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临床试验/NCT02613689
NCT02613689已完成不适用

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

Duke University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016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
100
试验地点
2
主要终点
Ratings of Usefulness of the Intervention Received

研究概览

简要总结

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.

详细描述

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

  • 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-
  • Interested in participating in a cessation program
  • Have access to a cell phone with unlimited texting ability and have knowledge of text messaging

排除标准

  • 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

研究组 & 干预措施

Scheduled Gradual Reduction (SGR)

Experimental

Subjects will receive the Scheduled Gradual Reduction (SGR) intervention, as well as SMS support text messages.

干预措施: Scheduled Gradual Reduction (SGR) (Behavioral)

Scheduled Gradual Reduction (SGR)

Experimental

Subjects will receive the Scheduled Gradual Reduction (SGR) intervention, as well as SMS support text messages.

干预措施: Text Messages (Behavioral)

Control Group

Active Comparator

Subjects will receive SMS support text messages

干预措施: Text Messages (Behavioral)

结局指标

主要结局

Ratings of Usefulness of the Intervention Received

时间窗: 1 month

Ratings will be assessed via patient questionnaire.

Quit Rate at 1 month

时间窗: 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.

Proportion of Return Text Messages sent in Response to SGR Intervention

时间窗: 1 month

Assessed via text history

Proportion of Support Messages Read by Participants

时间窗: 1 month

Self-report

Quit Rate at 6 Months

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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