Comparison of Smoking Cessation Interventions of Different Intensities in Patients With First Ever Ischemic Stroke.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Smoking cessation rate
研究概览
简要总结
The primary objective of the present randomized controlled trial is to compare the effectiveness of three anti-smoking interventions of different intensities. It has been hypothesised that early follow-up visits facilitate post-stroke smoking cessation in patients hospitalized because of first-ever ischemic stroke.
详细描述
BACKGROUND: It is well known, that continued smoking after stroke increases the risk of death and stroke recurrence within a few years after the first stroke. Searching for more efficient methods of antismoking interventions is therefore justified.
OBJECTIVES: The primary objective of the present study is to compare the effectiveness of three anti-smoking interventions of different intensities.
DESIGN: Randomized, controlled trial.
METHODS: Study participants will be recruited among patients of neurological clinics of Institute of Psychiatry and Neurology, hospitalized because of their first in a lifetime ischemic stroke. All stroke patients will be screened regarding their smoking status. The subjects will be patients smoking cigarettes immediately before their first-ever stroke, able to understand the research protocol procedures and able to cooperate during the investigation.
Antismoking interventions will be based on the "5A's" method. Study participants will be randomized to one of three interventions differing in follow-up intensity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients smoking immediately prior to stroke
- •The first in the lifetime ischemic stroke
- •Ability to understand the research protocol procedures and cooperation during the investigation
- •Reported availability of and declaration to participate in follow-up
- •Informed consent to participate in the study
排除标准
- •Severe stroke
- •Stroke onset more than 3 weeks before admission
- •History of previous stroke with clinical symptoms
- •Hemorrhagic stroke
- •Diagnosis of dementia or presence of other neurological disease (Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, Huntington's chorea, a previous subarachnoid haemorrhage, meningitis, cerebral trauma in an interview)
结局指标
主要结局
Smoking cessation rate
时间窗: 12 months
次要结局
未报告次要终点
研究者
Halina Sienkiewicz-Jarosz
Principal Investigator
Institute of Psychiatry and Neurology, Warsaw