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

Sponsor:	Georgetown University
Collaborator:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):	Chelsea Kidwell, M.D., 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:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Preventing Recurrence of Thromboembolic Events Through Coordinated Treatment in the District of Columbia

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking

U.S. FDA Resources

Further study details as provided by Georgetown University:

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:	230
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Navigation Group 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. Other Names: navigator model navigation intervention community health worker intervention
No Intervention: Control Group Participants enrolled in this group will receive periodic follow up through mailings, phone calls etc to ensure availability for 1 year assessment.

Arms

Assigned Interventions

Experimental: Navigation Group

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.

Other Names:

navigator model
navigation intervention
community health worker intervention

No Intervention: Control Group

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 ischemic stroke* event within the past 30 days OR Transient ischemic attack, confirmed by stroke neurologist.
Atherogenic etiology(large vessel, small vessel, cryptogenic with at least one stroke risk factor, or embolic stroke due to atherogenic cardiac disease) as defined by TOAST criteria.
Community dwelling prior to stroke
Resides within the District of Columbia or closely nearby (preferably within 10 miles of the DC border)
Expected to reside within the District of Columbia or closely nearby (preferably within 10 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; and 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 Blessed Memory Orientation Concentration Test)

Contacts and Locations

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

Locations

United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Howard University Hospital
Washington, District of Columbia, United States, 20060
National Rehabilitation Hospital
Washington, District of Columbia, United States, 20010
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Providence Hospital
Washington, District of Columbia, United States, 20017
George Washington University Hospital
Washington, District of Columbia, United States, 20037

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

Publications:

Dromerick AW, Gibbons MC, Edwards DF, Farr DE, Giannetti ML, Sánchez B, Shara NM, Fokar A, Jayam-Trouth A, Ovbiagele B, Kidwell CS. Preventing recurrence of thromboembolic events through coordinated treatment in the District of Columbia. Int J Stroke. 2011 Oct;6(5):454-60.

Responsible Party:	Chelsea Kidwell, M.D., Medical Director, Georgetown University Stroke Center, Georgetown University
ClinicalTrials.gov Identifier:	NCT00703274 History of Changes
Other Study ID Numbers:	U54NS057405, 1U54NS057405-01A1
Study First Received:	June 20, 2008
Last Updated:	January 11, 2012
Health Authority:	United States: Federal Government

Keywords provided by Georgetown University:

ischemic stroke
stroke
cerebrovascular stroke
cerebrovascular accident
CVA
community health services

community health workers
navigators
health education
barriers to care
healthcare access
healthcare disparities

Additional relevant MeSH terms:

Recurrence
Stroke
Thromboembolism
Embolism
Disease Attributes
Pathologic Processes
Cerebrovascular Disorders

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Embolism and Thrombosis
Thrombosis

ClinicalTrials.gov processed this record on February 12, 2012