Intensive Smoking-cessation Intervention Versus Smoking-cessation Advice in Smear-positive Patients With Pulmonary Tuberculosis
Impact of a Package of Intensive Smoking-cessation Interventions Versus Smoking-cessation Advice on Outcomes in Smear-positive Patients With Pulmonary Tuberculosis; a Randomised Controlled Trial (STB_RCT).
The aim of the study is to determine the impact of a package of smoking-cessation interventions on a composite measure of Tuberculosis (TB) treatment-related outcomes.
Given the lack of objective clinical data/evidence about the impact of smoking-cessation on TB-related outcomes, yet subjective expert opinion that smoking cessation is highly likely to be beneficial particularly in patients with TB, this study proposes to determine the impact of an intensive package of smoking-cessation interventions aimed to promote smoking-cessation (counseling plus nicotine replacement therapy, NRT), on patient response to anti-tuberculosis therapy. This is to be compared with the structured counselling for smoking-cessation that is recommended to be routinely provided by health care workers to all patients who are smokers. If the results prove that such a smoking-cessation PI indeed improves outcomes in TB patients, such information would strongly motivate for the institution of more intensive smoking-cessation interventions in TB clinics than is currently being employed for TB patients
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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New Delhi、印度、110029
- All India Institute of Medical Sciences, Ansari Nagar
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- any adult (> 18 years)
- Recently diagnosed (primary TB/Relapse TB) smear-positive TB patient who self-reports to smoke at least 10 whole cigarettes or bidis (rolled tobacco leaf) per day, every day
Exclusion Criteria:
patients will be excluded from recruitment to the study if they fall into any one or more of these exclusion categories:
- Inability to give consent or < 18 years
- Patients who self-report to smoke less than 10 whole cigarettes/bidis per day
- TB patients who have already started anti-tuberculosis therapy for more than 1 week.
- Patients with known multidrug-resistant TB (or XDR) (information provided by patient or the information is available in the clinic folder).
- Known HIV-positive patients
- Contra-indications to NRT (patients with a history of severe cardiovascular disease including arrhythmias, recent myocardial infarction (within the last 6 months), recent cerebrovascular incident (6 months), and/ or history of peripheral vascular disease, phaeochromocytoma, poorly controlled diabetes mellitus, hyperthyroidism, renal/hepatic impairment or gastritis/peptic ulcers). Patients with asthma or depression will also be excluded, as quitting may have an effect on medications used for these conditions. Patients with severe skin disorders (such as psoriasis or eczema) will also be excluded.
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:Control arm
Control arm patients will receive pre designed pamphlets and structured conselling for smoking cessation by trained counsellors along with routine DOTS treatment
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有源比较器:Intervention arm
Cessation arm patients will receive pre designed pamphlets and structured conselling for smoking cessation by trained counsellors along and nicotine replacement therapy(NRT) and routine DOTS treatment
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nicotine replacement therapy 2mg for patients cessation arm for period of 6 weeks
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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1. Change in TB Score at second month and sixth month
大体时间:Measured at baseline, second month and sixth month.
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Composite score for objective and subjective improvement measured at baseline, second month and sixth month
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Measured at baseline, second month and sixth month.
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Sputum culture conversion
大体时间:Measured at baseline and second month
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Sputum culture conversion at second month using solid/liquid culture technique
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Measured at baseline and second month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sputum smear conversion
大体时间:Measured at baseline, second week, fourth week, second month and sixth months
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Protocol was amended to access sputum conversion weekly up to second month
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Measured at baseline, second week, fourth week, second month and sixth months
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Mortality at sixth month
大体时间:Sixth month
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To determine number of mortality at the end of follow-up
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Sixth month
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More than 10% weight gain at six months
大体时间:Sixth month
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To determine rate of weight gain after completion of treatment
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Sixth month
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Proportion of subjects in each group that have quit smoking at second month
大体时间:Sixth month
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To determine the rate of smoking cessation in the cohort
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Sixth month
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Treatment completion
大体时间:Six months for new cases and eight months for re-treatment cases following regimen 2
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Six months for new cases and eight months for re-treatment cases following regimen 2
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Cure, failure and default rate
大体时间:At sixth month
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To determine cure, failure and default rate in the cohort
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At sixth month
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合作者和调查者
调查人员
- 首席研究员:Surendra K Sharma, MD, Ph.D.、AIIMS, New Delhi
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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