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

This study is currently recruiting participants.
Study NCT00703274.   Last updated on June 25, 2008.   Information provided by National Institute of Neurological Disorders and Stroke (NINDS)

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Descriptive Information Fields
Brief Title  Preventing Recurrence of Thromboembolic Events Through Coordinated Treatment in the District of Columbia
Official Title  Preventing Recurrence of Thromboembolic Events Through Coordinated Treatment in the District of Columbia
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 Phase Phase II
Study Type  Interventional
Study Design  Supportive Care, Randomized, Open Label, Parallel Assignment
Primary Outcome Measure  Low Density Lipoprotein Value [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Systolic Blood Pressure Value [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Hemoglobin A1C Value [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Pill count of antiplatelet therapy medications [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Smoking Cessation Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
AHA Diet Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Exercise Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Stroke Knowledge Level [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Condition  Stroke
Intervention  Behavioral: PROTECT DC
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  250
Start Date  April 2008
Completion Date February 2012
Eligibility Criteria 

Inclusion Criteria:

  • Age ≥ 18 years
  • Hospitalized due to ischemic stroke* or intercurrent stroke* event within the past 30 days (see stroke subtype form)
  • Atherogenic etiology, large or small vessel etiology as defined by TOAST criteria (see stroke subtype form)
  • Community dwelling prior to stroke
  • Resides within the District of Columbia or closely nearby (preferably within 5 miles of the DC border)
  • Expected to reside within the District of Columbia or closely nearby (preferably within 5 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; 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 Memory Orientation Concentration Test)
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Deeonna Farr, MPH CHES     202-877-1931     Deeonna.E.Farr@medstar.net    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00703274
Organization ID U54NS057405
Secondary IDs †† 1U54NS057405-01A1
Study Sponsor  Georgetown University
Collaborators †† National Institute of Neurological Disorders and Stroke (NINDS)
Investigators 
Principal Investigator:     Alexander Dromerick, MD     National Rehabilitation Hospital, Georgetown University    
Principal Investigator:     Chelsea S. Kidwell, MD     Washington Hospital Center, National Rehabilitation Hospital, Georgetown University    
Information Provided By National Institute of Neurological Disorders and Stroke (NINDS)
Verification Date June 2008
First Received Date  June 20, 2008
Last Updated Date June 25, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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