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，这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。这些缺陷降低了对DM药物的依从性，这会使血糖控制恶化，并增加了与DM不良健康结果的风险。改善药物依从性可以防止这些结果并降低医疗保健成本。这对于所有患有DM的老年人，尤其是非洲裔美国人（AAS）很重要。它们的率是DM的两倍，认知功能较差，药物依从性较低，血糖控制较差。现在有100万年龄较大的AAS拥有DM，到2030年，其数量将翻一番。由于30％的MCI也有MCI，因此对他们来说，低药物依从性是一个重要的问题。这需要具有文化相关的干预措施，以弥补其认知缺陷并改善其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，以测试与DM，MCI，HBA1C E 7.5％和D 80％依附的DM，MCI，HBA1C E 7.5％和D 80％依从性的较老的AAS中，协作初级护理疗法（PC-OT）干预措施降低血红蛋白A1C（HBA1C）水平。 PC -OT包括：1）初级保健医师（PCP） - 职业治疗师（OT）合作； 2）针对认知障碍量身定制的DM教育； 3）在家中的认知功能评估； 4）授予行为激活，以增加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，并将其随机用于PC-OT或增强的常规护理（EUC）。 EUC是通常的医疗服务，以及社区卫生工作者提供的低强度DM教育。 PC-OT和EUC的参与者将在3个月内进行6个初始的室内治疗课程，然后在这12个月的研究中进行3次助推器课程。主要结果是HBA1C的降低为0.5％，从而降低了不良医疗事件的风险。主要疗效分析比较了在第6个月（短期效应）和第12个月（维护效应）中实现此结果的PC-OT和EUC参与者的比例。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。次要目标决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；急诊就诊和住院；认识;功能;情绪;和生活质量；以及PC-OT的成本和净财务收益。这是第一个确定PCP，与OTS合作的研究（他们是开发弥补认知/身体缺陷的策略的专家），可以改善药物依从性和血糖控制，并防止DM和MCI老年人的认知和功能下降。如果PC-OT在老年AAS的高风险人群中有效，则其收益可能会扩展到所有DM的老年人，并且具有巨大的公共健康意义。