A Pragmatic, Randomized, Controlled Study Evaluating The Impact Of Access To Smoking Cessation Treatment Reimbursement On The Proportion Of Successful Quitters In A Canadian Population Of Smokers Motivated To Quit
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,380
- 试验地点
- 56
- 主要终点
- Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence
研究概览
简要总结
This study is based on the hypothesis that access to smoking cessation treatment (SCT) reimbursement may significantly increase the number of successful quitters in a population of smokers motivated to quit by: 1) increasing the use of SCTs in quit attempts, and 2) by improving subject adherence to treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 是
入选标准
- •Daily smokers (10 cigarettes per day or more);
- •Smokers motivated to make a quit attempt within the next 14 days;
- •Potential subjects must be outpatients;
- •A subject must have a stable mental and physical medical condition (as per investigator's judgment).
排除标准
- •A subject currently eligible for smoking cessation treatment (SCT) reimbursement, whether from a public or a private drug insurance;
- •A subject with an unknown drug insurance status;
- •A subject living in a household where there is someone already recruited in the study;
- •A subject with an unfilled SCT prescription issued within the past three months or with an unused SCT product;
- •A subject with a life-threatening illness (ie, known or suspected cancer or other disease with a life expectancy of less than one year).
研究组 & 干预措施
Full Smoking Cessation Treatment Coverage (100%)
A subject randomized to the intervention group will be eligible for smoking cessation treatment (SCT) reimbursement during the 26-week period following the randomization.
干预措施: Full Smoking Cessation Treatment Coverage (100%) (Other)
No Smoking Cessation Treatment Coverage (0%)
Subjects in the control group choosing to quit using an SCT method will not be eligible for smoking cessation treatment (SCT) reimbursement and, thus, will have to purchase their treatment out of pocket.
干预措施: No Smoking Cessation Treatment Coverage (0%) (Other)
结局指标
主要结局
Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence
时间窗: Week 26
Percentage of participants who self-reported tobacco abstinence for the previous 7 days (7-day PP) with a negative response to the following questions: "Have you smoked any cigarettes (even a puff) in the last 7 days?" and "Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a Nicotine Replacement Therapy (NRT) (smoking cessation treatment \[SCT\]) in the last 7 days?"
次要结局
- Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco(Week 26)
- Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52(Week 26, Week 39, and Week 52)
- Percentage of Participants With 7-Day PP of Abstinence at Week 13(Week 13)
- Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52(Week 26 to Week 52)