Comparative effectiveness of environmental intervention and standard care in abil

环境干预和标准护理在能力方面的比较效果

• 批准号: 8009156
• 负责人: Emily DIMANGO
• 金额: $ 917.76万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-01 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8009156
• 关键词: Comparative; effectiveness; environmental; intervention; standard

DESCRIPTION (provided by applicant): DiMango, Emily/Kattan, Meyer In this application, we propose a clinical research trial to compare non-pharmacologic therapy and standard pharmacologic therapy in asthma. The target population includes inner-city minority individuals living in Manhattan, the Bronx and the New York City area. This protocol is designed to determine whether multi- faceted environmental intervention aimed at reducing exposure to indoor allergens to which asthmatic patients are sensitized is more effective than usual care in reducing NAEPP step based therapy, a novel, but important outcome measure. Collaboration of Columbia University Medical Center in Manhattan, New York and Jacobi Hospital in the Bronx, New York will ensure that minority individuals are represented in this important study. The protocol involves a major public health concern in asthma, one that is critical for the entire asthma population, but is most salient for residents of inner cities. The proposed study rigorously tests national guidelines in asthma care and fills a gap in understanding the importance of environmental remediation as it compares with need for pharmacological therapy for asthma control. Results of the study have the potential to affect public health policy as well as reimbursement from third party health care insurance companies. Investigators in this application have the proven ability to design and execute clinical research trials in asthma, with a track record that exceed expectations for recruitment. Specifically, our study aims to: i.) determine via a randomized, controlled trial in allergen-sensitized asthmatic patients whether environmental intervention aimed at reducing exposure to indoor allergens and irritants is more effective in reducing NAEPP step based therapy than usual care over a 48 week study period, ii) determine if environmental intervention leads to reduction in indoor allergen levels, allergen- specific serum IgE levels, airway hyperresponsiveness, fractional excretion of nitric oxide, sputum eosinophil count, asthma symptom score, asthma exacerbations, treatment failures and improved lung function compared to usual care over a 48 week study period and iii) determine if there is an association between reduction in allergen specific IgE level and reduction in NAEPP step level required for asthma control among subjects randomized to environmental intervention compared with usual care. PHS 398/2590 (Rev. 11/07) Page Continuation Format Page PUBLIC HEALTH RELEVANCE: DiMango, Emily/Kattan, Meyer Exposure to allergens within the household is a major public health concern in asthma, one that is critical for the entire asthma population, but is most salient for residents of inner cities. The proposed study rigorously tests national guidelines in asthma care and fills a gap in understanding the importance of environmental remediation as it compares with need for pharmacological therapy for asthma control. Results of the study have the potential to affect public health policy as well as reimbursement from third party health care insurance companies. PHS 398/2590 (Rev. 11/07) Page Continuation Format Page

描述（由申请方提供）：DiMango，艾米丽/Kendy，Meyer在本申请中，我们提出了一项临床研究试验，以比较哮喘的非药物治疗和标准药物治疗。目标人口包括居住在曼哈顿、布朗克斯和纽约市地区的市中心少数族裔。该方案旨在确定旨在减少哮喘患者致敏的室内过敏原暴露的多方面环境干预是否比常规护理更有效地减少NAEPP基于步骤的治疗，这是一种新的但重要的结局指标。位于纽约曼哈顿的哥伦比亚大学医学中心和位于纽约布朗克斯的雅可比医院的合作将确保少数民族个体参与这项重要研究。该协议涉及哮喘的主要公共卫生问题，这对整个哮喘人群至关重要，但对内城居民最为突出。这项拟议的研究严格测试了哮喘护理的国家指南，并填补了理解环境修复重要性的空白，因为它与哮喘控制的药物治疗需求进行了比较。研究结果有可能影响公共卫生政策以及第三方医疗保险公司的报销。本申请中的研究者具有设计和执行哮喘临床研究试验的能力，其跟踪记录超过了招募的预期。具体而言，我们的研究旨在：i.）通过在过敏原致敏的哮喘患者中的随机对照试验确定在48周的研究期内，旨在减少暴露于室内过敏原和刺激物的环境干预是否比常规护理更有效地减少基于NAEPP步骤的治疗，ii）确定环境干预是否导致室内过敏原水平、过敏原特异性血清IgE水平、气道高反应性的降低，一氧化氮排泄分数、痰嗜酸性粒细胞计数、哮喘症状评分、哮喘急性发作，在48周的研究期内，与常规护理相比，治疗失败和肺功能改善，以及iii）确定在随机分配至以下的受试者中，过敏原特异性IgE水平降低与哮喘控制所需的NAEPP水平降低之间是否存在关联：环境干预与常规护理相比。PHS 398/2590（Rev. 11/07） 公共卫生相关性：DiMango，艾米丽/Kazy，Meyer家庭内过敏原的暴露是哮喘的一个主要公共卫生问题，对整个哮喘人群至关重要，但对市中心的居民最为突出。这项拟议的研究严格测试了哮喘护理的国家指南，并填补了理解环境修复重要性的空白，因为它与哮喘控制的药物治疗需求进行了比较。研究结果有可能影响公共卫生政策以及第三方医疗保险公司的报销。PHS 398/2590（Rev. 11/07）