A Cardiometabolic Health Program LINKED with Clinical-Community Support and Mobile HEAlth TelemonitoRing in Underserved PopulaTionS (LINKED-HEARTS PROGRAM)

与临床社区支持和服务不足人群的移动健康远程监控相联系的心脏代谢健康计划（LINKED-HEARTS 计划）

• 批准号: 10437338
• 负责人: Yvonne Commodore-Mensah
• 金额: $ 70.21万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-24 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10437338
• 关键词: Address; Adherence; Adoption; Adult; Affect; African American; American; Behavioral; Biological; Black race; Blood Glucose; Blood Pressure; Blood Pressure Monitors; Bluetooth; COVID-19 pandemic; Cardiovascular Diseases; Caring; Cessation of life; Chronic; Chronic Disease; Chronic Kidney Failure; Clinic; Clinical; Communities; Community Health Aides; Complex; Data; Devices; Diabetes Mellitus; Disease Management; Education; Engineering; Enrollment; Ethnic group; Glycosylated hemoglobin A; Health; Health Professional; Health Services Accessibility; Health Technology; Health behavior; Health system; Healthcare; High Prevalence; Hispanics; Home; Hybrids; Hypertension; Improve Access; Individual; Intervention; Kidney Diseases; Latino; Link; Maintenance; Measures; Minority Groups; Monitor; Morbidity - disease rate; Not Hispanic or Latino; Organ; Patient-Focused Outcomes; Patients; Persons; Pharmacists; Plant Roots; Policies; Population; Practical, Robust Implementation and Sustainability Model; Prevalence; Primary Health Care; Provider; Randomized; Randomized Controlled Trials; Self Management; Soil; Stroke; Structure; System; Time; Transportation; Underserved Population; Uninsured; Visit; Work; base; blood pressure regulation; cardiometabolism; cardiovascular disorder risk; cardiovascular risk factor; care delivery; clinical decision-making; community clinic; contextual factors; design; diabetes control; diabetes risk; digital; disease disparity; disparity reduction; dissemination strategy; effectiveness implementation design; ethnic minority population; evidence based guidelines; experience; glucose monitor; health care availability; health disparity; health equity; high risk; hypertension control; improved; innovation; mHealth; monitoring device; mortality; patient monitoring device; patient oriented; premature; prevent; primary outcome; programs; racial and ethnic; racial minority; randomized trial; remote patient monitoring; secondary outcome; social; social culture; social determinants; social health determinants; telehealth; telemonitoring

Project Summary/Abstract Innovation in chronic disease management is urgently needed to effectively control hypertension (HTN) and diabetes, conditions which affect millions of Americans. Uncontrolled HTN and diabetes cause cardiovascular disease, stroke, chronic kidney disease (CKD), and premature death. However, these conditions are poorly controlled despite the availability of effective and affordable therapy. A pressing priority is reducing disparities in the management and control of chronic diseases and making primary care more convenient for underserved populations. Black and Hispanic adults are disproportionately affected by HTN and diabetes than White adults. They also experience more adverse social determinants of health, including a lack of access to reliable transportation and fragmented access to primary care. Team-based care including community health workers and pharmacists are “best practices” in improving HTN and diabetes control. Telehealth has become a cornerstone of efforts to minimize disruptions in primary care and can be enhanced with remote patient monitoring devices. The COVID-19 pandemic has spurred efforts to increase access to timely and appropriate care through re-engineering primary care to be patient-centered and digitally-enabled. Sphygmo Home, a remote patient telemonitoring solution that links with validated blood pressure (BP) and glucose monitoring devices is a promising solution to improve patient's self-management of HTN and diabetes. We have designed the LINKED-HEARTS Program, an innovative, theoretically derived, patient-centered, multi-level intervention to address individual and community-level social determinants that affect chronic disease management. The LINKED-HEARTS Program focuses on addressing structural issues of access and includes a self-measured BP(SMBP) and blood glucose telemonitoring platform; team-based care including a pharmacist and community health worker and provider-level interventions. Using a hybrid type I effectiveness-implementation design, our proposed specific aims are 1) To compare the effect of the LINKED-HEARTS Program versus SMBP alone in improving BP control (systolic BP<140/90 mm Hg) and improving patient-centered outcomes at 6 and 12 months, in a cluster-randomized controlled trial of adults with uncontrolled HTN and either diabetes or CKD. 2) To use the Pragmatic Robust Implementation and Sustainability Model (PRISM) to evaluate the reach, adoption, maintenance of the LINKED-HEARTS program at 12 and 24 months post-randomization and explore contextual factors that associated with adoption and maintenance of the program. We will enroll 600 adults, clustered in 16 practices including federally qualified healthcare centers. Through early and continued stakeholder engagement with health system leaders, providers, patients, and our community, we seek to close the wide “know-do-gap” and reduce chronic disease disparities. We also propose a comprehensive dissemination strategy to reach critical audiences and achieve buy-in and policy change.

项目摘要/摘要 迫切需要在慢性病管理中进行创新以有效控制高血压（HTN）和 糖尿病，影响数百万美国人的疾病。不受控制的HTN和糖尿病引起心血管 疾病，中风，慢性肾脏疾病（CKD）和过早死亡。但是，这些条件很差 尽管有有效且负担得起的治疗，但仍受到控制。紧迫的优先级是减少分布 在慢性疾病的管理和控制方面，并使初级保健更方便地服务不足 人群。与白人成年人相比，黑人和西班牙裔成年人受HTN和糖尿病的影响不成比例。 他们还体验了更高级的健康决定者，包括无法获得可靠的机会 运输和零散获得初级保健。基于团队的护理包括社区卫生工作者 药剂师是改善HTN和糖尿病控制的“最佳实践”。远程医疗已成为 努力最大程度地减少初级保健中断的努力，可以通过远程患者增强 监视设备。 COVID-19大流行促使人们努力增加获得及时和适当的机会 通过重新设计的初级保健护理，以患者为中心并以数字方式启用。 Sphygmo Home，a 与经过验证的血压（BP）和葡萄糖监测连接的远程患者远程监控解决方案 设备是改善患者对HTN和糖尿病的自我管理的希望解决方案。我们已经设计了 Linked Hearts计划，一种创新的，理论的派生，以患者为中心的多层次干预 解决影响慢性疾病管理的个人和社区级社会决定者。这 链接的心脏计划着重于解决访问的结构问题，并包括一个自我测量 BP（SMBP）和血糖远程监控平台；基于团队的护理，包括药剂师和社区 卫生工作者和提供者级干预措施。使用I型I型有效性实施设计，我们 提出的具体目的是1）比较链接的心脏计划的效果与单独的SMBP的效果 改善BP对照（收缩压<140/90 mm Hg），并在6和12个月时改善以患者为中心的结果 在不受控制的HTN和糖尿病或CKD的成年人的聚类随机对照试验中。 2）使用 务实的强大实施和可持续性模型（PRISM）评估覆盖范围，采用， 随机化后12和24个月维护链接的心脏计划并探索上下文 与该计划的采用和维护相关的因素。我们将注册600名成年人，共16名 包括联邦资格的医疗保健中心在内的实践。通过早期和持续的利益相关者参与 在卫生系统领导者，提供者，患者和我们的社区的情况下，我们寻求关闭广泛的“知识差距” 并减少慢性疾病差异。我们还提出了一种全面的传播策略来达到 关键的受众并实现买入和政策变化。