Aging, Cognition, and Hearing Evaluation in Elders (ACHIEVE) Randomized Trial

老年人的衰老、认知和听力评估 (ACHIEVE) 随机试验

• 批准号: 9287053
• 负责人: JOSEF CORESH
• 金额: $ 378.98万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-06-01 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9287053
• 关键词: Adult; Affect; Age-associated memory impairment; Aging; Alleles; Alzheimer' s Disease; Alzheimer' s disease risk; Amyloid; Atherosclerosis Risk in Communities; Biological Markers; Blood Vessels; Brain; Cognition; Cognitive; Communities; Counseling; Data; Dementia; Development; Devices; Disabled Persons; Dropout; Education; Elderly; Enrollment; Evaluation; Funding; Goals; Grant; Health Educators; Hearing; Hearing Aids; Impaired cognition; Intervention; Loneliness; Magnetic Resonance Imaging; Measures; Mediating; Modeling; Needs Assessment; Nerve Degeneration; Neurocognitive; Observational Study; Outcome; Outcome Measure; Participant; Pathway interactions; Peripheral; Persons; Physical Function; Physical activity; Pilot Projects; Population; Positron-Emission Tomography; Prevalence; Process; Public Health; Quality of life; Randomized; Recruitment Activity; Rehabilitation therapy; Research Infrastructure; Research Personnel; Risk; Risk Factors; Self-Help Devices; Signal Transduction; Site; Social Functioning; Social Network; Structure; Technology; Training; Visit; adjudicate; arm; base; clinically significant; cognitive change; cognitive function; cognitive load; cohort; epidemiology study; follow-up; group intervention; health related quality of life; healthy aging; hearing impairment; improved; multidisciplinary; novel strategies; primary outcome; prospective; randomized trial; secondary outcome; social engagement; sound; synergism; trend

Novel approaches to reduce the risk of age-related cognitive decline, Alzheimer’s disease (AD), and other dementias in older adults are urgently needed given the aging of the population. Epidemiologic studies demonstrate that peripheral hearing loss in older adults is strongly and independently associated with accelerated cognitive decline and incident dementia. Hypothesized mechanistic pathways underlying this observed association include the effects of poor hearing and distorted peripheral encoding of sound on cognitive load, brain structure/function, and/or reduced social engagement. Importantly, these pathways may be modifiable with comprehensive hearing loss treatment consisting of the use of hearing technologies (hearing aids, other integrated hearing assistive devices) and rehabilitative training. To date, however, there has never been a randomized trial that has investigated whether such therapies could reduce cognitive decline and the risk of Alzheimer’s disease and other dementias in older adults. Over the past two years, we have developed the Aging, Cognition, and Hearing Evaluation in Elders (ACHIEVE) randomized trial. The ACHIEVE trial will recruit 750 70-84 year-old cognitively-normal older adults with hearing loss who will be randomized 1:1 to the hearing intervention (hearing needs assessment, fitting of hearing devices, education/counseling) or control intervention (individualized successful aging education sessions with a health educator covering healthy aging topics). The trial will be powered to detect a minimum of a 0.30 standard deviation (SD) difference in the annual rate of cognitive decline between the hearing intervention and the successful aging intervention arms over a 3-year follow-up period. The ACHIEVE study brings together a multidisciplinary group of investigators and leverages the existing research infrastructure, scientific expertise, and well-characterized participant cohort of the Atherosclerosis Risk in Communities Neurocognitive Study (ARIC-NCS). The ACHIEVE trial has the following aims: Aim 1 To determine the effect of hearing rehabilitative intervention versus a successful aging control intervention on rates of cognitive decline (primary outcome measure) in 70‐ 84 year‐old cognitively-normal older adults with hearing loss. Aim 2 To determine the effect of hearing rehabilitative intervention versus a successful aging control intervention on secondary outcome measures of adjudicated incident dementia, physical and social functioning, health-related quality of life, and physical activity. Secondary Aims: 1) To investigate whether hearing rehabilitative intervention alters established trajectories of cognitive decline in participants recruited from ARIC-NCS. 2) To investigate the effect of hearing rehabilitative intervention on rates of cognitive decline in persons with Alzheimer’s disease risk factors and biomarkers. Given that nearly two-thirds of all adults 70 years and older have a clinically-significant hearing loss, conducting the ACHIEVE study to determine if existing hearing rehabilitative interventions can reduce the rate of cognitive decline in older adults is of substantial public health importance.

降低与年龄相关的认知能力下降、阿尔茨海默病 (AD) 和其他疾病风险的新方法 鉴于人口老龄化，迫切需要对老年人进行痴呆症的流行病学研究。 证明老年人的周围性听力损失与以下因素密切且独立相关： 加速认知衰退和痴呆事件的假设机制。 观察到的关联包括听力不佳和声音的外围编码失真对 重要的是，这些途径可能会导致认知负荷、大脑结构/功能和/或社交参与减少。 可以通过使用听力技术等综合性听力损失治疗来改变 然而，迄今为止，还存在助听器、其他综合听力辅助设备）和康复训练。 从来没有一项随机试验调查过这种疗法是否可以减少认知能力下降 以及老年人患阿尔茨海默病和其他痴呆症的风险在过去两年中。 开展了老年人衰老、认知和听力评估 (ACHIEVE) 随机试验。 试验将招募 750 名 70-84 岁认知正常但患有听力损失的老年人，他们将按照 1:1 的比例随机分配 听力干预（听力需求评估、听力设备安装、教育/咨询）或 控制干预（由健康教育者提供的个性化成功的老龄化教育课程，涵盖 健康老龄化主题）。该试验将检测至少 0.30 标准差 (SD)。 听力干预与成功老龄化之间认知能力年下降率的差异 ACHIEVE 研究汇集了多学科小组。 的研究人员并利用现有的研究基础设施、科学专业知识和良好的特征 社区神经认知研究动脉粥样硬化风险 (ARIC-NCS) 的参与者队列。 ACHIEVE 试验有以下目标： 目标 1 确定听力康复干预的效果 与成功的衰老控制干预对 70 岁儿童认知能力下降率（主要结果指标）的比较 84 岁认知正常但患有听力损失的老年人 目标 2 确定听力的影响。 康复干预与成功的衰老控制干预对次要结果指标的影响 判定的痴呆事件、身体和社会功能、与健康相关的生活质量以及身体状况 次要目标： 1) 调查听力康复干预是否改变既定的结果。 ARIC-NCS 招募的参与者认知能力下降的轨迹 2) 研究听力的影响。 对患有阿尔茨海默氏病危险因素和认知能力下降的人进行康复干预 鉴于近三分之二的 70 岁及以上成年人具有具有临床意义的听力。 进行 ACHIEVE 研究以确定现有的听力康复干预措施是否可以减少听力损失 老年人认知能力下降的速度对公共卫生具有重要意义。