PREVENTABLE Trial Implementation Phase

可预防的试验实施阶段

基本信息

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
项目类别：
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&apos 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

项目摘要

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 - 试验实施可预防的（对老年人降低脂质的事件和降低脂质的好处的务实评估）确定现代强度他汀类药物对20,000的新痴呆症和无残疾生存的影响没有动脉粥样硬化冠心病或痴呆症的社区居民参与者≥75岁。此外，我们还将测试现代强度他汀类药物对减少简历复合材料的影响（住院治疗 MI/ACS，中风或HF，CV血运重建或CV死亡）或认知复合材料（MCI或痴呆症）。这他汀类药物的耐受性将由SAMS-CI，参与者报告以及停止学习药物的理由确定。试验实施核心将在Drs的领导下。 DCRI和Jeff的Karen Alexander Williamson在WFSM。我们的研究团队共同在务实的试验中拥有丰富的经验，协议的无缝实施，老年人的临床试验以及认知和评估身体功能。可以在试用期间可预防的位置，以招募权利人口，提供干预，有效，完全确定结果。我们将利用在研究工具的开发方面广泛而国际公认的成功（CRF，ICF，手册操作，注册材料），过程（IRB批准，数据传输，生物环境转移），通信（培训材料，项目会议）和运营计划（数据监控计划，网站监视计划，减轻入学率计划差）。所有这些都必须在研究前完成和传播启动。试验实施核心具有以下具体目标：目标1。随机分配20,000个社区 - 无痴呆症或CVD居住的卧床老年人（≥75岁）40mg或匹配安慰剂。目标2。以高度的准确性，依从性和安全性提供干预措施基于试验的可能性停止或恢复学习药物的意外事件。目标3。务实地收集健康通过与EHR，Medicare和NDI的联系，参与者的状态随着时间的流逝而确定新的痴呆，MCI或残疾的发生。