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氏病的风险和相关痴呆症（ADRD）的新方法 鉴于人口的老化，迫切需要老年人。在过去的十年中，观察性 研究暗示外围听力损失是最大的可能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％。该观察到的假设的途径 关联可能会与听力治疗的听力疗法进行修改，包括使用听力技术（例如， 助听器）和康复培训。老年人（成就）研究的衰老和认知健康评估是 正在进行的，NIA赞助的III期RCT（R01AG055426，MPIS：LIN/CORESH）正在研究是否有听力 损失治疗与老龄化的教育控制干预措施在三年后的后续行动中降低了认知能力下降 - 上升期。从2018-19开始，我们招募了977名70-84岁的成年人，未经治疗的轻度到中度听力损失谁 在基线（0年）中随机分配1：1以接受听证干预（HI；最佳实践听力服务和 技术与成功的衰老（SA）教育控制干预措施（即一对一的会议 健康教育者涵盖对健康衰老很重要的主题。目前正在遵循参与者 半年度在成就场地，最后3年级的研究访问定于2021 - 22年。 3年级之后 访问，所有参与者都将随机分配给SA教育控制小组。 最终试验的最后一年级结果将指示听证干预是否（与成功的衰老相比） 控制干预）在随机分组后的3年间隔内降低了认知能力下降。我们现在建议 继续跟随成就队列再持续3年（即6年级），以确定长期 听力干预的期限影响（即，参与者在0年度随机分配给HI）与成功 老化/延迟的HI控制（即，参与者在0年度随机分配给SA，并在他们的3年后提供HI 访问）认知和大脑结果。鉴于认知障碍通常反映出慢 病理变化的积累，HI在减慢这种下降方面的好处可能并不完全明显 仅3年。因此，该队列的6年随访将使我们能够完全评估较长的累积性 HI对老年人的影响。这样的发现将在2023年补充主要试验结果，并直接告知 围绕听力干预措施降低ADRD风险的潜在使用临床和政策决策。这 拟议的研究具有以下目的：目标1确定HI与SA/延迟HI的长期效应 控制以下共同结果的比率：（a）认知能力下降和（b）事件轻度认知障碍 （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 大脑MRI的测量值：（a）区域大脑体积和（b）白质道的完整性。次要目标：1） 研究导致HI治疗效应异质性的潜在因素； 2）调查医疗保健 通过分析Medicare索赔数据，HI与SA/延迟HI对照组之间的支出和利用。