支持公共住房中的无烟政策合规性
2023年2月8日 更新者:Diana Hernandez, PhD、Columbia University
支持公共住房无烟政策合规性的随机对照试验
该项目旨在确定两种干预措施的有效性,以减少住宅建筑中的二手烟暴露。
一种干预措施针对所有建筑物居民(居民认可),另一种干预措施针对吸烟者(通过搬迁减少吸烟和减少个人吸烟/戒烟),目的是减少个人吸烟和二手烟暴露。
研究概览
详细说明
多单元住房中的无烟住房政策是有前途且日益广泛的干预措施,可减少吸烟和二手烟暴露。 很少有研究确定提高低收入多单元住房对无烟住房政策的遵守程度的因素并测试相应的解决方案。
拟议的随机对照试验 (RCT) 解决了知识上的关键差距并利用了关键的科学机会:1) 利用联邦授权在规模超过足够规模的公共住房系统中禁止吸烟,以进行足够有力的随机对照试验; 2) 通过测试两种新颖的治疗方法,将我们对无烟政策合规性的理解扩展到政策实施之外:a) 住宅内戒烟和 b) 居民认可,同时 3) 解决人口和特定地点与烟草相关的差异。
研究人员假设,与独立干预和标准方法相比,搬迁/戒烟加上居民认可干预将大大减少个人吸烟和二手烟暴露。
研究类型
介入性
注册 (预期的)
512
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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New York
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New York、New York、美国、10032
- 招聘中
- Columbia University Irving Medical Center
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、OLDER_ADULT)
接受健康志愿者
是的
有资格学习的性别
全部
描述
建筑纳入标准:
- 曼哈顿和布朗克斯区的 NYCHA 建筑物(按行政区平均分层)有 50 多个单元,未进行重大翻新。
建筑排除标准:
- 不在曼哈顿或布朗克斯的行政区的建筑物
- 小于 50 个单元的建筑物
- 正在进行重大翻新的建筑物
- 正在或将成为租金援助示范 (RAD) 或永久负担能力共同承诺 (PACT) 一部分的建筑物
- 混合金融的建筑
- 专供老年人使用的建筑物
- 私人管理的建筑物
- 正在进行其他研究的建筑物
参与者纳入标准:
- 通过敲门和大堂拦截招募 NYCHA 居民,直到我们达到每组的目标人数(每栋楼有 4 名吸烟者,4 名非吸烟者)。
- 居民将接受吸烟状况筛查。 将招募吸烟者和非吸烟者,但每间公寓仅招募一名参与者(吸烟者或非吸烟者)。
- 吸烟将被定义为那些报告在过去一个月中至少有 5 天使用香烟或其他可燃烟草产品(例如,小雪茄、小雪茄)的人。 非吸烟者包括从不吸烟者和 12 个月前或更早戒烟的前吸烟者。
- 其他资格标准包括 18 岁以上的个人每周至少 5 天和至少 9 个月/每年居住在建筑物中,并且不打算在未来 2 年内搬家。
参与者排除标准:
- 身体或精神疾病严重的人(即 认知障碍)或其他可能限制参与或在基线或随访期间给予知情同意的能力的因素。
- 参加早期焦点小组的个人。
- 只吸食非烟草产品(例如大麻)的人。
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:阶乘
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:通过减少(搬迁和减少个人吸烟)和戒烟来遵守规定
调查小组会将吸烟者转介给来自社区组织的同伴教育者,这些组织经过培训可以提供同伴健康教育,包括戒烟支持。
同伴教育者将协调戒烟支持,包括充当参与者和研究团队之间的联络人,提供有关无烟政策和搬迁机会的信息,并在认为合适的情况下为参与者提供烟草替代疗法和/或医生支持.
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个人层面。
同伴教育者提供减少/停止和/或搬迁支持。
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实验性的:通过居民背书合规
分配的建筑物将针对一系列 2 个驻地计划,其中涉及社区论坛和创意艺术,以获得居民对无烟生活环境的认可。
该部门以居民参与为前提,力求影响居住环境的社会和物理维度以实现合规性。
这些会议将:1) 告知居民与吸烟和二手烟相关的风险; 2) 找出拥有无烟家庭的理由,3) 要求居民在纸上和/或线上签署承诺书; 4) 在门上和/或社交媒体页面上展示带有原始主题标签(#Smokefree[建筑地址])的无烟标志; 5) 建议居民访问无烟 NYCHA 网站,了解有关政策和现有戒烟资源的信息。
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建筑级。
同伴教育者进行建筑物级别的会议。
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实验性的:通过减少/停止加居民背书(组合)合规
联合干预将在分配给该 RCT 组的建筑物中进行,该组将提供基于居民认可治疗和吸烟搬迁/戒烟治疗的住院计划。
两者都将同时发生,一个针对所有建筑居民(居民认可),另一个针对吸烟者(吸烟搬迁/戒烟),目的是减少个人吸烟和二手烟暴露。
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建筑级。
同伴教育者进行建筑物级别的会议。
个人层面。
同伴教育者提供减少/停止和/或搬迁支持。
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NO_INTERVENTION:标准 NYCHA 方法(对照)
分配给该组的建筑物和研究参与者将被招募并在 12 个月的时间内进行跟踪以评估结果。
除了 NYCHA 可能提供的支持无烟指令的标准计划外,不会向分配给该部门的建筑物或居民提供额外的计划或服务。
现场工作人员将记录这些参与者接触到的任何与政策相关的标志、活动或信息。
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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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每天吸烟支数的变化
大体时间:在基线(面对面采访)、3 个月(电话采访)和 12 个月(面对面采访)时测量
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吸烟者自我报告的平均每天吸烟支数
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在基线(面对面采访)、3 个月(电话采访)和 12 个月(面对面采访)时测量
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唾液可替宁的变化
大体时间:在基线和 12 个月的随访中
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将对吸烟者和非吸烟者中 25% 的样本进行唾液可替宁(作为被动流口水收集的唾液)测量
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在基线和 12 个月的随访中
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二手烟暴露的变化
大体时间:在基线(面对面采访)、3 个月(电话采访)和 12 个月(面对面采访)时测量
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自我报告的二手烟暴露情况(过去 7 天内在建筑物内的二手烟暴露时间);在吸烟者和非吸烟者中
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在基线(面对面采访)、3 个月(电话采访)和 12 个月(面对面采访)时测量
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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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尝试戒烟成功的参与者人数变化
大体时间:在基线(面对面采访)、3 个月(电话采访)和 12 个月(面对面采访)时测量
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二进制;吸烟者是否成功戒烟
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在基线(面对面采访)、3 个月(电话采访)和 12 个月(面对面采访)时测量
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戒烟尝试次数的变化
大体时间:在基线(面对面采访)、3 个月(电话采访)和 12 个月(面对面采访)时测量
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吸烟者尝试戒烟的平均次数
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在基线(面对面采访)、3 个月(电话采访)和 12 个月(面对面采访)时测量
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二手烟观察参与者人数的变化
大体时间:在过去 7 天内曾观察到有人在室内吸烟,测量值分别为基线(面谈)、3 个月(电话面谈)和 12 个月(面谈)
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二进制;参与者是否观察到有人在大楼内吸烟;在吸烟者和非吸烟者中
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在过去 7 天内曾观察到有人在室内吸烟,测量值分别为基线(面谈)、3 个月(电话面谈)和 12 个月(面谈)
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二手烟暴露小时数的变化
大体时间:过去 7 天内在基线(面对面采访)、3 个月(电话采访)和 12 个月(面对面采访)时测量的有人在室内吸烟的小时数
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计算暴露小时数
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过去 7 天内在基线(面对面采访)、3 个月(电话采访)和 12 个月(面对面采访)时测量的有人在室内吸烟的小时数
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吸烟人数的变化
大体时间:在基线和 12 个月的每次建筑物访问中
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在公共区域观察到的吸烟人数统计
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在基线和 12 个月的每次建筑物访问中
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烟头数量的变化
大体时间:在基线和 12 个月的每次建筑物访问中
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在公共区域观察到的烟头数量
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在基线和 12 个月的每次建筑物访问中
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Hernandez D. "Extra Oomph:" Addressing Housing Disparities through Medical Legal Partnership Interventions. Hous Stud. 2016;31(7):871-890. doi: 10.1080/02673037.2016.1150431. Epub 2016 Apr 13.
- Hernandez D. Understanding 'energy insecurity' and why it matters to health. Soc Sci Med. 2016 Oct;167:1-10. doi: 10.1016/j.socscimed.2016.08.029. Epub 2016 Aug 21.
- Navas-Acien A, Carkoglu A, Ergor G, Hayran M, Erguder T, Kaplan B, Susan J, Magid H, Pollak J, Cohen JE. Compliance with smoke-free legislation within public buildings: a cross-sectional study in Turkey. Bull World Health Organ. 2016 Feb 1;94(2):92-102. doi: 10.2471/BLT.15.158238. Epub 2015 Nov 23.
- Stillman FA, Soong A, Zheng LY, Navas-Acien A. Clear Skies and Grey Areas: Flight Attendants' Secondhand Smoke Exposure and Attitudes toward Smoke-Free Policy 25 Years since Smoking was Banned on Airplanes. Int J Environ Res Public Health. 2015 Jun 4;12(6):6378-87. doi: 10.3390/ijerph120606378.
- Apelberg BJ, Hepp LM, Avila-Tang E, Gundel L, Hammond SK, Hovell MF, Hyland A, Klepeis NE, Madsen CC, Navas-Acien A, Repace J, Samet JM, Breysse PN. Environmental monitoring of secondhand smoke exposure. Tob Control. 2013 May;22(3):147-55. doi: 10.1136/tobaccocontrol-2011-050301. Epub 2012 Sep 4.
- Jones MR, Wipfli H, Shahrir S, Avila-Tang E, Samet JM, Breysse PN, Navas-Acien A; FAMRI Bar Study Investigators. Secondhand tobacco smoke: an occupational hazard for smoking and non-smoking bar and nightclub employees. Tob Control. 2013 Sep;22(5):308-14. doi: 10.1136/tobaccocontrol-2011-050203. Epub 2012 Jan 24.
- Erazo M, Iglesias V, Droppelmann A, Acuna M, Peruga A, Breysse PN, Navas-Acien A. Secondhand tobacco smoke in bars and restaurants in Santiago, Chile: evaluation of partial smoking ban legislation in public places. Tob Control. 2010 Dec;19(6):469-74. doi: 10.1136/tc.2009.035402. Epub 2010 Aug 25.
- Stillman F, Navas-Acien A, Ma J, Ma S, Avila-Tang E, Breysse P, Yang G, Samet J. Second-hand tobacco smoke in public places in urban and rural China. Tob Control. 2007 Aug;16(4):229-34. doi: 10.1136/tc.2006.018333.
- Navas-Acien A, Peruga A, Breysse P, Zavaleta A, Blanco-Marquizo A, Pitarque R, Acuna M, Jimenez-Reyes K, Colombo VL, Gamarra G, Stillman FA, Samet J. Secondhand tobacco smoke in public places in Latin America, 2002-2003. JAMA. 2004 Jun 9;291(22):2741-5. doi: 10.1001/jama.291.22.2741.
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- Giovenco DP, Spillane TE, Merizier JM. Neighborhood Differences in Alternative Tobacco Product Availability and Advertising in New York City: Implications for Health Disparities. Nicotine Tob Res. 2019 Jun 21;21(7):896-902. doi: 10.1093/ntr/nty244.
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有用的网址
- Helburn A. A Case for smoke-free housing. Asthma regional council of new England;2007.
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- American Lung Association. Smoke-free Policies in Multi-Unit Housing - Steps for Success. 2016; http://www.lung.org/our-initiatives/tobacco/smokefree-environments/multi-unit-housing/. Accessed August 4, 2016.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年2月3日
初级完成 (预期的)
2024年8月1日
研究完成 (预期的)
2025年8月1日
研究注册日期
首次提交
2021年7月20日
首先提交符合 QC 标准的
2021年8月16日
首次发布 (实际的)
2021年8月23日
研究记录更新
最后更新发布 (估计)
2023年2月9日
上次提交的符合 QC 标准的更新
2023年2月8日
最后验证
2023年2月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
一旦对最终数据集进行了分析并且主要发现被接受发表以支持和验证研究结果,来自大约 512 名参与者的数据将被发布给赞助商 (NIH)。
这将包括参与者的人口统计数据、访谈数据和唾液样本的实验室数据。
标识符可能会从可识别的私人信息或可识别的生物样本中删除,并且在删除后,信息或生物样本可用于未来的研究,而无需受试者的额外同意。
去识别化的参与者数据可用于其他研究人员重复分析的目的,以验证发现,和/或用新的或替代的假设促进进一步的研究。
分发机制将是数据共享协议。
IPD 共享时间框架
一旦对最终数据集进行了分析并且主要发现被接受发表以支持和验证研究结果,数据将可用。
只要数据预计有用,研究人员、机构和/或广大公众就可以访问。 考虑到数据共享协议,可以在进行分析所需的时间内提供数据。
IPD 共享访问标准
访问权限应授予那些在科学领域具有良好背景的人,他们拥有科学或医学学位和/或相关职位以索取数据。
个人还应该表达他们对数据的预期用途。
这些请求将由首席调查员 [和/或指定的团队成员] 定期审查。
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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