TB patients learning about second hand smoke (TBLASS): a pilot individual randomised controlled trial
TB patients learning about second hand smoke (TBLASS): a pilot individual randomised controlled trial
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DOI：
10.1186/2193-1801-2-556
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发表时间：
2013-01-01
期刊：
影响因子：
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通讯作者：
Siddiqi, Kamran
中科院分区：
文献类型：
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作者：
Safdar, Nauman;Zahid, Raana;Siddiqi, Kamran
背景：与吸烟者生活在一起是暴露于二手烟（SHS）的关键决定因素，其暴露主要发生在家中。在家庭中暴露于来自烟草的SHS易患结核病（TB），并且疾病的结果变得更糟。我们的目标是开发和评估一种行为干预“无烟家园”（SFH）的结核病患者，鼓励他们谈判一个无烟的环境在他们的homes.Methods和设计：试点个人随机对照试验SFH将通知未来的最终试验的设计。我们将首先使用行为改变技术的分类来开发SFH干预，旨在鼓励非吸烟结核病患者的家庭按照干预的逻辑模型在家中实施吸烟限制。随后将在常规结核病控制规划的背景下进行一项干预的试点随机对照试验。符合条件的非吸烟结核病患者将被随机分配到两个试验组之一，这两个试验组包括“个体化护理”和“个体化护理”加“补充支持”。我们的目标是从两个选定的结核病中心招募150名新登记的肺结核患者，每组75例。主要结局指标将是通过“尿可替宁”试验验证的非吸烟结核病患者的SFH。我们还将定性地确定创建无烟家庭的障碍和关键驱动因素，然后进行最终试验。讨论：巴基斯坦结核病病例的男女分布几乎相等，而男性吸烟率远高于女性。这反映出妇女的健康很可能受到男子行为的影响。将对参加者的个人详细资料作出适当的储存、限制进入和处置安排。所有的道德问题都将得到解决。参加者不会有任何额外的财政或其他负担。他们将不会获得任何参与本研究的经济奖励。
Background: Living with a smoker is a key determinant of exposure to Second Hand Smoke (SHS) and its exposure mainly occurs at home. Exposure to SHS from tobacco in the household predisposes to the development of tuberculosis (TB) and outcome of the disease gets worse. We aim to develop and evaluate a behavioural intervention 'Smoke Free Homes' (SFH) for TB patients that encourages them to negotiate a smoke free environment within their homes.Methods and design: The pilot individual randomised controlled trial of SFH will inform the design of a future definitive trial. We will first develop SFH intervention using taxonomy of behaviour change techniques aimed at encouraging families of non-smoking TB patients to implement smoking restrictions at home following a logic model of the intervention. This will be followed by conducting a pilot randomised controlled trial of intervention within the context of routine TB control programme. The eligible non-smoking TB patients will be randomised and allocated to one of the two trial arms consisting of "individual based care" and "individual based care" plus "supplementary support". We aim to recruit 150 newly registered pulmonary TB patients from two selected TB centres with 75 cases in each arm. The Primary outcome measure will be SFH of non-smoker TB patient by validating through 'Urine Cotinine' test. We will also determine qualitatively the barriers and key drivers to the creation of smoke free homes followed by developing a definitive trial.Discussion: The male to female distribution of TB cases in Pakistan is almost equal whereas, tobacco use among males is much high as compared to females in Pakistan. This reflects a strong possibility that women health can be affected by men behaviour. Appropriate storage, restricted access and disposal arrangements for participant's personal details will be implemented. All ethical issues will be addressed. There will be no extra burden, financial or otherwise, on the participants. They will not receive any financial incentive to participate in the study.