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

基本信息

批准号：
10624313
负责人：
Aimee Afable
金额：
$ 12.11万
依托单位：
SUNY DOWNSTATE MEDICAL CENTER
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：
2022-05-18 至 2025-02-28
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10624313
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 Caring Cessation of life Cholesterol Chronic Disease Clinic Clinical Color Communication Communities Community Networks Community Practice Complex Continuity of Patient Care Data Analyses Data Collection Diabetes Mellitus Diffusion of Innovation Disparity Electronic Mail Ensure Equity 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 Neurology Not Hispanic or Latino Outcome Participant Patients Peripheral Vascular Diseases Phase Population Prevalence Public Health Qualitative Methods Randomized Randomized, Controlled Trials Recurrence Research Research Design Risk Risk Factors Scientist Secure Societies Socioeconomic Status Speed Stroke Stroke prevention Surface Surveys System Tablets Testing Text Time Triage Underserved Population United States Universities Vulnerable Populations Work blood pressure control blood pressure reduction care fragmentation care systems community organizations data sharing design digital digital health disability efficacy evaluation encryption ethnic disparity 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 disparity residence satisfaction scale up secondary outcome simulation standard care stroke patient stroke risk stroke survivor systematic review telehealth telemonitoring theories touchscreen transmission process treatment as usual usability

项目摘要

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.

中风是残疾，认知障碍和死亡的主要原因。 COVID-19大流行浮出水面在包括中风在内的一系列条件下的长期和严重的健康差异。与其他群体相比非裔美国人的中风风险因素的患病率更高，包括高血压，糖尿病麦芽脂，高胆固醇和周围血管疾病。这些因素因差异而更加复杂社会经济地位，导致中风的患病率和死亡率更高。但是，有越来越多的证据建议通过控制可修改的危险因素来预防大多数中风。指导假设研究是针对有色人种的血压控制（BP）控制的干预措施可能会狭窄的种族和种族中风复发的差异。尽管研究有限，但已证明远程医疗可能是有效地用于减少颜色种群的BP。拟议的研究利用了在非裔美国人中进行中风分布的调查小组，以进行飞行员随机对照试验（RCT）布鲁克林中部的非洲加勒比海人口。拟议的研究通过转录来告知实施科学框架和我们开发的干预模型，称为中风数字资产方法（DESA）。 Desa的创新在于整合四个新颖组成部分：提供宽带互联网（或同等）解决数字鸿沟，增强的家庭护理人员支持，灵活（远程医疗，文字，电子邮件）患者和临床之间的远程双向通信以及实时远程BP监控。提案由三个目标组成，对应于以下阶段：审前准备RCT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。第一个目标通过制定数字股权计划为RCT奠定了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，流程和地址实施问题。在飞行员RCT中，我们将测试DESA组是否会导致净减少与通常的护理相比，参与组的BP控制和药物依从性的改善。我们将将中风患者随机分为9个月的PILOT RCT（标准护理，n = 40 vs. Desa，n = 40）。我们的主要假设是，在9个月时，随机与DESA的患者的收缩BP（SBP）降低了。比对照患者。所有患者将收到BP监视器，该显示器将捕获，存储和自动传输BP 通过加密的蜂窝连接实时读取安全服务器。参与者随机与DESA 还将在安装必要的应用和蜂窝启用连接。第三个目标/审判后阶段将通过调查和关键的线人访谈征求反馈。最终目标是为多学科研究计划和强大的高科技，高科技增强能力社区参与的数字健康解决方案将同步数据收集和数据共享基于社区的组织，医疗保健系统和学术机构网络。