A Randomized Pilot Trial of a Digital Health Platform To Control BP To Address Stroke Disparities

控制血压以解决中风差异的数字健康平台的随机试点试验

• 批准号: 10442098
• 负责人: Aimee Afable
• 金额: $ 32.3万
• 依托单位: SUNY DOWNSTATE MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-18 至 2024-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10442098
• 关键词: Accident and Emergency department; Address; Adoption; Adult; Affect; African American; African American population; African Caribbean; Black Populations; Black race; Blood Pressure; Blood Pressure Monitors; Blood Vessels; COVID-19 pandemic; Care given by nurses; Caregiver support; Caribbean region; Caring; Cessation of life; Cholesterol; Chronic Disease; Clinic; Clinical; Color; Communication; Communities; Community Networks; Complex; Continuity of Patient Care; Data Analyses; Data Collection; Diabetes Mellitus; Diffusion of Innovation; Electronic Mail; Ensure; Family Caregiver; Feedback; Foundations; Funding; Grant; Health Sciences; Healthcare Systems; High Prevalence; Home; Hospitalization; Hyperlipidemia; Hypertension; Impaired cognition; Institution; Interdisciplinary Study; Internet; Intervention; Interview; Latino; Latino Population; Measurement; Medical Informatics; Methods; Modeling; Neurologist; Not Hispanic or Latino; Outcome; Participant; Patients; Peripheral Vascular Diseases; Phase; Plant Roots; Population; Prevalence; Public Health; Qualitative Methods; Randomized; Randomized Controlled Trials; Reading; Recurrence; Research; Research Design; Risk; Risk Factors; Scientist; Secure; Seeds; Societies; Socioeconomic Status; Speed; Stroke; Stroke prevention; Surface; Surveys; System; Tablets; Testing; Text; Time; Triage; Underserved Population; United States; Universities; Vulnerable Populations; Work; base; blood pressure control; blood pressure reduction; care systems; data sharing; design; digital; digital health; disability; efficacy evaluation; encryption; experience; experimental study; flexibility; health disparity; implementation framework; improved; informant; innovation; intervention participants; mHealth; medication compliance; modifiable risk; mortality; novel; people of color; pilot test; pilot trial; prevent; primary outcome; programs; prototype; racial and ethnic disparities; residence; satisfaction; scale up; secondary outcome; simulation; standard care; stroke neurology; stroke patient; stroke risk; stroke survivor; systematic review; telehealth; telemonitoring; theories; touchscreen; treatment as usual; usability

Stroke is a leading cause of disability, cognitive impairment, and death. The COVID-19 pandemic has surfaced longstanding and severe health disparities in a range of conditions, including stroke. Compared to other groups, African American individuals have a higher prevalence of stroke risk factors, including hypertension, diabetes mellitus, high cholesterol, and peripheral vascular disease. These factors are compounded by differences in socioeconomic status, leading to higher stroke prevalence and mortality. However, there is growing evidence to suggest that most strokes can be prevented by controlling modifiable risk factors. The guiding assumption in this research is that interventions targeting blood pressure (BP) control in people of color can narrow racial and ethnic disparities in stroke recurrence. Although there is limited research, it has been shown that telehealth can be effectively used to reduce BP in populations of color. The proposed research leverages preliminary work by the investigative team on stroke disparities to conduct a pilot randomized control trial (RCT) in an African American and Afro-Caribbean population in Central Brooklyn. The proposed studies are informed by a TRANSCREATION implementation science framework and an intervention model we developed called the Digital Equity for Stroke Approach (DESA). DESA’s innovation lies in integrating four novel components: provision of broadband internet (or equivalent) to address the digital divide, enhanced family caregiver support, flexible (telehealth, text, email) remote two-way communication between patient and clinician, and real-time remote BP monitoring. The proposal is constituted by three aims, corresponding to the following stages: pre-trial preparatory RCT and post-trial phases that examine facilitators and barriers. We will employ a convergent mixed method design to guide data collection and analysis. The first aim lays the foundation for the RCT by developing a digital equity plan, assessing user experience, and conducting preliminary telehealth experiments to ensure usability, flow and address implementation issues. In the pilot RCT, we will test whether the DESA group will lead to a net reduction in BP control and improvement in medication adherence in the participant group compared to usual care. We will randomize stroke patients into a 9-month pilot RCT (standard care, N=40 vs. DESA, N=40). Our primary hypothesis is that patients randomized to DESA will have a greater reduction in systolic BP (SBP) at 9 months than control patients. All patients will receive a BP Monitor that will capture, store and automatically transmit BP readings in real-time to a secure server via an encrypted cellular connection. Participants randomized to DESA will also receive a touch screen telehealth tablet with the necessary applications installed, and a cellular connection enabled. The third aim/ post-trial phase will solicit feedback via a survey and key informant interviews. The ultimate objective is to build capacity for a multidisciplinary research program and a robust, high-tech, community-engaged digital health solution that will synchronize data collection and data sharing across a network of community-based organizations, healthcare systems, and academic institutions.

中风是导致残疾、认知障碍和死亡的主要原因。新冠肺炎大流行已经浮出水面 在包括中风在内的一系列疾病中，长期存在严重的健康差距。与其他群体相比， 非裔美国人有更高的中风风险因素，包括高血压、糖尿病 糖尿病、高胆固醇和外周血管疾病。这些因素由于不同的 社会经济地位，导致更高的中风患病率和死亡率。然而，越来越多的证据表明 提示大多数中风可以通过控制可改变的危险因素来预防。其中的指导性假设 研究表明，针对有色人种血压(BP)控制的干预措施可以缩小种族和民族范围 中风复发的差异。尽管研究有限，但已经表明远程医疗可以 有效地用于降低人群中的BP的颜色。拟议的研究充分利用了 中风差异调查小组将在一名非裔美国人身上进行试点随机对照试验(RCT) 和布鲁克林中部的非洲裔加勒比人。建议的研究是由一项翻译提供的信息 实施科学框架和我们开发的称为中风数字公平的干预模型 接近(经社部)。DESA的创新之处在于整合了四个新的组成部分：提供宽带互联网 (或同等)以解决数字鸿沟，增强家庭照顾者支持，灵活(远程医疗、短信、电子邮件) 患者与临床医生之间的远程双向通信，以及实时远程血压监测。这项建议 由三个目标构成，对应于以下阶段：审前准备、区域审判和审判后 检查促进者和障碍的阶段。我们将采用收敛的混合方法设计来指导数据 收集和分析。第一个目标是通过制定数字股权计划为区域合作奠定基础， 评估用户体验，并进行初步远程医疗实验，以确保可用性、流畅性和 解决实施问题。在试点RCT中，我们将测试经社部小组是否会导致净减少 与常规护理相比，参与者组的血压控制和服药依从性有所改善。我们 将中风患者随机分为9个月的试验性RCT(标准护理，N=40对DESA，N=40)。我们的初选 假设是，随机接受DESA治疗的患者在9个月后的收缩压(SBP)将有更大的下降 而不是控制病人。所有患者都将收到一台BP监护仪，它将捕获、存储并自动传输BP 通过加密的蜂窝连接将读数实时传输到安全服务器。参与者被随机分配到经社部 还将收到一台安装了必要应用程序的触摸屏远程医疗平板电脑，以及一台蜂窝 连接已启用。第三个目标/审判后阶段将通过调查和主要线人面谈征求反馈意见。 最终目标是建设多学科研究计划的能力，以及强大的、高科技的、 社区参与的数字健康解决方案，将在 由社区组织、医疗保健系统和学术机构组成的网络。