Clinical and Health-economic Effects of a Nurse-led Smoking Cessation Program With Follow-up in Healthy Life Centres With Free Cessation Drugs: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 3
- 主要终点
- Difference between the groups in point prevalence of self-report smoking abstinence at six months follow-up
研究概览
简要总结
A better understanding of how to incorporate effective smoking cessation measures into clinical practice is requested. In this is prospective, multi-center, randomized, open, blinded end-point (PROBE) trial, we assigned daily smokers hospitalized with an acute cardiac event 1:1 to an in-hospital nurse-led smoking cessation intervention with direct referral to further follow-up in the municipal healthy life-centres (intensive intervention) or to written information about smoking cessation and the municipal program (low-threshold intervention) . The primary outcome will be the smoking cessation rates between the groups at 6 months follow-up. Key secondary outcomes include a cost-effectiveness analysis of the intensive intervention and cessation rates at 3- and 12-months follow-up, the proportion who used nicotine replacement therapy and the proportion who attended the healthy-life center program between the two groups. We also assess effects of recurrent cardiovascular events and mortality after 12 months, two and five years follow-up. Exploratory analyses include new knowledge about the patient and system factors of importance for participation to healthy life-centers and for changes in smoking behaviour.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age> 18 years and smokes at least 1 cigarette daily
- •Hospitalized with an acute cardiovascular event (i.e. myocardial infarction, unstable or stable angina, arrythmias, stroke, transitory ischemic attac, carotid stenosis or claudication with need for revascularization)
- •established atheroscledrotic cardiovascular disease
- •Sign informed consent and is expected to participate according to ICH /GCP
排除标准
- •Does not usually live or work in the Vestre Viken catchment area
- •Any condition (e.g. psychosis, alcohol abuse, dementia) or situation that may pose a significant risk to the participant, confuse the results or make participation unethical
- •Lack of Norwegian and English knowledge
- •Short life expectancy (<12 months)
研究组 & 干预措施
Low-threshold intervention
干预措施: Nuse-led interview and referral to municipal healthy life-centres (Behavioral)
Intensive intervention
干预措施: Nuse-led interview and referral to municipal healthy life-centres (Behavioral)
结局指标
主要结局
Difference between the groups in point prevalence of self-report smoking abstinence at six months follow-up
时间窗: Six months after randomization
Difference between the groups in the proportion of participants who self-report smoking abstinence over the whole follow-up period at six months follow-up allowing up to five cigarettes in total
次要结局
- Differences in use of smoking cessation aids between the groups(8 to 12 weeks after randomization)
- Difference between the groups in proportion who quit smoking determined with objectively(Six months after randomization)
- Difference between the groups in point prevalence of self-report smoking abstinence three months after randomization(Three months after randomization)
- Difference between the groups in point prevalence of self-report smoking abstinence 12 months after randomization(Twelve months after randomization)
- Differences in participation rate at healthy life-centres between the groups(8 to 12 weeks after randomization)
- Difference between the groups in the composite end-point all-cause mortality, hospitalisation for myocardial infarction, stroke, transitrory ischemic attac, coronary revascularisation or symptomatic periperial artery disease(From baseline until 1.5 years follow-up)
- Difference between the groups in the composite end-point all-cause mortality, hospitalisation for myocardial infarction, stroke, coronary revascularisation, revascularization therapy for periperial artery disease or amputation(From baseline until 3.5 years follow-up)