Preventing Cognitive Decline by Reducing BP Target Trial (PCOT)

通过降低血压目标试验 (PCOT) 预防认知能力下降

基本信息

批准号：
10452795
负责人：
MIGUEL A VAZQUEZ
金额：
$ 124.19万
依托单位：
UT SOUTHWESTERN MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-01 至 2025-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10452795
关键词：
Acute Renal Failure with Renal Papillary Necrosis Age-Years Cardiovascular system Caring Cessation of life Chronic Chronic Kidney Failure Clinical Cognitive Communities Dementia Development Diabetes Mellitus Drug Combinations Effectiveness Elderly Electrolytes Emergency department visit Enrollment Event Evidence based intervention Fracture Future Goals Guidelines Health system Healthcare Systems Home Home Blood Pressure Monitoring Hospitalization Hypertension Hypotension Impaired cognition Incidence Intervention Intervention Trial Measures Medical Meta-Analysis Modeling Monitor Outcome Participant Patients Pharmaceutical Preparations Pharmacists Population Heterogeneity Pragmatic clinical trial Primary Health Care Professional Organizations Quality of life Randomized Sample Size Syncope Testing Titrations United States National Institutes of Health adjudication base blood pressure reduction blood pressure regulation clinical decision support clinical practice cognitive development cognitive testing collaboratory design effectiveness implementation study evidence base falls global health hazard inclusion criteria insight instrument mild cognitive impairment patient subsets pragmatic trial prevent primary care setting primary outcome recruit research clinical testing secondary outcome socioeconomics systems research treatment as usual usual care arm

项目摘要

SPRINT, and its accompanying cognitive-focused substudy SPRINT-MIND recently showed that blood pressure control (goal SBP<120 mm Hg) reduced incident mild cognitive impairment as well as a combined outcome of MCI and dementia. Divergence in opinion among experts and professional societies about BP goals still remain due to the concerns of potential harms. There is a clear need to implement new practical approaches to control blood pressure in clinical practice and test their effectiveness. Pragmatic clinical trials embedded in health systems (ePCTs) offer a unique opportunity to study the effectiveness of implementation of evidence- based interventions in real-world clinical settings. Our team is currently conducting ICD-Pieces (NCT02587936), the largest ePCT in patients with the coexistent chronic conditions of chronic kidney disease, hypertension and diabetes as part of a demonstration project in the NIH Health Care Systems Research Collaboratory. We now propose the Preventing Cognitive Decline by Reducing BP Target Trial (PCOT), to examine the effects of lowering BP to less than 130/80 upon the incidence of cognitive decline. Our main hypothesis is that patients who receive care with a collaboratory model that combines clinical decision support applied to home BPs and team-based care delivered in primary care practices will have better blood pressure control and a lower incidence of mild cognitive impairment and dementia than patients receiving usual medical care. In this ePCT (1) Will compare the effects of intensive BP control between the intervention and usual care arm on the rate of cognitive decline measuring the change in TICS-m per year. We will recruit 4,000 patients over 70 years of age with BP >130/80 mmHg from 2 diverse health systems and randomize patients within each health system to usual care or to a combination of care with clinical decision support using home BPs and practice facilitators and Pharm Ds to lower home BP to < 130/80 mmHg. The primary outcome will be development cognitive decline as determined by a decrease in TICS-m scores from baseline; (2) Determine the potential harms of intensive lowering BP home BP below 130/80 mmHg with usual care on hospitalizations, emergency department visits, cardiovascular events, deaths, syncope, falls, fractures, hypotension, electrolyte abnormalities and acute kidney injury and; (3) Determine the impact of intensive BP management on QOL with scores obtained using the PROMIS Scale v1.2 - Global Health instrument annually This trial is pragmatic, with broad inclusion criteria and evidence-based interventions informed by patients and delivered in primary care settings by the clinical teams in health systems serving ethnically and socioeconomically diverse population. Lessons from this trial should provide valuable insights to guide clinical practices in BP control and cognitive assessments in real-world settings as well as design and implementation of future pragmatic trials. 1

Sprint及其伴随的认知性质Sprint-Mind最近表明，血压控制（目标SBP <120 mM Hg）降低了入射轻度认知障碍，以及MCI和痴呆症的综合结果。专家和专业社会对BP目标的看法差异仍然是由于对潜在危害的关注。显然需要实施新的实用方法来控制临床实践中的血压并测试其有效性。嵌入卫生系统（EPCT）的实用临床试验为研究实施基于证据的干预措施在现实世界临床环境中实施的有效性提供了独特的机会。目前，我们的团队正在进行ICD件（NCT02587936），这是NIH Health Carey System Systems Research合作示威项目的一部分，患有慢性肾脏疾病，高血压和糖尿病的慢性慢性病患者的EPCT。现在，我们建议通过减少BP目标试验（PCOT）来预防认知能力下降，以检查将BP降低至小于130/80的影响。我们的主要假设是，通过合作模型获得护理的患者，该模型结合了应用于家庭BPS的临床决策支持和在初级保健实践中提供的基于团队的护理，将具有更好的血压控制和轻度认知障碍和痴呆症的发病率，而不是接受常规医疗保健的患者。在此EPCT（1）中，将比较干预和通常的护理部门之间强化BP控制的影响对测量每年TICS-M的变化的认知下降速度。我们将从2种不同的卫生系统中招募4,000名70岁以上的BP> 130/80 mmHg，并将每个卫生系统中的患者随机化为通常的护理，或者使用家庭BPS和练习促进者和Pharm DS的临床决策支持与临床决策支持，以将BP降低到<130/80 mmHg。主要结果将是发展的认知下降，这取决于基线的TICS-M分数下降。（2）确定强化降低BP家庭BP以下的潜在危害低于130/80 mmHg，并在住院治疗，急诊就诊，心血管事件，死亡，晕厥，跌倒，骨折，低血压，电解质异常和急性肾脏受伤以及；（3）确定强化BP管理对QOL的影响，并使用Promis量表v1.2-每年获得全球健康工具获得的分数该试验是务实的，具有广泛的纳入标准和基于证据的干预措施，由患者告知，并由临床团队在卫生系统的初级保健环境中提供，这些卫生系统为种族和社会经济多样化的人群提供服务。该试验的经验教训应提供有价值的见解，以指导现实环境中的BP控制和认知评估的临床实践，以及未来务实试验的设计和实施。 1