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

食品配送、远程监控和辅导——优化糖尿病管理的强化教育（自由）

• 批准号: 10437096
• 负责人: Tapan S Mehta
• 金额: $ 72.84万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 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/10437096
• 关键词: Address; Adult; Affect; African American; Age; Alabama; Blood Pressure; Cardiometabolic Disease; Cardiovascular Diseases; Cause of Death; Chronic; Chronic Disease; Chronic Kidney Failure; Clinical; Communication; Communities; Consolidated Framework for Implementation Research; Continuity of Patient Care; Deep South; Disease; Economics; Education; Enrollment; Food; Glycosylated hemoglobin A; Goals; Health; Health Food; Health Services Accessibility; Health system; Healthcare Systems; Hemoglobin; Household; Hypoglycemia; Individual; Insurance; Intervention; Louisiana; Low income; Mental Health; Methods; Mission; Mississippi; Non-Insulin-Dependent Diabetes Mellitus; Outcome; Participant; Patient Care Team; Plant Roots; Politics; Poverty; Prevention; Public Health; Public Policy; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Resources; Social Conditions; Transportation; Weight; Work; base; black patient; cardiometabolism; cardiovascular risk factor; comorbidity; contextual factors; cost effective; cost utility analysis; design; diabetes education; diabetes management; dietary; digital health; disorder risk; disparity reduction; effectiveness evaluation; experimental study; food insecurity; glucose monitor; glycemic control; health care availability; health care economics; health disparity; health equity; health equity promotion; implementation framework; implementation intervention; implementation outcomes; implementation process; improved; individual patient; industry partner; multiphase optimization strategy; primary outcome; programs; racial health disparity; recruit; relative cost; remote delivery; remote monitoring; remote patient monitoring; social health determinants; social vulnerability; trend

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.

抽象的 深南州，包括阿拉巴马州（AL）和密西西比州（MS），具有2型糖尿病的率最高 Mellitus（T2DM）以及由于T2DM相关的心血管疾病（CVD）和 慢性肾脏病（CKD）。 T2DM和相关心脏疾病不成比例地 美国人。与T2DM相关的种族健康差异的一半以上可以归因于社会决定者 健康（SDOH），包括减少医疗保健，贫困，运输障碍和粮食不安全。 需要有效且可持续的干预包，以解决与T2DM相关的结果和 改善健康公平。食物交付，远程监控和教练增强的总体目标 优化糖尿病管理（自由）研究（项目3）的教育是开发优化的， 多级且可扩展的干预措施，以改善具有T2DM和T2DM的低收入黑人成年人的T2DM控制 深南深的心脏并发症是通过针对相关的SDOH的。自由研究将注册304 黑人成年人通过AL和MS的三个卫生系统具有次优SDOH。随机阶乘 使用多相优化策略（大多数）优化设计将评估三个干预措施 组件：1）数字健康教练，2）食物盒交付和3）远程患者监控（RPM）。那， 该项目将评估解决个人（患者），人际关系变化的多层次干预措施 （患者护理团队的沟通），组织（医疗保健系统授予RPM）和社区（食物 盒子交付）水平以改善社会脆弱的黑人成年人的T2DM管理 合并症（CVD或CKD）。 AIM 1将确定三个干预组件的组合 减少12个月时的HBA1C（主要结果）。 AIM 2包括审前成本障碍分析的干预分析 成分。 AIM 3将确定影响这些不同干预措施实施的上下文因素 使用合并的框架进行实施（CFIR）方法，实现结果将 通过覆盖范围，有效性，采用，实施和维护（RE-AIM）框架进行评估。 这项研究将利用多健康保健系统和医疗保健系统 - 工业伙伴关系发展 优化，可持续的干预策略，以改善社会脆弱的黑人成年人的T2DM结果 住在南部。