PREVENTABLE Trial Implementation Phase

可预防的试验实施阶段

• 批准号: 10697317
• 负责人: KAREN P ALEXANDER
• 金额: $ 223.89万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10697317
• 关键词: Adherence; Age; Algorithms; Alzheimer' s Disease; Attention; Capsicum; Cardiovascular system; Cessation of life; Clinical; Clinical Research; Clinical Trials; Cognition; Cognitive; Collection; Communication; Communities; Coronary heart disease; Data; Dementia; Development; Disease; Doctor of Philosophy; Elderly; Electronic Health Record; Enrollment; Evaluation; Event; Faculty; Fee-for-Service Plans; Geriatric Assessment; Geriatrics; Gerontology; Hawthorne Effect; Health Status; Health Technology; Heart failure; Hospitalization; Impaired cognition; Impairment; Institutional Review Boards; International; Intervention; Leadership; Life; Lipids; Manuals; Medicare; Monitor; Needs Assessment; Neurocognitive; Outcome; Outcome Assessment; Participant; Persons; Pharmaceutical Preparations; Phase; Physical Function; Placebos; Population; Positioning Attribute; Principal Investigator; Procedures; Process; Protocols documentation; Psychiatry; Quality Control; Randomized; Reporting; Research; Research Institute; Research Personnel; Risk; Role; Safety; Services; Site; Stroke; Testing; Time; Training; United States National Institutes of Health; Validation; Vascularization; Vital Status; Work; adjudication; atorvastatin; biobank; cognitive function; cognitive testing; data exchange; design; disability; experience; forest; indexing; medical schools; meetings; member; operation; participant safety; performance site; pragmatic trial; primary outcome; professor; recruit; safety assessment; secondary outcome; skills; success; tool

ABSTRACT - Trial Implementation PREVENTABLE (PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults) will determine the effect of a moderate intensity statin on new dementia and disability-free survival in 20,000 community-dwelling participants age ≥75 years without atherosclerotic coronary heart disease or dementia. In addition, we will test the effect of a moderate intensity statin on reducing the CV composite (Hospitalization for MI/ACS, Stroke, or HF, CV revascularization or CV death) or the cognitive composite (MCI or dementia). The tolerability of statins will be determined by SAMS-CI, participant-report, and reason for stopping study drug. The Trial Implementation core will be under the leadership of Drs. Karen Alexander at DCRI and Jeff Williamson at WFSM. Together, our research team has substantial experience in pragmatic trial conduct, seamless implementation of the protocols, clinical trials in older adults, and assessment of cognitive and physical function. PREVENTABLE will be well positioned during trial implementation to enroll the right population, deliver the intervention, and efficiently and completely ascertain outcomes. We will draw on extensive and internationally recognized success in the development of study tools (CRF, ICF, manual of operations, enrollment materials), processes (IRB approval, data transfer, biospecimen transfer), communications (training materials, project meetings) and operational plans (data monitoring plan, site monitoring plan, poor enrollment mitigation plans). All of these must be finalized and disseminated before study start up. The Trial Implementation Core has the following specific aims: AIM 1. Randomize 20,000 community- dwelling ambulatory older adults (≥ 75 years) without dementia or CVD to atorvastatin 40mg or matching placebo. AIM 2. Deliver the intervention with a high degree of accuracy, adherence, and safety, with contingencies for stopping or resuming study drug based over the trial. AIM 3. Pragmatically collect health status of participants over time through linkage with EHR, Medicare, and NDI, and determine the new occurrence of dementia, MCI, or disability.

摘要-试行 可预防性（对老年人降脂事件和益处的评估）将 确定中等强度他汀类药物对20，000例新发痴呆和无残疾生存率的影响 年龄≥75岁、无动脉粥样硬化性冠心病或痴呆的社区居住受试者。在 此外，我们将测试中等强度他汀类药物对降低CV复合终点的影响（ MI/ACS、卒中或HF、CV血运重建或CV死亡）或认知复合终点（MCI或痴呆）。的 他汀类药物的耐受性将通过SAMS-CI、参与者报告和停止研究药物的原因来确定。 试验实施核心将由DCRI的Karen亚历山大博士和Jeff WFSM的威廉姆森。总之，我们的研究团队在实际的试验实施方面拥有丰富的经验， 方案的无缝实施，老年人的临床试验，以及认知和 物理功能。在试验实施期间，可预防将处于有利地位， 人口，提供干预措施，并有效和完全确定结果。我们将借鉴 在开发研究工具（通用报告格式、知情同意书、 操作、入组材料）、流程（IRB批准、数据传输、生物样本传输）， 通信（培训材料、项目会议）和业务计划（数据监测计划、现场 监测计划、不良入组缓解计划）。所有这些都必须在研究之前定稿和分发 启动。试行核心有以下具体目标：目标1。随机抽取2万个社区- 无痴呆或CVD的居家非卧床老年人（≥ 75岁）接受阿托伐他汀40 mg或匹配治疗 安慰剂AIM 2.以高度的准确性、依从性和安全性提供干预， 基于试验期间停用或恢复研究药物的意外事件。AIM 3.务实集健康 通过与EHR，Medicare和NDI的联系，随着时间的推移参与者的状态，并确定新的 发生痴呆、MCI或残疾。