Recruitment and baseline data of the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) study: A randomized trial of a hearing loss intervention for reducing cognitive decline.

Introduction: Hearing loss is highly prevalent among older adults and independently associated with cognitive decline. The Aging and Cognitive Health Evaluation in Elders (ACHIEVE) study is a multicenter randomized control trial (partially nested within the infrastructure of an observational cohort study, the Atherosclerosis Risk in Communities [ARIC] study) to determine the efficacy of best-practice hearing treatment to reduce cognitive decline over 3 years. The goal of this paper is to describe the recruitment process and baseline results.
Methods: Multiple strategies were used to recruit community-dwelling 70-84-year-old participants with adult-onset hearing loss who were free of substantial cognitive impairment from the parent ARIC study and de novo from the surrounding communities into the trial. Participants completed telephone screening, an in-person hearing, vision, and cognitive screening, and a comprehensive hearing assessment to determine eligibility.
Results: Over a 24-month period, 3004 telephone screenings resulted in 2344 in-person hearing, vision, and cognition screenings and 1294 comprehensive hearing screenings. Among 1102 eligible, 977 were randomized into the trial (median age = 76.4 years; 53.5% female; 87.8% White; 53.3% held a Bachelor's degree or higher). Participants recruited through the ARIC study were recruited much earlier and were less likely to report hearing loss interfered with their quality of life relative to participants recruited de novo from the community. Minor differences in baseline hearing or health characteristics were found by recruitment route (i.e., ARIC study or de novo) and by study site.
Discussion: The ACHIEVE study successfully completed enrollment over 2 years that met originally projected rates of recruitment. Substantial operational and scientific efficiencies during study startup were achieved through embedding this trial within the infrastructure of a longstanding and well-established observational study.
Highlights: The ACHIEVE study tests the effect of hearing intervention on cognitive decline.The study is partially nested within an existing cohort study.Over 2 years, 977 participants recruited and enrolled.Eligibility assessed by telephone and in-person for hearing, vision, and cognitive screening.The ACHIEVE study findings will have significant public health implications.
Competing Interests: Dr. Reed reported serving on the scientific advisory boards of Neosensory. Dr. Lin reported being a consultant to Frequency Therapeutics and Apple and being the director of a research center funded in part by a philanthropic gift from Cochlear Ltd to the Johns Hopkins Bloomberg School of Public Health. Dr. Lin is also a board member of the nonprofit Access HEARS. Dr. Sanchez reported industry funding related to consulting or research support from Otonomy Inc., Autifony Therapeutics Ltd., Boehringer Ingelheim, Frequency Therapeutics Ltd., Pipeline Therapeutics, Aerin Medical, Oticon Medical, Helen of Troy Ltd., Sonova Holding AG, and Phonak USA. Theresa Gmelin reports funding by The National Institute on Aging, Epidemiology of Aging training grant at the University of Pittsburgh T32 AG000181. All other authors report no relevant disclosures. Author disclosures are available in the Supporting information
(© 2024 The Authors. Alzheimer's & Dementia: Translational Research & Clinical Interventions published by Wiley Periodicals LLC on behalf of Alzheimer's Association.)