Improving Medication Adherence in Older African Americans with Diabetes

描述（由申请人提供）：老年人2型糖尿病（DM）的患病率正在迅速增加。DM增加了轻度认知障碍（MCI）的风险，MCI是正常认知和痴呆之间的过渡状态，通常以记忆和执行功能缺陷为特征。这些缺陷降低了对DM药物的依从性，这影响了血糖控制并增加了不良DM相关健康结果的风险。改善药物依从性可以防止这些结果并降低医疗保健成本。这对所有患有DM的老年人都很重要，尤其是对老年非裔美国人（AAs）。他们的糖尿病发病率是白人的两倍，认知功能更差，药物依从性更低，血糖控制更差。现在有100万老年AA患有DM，到2030年他们的数量将翻一番。由于30%的人也患有MCI，因此药物依从性低对他们来说是一个重要问题。这需要文化相关的干预措施，以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，以测试合作的初级护理-职业治疗（PC-OT）干预降低老年AA患者糖化血红蛋白（HbA1c）水平的有效性，这些患者患有DM、MCI、HbA1c e 7.5%和d 80%，并坚持口服降糖药物。PC-OT包括：1）初级保健医生（PCP）-职业治疗师（OT）合作; 2）针对认知障碍的DM教育; 3）家庭OT认知功能评估;以及4）OT递送的行为激活，以增加对药物和其他糖尿病自我管理（DSM）实践的依从性（例如，饮食）。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或增强型糖尿病护理（EUC）。EUC是由社区卫生工作者提供的常规医疗护理加低强度DM教育。PC-OT和EUC中的受试者将在3个月内接受6次初始家庭治疗，然后在这项为期12个月的研究期间接受3次加强治疗。主要结局是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中在第6个月（短期效应）和第12个月（维持效应）达到该结局的受试者比例。我们将使用电子药物事件监测系统、处方续药和自我报告来衡量药物依从性。次要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; ER访问和住院;认知;功能;情绪;和生活质量;以及PC-OT的成本和净经济效益。这是第一项确定PCP与OT（他们是开发策略以补偿认知/身体缺陷的专家）合作是否可以改善药物依从性和血糖控制，并预防DM和MCI老年人的认知和功能下降的研究。如果PC-OT在老年AA的高风险人群中有效，则其益处可能扩展到所有患有DM的老年人，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.