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.

减少与年龄相关的认知衰退、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，迫切需要老年人中的痴呆症。流行病学研究 证明老年人的外周听力损失与 认知功能减退和偶发痴呆症。这背后的假设的机械路径 观察到的关联包括听力差和声音的周围编码扭曲对 认知负荷、大脑结构/功能和/或社交参与度降低。重要的是，这些途径可能 可通过使用听力技术的综合听力损失治疗进行修改 (助听器、其他综合助听器)和康复训练。然而，到目前为止，有 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。在过去的两年里，我们 开发了老年人的年龄、认知和听力评估(AQUE)随机试验。成就 试验将招募750名70-84岁认知正常的听力损失老年人，他们将被随机分为1：1 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(个性化成功的老年教育课程，由健康教育者提供 健康老龄化主题)。该试验将检测到最小0.30标准偏差(SD) 听力干预和成功老龄化之间认知功能减退年率的差异 干预武器超过3年的随访期。成就研究汇集了一个多学科小组 并利用现有的研究基础设施、科学专业知识和良好的特点 社区神经认知研究中动脉粥样硬化风险的参与者队列(ARIC-NCS)。这个 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认知减退率(主要结果衡量标准)的对比 84岁，认知正常，听力受损的老年人。目的2确定听力效果 康复干预与成功的衰老控制干预对老年人二次结局测量的比较 已判定的事件痴呆、身体和社会功能、与健康相关的生活质量和身体 活动。次要目标：1)调查听力康复干预是否改变了已建立的 从ARIC-NCS招募的参与者认知衰退的轨迹。2)调查听证的效果 康复干预对阿尔茨海默病高危人群认知功能减退率的影响 生物标志物。鉴于近三分之二的70岁及以上的成年人有临床意义的听力 损失，进行实现研究，以确定现有的听力康复干预是否可以减少 老年人的认知减退率对公共卫生具有重大意义。