Preventing Recurrence of Thromboembolic Events Through Coordinated Treatment in the District of Columbia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 12
- 主要终点
- Hemoglobin A1C Value
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
Hemoglobin A1C Value
时间窗: 1 year
Low Density Lipoprotein Value
时间窗: 1 year
Systolic Blood Pressure Value
时间窗: 1 year
Pill count of antiplatelet therapy medications
时间窗: 1 year
次要结局
- Smoking Cessation Status(1 year)
- AHA Diet Status(1 year)
- Exercise Status(1 year)
- Stroke Knowledge Level(1 year)
研究者
Chelsea Kidwell, M.D.
Medical Director, Georgetown University Stroke Center
Georgetown University