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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00724555
Other study ID # U54NS057405_ASPIRE
Secondary ID 2007-439
Status Completed
Phase N/A
First received July 28, 2008
Last updated January 30, 2014
Start date February 2008
Est. completion date January 2013

Study information

Verified date January 2014
Source Georgetown University
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Georgetown University Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to increase treatment of acute stroke with tissue plasminogen activator (tPA) across the District of Columbia. This study, however, will not evaluate tPA as an intervention.


Description:

There are a number of well-known barriers to receiving tissue plasminogen activator (tPA) including transit time to hospital, paramedic and provider training, tPA standing orders, and provider guidelines. Among underserved populations, limited stroke knowledge, socioculturally determined attitudes, and beliefs and myths held by community members may serve as additional barriers that hinder these populations from receiving tPA and acute stroke care. Targeted multilevel interventions designed to overcome specific barriers may significantly increase the number of individuals with stroke who are appropriately treated with intravenous tPA (IV tPA) in underserved communities. Identification of the specific components of healthcare interventions that are the most effective is critical to improve delivery of acute stroke therapy.

The goal of this study is to learn more about public knowledge, attitudes, beliefs and perceptions regarding stroke and stroke treatment in order to identify sociocultural and environmental barriers to receiving tPA and acute stroke care in an underserved community. This study will also determine if implementation of a multilevel intervention program can significantly increase the number of people with ischemic stroke who are appropriately treated with IV tPA in a predominantly underserved community.

In the study, researchers will evaluate the different levels of the intervention to determine which efforts are most effective.


Recruitment information / eligibility

Status Completed
Enrollment 2005
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- diagnosis of acute ischemic stroke

- over the age of 18

Exclusion Criteria:

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Columbia University Medical Center New York New York
United States George Washington University Hospital Washington District of Columbia
United States Georgetown University, ASPIRE Coordinating Center Washington District of Columbia
United States Howard University Hospital Washington District of Columbia
United States Providence Hospital Washington District of Columbia
United States Sibley Memorial Hospital Washington District of Columbia
United States United Medical Center (formerly known as Greater Southeast Community Hospital) Washington District of Columbia
United States Washington Hospital Center Washington District of Columbia

Sponsors (11)

Lead Sponsor Collaborator
Georgetown University George Washington University, Howard University, Johns Hopkins University, MedStar Good Samaritan Hospital, Medstar Research Institute, Union Memorial Hospital, University of Alabama at Birmingham, University of Michigan, University of Wisconsin, Madison, Washington Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The proportion of people with ischemic stroke appropriately treated with IV tPA. 4 years No
Secondary Qualitative data collected from the community will identify baseline levels of knowledge, attitudes, and perceived and encountered barriers to acute stroke treatment. 1 year No
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