Aging, Cognition, and Hearing Evaluation in Elders (ACHIEVE) Randomized Trial

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Novel approaches to reduce the risk of age-related cognitive decline, Alzheimer’s disease (AD), and other dementias 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. To date, however, there has never been a randomized trial that has investigated whether such therapies could reduce cognitive decline and the risk of Alzheimer’s disease and other dementias in older adults. Over the past two years, we have developed the Aging, Cognition, and Hearing Evaluation in Elders (ACHIEVE) randomized trial. The ACHIEVE trial will recruit 750 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). The trial will be powered to detect a minimum of a 0.30 standard deviation (SD) difference in the annual rate of cognitive decline between the hearing intervention and the successful aging intervention arms over a 3-year follow-up period. The ACHIEVE study brings together a multidisciplinary group of investigators and leverages the existing research infrastructure, scientific expertise, and well-characterized participant cohort of the Atherosclerosis Risk in Communities Neurocognitive Study (ARIC-NCS). 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. Secondary Aims: 1) To investigate whether hearing rehabilitative intervention alters established trajectories of cognitive decline in participants recruited from ARIC-NCS. 2) To investigate the effect of hearing rehabilitative intervention on rates of cognitive decline in persons with Alzheimer’s disease risk factors and biomarkers. Given that nearly two-thirds of all adults 70 years and older have a clinically-significant hearing loss, conducting the ACHIEVE study to determine if existing hearing rehabilitative interventions can reduce the rate of cognitive decline in older adults is of substantial public health importance.