Food Delivery, Remote Monitoring, and coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM)

摘要 包括亚拉巴马（AL）和密西西比（MS）在内的南部各州的2型糖尿病发病率最高 糖尿病（T2 DM）和T2 DM相关心血管疾病（CVD）导致的一些最差结局， 慢性肾病（CKD）。T2 DM和相关心肾疾病对黑人的负担不成比例 美国人与T2 DM相关的种族健康差异中有一半以上可归因于以下社会决定因素： 健康（SDoH），包括医疗保健机会减少，贫困，交通障碍和粮食不安全。 有必要制定有效和可持续的一揽子干预措施，处理与T2 DM相关的结果， 改善卫生公平性。食品配送、远程监控和指导增强的总体目标 优化糖尿病管理教育（FREEDOM）研究（项目3）是为了开发一种优化的， 多层次、可扩展的干预措施，以改善低收入黑人T2 DM患者的T2 DM控制， 通过针对相关的SDoH，在深南地区治疗心肾并发症。FREEDOM研究将招募304名 阿拉巴马州和密西西比州三个卫生系统中SDoH不佳的黑人成年人。随机因子 使用多阶段优化策略（MOST）的优化设计将评估三种干预措施 这些组件包括：1）数字健康指导，2）食品盒交付，以及3）远程患者监护（RPM）。因此，在本发明中， 该项目将评估多层次的干预措施，解决个人（患者），人际关系， （患者护理团队沟通）、组织（医疗保健系统提供的RPM）和社区（食品 盒交付）水平，以改善社会脆弱的黑人成人心肾疾病患者的T2 DM管理 合并症（CVD或CKD）。目标1将确定三个干预组成部分的组合， 在12个月时降低HbA 1c（主要结局）。目标2包括干预的试验内成本效用分析 件.目标3将确定影响这些不同干预措施实施的背景因素 采用综合执行框架方法，执行成果将 通过覆盖、有效性、采用、实施和维护（RE-AIM）框架进行评估。 本研究将利用多医疗保健系统和医疗保健系统-行业合作伙伴关系， 优化的，可持续的干预策略，以改善社会弱势黑人成年人的T2 DM结局 生活在南方腹地

ABSTRACT Deep South states, including Alabama (AL) and Mississippi (MS), have the highest rates of type 2 diabetes mellitus (T2DM) and some of the worst outcomes due to T2DM-related cardiovascular disease (CVD) and chronic kidney disease (CKD). T2DM and related cardiorenal diseases disproportionately burden Black Americans. Over half of the racial health disparities related to T2DM can be attributed to social determinants of health (SDoH), including reduced healthcare access, poverty, transportation barriers, and food insecurity. There is a need for effective and sustainable intervention packages that address T2DM-related outcomes and improve health equity. The overall goal of the Food Delivery, Remote Monitoring, and Coaching-Enhanced EDucation for Optimized Diabetes Management (FREEDOM) study (Project 3) is to develop an optimized, multilevel, and scalable intervention to improve T2DM control in low-income Black adults with T2DM and cardiorenal complications in the Deep South by targeting relevant SDoH. The FREEDOM study will enroll 304 Black adults with suboptimal SDoH through three health systems in AL and MS. A randomized factorial optimization design using a multiphase optimization strategy (MOST) will evaluate three intervention components: 1) digital health coaching, 2) food box delivery, and 3) remote patient monitoring (RPM). Thus, this project will evaluate multilevel interventions that address changes at the individual (patient), interpersonal (patient-care team communication), organizational (healthcare system–delivered RPM), and community (food box delivery) levels to improve T2DM management among socially vulnerable Black adults with cardiorenal comorbidities (CVD or CKD). Aim 1 will identify the combination(s) of the three intervention components that reduce HbA1c (primary outcome) at 12 months. Aim 2 includes within-trial cost-utility analyses of intervention components. Aim 3 will identify contextual factors that impact implementation of these different interventions using a Consolidated Framework for Implementation (CFIR) approach, and the implementation outcomes will be assessed via the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. This study will leverage multi-healthcare system and healthcare system–industry partnerships to develop optimized, sustainable intervention strategies to improve T2DM outcomes in socially vulnerable Black adults living in the Deep South.