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| Sponsors and Collaborators: |
Georgetown University National Institute of Neurological Disorders and Stroke (NINDS) |
|---|---|
| Information provided by: | Georgetown University |
| ClinicalTrials.gov Identifier: | NCT00703274 |
Purpose
The purpose of this study is to refine and evaluate the Preventing Recurrence of Thromboembolic Events through Coordinated Treatment in the District of Columbia (PROTECT DC) intervention. PROTECT DC is a program consisting of in-hospital education coupled with community-based "stroke navigators" and is designed to reduce the rate of vascular events or death in a population of underserved individuals with stroke.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Behavioral: PROTECT DC |
Phase II |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Open Label, Parallel Assignment |
| Official Title: | Preventing Recurrence of Thromboembolic Events Through Coordinated Treatment in the District of Columbia |
| Estimated Enrollment: | 250 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Navigation Group: Experimental
Participants enrolled in this group will receive education concerning primary and secondary PROTECT DC goals. Primary PROTECT DC goals adhere to the following medication directives: 1) Anti-hypertensive, 2) Lipid Lowering, 3) Anti-Coagulant, and 4) Anti-Diabetic. PROTECT DC secondary goals include the following behaviors 1) Smoking Cessation, 2) Consuming an AHA Diet, 3) Regular Exercise, and 4) Knowledge of Stroke Risk and Warning Signs. Participants will also receive assistance with overcoming resource-related barriers to the PROTECT DC goals. |
Behavioral: PROTECT DC
PROTECT DC facilitates the initiation of secondary prevention behaviors in an attempt to prevent the recurrence of stroke among participants. The program trains a lay person, called a stroke navigator, to provide participants with education on secondary prevention behavior and to navigate the health and human service system, which will assist participants in obtaining the necessary services and programs to engage in secondary prevention behaviors.
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Control Group: No Intervention
Participants enrolled in this group will receive periodic follow up through mailings, phone calls etc to ensure availability for 1 year assessment.
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Despite significant advances in the prevention and treatment of cerebrovascular disease in the last few decades, stroke remains the third leading cause of death and the leading cause of adult disability in the United States.
For the population that has experienced a cerebrovascular event, the risk of future stroke is greatly increased.
The initiation of effective secondary prevention strategies is most effective when implemented early (before disabling stroke occurs), monitored frequently, and maintained long-term after a cerebrovascular event.
The Preventing Recurrence of Thromboembolic Events through Coordinated Treatment in the District of Columbia (PROTECT DC) intervention uses stroke navigators to help people who have suffered a stroke implement secondary prevention strategies. Stroke navigators are lay persons trained to provide education on secondary prevention behavior, and trained to navigate the health and human service system. The goals are to help individuals who have had a stroke obtain the necessary services and programs to engage in secondary prevention behaviors and, ultimately, to prevent the recurrence of stroke.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Deeonna Farr, MPH CHES | 202-877-1931 | Deeonna.E.Farr@medstar.net |
| United States, District of Columbia | |
| Washington Hospital Center | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact: Deeonna Farr, MPH CHES 202-877-1931 Deeonna.E.Farr@medstar.net | |
| Howard University Hospital | Recruiting |
| Washington, District of Columbia, United States, 20060 | |
| Contact: Deeonna Farr, MPH CHES 202-877-1931 Deeonna.E.Farr@medstar.net | |
| National Rehabilitation Hospital | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact: Deeonna Farr, MPH CHES 202-877-1931 Deeonna.E.Farr@medstar.net | |
| Georgetown University Hospital | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Deeonna Farr, MPH CHES 202-877-1931 Deeonna.E.Farr@medstar.net | |
| Principal Investigator: | Alexander Dromerick, MD | National Rehabilitation Hospital, Georgetown University |
| Principal Investigator: | Chelsea S. Kidwell, MD | Washington Hospital Center, National Rehabilitation Hospital, Georgetown University |
More Information
| Responsible Party: | National Rehabilitation Hospital/Georgetown University ( Alexander Dromerick, MD, Principal Investigator ) |
| Study ID Numbers: | U54NS057405, 1U54NS057405-01A1 |
| Study First Received: | June 20, 2008 |
| Last Updated: | July 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00703274 History of Changes |
| Health Authority: | United States: Federal Government |
|
ischemic stroke stroke cerebrovascular stroke cerebrovascular accident CVA community health services |
community health workers navigators health education barriers to care healthcare access healthcare disparities |
|
Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases |
Ischemia Brain Diseases Cerebrovascular Disorders Recurrence |
|
Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases |
Cardiovascular Diseases Brain Diseases Cerebrovascular Disorders |
