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临床试验/NCT01826331
NCT01826331撤回不适用

Incentives for Participation Versus Outcomes for Population Cessation of Smoking

University of Rhode Island1 个研究点 分布在 1 个国家目标入组 880 人开始时间: 2014年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
880
试验地点
1
主要终点
Smoking abstinence

研究概览

简要总结

One of the most important debates in the field of disease prevention is whether financial incentives should be contingent on participation in evidence-based programs for smoking cessation or on actual outcomes, like prolonged abstinence. This study can fill a major knowledge gap in this debate, which is the lack of any population trial that compared the impacts of outcomes- and participation-based incentives in a population of smokers. This research can help policy makers and health service providers choose the incentives approach that provides the most effectiveness, cost-effectiveness and cost-savings for entire populations of smokers.

详细描述

This population-based randomized clinical trial is designed to compare long-term abstinence rates in three groups of smokers: 1. Those incentivized for participation in an evidence-based treatment designed for smokers at each stage of change; 2. Those incentivized for biologically validated prolonged abstinence at 6 and 12 months who could also choose to participate in the TTM (Transtheoretical Model)-tailored intervention; and 3. An assessment only control condition.

The Specific Aims are:

  1. To assess whether the treatment group incentivized for participation outperforms the control group at 12, 24 and 36 months as hypothesized;
  2. To assess whether the treatment group incentivized for prolonged abstinence at 6 and 12 months outperforms the control group at each follow-up as hypothesized;
  3. To assess whether the treatment group incentivized for participation outperforms the treatment group incentivized for outcomes at 36 months as hypothesized.
  4. To compare the cost-effectiveness of each treatment in a population of mostly unmotivated smokers;

The Secondary Aims are:

  1. To assess the long-term treatment trajectories of each treatment compared to controls with hypothesized increasing trajectory in the participation contingent incentives and decreasing trajectory in the outcome contingent incentives.
  2. To identify mediators of long-term outcomes in each treatment, such as amount of treatment participation, income, severity of smoking, stage of change, self-efficacy, perceived health and intrinsic and extrinsic motivation to quit.
  3. To compare cost-savings of each treatment by modeling all additional costs of smoking for employers and smokers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
Single (Participant)

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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Control Group

No Intervention

Participants will be incentivized for assessments only

Incentives for Cessation

Experimental

Participants will be incentivized for each assessment and biochemically confirmed abstinence at 12 and 24 months

干预措施: Incentives for Cessation (Behavioral)

Incentives for Participation

Experimental

Participants will be incentivized for each assessment and for each smoking cessation session they complete

干预措施: Incentives for Participation (Behavioral)

结局指标

主要结局

Smoking abstinence

时间窗: 24 months

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 (1)

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