Preventing Recurrence of Thromboembolic Events Through Coordinated Treatment in the District of Columbia
PROTECT DC
2 other identifiers
interventional
230
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 stroke
Started Apr 2008
Longer than P75 for phase_2 stroke
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 20, 2008
CompletedFirst Posted
Study publicly available on registry
June 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFebruary 21, 2013
February 1, 2013
4.8 years
June 20, 2008
February 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Low Density Lipoprotein Value
1 year
Systolic Blood Pressure Value
1 year
Hemoglobin A1C Value
1 year
Pill count of antiplatelet therapy medications
1 year
Secondary Outcomes (4)
Smoking Cessation Status
1 year
AHA Diet Status
1 year
Exercise Status
1 year
Stroke Knowledge Level
1 year
Study Arms (2)
Navigation Group
EXPERIMENTALParticipants 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.
Control Group
NO INTERVENTIONParticipants enrolled in this group will receive periodic follow up through mailings, phone calls etc to ensure availability for 1 year assessment.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
National Rehabilitation Hospital
Washington D.C., District of Columbia, 20010, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Providence Hospital
Washington D.C., District of Columbia, 20017, United States
George Washington University Hospital
Washington D.C., District of Columbia, 20037, United States
Howard University Hospital
Washington D.C., District of Columbia, 20060, United States
Related Publications (1)
Dromerick AW, Gibbons MC, Edwards DF, Farr DE, Giannetti ML, Sanchez 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.
PMID: 21951411BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Dromerick, MD
National Rehabilitation Hospital, Georgetown University
- PRINCIPAL INVESTIGATOR
Chelsea S. Kidwell, MD
Washington Hospital Center, National Rehabilitation Hospital, Georgetown University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director, Georgetown University Stroke Center
Study Record Dates
First Submitted
June 20, 2008
First Posted
June 23, 2008
Study Start
April 1, 2008
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
February 21, 2013
Record last verified: 2013-02