In-patient Smoking Cessation Intervention Using Counseling, Spirometry and Nicotine Replacement Therapy
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Composite outcome: •Enrollment to a cessation behavioral intervention program according to participation in first two meetings of group therapy or personal counseling • Smoking cessation validated by CO exhale test<5 ppm
研究概览
简要总结
The objective of the study is to assess the effect of in-hospital intensive counseling and NRT (nicotine replacement therapy) vs. usual care, on smoking cessation or enrollment to smoking cessation behavioral intervention.
This is prospective randomized clinical trial. The study population will include smokers subjects admitted to internal medicine departments at Soroka University Medical Center.
The study population will be divided randomly into three arms according to intervention intensity (ratio 1:1:1).
详细描述
Prospective randomized clinical trial. The study population will include smokers subjects admitted to internal medicine departments at Soroka University Medical Center.
The study population will be divided randomly into three arms according to intervention intensity (ratio 1:1:1):
Group 1 - Usual care including medical advice to quit and confrontation with abnormal spirometry results if relevant.
Group 2 - Intensive counseling (15 minutes) by a smoking cessation counselor including confrontation with abnormal spirometry results if relevant, and follow up for at least 5 weeks after discharge (will be done weekly by phone for five consecutive weeks).
Group 3 - Intensive counseling (15 minutes) by a smoking cessation counselor including confrontation with abnormal spirometry results if relevant, offering and providing nicotine replacement therapy (NRT) and follow up (will be done weekly by phone for five consecutive weeks).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to Internal Medicine at Soroka University Medical Center.
- •Current cigarette smokers (≥ 10 cigarettes per day)
- •Provided written informed consent.
排除标准
- •Substance abuse (except for tobacco).
- •Handicapped or bed ridden patients.
- •Patients who don't speak Hebrew, English, Russian or Arabic.
- •Medically not suitable for NRT-decided by physician on the basis of the patient's medical file.
研究组 & 干预措施
Group 1
Usual care including medical advice to quit and confrontation with abnormal spirometry results if relevant.
干预措施: Medical advice (Behavioral)
Group 2
Intensive counseling (15 minutes) by a smoking cessation counselor including confrontation with abnormal spirometry results if relevant, and follow up for at least 5 weeks after discharge (will be done weekly by phone for five consecutive weeks).
干预措施: Intensive counseling (Behavioral)
Group 3
Intensive counseling (15 minutes) by a smoking cessation counselor including confrontation with abnormal spirometry results if relevant, offering and providing nicotine replacement therapy (NRT) and follow up (will be done weekly by phone for five consecutive weeks).
干预措施: Nicotine replacement therapy (Drug)
结局指标
主要结局
Composite outcome: •Enrollment to a cessation behavioral intervention program according to participation in first two meetings of group therapy or personal counseling • Smoking cessation validated by CO exhale test<5 ppm
时间窗: Within six months since discharge
The need for composite primary outcome based on the hypothesis that in Israel, the best supported way to quit smoking in by participating in group or personal counseling, with 50% success rate of smoking cessation.
次要结局
未报告次要终点