PROTECT DC

对血管危险因素的不充分控制导致健康差异，特别是在继发性中风中 预防。PROTECT DC是一项随机的II期干预临床试验，旨在确定 以医院为基础启动二级预防策略，并结合社区病例 管理(通过“卒中导航仪”)可以改善缺乏服务的患者的二级预防措施。 保护DC改编自卒中保护(防止血栓栓塞症事件的复发 通过协调治疗)计划，该计划系统地实施药物/行为 二级预防措施。这项建议的总体目标是为未来的第三阶段试验做准备 保护性DC干预：院内教育结合社区“卒中导航员” 旨在降低服务不足的中风患者的血管事件或死亡率。这个 目前拟议的第二阶段研究将使用风险因素控制的替代措施来检测 保护性DC干预的效果。这两个具体目标是：1)评估保护的效果 DC对继发性中风危险因素控制的四个客观标记物(抗血栓治疗， 降压治疗、降脂药物和抗糖尿病药物)的患者随机分为 保护DC与那些随机进行观察对照的DC，以及2)评估健康的贡献 地位、抑郁、认知、社会经济地位、种族和其他因素对障碍和 对研究干预措施的响应率。总共有250个主要是市中心的，服务不足，缺血 中风患者将从两家DC医院招募：霍华德大学医院和华盛顿医院 中心。患者将随机接受保护性DC干预(基于医院的二级预防 教育加上为期一年的社区中风导航员)与标准化的日常和常规护理 一年的时间。主要终点是4个用药目标的次级卒中风险因素控制，如下 由实验室目标值(收缩压、低密度脂蛋白、血红蛋白A1c)正常化或 抗血小板目标的药片计数。次要终点包括血管事件发生率、功能状态 以及各种残疾、生活质量和社会参与措施。保护DC干预将是 通过审查和调整保护哥伦比亚特区的具有文化敏感性的教育材料，进一步完善； 确定可修改和不可修改的合规特定障碍的频率；改进和 标准化战略，以克服已确定的合规障碍；以及改进材料和计划 培训和监督划船领航员。拟议的工作预计将导致第三阶段试验 电源充足，可证明保护DC在减少血管事件复发方面的有效性 在服务不足的人群中的比率。

Inadequate control of vascular risk factors contributes to health disparities, particularly in secondary stroke prevention. PROTECT DC is a randomized phase II intervention clinical trial designed to determine whether hospital-based initiation of secondary prevention strategies coupled with community-based case management (via "stroke navigators") can improve secondary prevention measures in underserved patients. PROTECT DC is adapted from the Stroke PROTECT (Preventing Recurrence Of Thromboembolic Events through Coordinated Treatment) program, which systematically implements medication/behavioral secondary prevention measures. The general aim of this proposal is to prepare for a future Phase III trial of the PROTECT DC intervention: an in-hospital education coupled with community-based "stroke navigators" designed to reduce the rate of vascular events or death in a population of underserved stroke patients. The current proposed phase II study will employ surrogate measures of risk factor control to detect a signal of efficacy from the PROTECT DC intervention. The two specific aims are to: 1) assess the effect of PROTECT DC on four objective markers of secondary stroke risk factor control (antithrombotic therapy, antihypertensive therapy, lipid-lowering medication, and anti-diabetic medication) in patients randomized to PROTECT DC vs. those randomized to ah observational control, and 2) assess the contribution of health status, depression, cognition, socio-economic status, race and other factors to the incidence of barriers and the rate of response to the study interventions. A total of 250 primarily inner-city, underserved, ischemic stroke patients will be recruited from 2 DC hospitals: Howard University Hospital and Washington Hospital Center. Patients will be randomized to the PROTECT DC intervention (hospital based secondary prevention education plus community-based stroke navigators for one year) vs. standardized usual and customary care for one year. The primary endpoint is secondary stroke risk factor control for the 4 medication goals as determined by normalization of target laboratory values (systolic blood pressure, LDL, Hemoglobin A1c) or pill count for the antiplatelet goal. Secondary endpoints include rates of vascular events, functional status and a variety of disability, quality of life, and social participation measures. PROTECT DC intervention will be further refined by reviewing and adapting culturally sensitive educational materials for PROTECT DC; determining the frequency of modifiable and non-modifiable specific barriers to compliance; refining and standardizing strategies to overcome identified barriers to compliance; and refining materials and programs to train and supervise stroke navigators. The work proposed is expected to lead to a Phase III trial adequately powered to demonstrate the effectiveness of PROTECT DC in reducing recurrent vascular event rates in underserved populations.