Preventing Recurrence of All Inner-city Strokes Through Education
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Blood Pressure
研究概览
简要总结
The purpose of this study is to evaluate if a peer-led stroke recurrence prevention intervention, versus usual care, will help reduce risk factors for recurrent strokes among adults in Harlem.
详细描述
Twenty nine percent of the 700,000 strokes that occur yearly nationwide are among stroke survivors. Blacks, both nationally and among Harlem residents, have a twofold increase in recurrent strokes. Harlem Latinos have a threefold increase in risk relative to Whites.
Primary risk factors for recurrent stroke include hypertension, hyperlipidemia, and under use of anti-thrombotic agents. Controlling risk factors can be particularly challenging for low-income, minority populations who lack the resources needed to adhere to necessary therapies. In Harlem, 72% of adults studied six months post stroke did not have these three risk factors treated adequately.
We propose to determine if participation in a recurrent stroke prevention educational intervention, versus usual care, can activated stroke survivors to at reduce primary risk factors for recurrent strokes while providing an effective, low-cost, sustainable recurrent stroke prevention program in neighborhoods like Harlem, whose residents bear a disproportionate burden of suffering from strokes. Specifically, we propose:
- Recruit 600 adults who sustained a stroke or transient ischemic attack (TIA) within the past five years by working with Harlem community leaders, local clinical sites including the Mount Sinai Medical Center and the Institute for Family Health, and the Visiting Nurse Service of New York;
- To conduct a randomized, controlled trial to determine if participation in a peer-led stroke prevention program activates stroke and TIA survivors to improve their knowledge and self-management strategies and treatments related to stroke prevention; and
- To rigorously compare the impact of the intervention with usual care (delayed intervention), on increasing the proportion of individuals with strokes and TIAs who are appropriately treated to reduce the risk of recurrent events, specifically through control of hypertension (blood pressure ≤ 140/90mmHg), hyperlipidemia (LDL cholesterol≤100 mg/dl) and use of anti-thrombotic medicines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Had a stroke or TIA diagnosed within 5 years
- •40 years of age or older
- •Able to participate in group education classes
- •English or Spanish speaking
- •Community dwelling
排除标准
- •No incidence of stroke or TIA
- •Stroke or TIA occurred more than 5 years ago
- •less than 40 years of age
- •Cognitive or physical impairment that would preclude comprehension of a conversation and communicating as part of a group (i.e., dementia, deafness, inability to speak, aphasia)
- •Self-reported terminal illness with life expectancy of less than 1 year
- •Plans to relocate from New York City within one year of enrollment
- •Nursing home resident
研究组 & 干预措施
Peer-Led Stroke Recurrence Prevention Education
The intervention group will participate in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aims to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.
干预措施: Prevent Return of Stroke (Behavioral)
Usual Care (Delayed Intervention)
The control group will be offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.
干预措施: Prevent Return of Stroke (Behavioral)
结局指标
主要结局
Blood Pressure
时间窗: 6 months post enrollment into trial
Percentage of Participants with Blood Pressure controlled at \<140/90 mm Hg
LDL Cholesterol
时间窗: 6 months post enrollment into trial
Percentage of participants with controlled Low Density Lipoprotein low (LDL) of less than 100 mg/dL
Use of Anti-thrombotic Medication
时间窗: 6 months post enrollment into trial
Number of participants taking anti-thrombotic medication
次要结局
- Knowledge and Attitudes About Stroke Recurrence Risk(6 months post enrollment into trial)
- Medication Adherence(6 months post enrollment into trial)
- Emotional Health(6 months post enrollment into trial)
- Access to Medical Care(6 months post enrollment into trial)
