Acute Stroke Program of Interventions Addressing Racial and Ethnic Disparities (ASPIRE)

This study has been completed.
Sponsor:
Collaborators:
Medstar Research Institute
Howard University
Washington Hospital Center
George Washington University
University of Michigan
University of Wisconsin, Madison
Johns Hopkins University
University of Alabama at Birmingham
MedStar Good Samaritan Hospital
Union Memorial Hospital
Information provided by (Responsible Party):
Chelsea Kidwell, M.D., Georgetown University
ClinicalTrials.gov Identifier:
NCT00724555
First received: July 28, 2008
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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.


Condition
Stroke

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Acute Stroke Program of Interventions Addressing Racial and Ethnic Disparities

Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • The proportion of people with ischemic stroke appropriately treated with IV tPA. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Qualitative data collected from the community will identify baseline levels of knowledge, attitudes, and perceived and encountered barriers to acute stroke treatment. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 2005
Study Start Date: February 2008
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Adults living in DC neighborhoods with high proportions of underserved adults. The age of the cohort members will reflect the age of DC residents who suffer most from stroke.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adult residents of the District of Columbia

Criteria

Inclusion Criteria:

  • diagnosis of acute ischemic stroke
  • over the age of 18

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724555

Locations
United States, District of Columbia
Georgetown University, ASPIRE Coordinating Center
Washington, District of Columbia, United States, 20007
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
Providence Hospital
Washington, District of Columbia, United States, 20017
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United Medical Center (formerly known as Greater Southeast Community Hospital)
Washington, District of Columbia, United States, 20032
Howard University Hospital
Washington, District of Columbia, United States, 20060
George Washington University Hospital
Washington, District of Columbia, United States, 20037
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Georgetown University
Medstar Research Institute
Howard University
Washington Hospital Center
George Washington University
University of Michigan
University of Wisconsin, Madison
Johns Hopkins University
University of Alabama at Birmingham
MedStar Good Samaritan Hospital
Union Memorial Hospital
Investigators
Principal Investigator: Chelsea Kidwell, MD Georgetown University
  More Information

No publications provided by Georgetown University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chelsea Kidwell, M.D., Professor of Neurology and Medical Director, Georgetown University Stroke Center, Georgetown University
ClinicalTrials.gov Identifier: NCT00724555     History of Changes
Other Study ID Numbers: U54NS057405_ASPIRE, 2007-439
Study First Received: July 28, 2008
Last Updated: January 30, 2014
Health Authority: United States: Federal Government
United States: Georgetown University Institutional Review Board

Keywords provided by Georgetown University:
stroke
tissue plasminogen activator
tPA

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on October 19, 2014