Preventing Recurrence of Thromboembolic Events Through Coordinated Treatment in the District of Columbia (PROTECT DC)

Georgetown University

Status and phase: Completed; Phase 2

Conditions: Stroke

Treatments: Behavioral: PROTECT DC

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00703274

1U54NS057405-01A1 (U.S. NIH Grant/Contract)

U54NS057405

Details and patient eligibility

About

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.

Full 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.

Enrollment: 230 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

Navigation Group

Experimental group

Description:

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.

Treatment:

Behavioral: PROTECT DC

Control Group

No Intervention group

Description:

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