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: 10418325
• 负责人: JOSEF CORESH
• 金额: $ 412.39万
• 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/10418325
• 关键词: Adult; Affect; Age; Aging; Alzheimer' s disease related dementia; Alzheimer' s disease risk; Brain; Clinical; Cognitive; Cognitive aging; 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; Measures; Mediator of activation protein; Medical; Medicare claim; Observational Study; Outcome; Participant; Pathologic; Pathway interactions; Peripheral; Phase; Policies; Population; Randomized; Rehabilitation therapy; Risk; 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氏病及相关痴呆症 (ADRD) 风险的新方法 鉴于人口老龄化，迫切需要老年人。近十年来，通过观察 研究表明，周围性听力损失是最大的潜在可改变风险因素之一 痴呆症可能占所有痴呆症病例的 8-9%。所观察到的假设途径 通过使用听力技术（例如， 助听器）和康复训练。老年人衰老与认知健康评估 (ACHIEVE) 研究是 NIA 资助的正在进行的 III 期随机对照试验（R01AG055426，MPIs：Lin/Coresh）调查是否听力 丧失治疗与老龄化教育控制干预相比，可减少三年随访期间的认知衰退 上升期。 2018-19 年，我们招募了 977 名年龄在 70-84 岁、患有未经治疗的轻度至中度听力损失的成年人，他们 在基线（第 0 年）按 1:1 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（即与 健康教育者涵盖对健康老龄化重要的主题）。目前正在关注参与者 每半年在 ACHIEVE 现场进行一次，并计划于 2021-22 年进行最后一次三年级研究访问。三年级之后 访问期间，所有随机分配到 SA 教育对照组的参与者也将接受听力干预。 这项原始试验的第三年最终结果将表明听力干预（与成功的老龄化相比）是否 控制干预）可减少随机分组后 3 年间隔内的认知能力下降。我们现在建议 继续跟踪 ACHIEVE 队列另外 3 年（即直至第 6 年）以确定长期 听力干预的长期效果（即参与者在第 0 年随机分配到 HI）与成功的效果 老龄化/延迟 HI 控制（即，参与者在第 0 年随机分配到 SA，并在第 3 年之后提供 HI 访问）认知和大脑结果。鉴于认知障碍通常反映了缓慢的 随着病理变化的积累，HI 在减缓这种衰退方面的好处可能无法在 仅仅3年。因此，对队列进行为期 6 年的随访将使我们能够全面评估更长的、累积的 HI 对老年人的影响。这些发现将补充 2023 年的主要试验结果，并直接告知 围绕潜在使用听力干预措施降低 ADRD 风险的临床和政策决策。这 拟议的研究有以下目标： 目标 1 确定 HI 与 SA/延迟 HI 的长期影响 控制以下共同主要结果的发生率：(a) 认知能力下降和 (b) 轻度认知障碍事件 （MCI）/痴呆症。目标 2 确定 HI 与 SA/延迟 HI 控制对变化的长期影响 脑 MRI 测量：(a) 区域脑体积和 (b) 白质束完整性。次要目标：1) 研究导致 HI 治疗效果异质性的潜在因素； 2）调查医疗保健 通过分析医疗保险索赔数据，了解 HI 与 SA/延迟 HI 对照组之间的支出和利用率。