RCT of an Intervention to Enable Stroke Survivors in Los Angeles County Hospitals to "Stay Within the Guidelines" (SUSTAIN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 410
- 试验地点
- 10
- 主要终点
- Blood Pressure
研究概览
简要总结
The purpose of this study is to test a newly developed outpatient care intervention called SUSTAIN (Systematic Use of Stroke Averting Interventions) for improving delivery of stroke preventive services at Los Angeles County hospitals and to measure the costs of running such an intervention.
详细描述
Patients randomized to SUSTAIN will participate in group clinics about stroke, given self-management tools about stroke, and will be called by nurse practitioners to coordinate their stroke care. Patients randomized to the control arm will be mailed educational materials about stroke. Subjects in either arm are eligible to receive their usual source of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (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
- •Patients of LAC+USC, Rancho Los Amigos, Olive View-UCLA, or Harbor-UCLA
- •Patients who have had an acute transient ischemic attack (TIA) or ischemic stroke or carotid procedure within the last six months
- •English or Spanish speaking
- •At least 40 years of age
- •Capable of giving informed consent (no proxies will be used to obtain consent)
- •Blood pressure not optimally controlled (>120/80, at least 72 hours post-stroke)
排除标准
- •Age 39 years or younger
- •Hemorrhagic stroke
- •Patients with severe global disability which would preclude him/her from participating in group clinics
- •Patients with advanced dementia
研究组 & 干预措施
1: Care management
干预措施: Care Management (Behavioral)
2: Written Materials
干预措施: Written Materials (Behavioral)
结局指标
主要结局
Blood Pressure
时间窗: 12 months
Blood pressure at 12 months will be the primary outcome. Blood pressure will also be measured at baseline and at the 3-month mark to track blood pressure during the entire participation period.
次要结局
- Lipid levels(12 month)
- Medication Adherence(8 months)
研究者
Barbara Vickrey, MD, MPH
Principal Investigator
University of California, Los Angeles