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

Phase 2

Completed

• Conditions: Stroke

• Registration Number: NCT00703274
• Lead Sponsor: Georgetown University

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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-06-20
• Study First Submitted QC: 2008-06-20
• Study First Posted: 2008-06-23
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1C Value	1 year
Low Density Lipoprotein Value	1 year
Systolic Blood Pressure Value	1 year
Pill count of antiplatelet therapy medications	1 year

Secondary Outcome Measures

Name	Time	Method
Smoking Cessation Status	1 year
AHA Diet Status	1 year
Exercise Status	1 year
Stroke Knowledge Level	1 year

Trial Locations

Locations (6)

Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States

National Rehabilitation Hospital; 🇺🇸 Washington, District of Columbia, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Providence Hospital; 🇺🇸 Washington, District of Columbia, United States

George Washington University Hospital; 🇺🇸 Washington, District of Columbia, United States

Howard University Hospital; 🇺🇸 Washington, District of Columbia, United States