Long-term effects of hearing intervention on brain health in the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) randomized study

老年人衰老和认知健康评估 (ACHIEVE) 随机研究中听力干预对大脑健康的长期影响

• 批准号: 10680434
• 负责人: JOSEF CORESH
• 金额: $ 340.65万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-15 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10680434
• 关键词: Adult; Affect; Age; Aging; Alzheimer' s disease related dementia; Brain; Brain region; Clinical; Cognitive; Complement; Control Groups; County; Data; Dementia; Education; Elderly; Evaluation; Follow-Up Studies; Health; Health Educators; Health Expenditures; Healthcare; Hearing; Hearing Aids; Heterogeneity; Impaired cognition; Intervention; Long-Term Effects; Magnetic Resonance Imaging; Measures; Mediator; Medical; Medicare claim; Observational Study; Outcome; Participant; Pathologic; Pathway interactions; Peripheral; Phase; Policies; Population; Randomized; Rehabilitation therapy; Risk; Risk Reduction; Role; Schedule; Services; Severities; Site; Social Functioning; Structure; Technology; Time; Training; Visit; Washington; brain health; brain magnetic resonance imaging; brain volume; clinical care; cognitive load; cohort; dementia risk; follow-up; healthy aging; hearing impairment; hearing loss treatment; mild cognitive impairment; modifiable risk; novel strategies; primary outcome; randomized trial; recruit; social engagement; sound; treatment effect; white matter

Novel approaches to reduce the risk of cognitive decline and Alzheimer's disease and related dementias (ADRD) in older adults are urgently needed given the aging of the population. Over the past decade, observational research has implicated peripheral hearing loss as being one of the largest potentially modifiable risk factors for dementia that may account for 8-9% of all dementia cases. Hypothesized pathways underlying this observed association may be modifiable with hearing loss treatment consisting of the use of hearing technologies (e.g., hearing aids) and rehabilitative training. The Aging & Cognitive Health Evaluation in Elders (ACHIEVE) study is an ongoing, NIA-sponsored Phase III RCT (R01AG055426, MPIs: Lin/Coresh) investigating whether hearing loss treatment versus an aging education control intervention reduces cognitive decline over a three-year follow- up period. From 2018-19, we recruited 977 adults ages 70-84 with untreated mild-to-moderate hearing loss who were randomized 1:1 at baseline (Year 0) to receive hearing intervention (HI; best-practice hearing services and technologies) versus a successful aging (SA) education control intervention (i.e., one-on-one sessions with a health educator covering topics important for healthy aging). Participants are currently being followed semiannually at the ACHIEVE field sites with final Year 3 study visits scheduled from 2021-22. After their Year 3 visit, all participants randomized to the SA education control group will also be offered the hearing intervention. Final Year 3 results from this original trial will indicate whether hearing intervention (versus a successful aging control intervention) reduces cognitive decline over a 3-year interval after randomization. We now propose to continue following the ACHIEVE cohort for an additional 3 years (i.e., up to Year 6) to determine the long- term effects of hearing intervention (i.e., participants randomized to HI at Year 0) versus successful aging/delayed HI control (i.e., participants randomized to SA at Year 0 and offered HI after their Year 3 visit) on cognitive and brain outcomes. Given that cognitive impairment typically reflects the slow accumulation of pathologic changes, the benefits of HI in slowing this decline may not be fully appreciable within just 3 years. Therefore, this 6-year follow-up of the cohort will allow us to fully evaluate the longer, cumulative impact of HI on older adults. Such findings will complement the main trial results in 2023 and directly inform clinical and policy decisions around the potential use of hearing interventions to reduce the risk of ADRD. This proposed study has the following aims: Aim 1 To determine the long-term effect of HI versus SA/Delayed HI control on rates of the co-primary outcomes of: (a) cognitive decline and (b) incident mild cognitive impairment (MCI)/dementia. Aim 2 To determine the long-term effect of HI versus SA/Delayed HI control on changes in brain MRI measures of: (a) regional brain volumes and (b) white matter tract integrity. Secondary Aims: 1) To investigate potential factors contributing to HI treatment effect heterogeneity; 2) To investigate health care expenditures and utilization between the HI vs SA/Delayed HI control groups by analyzing Medicare claims data.

降低认知能力下降和阿尔茨海默病及相关痴呆（ADRD）风险的新方法 鉴于人口老龄化，迫切需要老年人。在过去的十年里，观察 研究表明，外周听力损失是最大的潜在可改变的风险因素之一， 痴呆症可能占所有痴呆症病例的8-9%。观察到的潜在假设途径 关联可以用包括使用听力技术的听力损失治疗来改变（例如， 助听器和康复训练。老年人老化和认知健康评估（ACHIEVE）研究 一项正在进行的、由NIA申办的III期RCT（R 01 AG 055426，MPI：Lin/Coresh），研究听力 损失治疗与老龄化教育控制干预相比，在三年的随访中减少了认知能力的下降- 上时期。从2018年到2019年，我们招募了977名年龄在70-84岁之间的成年人，他们患有未经治疗的轻度至中度听力损失， 在基线（第0年）按1：1的比例随机接受听力干预（HI;最佳实践听力服务和 技术）与成功的老龄化（SA）教育控制干预（即，一对一的会议， 健康教育者，涵盖健康老龄化重要主题）。目前正在跟踪参与者 每半年在ACHIEVE现场进行一次，计划于2021-22年进行最后一次第3年研究访视。3年后 访视时，所有随机分配到SA教育对照组的受试者也将接受听力干预。 这项原始试验的最终第3年结果将表明听力干预（与成功老化相比） 对照干预）在随机化后的3年时间间隔内减少认知下降。我们现建议 继续随访ACHIEVE队列3年（即，（6）确定长期- 听力干预的长期效果（即，第0年随机分配至HI的受试者）与成功 老化/延迟HI控制（即，参与者在第0年随机分配到SA，并在第3年后提供HI 认知和大脑结果。鉴于认知障碍通常反映了 由于病理变化的累积，HI在减缓这种下降方面的益处可能并不完全明显， 仅仅3年。因此，该队列的6年随访将使我们能够充分评估较长的累积 HI对老年人的影响。这些发现将补充2023年的主要试验结果，并直接提供信息。 围绕听力干预的潜在用途的临床和政策决策，以降低ADRD的风险。这 本研究的目的如下：目的1：确定HI与SA/延迟HI的长期效应 控制以下共同主要结局的发生率：（a）认知下降和（B）偶发轻度认知障碍 (MCI)/痴呆症。目的2：确定HI与SA/延迟HI对照对以下变化的长期影响： 脑MRI测量：（a）局部脑体积和（B）白色物质束完整性。第二个目标：1） 探讨HI治疗效果异质性的潜在因素; 2）调查卫生保健 通过分析医疗保险索赔数据，比较HI与SA/延迟HI对照组之间的支出和利用率。