Comparative Effectiveness of Adding Family Supporter Training and Engagement to a CHW-Led Intervention to Improve Behavioral Management of Multiple Risk Factors for Diabetes Complications

项目摘要（摘要） 糖尿病自我管理（DSM）干预措施一直在努力提供相关，有效和可持续的 支持糖尿病高危成年人改善DSM的关键行为，成为更活跃的参与者， 减少糖尿病并发症。这种支持的一个基本上未开发的资源是患者的 家人和朋友四分之三的糖尿病成年人会向无报酬的家庭成员或朋友求助（a “家庭医生”）持续帮助糖尿病管理。糖尿病管理干预 到目前为止，缺乏结构化和有效的方法来直接让病人家属参与支持 成功的糖尿病管理这项研究的长期目标是产生结构化和证据- 让家庭支持者参与帮助高危成年人启动和维持有效的糖尿病的方法 管理行为。本研究的目的是比较一个新的程序的有效性- 家庭健康行动伙伴（FAM-ACT）-更传统的，以个体患者为中心的糖尿病自我- 管理教育和护理管理（I-DSME/CM）。FAM-ACT采用三种创新方法， 加强家庭支持对糖尿病管理的影响：1）为家庭成员提供核心行为支持， 针对支持糖尿病医疗和生活方式管理的特定角色的策略，2）教导家庭 成员如何以患者自主支持的方式提供支持，以及3）教家庭支持者如何 促进患者积极参与医疗保健。社区卫生工作者（CHW）将提供FAM-ACT 到一个有联邦资格的城市健康中心的病人家庭支持者配对。268例2型糖尿病患者 血糖或血压控制不佳，以及家庭支持者，将被随机分配到 在6个月内接受FAM-ACT或CHW领导的I-DSME/CM。本研究的具体目的是：1） 确定FAM-ACT与I-DSME/CM相比对患者糖尿病健康结局的影响，2） 确定与I-DSME/CM相比，FAM-ACT对患者健康行为和感知支持的影响， 和3）确定FAM-ACT中健康结果和健康行为收益的可持续性， 到I-DSME/CM。主要的糖尿病健康结局是血红蛋白A1 c从基线到6个月的变化。 患者行为结果将包括糖尿病自我管理行为和感知的社会支持 和对家庭的自主性。可持续性将在12个月后进行评估， 没有CHW的干预。这个项目是重要的，因为它建立在以前的CHW和同行的支持 帮助资源匮乏的高危糖尿病患者实现和维持核心健康行为的模式， 是糖尿病并发症多种风险因素成功管理的基础。最终，这项研究将 通过产生一种新颖的、可扩展的、基于证据的方案和工具， 帮助患者改善和维持糖尿病自我管理行为。

Project Summary (Abstract) Diabetes self-management (DSM) interventions have struggled to deliver relevant, effective, and sustainable support for at-risk adults with diabetes to improve key DSM behaviors, become more activated participants in healthcare, and reduce diabetes complications. One largely untapped resource for this support is patients’ family and friends. Three out of four adults with diabetes reach out to an unpaid family member or friend (a ‘family supporter’) for ongoing help with diabetes management. However, diabetes management interventions to date lack structured and effective approaches to directly engage patients’ family members in supporting successful diabetes management. The long-term goal of this research is to produce structured and evidence- based approaches that engage family supporters in helping at-risk adults initiate and sustain effective diabetes management behaviors. The objective of this study is to compare the effectiveness of a novel program— Family Partners for Health Action (FAM-ACT)—to more traditional, individual patient-focused diabetes self- management education and care management (I-DSME/CM). FAM-ACT uses three innovative approaches to enhance the impact of family support on diabetes management: 1) provide family members core behavioral strategies directed at specific roles in supporting diabetes medical and lifestyle management, 2) teach family members how to deliver support in patient-autonomy supportive ways, and 3) teach family supporters ways to boost patients’ activated participation in healthcare. Community Health Workers (CHWs) will deliver FAM-ACT to patient-family supporter dyads at an urban federally qualified health center. 268 patients with type 2 diabetes and either poor glycemic or blood pressure control, together with a family supporter, will be randomized to receive either FAM-ACT or CHW-led I-DSME/CM over 6 months. The specific aims of this study are to 1) Determine the effect of FAM-ACT on patients’ diabetes health outcomes compared to I-DSME/CM, 2) Determine the effect of FAM-ACT on patient health behaviors and perceived support compared to I-DSME/CM, and 3) Determine the sustainability of health outcomes and health behavior gains made in FAM-ACT compared to I-DSME/CM. The main diabetes health outcome is change from baseline to 6 months in Hemoglobin A1c. Patient behavioral outcomes will include diabetes self-management behaviors, and perceived social support and autonomy supportiveness from family. Sustainability will be assessed at 12 months, after a period of 6 months without CHW intervention. This project is significant because it builds on prior CHW and peer support models to help at-risk diabetes patients with few resources achieve and sustain core health behaviors that underlie successful management of multiple risk factors for diabetes complications. Ultimately, this study will have a positive impact by producing a novel, scalable, evidence-based protocol and tools that leverage family support to help patients improve and sustain diabetes self-management behaviors.