PREVENTABLE Trial Implementation Phase

可预防的试验实施阶段

• 批准号: 10260222
• 负责人: KAREN P ALEXANDER
• 金额: $ 237.27万
• 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/10260222
• 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; Lead; Leadership; 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; Risk; Role; Safety; Services; Site; Stroke; Testing; Time; Training; United States National Institutes of Health; Validation; Vital Status; Work; adjudication; atorvastatin; base; 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 可预防的(对老年人降脂事件和好处的务实评估)将 确定中等强度他汀类药物对20,000名新发痴呆症患者和无残疾存活率的影响 社区居住的参与者年龄≥为75岁，没有动脉粥样硬化性冠心病或痴呆症。在……里面 此外，我们将测试中等强度的他汀类药物在减少心血管并发症(住院治疗)方面的效果。 心肌梗死/急性冠脉综合征、卒中或心力衰竭、心血管再血管化或心血管死亡)或认知复合体(MCI或痴呆症)。这个 他汀类药物的耐受性将由SAMS-CI、参与者报告和停止研究药物的原因确定。 试验实施核心将由DCRI的Karen Alexander博士和Jeff博士领导 威廉姆森在WFSM。总之，我们的研究团队在务实的审判行为方面拥有丰富的经验， 无缝实施这些方案，在老年人中进行临床试验，并评估认知和 身体机能。可预防的将在试行期间处于有利地位，以登记权利 提供干预措施，并有效和彻底地确定结果。我们将利用 在开发研究工具方面取得广泛和国际公认的成功(CRF、ICF、#年手册 业务、登记材料)、流程(IRB审批、数据传输、生物样品传输)、 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、不良招生缓解计划)。所有这些都必须在研究之前敲定和传播 发动起来。试验实施核心有以下具体目标：目标1.随机选择20,000个社区-- 居住在无痴呆或心血管疾病的活动老年人(≥75岁)，服用阿托伐他汀40 mg或匹配 安慰剂。目标2.以高度的准确性、坚持性和安全性提供干预， 在试验期间停止或恢复研究药物的意外情况。目标3.务实地收集健康信息 通过与EHR、Medicare和NDI的链接，随时间推移参与者的状态，并确定新的 痴呆症、MCI或残疾的发生。