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.

30%患有轻度认知障碍（MCI）的非洲裔美国人（AA）患有（DM）， 发展为痴呆症的风险。血糖控制不佳的糖尿病会放大这种风险，但改善血糖控制是否 控制降低了不确定性风险。以前的研究缺乏解决这种不确定性的严谨性。的 拟议的随机对照试验（RCT）研究高风险人群，这赋予了更大的严格性。这 一项单中心、双盲、活性对照、II期RCT将比较DM特异性行为治疗的疗效。 激活（DM-BA）与增强型脑保护（EUC）预防非文字记忆下降（主要结局） 在200例年龄超过65岁的AA中，患有遗忘型多领域MCI和控制不佳的DM。DM- BA是DM的行为治疗，也是痴呆的二级预防策略。在DM-BA中，种族- 和谐的社区卫生工作者将：1）提供适合MCI患者的家庭糖尿病教育; 2)使用行动计划，以加强糖尿病自我护理; 3）促进远程医疗访问与糖尿病护士教育，以指导 DM护理和解决参与者的健康信念;和4）提高初级保健医生（PCP）对 参与者的认知缺陷和健康信念，以优化治疗DM。对照治疗EUC为 常规的医疗护理与DM自我护理教育相结合。DM-BA和EUC都提供DM教育， 具有相同数量的家庭治疗访问（即，6个月内6次访视， 未来18个月）。然而，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的具体疗效， 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 言语学习测验-修订版（HVLT-R）（评估言语记忆;主要结果）和统一 数据集神经心理成套测验（评估执行功能、处理速度、语言、视觉空间 功能和整体认知;所有探索性结局）。的 主要疗效分析将按治疗比较2年内HVLT-R总回忆评分的轨迹 组我们还将探讨APOE基因型是否会调节治疗效果，以及是否光学 视网膜血管面积密度的相干断层扫描测量（脑微血管疾病的代表） 和/或视网膜神经纤维层厚度（脑神经变性的代表）介导治疗效果。 这项随机对照试验具有创新性，因为它将阐明改善血糖控制是否可以预防认知功能下降， 高风险人群，并确定可能的治疗机制。这项随机对照试验意义重大，因为它针对两个 较旧的AA面临的主要问题（即，血糖控制不良和痴呆）。AA对这种并发症的高风险 反映了文化因素的影响（例如，健康信念），并需要文化相关的治疗。我们有 测试这种治疗的经验和专业知识，以及改变DM治疗方式以预防 认知功能下降的AAs与MCI和DM，并满足国家阿尔茨海默病项目法案的目标。