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临床试验/NCT04682067
NCT04682067已完成不适用

Incentives to Promote Smoking Cessation for Individuals With Diabetes

University of Oklahoma2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2021年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Number of participants completing 6 study visits

研究概览

简要总结

The purpose of this study is to evaluate the feasibility of contingency management on improving smoking cessation among individuals with type 2 diabetes.

详细描述

Type 2 diabetes (T2DM) and cigarette smoking are major causes of morbidity and mortality in US, and research indicates there is a complex relationship between these two risk factors. Smoking cessation is recommended as a standard treatment of diabetes by the American Diabetes Association; however, patients with T2DM and their providers are often inundated with other challenging lifestyle changes and disease management. Due to the complex relationship between diabetes and smoking and the large number of competing lifestyle changes recommended at diagnosis, smokers with T2DM may benefit from a contingency management (CM) program that incentivizes cessation. Providing patients tangible rewards to reinforce positive behaviors such as smoking abstinence has been proven effective in substance abuse programs, smoking cessation among pregnant women unwilling or unable to quit, and other population subgroups. In this CRUK2 study the investigators aim to test and further explore the potential effectiveness of financial incentives contingent upon proof of quitting smoking. The investigators will gather diabetes-related contextual factors associated with participation in the program and smoking cessation.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with type 2 diabetes
  • earn a score > 4 on REALM indicating > 6th grade English literacy level
  • willing to quit smoking 7 days from their first visit
  • have an expired CO level >8 ppm suggestive of current smoking at baseline
  • currently smoking > 5 cigarettes per day
  • willing and able to attend 6 study visits

排除标准

  • unable to demonstrate use of or unwilling to use the remote CO monitor and phone app

结局指标

主要结局

Number of participants completing 6 study visits

时间窗: 5 weeks

Feasibility outcome: completion of 6 study visits

Number of participants with >80% completion of daily ecological momentary assessments (EMA) completed

时间窗: 4 weeks

Feasibility outcome: completion of EMA portion of study

次要结局

  • Number of participants with biochemically verified abstinence at 4 weeks post quit(5 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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