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

控制血糖、血压和胆固醇水平的挑战使1600万美国成年人 糖尿病并发症致残的风险很高。糖尿病自我管理(DSM)干预措施 努力为糖尿病高危成人提供相关、有效和可持续的支持以改善 多项关键需求侧管理行为，成为更活跃的医疗参与者，减少糖尿病 并发症。这种支持的一个很大程度上尚未开发的资源是患者的家人和朋友。75%的 患有糖尿病的成年人向无偿的家庭成员或朋友(家庭支持者)寻求持续的帮助 糖尿病管理。然而，到目前为止，糖尿病管理干预措施缺乏系统和 经过测试的方法，直接让患者的支持性家庭成员参与促进和维持 激活患者和改善糖尿病管理。这项研究的目的是比较 一种新的战略--家庭卫生行动伙伴(FAM-ACT)--对个体患者的有效性 重点开展糖尿病自我管理教育(DSME)和护理管理。FAM-ACT直接与 通过向糖尿病高危成年人提供核心技能，使他们能够 有效地支持健康行为的改变、药物依从性和与患者的积极接触 医疗保健提供者。FAM-ACT的一个基本重点是为家庭提供 对患者的自主性、支持性和响应性帮助。社区卫生工作者(CHW)将 向低收入患者及其家庭支持者提供FAM-ACT，并采取新的步骤帮助 家庭支持者将他们的努力与患者的初级保健团队的努力结合起来。的具体目标 本研究旨在1)比较FAM-ACT对糖尿病患者健康结局的影响。 以个人为重点、以CHW为主导的DSME和关怀管理(DSME+CM)，2)比较 FAM-ACT对患者健康行为和对标准的、以个人为重点的感知支持的影响 DSME+CM，以及3)检查FAM-ACT中的健康和健康行为收益是否更好 在干预期后持续的时间要比DSME+CM组高。240名患者+家属 配对将被随机分配到FAM-ACT或DSME+CM，为期12个月。主要糖尿病健康结局 将包括UKPDS 5年心脏风险评分、HbA1c和收缩压从基线到12个月的变化 血压。患者的主要行为结果将包括糖尿病自我管理行为，以及 领悟到来自家庭的社会支持和自主支持。可持续性将在18岁时进行评估 6个月后，不进行CHW干预。我们预计这项研究将产生一个 创新的循证方案和工具集，利用家庭支持帮助患者优化 随着时间的推移，对多种糖尿病并发症风险因素的持续管理。这个项目是 创新是因为它为家庭支持者提供了潜在的支持、沟通和健康 可应用于改善和维持多种健康的行为促进技术 糖尿病管理的基础行为，结合了潜在的额外有效性和 有效的家庭支持的可持续性与社区卫生服务已证明的有效性，并将 以病人为中心的医疗护理的家庭支持。

Challenges to controlling blood glucose, blood pressure, and cholesterol levels put 16 million U.S. adults at high risk of disabling diabetes complications. Diabetes self-management (DSM) interventions have struggled to deliver relevant, effective, and sustainable support for at-risk adults with diabetes to improve multiple 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. 75% of 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 tested approaches to directly engage patients' supportive family members in promoting and sustaining patient activation and improved diabetes management. The objective of this study is to compare the effectiveness of a novel strategy – Family Partners for Health Action (FAM-ACT) – to individual patient- focused diabetes self-management education (DSME) and care management. FAM-ACT directly engages family supporters of at-risk adults with diabetes by providing them the core skills to allow them to effectively support health behavior change, medication adherence, and active engagement with patient's healthcare providers. A fundamental focus of FAM-ACT is providing family with the ability to give autonomy supportive and need-responsive help to patients. Community Health Workers (CHWs) will deliver FAM-ACT to low-income patients and their family supporters, plus take the novel step of helping family supporters integrate their efforts with those of patients' primary care teams. The specific aims of this study are to 1) Compare the effect of FAM-ACT on patients' diabetes health outcomes to standard, individually-focused, CHW-led DSME and Care Management (DSME+CM), 2) Compare the effect of FAM-ACT on patient health behaviors and perceived support to standard, individually-focused DSME+CM, and 3) Examine whether health and health behavior gains made in FAM-ACT are better sustained after the intervention period than those made in DSME+CM. 240 patient + family member pairs will be randomized to FAM-ACT or DSME+CM for 12 months. Main diabetes health outcomes will include change from baseline to 12 months in UKPDS 5-Year cardiac risk score, HbA1c, and systolic blood pressure. Main patient behavioral outcomes will include diabetes self-management behaviors, and perceived social support and autonomy supportiveness from family. Sustainability will be assessed at 18 months, after a period of 6 months without CHW intervention. We expect this study to produce an innovative, evidence-based protocol and tool set that leverages family support to help patients optimize and sustain management of multiple diabetes complication risk factors over time. This project is innovative because it provides family supporters with underlying support, communication, and health behavior facilitation techniques that can be applied to improving and sustaining multiple healthy behaviors underlying diabetes management, combines the potential additional effectiveness and sustainability of effective family support with the demonstrated effectiveness of CHWs, and integrates family support with patient-centered medical care.