • Have access to a cell phone with unlimited texting ability and have knowledge of text messaging

Exclusion Criteria:

  • Non-English speaking
  • Have smoked cigarettes or used any other tobacco product in the past 30 days (i.e., dual user)
  • Currently participating in a smokeless tobacco cessation study
  • Family member participating in a smokeless tobacco cessation study

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Scheduled Gradual Reduction (SGR)
Subjects will receive the Scheduled Gradual Reduction (SGR) intervention, as well as SMS support text messages.
Participants in this group will group will receive the Scheduled Gradual Reduction (SGR) smokeless tobacco cessation reduction intervention via text message over a period of four weeks. Participants will initially report their smokeless tobacco use according to their usual habit, and over the course of the intervention be directed via text message precise times to start and stop each instance of smokeless tobacco use, gradually reducing the occurrences of use. In addition, this group will also receive the support messages that are sent to the control group.
Participants in this group will receive text messages about smokeless tobacco cessation in the form of counseling messages at various times throughout the day over a period of four weeks.
有源比较器:Control Group
Subjects will receive SMS support text messages
Participants in this group will receive text messages about smokeless tobacco cessation in the form of counseling messages at various times throughout the day over a period of four weeks.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Proportion of Return Text Messages sent in Response to SGR Intervention
大体时间:1 month
Assessed via text history
1 month
Proportion of Support Messages Read by Participants
大体时间:1 month
Self-report
1 month
Ratings of Usefulness of the Intervention Received
大体时间:1 month
Ratings will be assessed via patient questionnaire.
1 month
Quit Rate at 1 month
大体时间:1 month
Quit rate will be assessed by participant self report via questionnaires. Participants will also be asked to provide a saliva sample to check for nicotine if they report that they have quit using smokeless tobacco.
1 month
Quit Rate at 6 Months
大体时间:6 months
Quit rate will be assessed by participant self report via questionnaires. Participants will also be asked to provide a saliva sample to check for nicotine if they report that they have quit using smokeless tobacco.
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Devon Noonan, PhD、Duke University School of Nursing

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年2月1日

初级完成 (实际的)

2018年11月1日

研究完成 (实际的)

2018年12月31日

研究注册日期

首次提交

2015年11月12日

首先提交符合 QC 标准的

2015年11月23日

首次发布 (估计)

2015年11月24日

研究记录更新

最后更新发布 (实际的)

2019年1月16日

上次提交的符合 QC 标准的更新

2019年1月15日

最后验证

2019年1月1日

更多信息

与本研究相关的术语

其他研究编号

  • Pro00063791
  • 1R15CA198841-01 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

3
订阅