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Completed

NCT Number: NCT00703274

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

George Washington University Hospital, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PROTECT DC

Behavioral

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.

Other names: navigator model, navigation intervention, community health worker intervention

Primary outcomes

  1. Low Density Lipoprotein Value

    Time frame: 1 year

  2. Systolic Blood Pressure Value

    Time frame: 1 year

  3. Hemoglobin A1C Value

    Time frame: 1 year

  4. Pill count of antiplatelet therapy medications

    Time frame: 1 year

Secondary outcomes

  1. Smoking Cessation Status

    Time frame: 1 year

  2. AHA Diet Status

    Time frame: 1 year

  3. Exercise Status

    Time frame: 1 year

  4. Stroke Knowledge Level

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Acronym: PROTECT DC

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jun 23, 2008
Registry last updated
Feb 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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