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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00703274
Acronym
PROTECT DC
Enrollment
230
Registered
2008-06-23
Start date
2008-04-30
Completion date
2013-01-31
Last updated
2013-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

ischemic stroke, stroke, cerebrovascular stroke, cerebrovascular accident, CVA, community health services, community health workers, navigators, health education, barriers to care, healthcare access, healthcare disparities

Brief summary

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.

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.

Interventions

BEHAVIORALPROTECT 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.

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
Georgetown University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Pill count of antiplatelet therapy medications1 year
Low Density Lipoprotein Value1 year
Systolic Blood Pressure Value1 year
Hemoglobin A1C Value1 year

Secondary

MeasureTime frame
Smoking Cessation Status1 year
AHA Diet Status1 year
Exercise Status1 year
Stroke Knowledge Level1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026