Health Beliefs, Glycemic Control, and Preventing Cognitive Decline in African Americans with Diabetes and Mild Cognitive Impairment: A Randomized Clinical Trial

患有糖尿病和轻度认知障碍的非裔美国人的健康信念、血糖控制和预防认知能力下降：一项随机临床试验

• 批准号: 10557165
• 负责人: BARRY W. ROVNER
• 金额: $ 75.7万
• 依托单位: THOMAS JEFFERSON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-15 至 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10557165
• 关键词: Address; African American population; Age; Alzheimer' s Disease; American; Area; Awareness; Behavior Therapy; Behavioral; Belief; Blood Vessels; Caring; Cerebrum; Cognition; Cognitive; Cognitive deficits; Communication; Community Health Aides; Data Set; Dementia; Diabetes Mellitus; Double-Blind Method; Education; Effectiveness; Genotype; Glycosylated hemoglobin A; Goals; Health; Home; Impaired cognition; Incidence; Language; Measures; Mediating; Medical; Memory; Microvascular Dysfunction; Nerve Degeneration; Neurodegenerative Disorders; Neuropsychology; Non-Insulin-Dependent Diabetes Mellitus; Nursing Faculty; Optical Coherence Tomography; Outcome; Participant; Patient Recruitments; Persons; Pharmaceutical Preparations; Phase; Physicians; Prevention strategy; Preventive treatment; Primary Care Physician; Proxy; Public Health; Race; Randomized, Controlled Trials; Renal function; Research; Retina; Risk; Risk Reduction; Secondary Prevention; Self Care; Site; Testing; Thick; Treatment Efficacy; Uncertainty; Underserved Population; Verbal Learning; Vision; Visit; Visuospatial; active control; comorbidity; comparative efficacy; density; diabetes mellitus nursing; efficacy evaluation; efficacy testing; enhanced care; executive function; experience; glycemic control; health belief; health equity; high risk; high risk population; human old age (65+); improved; innovation; mild cognitive impairment; preservation; prevent; primary care practice; primary outcome; processing speed; progression risk; racial health disparity; randomized, clinical trials; recruit; retina blood vessel structure; retinal nerve fiber layer; telehealth; treatment as usual; treatment comparison; treatment effect; treatment group; treatment optimization; verbal

Thirty percent of African Americans (AAs) with Mild Cognitive Impairment (MCI) have (DM), which increases risk for progression to dementia. Poorly controlled DM magnifies this risk, but whether improving glycemic control reduces the risk is uncertain. Previous studies have lacked rigor to resolve this uncertainty. The proposed randomized controlled trial (RCT) studies a high-risk population, which confers greater rigor. This single-site, double-blind, active-control, phase II RCT will compare the efficacy of DM-Specific Behavioral Activation (DM-BA) vs. Enhanced Usual Care (EUC) to prevent decline in verbal memory (primary outcome) over 2 years in 200 AAs over age 65 years with amnestic multiple-domain MCI and poorly controlled DM. DM- BA is a behavioral treatment for DM, as well as a secondary prevention strategy for dementia. In DM-BA, race- concordant community health workers will: 1) deliver in-home DM education tailored to persons with MCI; 2) use action plans to reinforce DM self-care; 3) facilitate telehealth visits with a DM nurse educator to guide DM care and address participants’ health beliefs; and 4) increase primary care physicians’ (PCP) awareness of participants’ cognitive deficits and health beliefs to optimize treatment of DM. The control treatment, EUC, is usual medical care enhanced with DM self-care education. Both DM-BA and EUC deliver DM education and have the same number of in-home treatment visits (i.e., 6 visits over 6 months, and 5 booster visits over the next 18 months). EUC, however, does not include DM-BA’s behavioral approach to improve glycemic control, telehealth visits, or PCP communication. The treatment comparison will identify DM-BA’s specific efficacy over and above EUC. Participants will be recruited from primary care practices. We will administer the Hopkins Verbal Learning Test-Revised (HVLT-R) (to assess verbal memory; the primary outcome) and the Uniform Data Set neuropsychological battery (to assess executive function, processing speed, language, visuospatial function, and global cognition; all exploratory outcomes) at baseline and months 6, 12, 18, and 24. The primary efficacy analysis will compare trajectories in HVLT-R Total Recall scores over 2 years by treatment group. We will also explore whether APOE genotype moderates treatment effects, and whether Optical Coherence Tomography measures of retinal Vessel Area Density (a proxy for cerebral microvascular disease) and/or Retinal Nerve Fiber Layer thickness (a proxy for cerebral neurodegeneration) mediate treatment effects. This RCT is innovative because it will clarify whether improving glycemic control prevents cognitive decline in a high risk population and identify possible treatment mechanisms. This RCT is significant because it targets two major problems facing older AAs (i.e., poor glycemic control and dementia). AAs’ high risk for this comorbidity reflects the impact of cultural factors (e.g., health beliefs) and requires culturally relevant treatment. We have the experience and expertise to test this treatment, and the opportunity to change how DM is treated to prevent cognitive decline in AAs with MCI and DM and meet the goals of the National Alzheimer’s Project Act.

有30％的非洲裔美国人（AAS）具有轻度认知障碍（MCI）（DM），这增加了 控制不良的DM会大大增加这种风险，但是是否改善血糖 控制降低风险是不确定的。先前的研究缺乏解决这种不确定性的严格性。这 拟议的随机对照试验（RCT）研究高危人群，承认更严格。 单位点，双盲，主动控制，II期RCT将比较DM特异性行为的效率 激活（DM-BA）与增强的常规护理（EUC），以防止言语记忆下降（主要结果） 在65岁以上的200个AA中，有2年以上，具有敏感的多域MCI和控制不良的DM。 DM- BA是DM的行为治疗，也是痴呆症的次要预防策略。在DM-BA中，种族 - 一致的社区卫生工作者将：1）为MCI患者量身定制的家庭DM教育； 2）使用行动计划来增强DM自我保健； 3）与DM护士教育者一起促进远程医疗访问 DM护理和解决参与者的健康信念； 4）提高初级保健医生（PCP）对 参与者的认知缺陷和健康信念，以优化DM的治疗方法。控制治疗EUC是 通过DM自我保健教育增强了通常的医疗服务。 DM-BA和EUC都提供DM教育以及 拥有相同数量的家庭治疗访问（即6个月以来6次访问，在5次访问中进行了5次助推器访问 接下来的18个月）。但是，EUC不包括DM-BA改善血糖控制的行为方法， 远程医疗访问或PCP通信。治疗比较将确定DM-BA的特定效率 且高于EUC。参与者将从初级保健实践中招募。我们将管理霍普金斯 言语学习测试重新定义（HVLT-R）（评估口头记忆；主要结果）和统一 数据集神经心理电池（评估执行功能，处理速度，语言，视觉 功能和全球认知；所有探索性结果）在基线和第6、12、18和24月。 一级效率分析将比较2年内HVLT-R总回忆得分的轨迹 团体。我们还将探讨APOE基因型是否适应治疗效果以及光学是否 视网膜血管区域密度的相干断层扫描量度（脑微血管疾病的替代） 和/或视网膜神经纤维层厚度（脑神经退行性变性的代理）培养基治疗效果。 该RCT具有创新性，因为它将阐明改善血糖控制是否可以防止 高风险人群并确定可能的治疗机制。此RCT很重要，因为它针对两个 较老的AAS（即血糖控制和痴呆症）面临的主要问题。 AAS这种合并症的高风险 反映了文化因素（例如，健康信念）的影响，需要与文化相关的治疗。我们有 测试这种治疗方法的经验和专业知识，以及更改DM处理方式以防止的机会 MCI和DM的AAS认知能力下降，并符合《国家阿尔茨海默氏症计划法》的目标。