Preventing Recurrence of Thromboembolic Events Through Coordinated Treatment in the District of Columbia - Full Text View

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

U.S. FDA Resources

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

Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Primary Outcome Measures:

Low Density Lipoprotein Value [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Systolic Blood Pressure Value [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Hemoglobin A1C Value [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Pill count of antiplatelet therapy medications [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Smoking Cessation Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
AHA Diet Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Exercise Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Stroke Knowledge Level [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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.
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.

Detailed Description:

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

Criteria

Inclusion Criteria:

Age ≥ 18 years
Hospitalized due to ischemic stroke* or intercurrent stroke* event within the past 30 days (see stroke subtype form)
Atherogenic etiology, large or small vessel etiology as defined by TOAST criteria (see stroke subtype form)
Community dwelling prior to stroke
Resides within the District of Columbia or closely nearby (preferably within 5 miles of the DC border)
Expected to reside within the District of Columbia or closely nearby (preferably within 5 miles of DC border)
Caregiver or interested party available, if moderately or severely disabled (not required to actually reside with participant)
Sufficient number of collateral contacts to assure follow-up. Defined as: --Preferred: at least 6 contacts; No fewer than 3 contacts (unless approved by study PI/co-PI/co-I); Judged likely to return to community setting at completion of post-acute care

Exclusion Criteria:

Non-atherogenic cause of stroke
NIHSS > 20
Any medical condition that would limit participation in follow up assessments
Baseline dementia per informant report (AD8) or screening assessment (Short Memory Orientation Concentration Test)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703274

Contacts


Contact: Deeonna Farr, MPH CHES	202-877-1931	Deeonna.E.Farr@medstar.net

Locations


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	Not yet recruiting
	Washington, District of Columbia, United States, 20060
	Contact: Deeonna Farr, MPH CHES 202-877-1931 Deeonna.E.Farr@medstar.net

Sponsors and Collaborators

Georgetown University

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators


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
First Received:	June 20, 2008
Last Updated:	June 25, 2008
ClinicalTrials.gov Identifier:	NCT00703274
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):

ischemic stroke

stroke

cerebrovascular stroke

cerebrovascular accident

CVA

community health services

community health workers

navigators

health education

barriers to care

healthcare access

healthcare disparities

Study placed in the following topic categories:

Cerebral Infarction

Stroke

Vascular Diseases

Central Nervous System Diseases

Ischemia

Brain Diseases

Cerebrovascular Disorders

Recurrence

Additional relevant MeSH terms:

Nervous System Diseases

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 08, 2008

Sponsors and Collaborators:	Georgetown University National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier:	NCT00703274