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: 9986336
• 负责人: JOSEF CORESH
• 金额: $ 38.98万
• 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/9986336
• 关键词: Administrative Supplement; Adult; Age-associated memory impairment; Aging; Alzheimer' s Disease; Alzheimer' s disease related dementia; Brain; Cognition; Cognitive; Counseling; Dementia; Education; Elderly; Enrollment; Evaluation; Health Educators; Hearing; Hearing Aids; Impaired cognition; Intervention; Needs Assessment; Outcome Measure; Pathway interactions; Peripheral; Physical Function; Physical activity; Population; Public Health; Randomized; Rehabilitation therapy; Research Design; Risk; Sample Size; Social Functioning; Structure; Technology; Training; adjudicate; clinically significant; cognitive change; cognitive load; epidemiology study; follow-up; health related quality of life; healthy aging; hearing impairment; hearing loss treatment; novel strategies; primary outcome; randomized trial; recruit; secondary outcome; social engagement; sound

Novel approaches to reduce the risk of age-related cognitive decline and Alzheimer's disease and related dementias (ADRD) 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. The ACHIEVE trial will recruit 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). This trial will have 90% power to detect a net effect size of 0.26 for the difference in cognitive change between the hearing intervention vs successful aging intervention at 3 years follow-up (corresponding to a 35% slowing in the annual rate of cognitive decline). 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. The ACHIEVE trial began recruitment in January 2018 and reached the target N of 850 on July 17, 2019. This application for an administrative supplement to the ACHIEVE randomized trial is to support an increase in the sample size of the ACHIEVE study from the original target of N = 850 up to potentially N ~ 1000. An extension in recruitment is consistent with recent discussions from the ACHIEVE DSMB which convened on June 27, 2019 and “supports consideration of a modest extension of the planned enrollment period to provide additional robustness of the study design to possible violations in the assumptions used in the power calculations”.

减少与年龄相关的认知下降和阿尔茨海默氏病及相关风险的新方法 迫切需要老年人的痴呆症（ADRD）才能使人口老龄化。流行病学研究 证明老年人的外围听力损失与 加速认知能力下降和事件痴呆症。假设的机械途径 观察到的关联包括听力不良和声音外围编码的影响 认知负载，大脑结构/功能和/或社会参与减少。重要的是，这些途径可能 通过使用听力技术的全面听力损失治疗进行修改 （助听器，其他集成的听力辅助设备）和康复培训。实现审判将 招募70-84岁的认知正常老年人听力损失，他们将被随机分为1：1 听力干预（听力需求评估，听力设备的安装，教育/咨询）或控制 干预措施（通过健康衰老的健康教育，个性化的成功衰老教育课程 主题）。该试验将具有90％的功率来检测认知变化差异的净效应大小为0.26 在3年随访时，听力干预与成功的老化干预措施之间（相当于35％ 认知能力下降的年度速度放缓）。实现试验具有以下目的：目标1确定 - 听力康复干预与成功的衰老控制干预措施的影响 70 84岁的认知衰落（主要结局指标）认知正常的老年人有听力 损失。目标2以确定听力康复干预与成功衰老控制的效果 干预调整事件痴呆，身体和社会的次要结局指标 功能，与健康相关的生活质量和体育锻炼。一月份的审判开始招聘 2018年，并于2019年7月17日达到850的目标n。 实现随机试验是支持从 n = 850至潜在n〜1000的原始目标。募集的扩展与最近 2019年6月27日召集的成就DSMB的讨论，“支持考虑 计划的入学期限适度的扩展，以提供研究设计的额外鲁棒性 在电源计算中使用的假设中可能违规”。