Capacity building for Tobacco Cessation in India and Indonesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Quit Rate (seven day smoking abstinence)validated by salivary cotinine test
研究概览
简要总结
Capapcity building for toabcco cessation in India and Indonesia project is a multicountry project covering India and Indonesia. But the present trial is conducted in India only
**Background:**The Indian State of Kerala has he highest rate of adult type-2 diabetes in South Asia(21%). A previous study carried out in 2008 of 444 diabetes patients found that a significant proportion (59%) of diabetes patients were tobacco users prior to the diagonosis and more than half of these ever routine users continued to use tobacco. The objective of the present study is to document the effectiveness of both a strong doctor’s cessation message and cessation counseling delivered by a no-doctor health professional. The patients will be followed up one at one month, three month and at six months with counseling for the intervention group and doctor’s advice for the control group. The yearly follow up up to five years will be without doctor’s advice and counseling.
Method: All the male diabetic patients who attended a referral diabetic clinic located in South Kerala was screened for smoking. 224 consecutive male diabetic patients, who smoked in the past month and willing to participate in the study were randomized into intervention-1 and intervention-2 group. Both groups were given smoking diabetes specific cessation advice by a doctor and quit tobacco booklets. The intervention-2 group received an additional counseling session by a trained non-physician health professional.
Expected Outcome: Quit rate, quit attempt, harm reduction. Quit rate will be validated by salivary cotinine test
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male Diabetic smokers.
排除标准
- •females Non-smokers Cannot come for follow ups refusal.
结局指标
主要结局
Quit Rate (seven day smoking abstinence)validated by salivary cotinine test
时间窗: at 6 months, one year, two year , three year four year, five year
次要结局
- quit attempt and harm reduction(at six months, one year, two year, three year, four year, five year)