Objectives

The main objective of ACHIEVE was to determine the effect of a hearing intervention (vs. a health education control) on the primary outcome of global cognitive decline over a period of 3 years in 70-84-year-old community-dwelling, cognitively normal adults with hearing loss.

Background

Novel approaches for reducing cognitive decline in older adults are needed, given the aging of the population and the personal, socioeconomic, and public health burden of cognitive impairment and dementia in older adults. Efforts to address this global health issue have increasingly focused on identifying potentially modifiable risk factors that could be targeted to help reduce the risk of cognitive decline and dementia. Epidemiologic data now strongly suggest that age-related peripheral hearing loss, prevalent in 65% of adults older than 60 years, is independently associated with accelerated cognitive decline and incident dementia. Mechanistic pathways that could underlie this observed association include the effects of poor audition and distorted peripheral encoding of sound on cognitive load, brain structure, and/or reduced social engagement. These pathways may be modifiable with comprehensive hearing treatment and rehabilitative training, but notably, hearing aids are currently underutilized by adults with hearing impairment in the US and worldwide. To date, there has never been a randomized trial that has investigated whether hearing loss treatment could reduce cognitive and other functional declines in older adults. Therefore, the ACHIEVE study aimed to investigate the effects of a hearing intervention (vs. health education control) on cognitive decline among community-dwelling older adults.

Participants

ACHIEVE participants were recruited from the ongoing Atherosclerosis Risk in Communities (ARIC) study or de novo from the surrounding communities. Main inclusion criteria were being aged 70-84 years, with adult-onset bilateral hearing loss with a better-ear four-frequency (0.5-4.0 kHz) pure-tone average (PTA) of 30 or more dB and less than 70 dB, free of substantial cognitive impairment (Mini-Mental State Examination [MMSE] score >23 for participants with a high-school degree or less and >25 for those with some college education or more), word-recognition score in quiet at least 60% correct in the better-hearing ear, community dwelling, and being a fluent English speaker. Main exclusion criteria were self-reported disability in two or more activities of daily living, presenting visual acuity worse than 20/63 on the MNREAD acuity chart (corresponding to inability to comfortably read 14-point font), self-reported hearing aid use in the past year, permanent conductive hearing loss, medical contraindication to hearing aid use, or unwillingness to wear hearing aids on a regular basis. Audiologically-related inclusion and exclusion criteria were specified to identify individuals who would be expected to benefit from amplification with conventional hearing aids and related audiological services.

The ACHIEVE study randomized 977 older adults 1:1 to either a clinic-based, best practices hearing intervention with hearing aids (n=490) or a successful aging health education control intervention (n=487). Of the 977 participants, 238 were recruited from the ARIC study, while 739 were new healthy community volunteers recruited de novo from the surrounding communities.

Design

ACHIEVE was a multicenter, parallel-group, unmasked randomized controlled trial. Eligible participants were randomized (1:1) to the hearing intervention or the health education control intervention. Eligible spouses or cohabitating partners were randomized as a unit. Participants randomized to the hearing intervention condition were fitted with hearing aids, instructed to wear them on a daily basis for study duration, and attended four 1-hour intervention sessions spaced over the 2-3 months post-randomization. Re-instruction in use of devices and hearing rehabilitative strategies were provided every 6 months. Participants randomized to the health education control intervention completed four 1-hour intervention sessions spaced over the 2-3 months post-randomization, focusing on topics related to chronic disease and disability prevention from the 10 Keys™ to Healthy Aging program and also completed upper-body stretching. Additional sessions were provided every 6 months. Routine follow-up clinic visits for both groups occurred every six months until year 3.

The primary endpoint was 3-year change in a global cognition standardized factor score from a comprehensive neurocognitive battery. An important secondary outcome was time until cognitive impairment. Additional secondary outcomes included decline in the cognitive domains of memory, executive function, and language. The ACHIEVE study also looked at the effects of treating hearing loss on other health outcomes, including mental health and well-being, physical activity and function, and health care use.

Conclusions

Hearing intervention (vs. health education control) did not reduce 3-year global cognitive decline in the overall cohort. However, in a prespecified sensitivity analysis of the ARIC and de novo cohorts, findings suggest that hearing intervention may reduce cognitive decline over 3 years in populations of older adults at increased risk for cognitive decline, but not in populations at decreased risk for cognitive decline.

Lin FR, Pike JR, Albert MS, et al. Hearing intervention versus health education control to reduce cognitive decline in older adults with hearing loss in the USA (ACHIEVE): a multicentre, randomised controlled trial. Lancet. 2023;402(10404):786-797. doi:10.1016/S0140-6736(23)01406-X

Deal JA, Goman AM, Albert MS, et al. Hearing treatment for reducing cognitive decline: Design and methods of the Aging and Cognitive Health Evaluation in Elders randomized controlled trial. Alzheimers Dement (N Y). 2018;4:499-507. Published 2018 Oct 5. doi:10.1016/j.trci.2018.08.007

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