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临床试验/NCT03527667
NCT03527667已完成不适用

Incentivized Smoking Cessation for Tobacco Treatment-Resistant Diabetics

University of Oklahoma3 个研究点 分布在 2 个国家目标入组 19 人开始时间: 2018年6月22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
19
试验地点
3
主要终点
Proportion of CO readings completed

研究概览

简要总结

This pilot study aims to test the feasibility of providing incentives to patients with T2D contingent on remote biochemical verification using a smartphone carbon monoxide (CO) monitor. The investigators will use an ecological momentary assessment (EMA) smartphone application and CO sensor to monitor urges to smoke, stressors, smoking behaviors, and to validate continuous abstinence throughout the intervention. Two different contingency management structures will be explored to investigate the length of time incentives need to be offered.

详细描述

Individuals with type 2 diabetes (T2D) are at an increased risk of many cancers, though the causal link is not well understood. Continuing to smoke after a T2D diagnosis is also associated with accelerated progression of microvascular and macrovascular complications and an increased risk of death. Smoking cessation is recommended as a standard treatment for diabetes. However, both patients and providers are faced with other challenging lifestyle changes and disease management processes, which lead to greater difficulty in quitting.

Contingency management, or a method of providing financial incentives contingent upon positive behaviors, has shown promise for improving adherence to medication among diabetics and for improving smoking cessation in other populations. This approach could offer an innovative and scalable means of increasing abstinence in this group, ultimately reducing their risk of cancer. This is a multicenter pilot randomized controlled trial that will recruit participants in Oklahoma and in Strathclyde, Scotland.

This pilot study aims to test the feasibility of providing incentives to patients with T2D contingent on remote biochemical verification using a smartphone carbon monoxide (CO) monitor. The investigators will use an ecological momentary assessment (EMA) smartphone application and CO sensor to monitor urges to smoke, stressors, smoking behaviors, and to validate continuous abstinence throughout the intervention. Two different contingency management structures will be explored to investigate the length of time incentives need to be offered. Qualitative semi-structured interviews will be used to explore the patient and provider acceptability of an incentive-based cessation program, any unintended consequences and possible differences between UK and US health settings.

The results of this research will inform the feasibility of carrying out a randomized controlled trial of this intervention. The ultimate aim is to develop an effective intervention that could be scaled to the T2D population at large, which reduces cancer risk and improves disease outcomes among a high-risk group.

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

  • Aged 18 to 75
  • Type 2 diabetes diagnosis greater than 1 year prior to enrollment
  • Currently smoking at least 5 cigarettes per day
  • Self-reported quit attempt in past 12 months

排除标准

  • Unwilling to make a quit attempt
  • Unable to use smartphone iCO monitor following training session

结局指标

主要结局

Proportion of CO readings completed

时间窗: 12 weeks

Feasibility of study determined by number of CO readings completed by each participant

次要结局

  • Cigarettes per day(12 weeks)
  • Quit outcomes(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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