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

January 30, 2014 updated by: Chelsea Kidwell, M.D., Georgetown University
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

2005

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
      • Washington, District of Columbia, United States, 20016
        • Sibley Memorial Hospital
      • Washington, District of Columbia, United States, 20037
        • George Washington University Hospital
      • Washington, District of Columbia, United States, 20060
        • Howard University Hospital
      • Washington, District of Columbia, United States, 20017
        • Providence Hospital
      • Washington, District of Columbia, United States, 20007
        • Georgetown University, ASPIRE Coordinating Center
      • Washington, District of Columbia, United States, 20032
        • United Medical Center (formerly known as Greater Southeast Community Hospital)
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult residents of the District of Columbia

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of people with ischemic stroke appropriately treated with IV tPA.
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Collaborators

Johns Hopkins University
University of Alabama at Birmingham
University of Michigan
University of Wisconsin, Madison
George Washington University
Medstar Health Research Institute
Howard University
MedStar Good Samaritan Hospital
Union Memorial Hospital

Investigators

  • Principal Investigator: Chelsea Kidwell, MD, Georgetown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

July 28, 2008

First Submitted That Met QC Criteria

July 28, 2008

First Posted (Estimate)

July 29, 2008

Study Record Updates

Last Update Posted (Estimate)

January 31, 2014

Last Update Submitted That Met QC Criteria

January 30, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U54NS057405_ASPIRE
  • U54NS057405 (U.S. NIH Grant/Contract)
  • 2007-439

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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