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

Stroke Clinical Trial

— PROTECT DC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00703274
• Other study ID #: U54NS057405
• Secondary ID: 1U54NS057405-01A
• Status: Completed
• Phase: Phase 2
• First received: June 20, 2008
• Last updated: February 20, 2013
• Start date: April 2008
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Stroke
• Thromboembolism

Intervention

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.

Locations

Country	Name	City	State
United States	George Washington University Hospital	Washington	District of Columbia
United States	Georgetown University Hospital	Washington	District of Columbia
United States	Howard University Hospital	Washington	District of Columbia
United States	National Rehabilitation Hospital	Washington	District of Columbia
United States	Providence Hospital	Washington	District of Columbia
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. doi: 10.1111/j.1747-4949.2011.00654.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low Density Lipoprotein Value		1 year	No
Primary	Systolic Blood Pressure Value		1 year	No
Primary	Hemoglobin A1C Value		1 year	No
Primary	Pill count of antiplatelet therapy medications		1 year	No
Secondary	Smoking Cessation Status		1 year	No
Secondary	AHA Diet Status		1 year	No
Secondary	Exercise Status		1 year	No
Secondary	Stroke Knowledge Level		1 year	No