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临床试验/NCT00281151
NCT00281151已完成不适用

Center for Reducing Asthma Disparities - Meharry/Vanderbilt Centers

Vanderbilt University2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2002年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
2
主要终点
Asthma related maternal/fetal morbidities and asthma control

研究概览

简要总结

The purpose of this study is to determine the mechanisms underlying the disparities in asthma and to improve asthma care in pregnant women, a targeted group at high risk for asthma-specific maternal and perinatal complications.

详细描述

BACKGROUND:

Asthma is a serious chronic condition affecting over 14 million Americans. Data indicate that rates of asthma are higher in certain populations. In fact, African Americans and Hispanics from the Northeast are twice as likely to die from asthma as whites. African Americans are four times as likely to be hospitalized for asthma and are five times more likely than whites to seek care for asthma at an emergency department. Reasons for these higher rates are not certain, and most likely result from an interaction of risk factors such as environmental exposures, genetic predisposition, access to appropriate medical care, socioeconomic status, and cultural health practices. The National Heart, Lung, and Blood Institute (NHLBI) supports a variety of activities to address the pressing public health problems posed by asthma. However, progress in reducing disparities has been disappointingly slow. Separate, independent research projects have generated important clues for understanding the nature and scope of the problem, but a more coordinated, interdisciplinary, and comprehensive approach to research is needed. By fostering partnerships among minority medical centers, research intensive institutions, and the communities in which asthma patients live, cooperative research centers can help increase the capacity to improve health outcomes among minority and economically disadvantaged populations.

DESIGN NARRATIVE:

This study will comprise three groups: pregnant women with asthma, children requiring intensive care unit (ICU) admission for asthma, and asthmatics requiring emergency care. In one part of the study, researchers will randomly assign pregnant women with asthma of African American or Hispanic race/ethnicity to one of two culturally sensitive asthma education and smoking cessation programs. At the same time, investigators will examine asthma-related morbidity in a large cohort of pregnant asthmatic women utilizing administrative data and vital records. Perceptions of asthma severity and ways to describe it appear to differ in African Americans compared to whites. Therfore, asthmatic patients attending the emergency room, along with their families, will be invited to participate in a focus group to validate a culturally sensitive instrument to allow improved descriptors of asthma severity for African Americans. Estimates by the patients of asthma severity will be matched to objective measure, and compared with those of whites. This methodology will then be used to extend the hypothesis to children admitted with severe asthma to the region's only pediatric ICU. In the pediatric ICU, the admission rates and outcomes will be associated with the potentially important genetic variations in the beta 2 adrenergic receptor (BADR2). Using parents and non-affected siblings as case controls, a novel computational method will test for gene-gene interactions that explain a genetic basis for asthma disparities in severe asthma.

研究设计

研究类型
Observational
观察模型
Cohort

入排标准

年龄范围
— 至 60 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women with asthma
  • Children requiring intensive care unit (ICU) admission for asthma
  • Asthmatics requiring emergency care.

排除标准

  • 未提供

结局指标

主要结局

Asthma related maternal/fetal morbidities and asthma control

时间窗: Measured between two and six weeks following delivery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Sheller

Professor of Medicine

Vanderbilt University

研究点 (2)

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