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.

项目总结/摘要 为了有效控制高血压（HTN）， 糖尿病，影响数百万美国人的疾病。不受控制的HTN和糖尿病导致心血管疾病 疾病、中风、慢性肾病（CKD）和过早死亡。然而，这些条件差 尽管有有效和负担得起的治疗方法，当务之急是缩小差距 在慢性病的管理和控制方面， 人口。与白色成年人相比，黑人和西班牙裔成年人不成比例地受到HTN和糖尿病的影响。 他们还面临更多不利的健康社会决定因素，包括缺乏可靠的医疗服务， 交通和获得初级保健的机会分散。包括社区卫生工作者在内的团队护理 和药剂师是改善HTN和糖尿病控制的“最佳实践”。远程保健已成为 努力减少初级保健中断的基石，并可通过远程患者 监控设备。2019冠状病毒病大流行促使人们努力增加及时和适当的医疗服务， 通过重新设计初级保健，使其以患者为中心，并实现数字化。斯菲格莫之家a 远程患者远程监护解决方案，与经验证的血压（BP）和血糖监测相连接 设备是一个很有前途的解决方案，以改善病人的自我管理HTN和糖尿病。我们设计了 链接的心计划，一个创新的，理论推导，以病人为中心，多层次的干预 解决影响慢性病管理的个人和社区一级的社会决定因素。的 链接的心计划侧重于解决结构性问题的访问，并包括一个自我衡量 BP（SMBP）和血糖远程监测平台;团队护理，包括药剂师和社区 保健工作者和提供者一级干预。使用混合I型有效性-实现设计，我们的 建议的具体目标是：1）比较LINKED-HEARTS计划与SMBP单独治疗的效果， 改善6个月和12个月时的血压控制（收缩压<140/90 mm Hg）和改善以患者为中心的结局， 在一项对未控制的HTN和糖尿病或CKD的成人进行的随机对照试验中。2)使用 务实稳健实施和可持续发展模型（PRISM），用于评估覆盖范围、采用率 在随机化后12个月和24个月维持LINKED-HEARTS项目，并探索 与程序的采用和维护相关的因素。我们将招募600名成年人，集中在16个 包括联邦合格的医疗保健中心。通过利益攸关方的早期和持续参与 我们与卫生系统的领导者、提供者、患者和我们的社区一道，寻求缩小“知-行-差距” 并减少慢性病的差异。我们还提出了一个全面的传播战略， 关键受众，并实现买入和政策变革。