Preventing Recurrence of Thromboembolic Events Through Coordinated Treatment in the District of Columbia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PROTECT DC

Intervention Type BEHAVIORAL

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

Participants enrolled in this group will receive periodic follow up through mailings, phone calls etc to ensure availability for 1 year assessment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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navigator model navigation intervention community health worker intervention

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Chelsea Kidwell, M.D.

Medical Director, Georgetown University Stroke Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexander Dromerick, MD

Role: PRINCIPAL_INVESTIGATOR

National Rehabilitation Hospital, Georgetown University

Chelsea S. Kidwell, MD

Role: PRINCIPAL_INVESTIGATOR

Washington Hospital Center, National Rehabilitation Hospital, Georgetown University

Locations

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