StrokeASPIRENCT00724555
Acute Stroke Program of Interventions Addressing Racial and Ethnic Disparities
An observational study of Stroke, run by Georgetown University at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 2,005 participants
- Where
- 8 sitesUnited States
- Study dates
- Feb 2008to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult residents of the District of Columbia
Who may be able to join
- diagnosis of acute ischemic stroke
- over the age of 18
Who cannot join
- -
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Columbia University Medical Center
New York, New York, 10032
Georgetown University, ASPIRE Coordinating Center
Washington D.C., District of Columbia, 20007
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Providence Hospital
Washington D.C., District of Columbia, 20017
United Medical Center (formerly known as Greater Southeast Community Hospital)
Washington D.C., District of Columbia, 20032
George Washington University Hospital
Washington D.C., District of Columbia, 20037
Howard University Hospital
Washington D.C., District of Columbia, 20060
About this study
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.
Read the 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.
- Conditions
- Stroke
- Keywords
- stroke, tissue plasminogen activator, tPA
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
The proportion of people with ischemic stroke appropriately treated with IV tPA.
Measured: 4 years
Secondary outcomes (1)
Qualitative data collected from the community will identify baseline levels of knowledge, attitudes, and perceived and encountered barriers to acute stroke treatment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 2,005 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Medstar Health Research Institute, Howard University, 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
- Responsible party
- Principal investigator, Chelsea Kidwell, M.D., Georgetown University
- Investigators
- Chelsea Kidwell, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724555
- Sponsor's protocol ID
- U54NS057405_ASPIRE
- Other IDs
- 2007-439, U54NS057405
- Acronym
- ASPIRE
- Status last verified
- Jan 2014
- First submitted
- 28 Jul 2008
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Boden-Albala B, Edwards DF, St Clair S, Wing JJ, Fernandez S, Gibbons MC, Hsia AW, Morgenstern LB, Kidwell CS. Methodology for a community-based stroke preparedness intervention: the Acute Stroke Program of Interventions Addressing Racial and Ethnic Disparities Study. Stroke. 2014 Jul;45(7):2047-52. doi: 10.1161/STROKEAHA.113.003502. Epub 2014 May 15.
PubMed 24876243
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Stroke Program of Interventions Addressing Racial and Ethnic Disparities
- ClinicalTrials.gov ID
- NCT00724555
- Acronym / sponsor ID
- ASPIRE / U54NS057405_ASPIRE
- Conditions
- Stroke
- Keywords
- stroke, tissue plasminogen activator, tPA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,005 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Medstar Health Research Institute, Howard University, 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
- Study start
- Feb 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 29 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult residents of the District of Columbia
Key inclusion criteria (2 listed)
- diagnosis of acute ischemic stroke
- over the age of 18
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of people with ischemic stroke appropriately treated with IV tPA.
Time frame: 4 years
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2014.
- Derived from this study: PubMed 24876243Boden-Albala B, Edwards DF, St Clair S, Wing JJ, Fernandez S, Gibbons MC, Hsia AW, Morgenstern LB, Kidwell CS. Methodology for a community-based stroke preparedness intervention: the Acute Stroke Program of Interventions Addressing Racial and Ethnic Disparities Study. Stroke. 2014 Jul;45(7):2047-52. doi: 10.1161/STROKEAHA.113.003502. Epub 2014 May 15.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chelsea Kidwell, MD principal investigator
Georgetown University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Georgetown University at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of people with ischemic stroke appropriately treated with IV tPA. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00724555, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2014.