Effectiveness of a Stepped Primary Care Smoking Cessation Intervention Based on an Evidence Based Clinical Practice Guideline (ISTAPS Project)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,012
- 试验地点
- 2
- 主要终点
- Self reported abstinence confirmed by an expired air carbon monoxide concentration of 10 parts per millions or less
研究概览
简要总结
Primary care centers can play a very important role in helping people to stop smoking. There is a large body of research on the effectiveness of specific interventions especially addressed to people who want to stop smoking. In addition to that, there are no studies with a large sample of individuals included that tested the complete range of interventions recommended nowadays for helping people in the different smoking cessation stages of change and with different degrees of physical and psychological dependence, especially including motivational interviewing in those not interested in cessation in the very next weeks. This study will test a complex intervention that at first classifies smokers in stages and after that treats every smoker according to what stage he/she is in at the moment, his/her degree of dependence and his/her own characteristics.
详细描述
OBJECTIVES:
- To evaluate the effectiveness of a stepped smoking cessation intervention based on a transtheoretical model of change that uses the pharmacological and no-pharmacological methods proposed by evidence based Clinical Practice Guidelines for smoking cessation from primary care centers.
- To assess the health status change in relationship with the smoking cessation process.
DESIGN: Cluster randomized clinical trial
Unit of Randomization: Care basic unit (family physician or nurse that cares for the same group of patients). Intention to treat analysis.
PARTICIPANTS: 2911 smokers (ages 14-75 years) consulting for any reason to primary care centers
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
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Accept participation and follow-up by phone interviews for 2 years
排除标准
- •Terminal illness
- •Active addictive behaviours or important health problems
结局指标
主要结局
Self reported abstinence confirmed by an expired air carbon monoxide concentration of 10 parts per millions or less
Point prevalence at the end of intervention, 1 and 2 years after the beginning of intervention
Continuous abstinence rate for 1 year
Change of stage in the smoking cessation process
次要结局
- Health status measured by SF-36