Home Blood Pressure Outcomes Evaluation Study (HOMESTEAD)

家庭血压结果评估研究 (HOMESTEAD)

基本信息

批准号：
10364199
负责人：
Paul Englund Drawz
金额：
$ 49.43万
依托单位：
UNIVERSITY OF MINNESOTA
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-06-01 至 2026-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10364199
关键词：
Acute Renal Failure with Renal Papillary Necrosis Address Adherence Adult Adverse event Advisory Committees Age American American Heart Association Antihypertensive Agents Blood Pressure Cardiology Cardiovascular system Caring Case Management Case Manager Cessation of life Characteristics Chronic Disease Clinic Clinical Clinical Trials Country Data Diagnosis Disease Management Effectiveness Electrolytes Enrollment Ethnic Origin Evaluation Studies Event Goals Guidelines Home Home Blood Pressure Monitoring Hypertension Individual Knowledge Link Measurement Measures Methods Morbidity - disease rate Nephrology Observational Study Outcome Patient Selection Patients Persons Pharmaceutical Preparations Population Heterogeneity Preventive service Provider Race Randomized Controlled Trials Recommendation Reporting Risk Risk Factors Site Socioeconomic Status Subgroup Time United States Variant Veterans adverse event risk adverse outcome base blood pressure medication blood pressure reduction clinical practice clinical risk cohort college comorbidity design effectiveness evaluation hypertension control implementation strategy improved medication compliance mortality programs routine practice sex telehealth

项目摘要

PROJECT ABSTRACT Over 100 million US adults have hypertension, the number one chronic disease risk factor in the world. The United States Preventive Services Task Force and the 2017 American College of Cardiology/American Heart Association blood pressure (BP) guidelines recommends measuring BP outside of the clinic for the diagnosis and management of hypertension. Home blood pressure monitoring (HBPM) involves self-measurement of BP by the patient and is the most common method for assessing out-of-office BP in the US. The guideline recommendations are based on high-quality observational studies in which out-of-office BP was typically obtained at a single point and individuals with high out-of-office BP were observed to have higher rates of cardiovascular outcomes and increased rates of all-cause mortality, regardless of office BP levels. Additionally, clinical trials have demonstrated that HBPM reduces clinic BP over short 6-12 month time frames, especially when combined with disease management programs. There are no studies evaluating the effectiveness of HBPM in routine clinical practice in a diverse population from across the country. Additionally, there are a lack of data on: a) whether use of HBPM reduces risk for clinical outcomes; b) the impact of HBPM on both short- and long-term clinic BP, clinical inertia, and medication adherence in routine clinical practice; and c) how clinicians and patients utilize HBPM. Over the last ~10 years, approximately 400,000 Veterans have measured home BPs as part of the VA’s telehealth program. We propose to identify Veterans age 18-90 years with uncontrolled clinic BP enrolled in HBPM programs and a cohort of Veterans not enrolled in HBPM programs. We will link telehealth data to clinical and outcome data. The proposal will make use of the large number of patients enrolled in the VA’s HBPM program and the variation in how the HBPM program is implemented across VA sites. In Aim 1, we will evaluate the effect of HBPM on major adverse cardiovascular events, non- cancer mortality, and adverse events. In Aim 2, we will assess the impact of HBPM on clinic BP, BP medication intensification, and medication adherence. In Aim 3, we will determine facility-, provider-, and patient-level factors associated with use of HBPM in routine practice. Results will establish a) the long-term benefits of HBPM, b) the association between HBPM and clinical events, and c) the effects in important subgroups. These findings will inform selection of patients for and the design of a much-needed randomized controlled trial evaluating the effect of HBPM on clinical outcomes compared to office-based hypertension management. Additionally, identifying factors associated with greater reductions in BP and greater number of home BP values transmitted, such as case management programs, may identify barriers to adherence that can be addressed and inform implementation strategies and the use of HBPM in clinical practice. The proposed study will answer questions critically important to implementation of HBPM in routine clinical practice with the ultimate goal of reducing the morbidity and mortality associated with hypertension.

项目摘要超过 1 亿美国成年人患有高血压，这是世界上排名第一的慢性病危险因素。美国预防服务工作组和 2017 年美国心脏病学会/American Heart 协会血压 (BP) 指南建议在诊所外测量血压以进行诊断家庭血压监测（HBPM）涉及自我测量血压。由患者自行测量，是美国评估诊室外血压的最常用方法。建议基于高质量的观察性研究，其中诊室外血压通常是在单点获得的结果，观察到诊室外血压高的个体的发生率较高心血管结局和全因死亡率增加，无论诊室血压水平如何。临床试验表明，HBPM 在短短 6-12 个月的时间内降低了诊所血压，尤其是没有研究评估与疾病管理计划相结合的有效性。此外，HBPM 在全国各地不同人群的常规临床实践中也存在缺乏。有关以下方面的数据：a) HBPM 的使用是否会降低临床结果的风险；b) HBPM 对短期和长期的影响；以及常规临床实践中的长期临床血压、临床惰性和药物依从性；以及 c) 如何进行；法医和患者使用 HBPM 在过去约 10 年中，大约 400,000 名退伍军人进行了测量。作为 VA 远程医疗计划的一部分，我们建议确定 18-90 岁的退伍军人。参加 HBPM 计划的不受控制的诊所 BP 和一群未参加 HBPM 计划的退伍军人。我们将把远程医疗数据与临床和结果数据联系起来。该提案将利用大量数据。参加 VA HBPM 计划的患者以及 HBPM 计划实施方式的变化在目标 1 中，我们将评估 HBPM 对主要不良心血管事件（非）的影响。在目标 2 中，我们将评估 HBPM 对临床血压、血压的影响。在目标 3 中，我们将确定设施、提供者和药物依从性。与常规实践中使用 HBPM 相关的患者层面因素结果将确定 a) 长期效果。 HBPM 的益处，b) HBPM 与临床事件之间的关联，以及 c) 对重要疾病的影响这些发现将为急需的随机分组的患者选择和设计提供信息。对照试验评估 HBPM 与办公室高血压相比对临床结果的影响此外，还确定了与血压大幅下降和更多数量相关的因素。传输的家庭血压值，例如病例管理计划，可能会发现遵守障碍 HBPM 在临床实践中得到解决并为策略和使用提供信息。研究将回答对于在常规临床实践中实施 HBPM 至关重要的问题最终目标是降低高血压相关的发病率和死亡率。