PROTECT DC

保护直流

• 批准号: 7512007
• 负责人: CHELSEA S KIDWELL
• 金额: $ 31.36万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-30 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7512007
• 关键词: African American; Antihypertensive Agents; Behavior; Behavioral; Blood Pressure; Blood Vessels; Caring; Case Management; Cessation of life; Clinical Trials Design; Cognition; Communities; Count; Coupled; Education; Educational Materials; Effectiveness; End Point; Event; Exclusion Criteria; Frequencies; Future; Glycosylated hemoglobin A; Goals; Health Status; Hospitals; Incidence; Intervention; Intervention Studies; Ischemic Stroke; Laboratories; Lead; Lipids; Low-Density Lipoproteins; Measures; Mental Depression; Modification; Patients; Pharmaceutical Preparations; Phase; Phase II Clinical Trials; Phase III Clinical Trials; Prevention education; Prevention strategy; Prophylactic treatment; Quality of life; Race; Randomized; Rate; Recruitment Activity; Recurrence; Risk; Risk Factors; Secondary Prevention; Signal Transduction; Socioeconomic Status; Stroke; Stroke prevention; Training; Underserved Population; University Hospitals; Washington; Work; base; design; diabetic; disability; functional status; health disparity; improved; inner city; mortality; pill; prevent; programs; racial/ethnic difference; response; social; treatment program

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.

血管危险因素控制不足导致健康差异，特别是继发性卒中 预防CRTDC是一项随机II期干预临床试验，旨在确定 以医院为基础启动二级预防战略，并结合社区病例 管理（通过“中风导航器”）可以改善服务不足患者的二级预防措施。 预防血栓栓塞DC改编自卒中预防血栓栓塞（Stroke Preventing Recurrence Of Thromboembolic Events） 通过协调治疗）方案，系统地实施药物/行为 二级预防措施。本提案的总体目标是为未来的III期试验做准备， 联合治疗中心的干预措施：院内教育与社区“卒中导航员”相结合 旨在降低服务不足的中风患者群体的血管事件或死亡率。的 目前提出的II期研究将采用风险因素控制的替代措施，以检测 从治疗DC干预的有效性。两个具体目标是：1）评估生物多样性技术的效果 DC对继发性卒中危险因素控制（抗血栓治疗， 抗高血压治疗、降脂药物和抗糖尿病药物），随机分配至 观察性对照组与随机分配至观察性对照组的受试者，以及2）评估健康状况的贡献 地位、抑郁、认知、社会经济地位、种族等因素对发病障碍的影响， 对研究干预措施的应答率。总共有250个主要是市中心，服务不足，缺血 将从2家DC医院招募卒中患者：霍华德大学医院和华盛顿医院 中心患者将被随机分配至CDRT DC干预（基于医院的二级预防 教育加社区卒中导航员治疗1年）与标准化常规和习惯护理 一年的主要终点是4个药物目标的次要中风风险因素控制， 通过标准化目标实验室值（收缩压、LDL、血红蛋白A1 c）确定，或 抗血小板药物的数量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。DC干预将是 通过审查和调整针对东帝汶、过渡时期和发展中国家的文化敏感教育材料，进一步完善这些材料; 确定可修改和不可修改的具体遵约障碍的频率; 标准化战略，以克服已确定的遵守障碍;完善材料和方案 训练和监督中风导航员。拟议的工作预计将导致第三阶段试验 有足够的把握度来证明BRTDC在减少复发性血管事件方面的有效性 服务不足的人群。