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

Frank R Lin; James R Pike; Marilyn S Albert; Michelle Arnold; Sheila Burgard; Theresa Chisolm; David Couper; Jennifer A Deal; Adele M Goman; Nancy W Glynn; Theresa Gmelin; Lisa Gravens-Mueller; Kathleen M Hayden; Alison R Huang; David Knopman; Christine M Mitchell; Thomas Mosley; James S Pankow; Nicholas S Reed; Victoria Sanchez; Jennifer A Schrack; B Gwen Windham; Josef Coresh; ACHIEVE Collaborative Research Group

doi:10.1016/S0140-6736(23)01406-X

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 Sep 2;402(10404):786-797. doi: 10.1016/S0140-6736(23)01406-X. Epub 2023 Jul 18.

Authors

Frank R Lin¹, James R Pike², Marilyn S Albert³, Michelle Arnold⁴, Sheila Burgard⁵, Theresa Chisolm⁴, David Couper⁵, Jennifer A Deal⁶, Adele M Goman⁷, Nancy W Glynn⁸, Theresa Gmelin⁸, Lisa Gravens-Mueller⁵, Kathleen M Hayden⁹, Alison R Huang¹⁰, David Knopman¹¹, Christine M Mitchell², Thomas Mosley¹², James S Pankow¹³, Nicholas S Reed⁶, Victoria Sanchez¹⁴, Jennifer A Schrack¹⁵, B Gwen Windham¹², Josef Coresh²; ACHIEVE Collaborative Research Group

Affiliations

¹ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Otolaryngology-Head & Neck Surgery, Johns Hopkins School of Medicine, Baltimore, MD, USA; Center on Aging and Health, Johns Hopkins University, Baltimore, MD, USA. Electronic address: flin1@jh.edu.
² Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
³ Department of Neurology, Johns Hopkins School of Medicine, Baltimore, MD, USA.
⁴ Department of Communication Sciences & Disorders, College of Behavioral & Community Sciences, University of South Florida, Tampa, FL, USA.
⁵ Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.
⁶ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Otolaryngology-Head & Neck Surgery, Johns Hopkins School of Medicine, Baltimore, MD, USA.
⁷ School of Health and Social Care, Edinburgh Napier University, Edinburgh, UK.
⁸ Department of Epidemiology, University of Pittsburgh School of Public Health, Pittsburgh, PA, USA.
⁹ Department of Social Sciences and Health Policy, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
¹⁰ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
¹¹ Department of Neurology, Mayo Clinic, Rochester, MN, USA.
¹² The MIND Center, University of Mississippi Medical Center, Jackson, MS, USA.
¹³ Division of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis, MN, USA.
¹⁴ Department of Otolaryngology-Head & Neck Surgery, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.
¹⁵ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Center on Aging and Health, Johns Hopkins University, Baltimore, MD, USA.

Abstract

Background: Hearing loss is associated with increased cognitive decline and incident dementia in older adults. We aimed to investigate whether a hearing intervention could reduce cognitive decline in cognitively healthy older adults with hearing loss.

Methods: The ACHIEVE study is a multicentre, parallel-group, unmasked, randomised controlled trial of adults aged 70-84 years with untreated hearing loss and without substantial cognitive impairment that took place at four community study sites across the USA. Participants were recruited from two study populations at each site: (1) older adults participating in a long-standing observational study of cardiovascular health (Atherosclerosis Risk in Communities [ARIC] study), and (2) healthy de novo community volunteers. Participants were randomly assigned (1:1) to a hearing intervention (audiological counselling and provision of hearing aids) or a control intervention of health education (individual sessions with a health educator covering topics on chronic disease prevention) and followed up every 6 months. The primary endpoint was 3-year change in a global cognition standardised factor score from a comprehensive neurocognitive battery. Analysis was by intention to treat. This trial was registered at ClinicalTrials.gov, NCT03243422.

Findings: From Nov 9, 2017, to Oct 25, 2019, we screened 3004 participants for eligibility and randomly assigned 977 (32·5%; 238 [24%] from ARIC and 739 [76%] de novo). We randomly assigned 490 (50%) to the hearing intervention and 487 (50%) to the health education control. The cohort had a mean age of 76·8 years (SD 4·0), 523 (54%) were female, 454 (46%) were male, and most were White (n=858 [88%]). Participants from ARIC were older, had more risk factors for cognitive decline, and had lower baseline cognitive scores than those in the de novo cohort. In the primary analysis combining the ARIC and de novo cohorts, 3-year cognitive change (in SD units) was not significantly different between the hearing intervention and health education control groups (-0·200 [95% CI -0·256 to -0·144] in the hearing intervention group and -0·202 [-0·258 to -0·145] in the control group; difference 0·002 [-0·077 to 0·081]; p=0·96). However, a prespecified sensitivity analysis showed a significant difference in the effect of the hearing intervention on 3-year cognitive change between the ARIC and de novo cohorts (p_interaction=0·010). Other prespecified sensitivity analyses that varied analytical parameters used in the total cohort did not change the observed results. No significant adverse events attributed to the study were reported with either the hearing intervention or health education control.

Interpretation: The hearing intervention did not reduce 3-year cognitive decline in the primary analysis of the total cohort. However, a prespecified sensitivity analysis showed that the effect differed between the two study populations that comprised the cohort. These findings suggest that a hearing intervention might reduce cognitive change over 3 years in populations of older adults at increased risk for cognitive decline but not in populations at decreased risk for cognitive decline.

Funding: US National Institutes of Health.

Publication types

Randomized Controlled Trial
Multicenter Study
Observational Study
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

Aged
Atherosclerosis*
Cognition
Cognitive Dysfunction* / prevention & control
Female
Health Education
Hearing
Hearing Loss* / prevention & control
Humans
Male

Associated data

ClinicalTrials.gov/NCT03243422

Abstract

Publication types

MeSH terms

Associated data

Grants and funding