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: 10494295
• 负责人: Tapan S Mehta
• 金额: $ 67.62万
• 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/10494295
• 关键词: Address; Adult; Affect; Age; Alabama; Black American; Black race; 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; Persons; 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.

摘要 包括阿拉巴马州(AL)和密西西比州(MS)在内的南方腹地州的2型糖尿病发病率最高 糖尿病(T2 DM)和一些由T2 DM相关心血管疾病(CVD)和 慢性肾病(CKD)。2型糖尿病和相关的心肾疾病给布莱克带来了不成比例的负担 美国人。超过一半的与T2 DM有关的种族健康差距可以归因于 健康(SDoH)，包括减少医疗保健、贫困、交通障碍和粮食不安全。 需要有效和可持续的一揽子干预措施，以解决与T2 DM相关的结果和 提高健康公平。食品配送、远程监控和培训的总体目标-增强 优化糖尿病管理教育(自由)研究(项目3)是为了开发一个优化的， 多水平、可扩展的干预措施，以改善患有T2 DM和T2 DM的低收入黑人成年人的T2 DM控制 通过靶向相关的SDoH研究南方腹地的心肾并发症。自由学院将招收304名学生 AL和MS的三种健康系统中患有次优SDoH的黑人成年人A随机因素分析 使用多阶段优化策略(MOST)的优化设计将评估三种干预措施 组件：1)数字健康指导，2)食品盒递送，3)远程患者监控(RPM)。因此， 该项目将评估针对个人(患者)、人际关系变化的多层次干预措施 (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 在患有心脏肾功能的社会弱势黑人成年人中，改善T2 DM管理的水平 合并症(CVD或CKD)。目标1将确定以下三个干预组件的组合(S) 在12个月时降低HbA1c(主要结局)。目标2包括干预措施的试验内成本效用分析 组件。目标3将确定影响这些不同干预措施实施的背景因素 使用综合执行框架(CFIR)办法，执行成果将 通过REACH、有效性、采用、实施和维护(RE-AIM)框架进行评估。 这项研究将利用多医疗保健系统和医疗保健系统-行业合作伙伴关系来开发 优化、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 住在南方腹地。