Improving Medication Adherence in Older African Americans with Diabetes

描述（由申请人提供）：2型糖尿病（DM）在老年人中的患病率正在迅速增加。糖尿病增加轻度认知障碍（MCI）的风险，轻度认知障碍是正常认知和痴呆症之间的过渡状态，通常以记忆和执行功能缺陷为特征。这些缺陷降低了糖尿病药物的依从性，从而恶化了血糖控制，增加了糖尿病相关不良健康结果的风险。改善药物依从性可以预防这些结果并降低医疗保健费用。这对所有老年糖尿病患者都很重要，尤其是对老年非裔美国人（AAs）。他们患糖尿病的几率是白人的两倍，认知功能更差，药物依从性更低，血糖控制也比白人差。现在有100万老年aa患有糖尿病，到2030年这一数字将翻一番。因为30%的患者同时患有轻度认知障碍，对他们来说，低药物依从性是一个重要问题。这就需要与文化相关的干预措施来弥补他们的认知缺陷，并改善他们的药物依从性和血糖控制。我们提出了一项随机对照临床试验，以测试初级保健-职业治疗（PC-OT）协作干预对降低老年糖尿病、MCI患者血红蛋白A1c （HbA1c）水平的疗效，HbA1c为7.5%，口服降糖药依从率为80%。PC-OT包括：1)初级保健医生(PCP) -职业治疗师（OT）的协作；2)针对认知障碍的DM教育；3)居家OT认知功能评估；4) ot提供的行为激活，以增加对药物治疗和其他糖尿病自我管理（DSM）实践（如饮食）的依从性。我们将从初级保健诊所招募100名参与者，并将他们随机分配到PC-OT或增强常规护理（EUC）组。EUC是由社区卫生工作者提供的常规医疗保健和低强度糖尿病教育。PC- OT和EUC的参与者将在3个月内进行6次初始家庭治疗，然后在12个月的研究中进行3次强化治疗。主要结果是HbA1c降低0.5%，这降低了不良医疗事件的风险。主要疗效分析比较了PC-OT和EUC患者在第6个月（短期效果）和第12个月（维持效果）达到这一结果的比例。我们将使用电子用药事件监测系统、处方补充和自我报告来衡量药物依从性。第二个目的是确定改善药物依从性是否介导PC-OT对HbA1c水平的影响。我们还将评估PC-OT对其他DSM实践的影响；急诊和住院；认知;函数;情绪;生活质量；PC-OT的成本和净财务收益。这是第一个确定pcp与OTs（开发认知/身体缺陷补偿策略的专家）合作是否可以改善药物依从性和血糖控制，并预防老年DM和MCI患者的认知和功能下降的研究。如果PC-OT在老年AAs高危人群中有效，其益处可能扩展到所有老年糖尿病患者，并具有巨大的公共卫生意义。

DESCRIPTION (provided by applicant): The prevalence of type 2 diabetes (DM) in older persons is increasing rapidly. DM increases the risk for Mild Cognitive Impairment (MCI), which is a transition state between normal cognition and dementia that is often characterized by memory and executive function deficits. These deficits reduce adherence to DM medications, which worsens glycemic control and increases the risk for adverse DM-related health outcomes. Improving medication adherence may prevent these outcomes and reduce health care costs. This is important to all older persons with DM but particularly to older African Americans (AAs). They have twice the rate of DM, worse cognitive function, lower medication adherence, and worse glycemic control than whites. One million older AAs now have DM and their number will double by 2030. Because 30% also have MCI, low medication adherence is an important problem for them. This necessitates culturally relevant interventions that compensate for their cognitive deficits and improves their medication adherence and glycemic control. We propose a randomized controlled clinical trial to test the efficacy of a collaborative Primary Care-Occupational Therapy (PC-OT) intervention to lower hemoglobin A1c (HbA1c) levels in older AAs with DM, MCI, HbA1c e 7.5%, and d 80% adherence to an oral hypoglycemic medication. PC-OT consists of: 1) primary care physician (PCP) - occupational therapist (OT) collaboration; 2) DM education tailored to cognitive impairment; 3) in-home OT cognitive-functional assessment; and 4) OT-delivered Behavior Activation to increase adherence to medications and other diabetes self-management (DSM) practices (e.g., diet). We will recruit 100 participants from primary care clinics and randomize them to PC-OT or Enhanced Usual Care (EUC). EUC is usual medical care plus low intensity DM education delivered by community health workers. Participants in both PC- OT and EUC will have 6 initial in-home treatment sessions over 3 months, and then 3 booster sessions during this 12 month study. The primary outcome is a reduction in HbA1c of 0.5%, which reduces the risk of adverse medical events. The primary efficacy analysis compares the proportion of participants in PC-OT and EUC who achieve this outcome at month 6 (short term effect) and at month 12 (maintenance effect). We will measure medication adherence using an electronic Medication Event Monitoring System, prescription refills, and self- reports. A secondary aim determines if improving medication adherence mediates PC-OT's impact on HbA1c levels. We will also evaluate PC-OT's effect on other DSM practices; ER visits and hospitalizations; cognition; function; mood; and quality of life; and PC-OT's costs and net financial benefits. This is the first study to determine if PCPs, collaborating with OTs (who are experts in developing strategies to compensate for cognitive/physical deficits), can improve medication adherence and glycemic control, and prevent cognitive and functional decline in older persons with DM and MCI. If PC-OT is effective in a high risk population of older AAs, its benefits may extend to all older persons with DM and have enormous public health significance.