Viewing Study NCT00281151



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Last Modification Date: 2024-10-26 @ 9:22 AM
Study NCT ID: NCT00281151
Status: COMPLETED
Last Update Posted: 2014-12-11
First Post: 2006-01-20

Brief Title: Center for Reducing Asthma Disparities - MeharryVanderbilt Centers
Sponsor: Vanderbilt University
Organization: Vanderbilt University

Study Overview

Official Title: Center for Reducing Asthma Disparities - MeharryVanderbilt Centers
Status: COMPLETED
Status Verified Date: 2009-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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 raceethnicity 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 regions 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
U01HL072471 NIH None httpsreporternihgovquickSearchU01HL072471
U01HL072431 NIH None None