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Improving Medication Adherence in Older African Americans with Diabetes

提高老年非裔美国人糖尿病患者的药物依从性

基本信息

批准号：
9291461
负责人：
BARRY W. ROVNER
金额：
$ 53.4万
依托单位：
THOMAS JEFFERSON UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-07-21 至 2019-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9291461
关键词：
Address Adherence African American Age Aging Behavior Caring Clinic Cognition Cognitive Cognitive deficits Collaborations Community Health Aides Computerized Medical Record Dementia Diabetes Mellitus Diet Education Elderly Elements Emergency department visit Event Executive Dysfunction Glycosylated hemoglobin A Health Health Care Costs Home environment Hospitalization Hyperglycemia Hypoglycemia Impaired cognition Intervention Link Maintenance Measures Mediating Medical Medicare Memory Monitor Moods Non-Insulin-Dependent Diabetes Mellitus Occupational Therapist Occupational Therapy Older Population Oral Outcome Participant Patient Self-Report Pharmaceutical Preparations Population Practice Management Prevalence Primary Care Physician Primary Health Care Public Health Quality of life Randomized Randomized Controlled Clinical Trials Recruitment Activity Reimbursement Mechanisms Reproducibility Research Risk Self Management Societies Socioeconomic Factors System Therapeutic Intervention cognitive function cost design diet and exercise efficacy testing functional decline glycemic control high risk population improved medication compliance mild cognitive impairment prevent primary outcome public health relevance racial diversity targeted treatment treatment as usual treatment planning

项目摘要

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.

描述（由申请人提供）：老年人中 2 型糖尿病 (DM) 的患病率正在迅速增加。糖尿病会增加轻度认知障碍 (MCI) 的风险，这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。这些缺陷会降低对糖尿病药物的依从性，从而恶化血糖控制并增加与糖尿病相关的不良健康结果的风险。提高药物依从性可以防止这些结果并降低医疗保健成本。这对于所有患有 DM 的老年人都很重要，尤其是对于老年非裔美国人 (AA)。与白人相比，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。目前有 100 万老年 AA 患有 DM，到 2030 年，这一数字将翻一番。由于 30% 的人还患有 MCI，因此药物依从性低对他们来说是一个重要问题。这就需要采取与文化相关的干预措施来补偿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 DM、MCI、HbA1c e 7.5% 和 d 80% 坚持口服降糖药物的老年 AA 血红蛋白 A1c (HbA1c) 水平的功效。 PC-OT包括： 1）初级保健医师（PCP）-职业治疗师（OT）协作； 2）针对认知障碍量身定制的糖尿病教育； 3) 家庭 OT 认知功能评估； 4) OT 提供的行为激活，以提高对药物和其他糖尿病自我管理 (DSM) 实践（例如饮食）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 或增强型日常护理 (EUC)。 EUC 是社区卫生工作者提供的常规医疗护理加上低强度的糖尿病教育。 PC-OT 和 EUC 的参与者将在 3 个月内接受 6 次初始家庭治疗，然后在为期 12 个月的研究中接受 3 次加强治疗。主要结果是 HbA1c 降低 0.5%，从而降低不良医疗事件的风险。主要功效分析比较了 PC-OT 和 EUC 参与者在第 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。我们将使用电子药物事件监测系统、处方补充和自我报告来衡量药物依从性。第二个目标是确定提高药物依从性是否会介导 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；急诊室就诊和住院治疗；认识;功能;情绪;和生活质量； PC-OT 的成本和净财务收益。这是第一项确定 PCP 与 OT（他们是制定补偿认知/身体缺陷策略的专家）合作是否可以改善患有 DM 和 MCI 的老年人的药物依从性和血糖控制并预防认知和功能下降的研究。如果 PC-OT 对老年 AA 高危人群有效，那么它的益处可能会延伸到所有患有 DM 的老年人，并且具有巨大的公共卫生意义。