Clinical trial NCT00703274: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2008-06-23
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Low Density Lipoprotein Value
timeFrame: 1 year
measure: Systolic Blood Pressure Value
timeFrame: 1 year
measure: Hemoglobin A1C Value
timeFrame: 1 year
measure: Pill count of antiplatelet therapy medications
timeFrame: 1 year
Secondary outcomes:
measure: Smoking Cessation Status
timeFrame: 1 year
measure: AHA Diet Status
timeFrame: 1 year
measure: Exercise Status
timeFrame: 1 year
measure: Stroke Knowledge Level
timeFrame: 1 year
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Washington
country: United States
facility: National Rehabilitation Hospital
state: District of Columbia
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Washington
country: United States
facility: Providence Hospital
state: District of Columbia
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
city: Washington
country: United States
facility: Howard University Hospital
state: District of Columbia
Study officials:
affiliation: National Rehabilitation Hospital, Georgetown University
name: Alexander Dromerick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington Hospital Center, National Rehabilitation Hospital, Georgetown University
name: Chelsea S. Kidwell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.