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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. |
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| 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. |
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| 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 ] |
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| 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 ] |
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| 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:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| 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 † |
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| 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 | ||||||||