Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2024 Nov 4;7(11):e2446591.
doi: 10.1001/jamanetworkopen.2024.46591.

A Hearing Intervention and Health-Related Quality of Life in Older Adults: A Secondary Analysis of the ACHIEVE Randomized Clinical Trial

Alison R Huang  1   2 , Emmanuel Garcia Morales  1   2 , Michelle L Arnold  3 , Sheila Burgard  4 , David Couper  4 , Jennifer A Deal  1   2 , Nancy W Glynn  5 , Theresa Gmelin  5 , Adele M Goman  6 , Lisa Gravens-Mueller  4 , Kathleen M Hayden  7 , Christine M Mitchell  1 , James S Pankow  8 , James R Pike  9 , Nicholas S Reed  1   2 , Victoria A Sanchez  3 , Jennifer A Schrack  1 , Kevin J Sullivan  10 , Josef Coresh  9 , Frank R Lin  1   2 , Theresa H Chisolm  3 ; ACHIEVE Collaborative Research Group
Collaborators, Affiliations
Randomized Controlled Trial

A Hearing Intervention and Health-Related Quality of Life in Older Adults: A Secondary Analysis of the ACHIEVE Randomized Clinical Trial

Alison R Huang et al. JAMA Netw Open. .

Abstract

Importance: Health-related quality of life is a critical health outcome and a clinically important patient-reported outcome in clinical trials. Hearing loss is associated with poorer health-related quality-of-life in older adults.

Objective: To investigate the 3-year outcomes of hearing intervention vs health education control on health-related quality of life.

Design, setting, and participants: This secondary analysis of a randomized clinical trial included participants treated for hearing loss at multiple US centers between 2018 and 2019 with 3-year follow-up completed in 2022. Eligible participants were aged 70 to 84 years, had untreated hearing loss, and were without substantial cognitive impairment. Participants were randomized (1:1) to hearing intervention or health education control and followed every 6 months.

Intervention: Hearing intervention (provision of hearing aids and related technologies, counseling, education) or health education control (individual sessions covering topics relevant to chronic disease, disability prevention).

Main outcomes and measures: Three-year change in the RAND-36 physical and mental health component scores over 3 years. The 8 individual domains of health-related quality-of-life were additionally assessed. Outcomes measured at baseline and at 6-month, 1-year, 2-year, and 3-year follow-ups. Intervention effect sizes estimated using a 2-level linear mixed effects model under the intention-to-treat principle.

Results: A total of 977 participants were analyzed (mean [SD] age, 76.8 [4.0] years; 523 female [53.5%]; 112 Black [11.5%], 858 White [87.8%]; 521 had a Bachelor's degree or higher [53.4%]), with 490 in the hearing intervention and 487 in the control group. Over 3 years, hearing intervention (vs health education control) had no significant association with physical (intervention, -0.49 [95% CI, -3.05 to 2.08]; control, -0.92 [95% CI, -3.39 to 1.55]; difference, 0.43 [95% CI, -0.64 to 1.51]) or mental (intervention, 0.38 [95% CI, -1.58 to 2.34]; control, -0.09 [95% CI, -1.99 to 1.81]; difference, 0.47 [95% CI, -0.41 to 1.35]) health-related quality of life.

Conclusions and relevance: In this secondary analysis of a randomized clinical trial, hearing intervention had no association with physical and mental health-related quality-of-life over 3 years among older adults with hearing loss. Additional intervention strategies may be needed to modify health-related quality among older adults with hearing loss.

Trial registration: ClinicalTrials.gov Identifier: NCT03243422.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Dr Arnold reported receiving grants from National Institute on Deafness and Other Communication Disorders and National Institute on Aging (NIA) outside the submitted work. Dr Couper reported contracts to his institution from National Institutes of Health (NIH) during the conduct of the study. Dr Reed reported service on an advisory board with Neosensory Inc during the conduct of the study. Dr Sanchez reported industry funding related to consulting or research support from Otonomy 395 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. Dr Schrack reported service on the scientific advisory board from BellSant, Inc and personal fees from Edwards Lifesciences outside the submitted work. Dr Lin reported consulting work with Frequency Therapeutics and Apple Inc outside the submitted work; he served as a board member for the nonprofit Access HEARS; he reported serving as director of a public health research center funded in part by a philanthropic gift from Cochlear Ltd to the Johns Hopkins Bloomberg School of Public Health. Dr Chisolm reported a subcontract grant from NIH NIA during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Trial Profile
RAND-36 indicates the RAND-36 Health Survey.
Figure 2.
Figure 2.. Covariate-Adjusted Analysis of 3-Year Change in RAND-36 Health-Related Quality of Life Physical and Mental Health Component Summary Scores and Domain Scores by Intervention Assignment in the ACHIEVE Study
Higher RAND-36 Health Survey health-related quality of life domain scores and physical and mental health component scores represent better health-related quality of life. A positive value for the difference in 3-year domain scores between hearing intervention and control indicates a positive effect of hearing intervention; a negative value for the difference in 3-year domain scores between hearing intervention and control indicates a positive effect of the health education control. Models adjusted for covariates measured at baseline (age, sex, education, marital status, hearing loss severity, global cognition, recruitment source, field site, and whether the participant was part of a recruited spousal pair), and the interaction between time and all covariates. ACHIEVE indicates Aging and Cognitive Health Evaluation in Elders.
See this image and copyright information in PMC

References

    1. Lin FR, Pike JR, Albert MS, et al. ; ACHIEVE Collaborative Research Group . 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 - DOI - PMC - PubMed
    1. Karimi M, Brazier J. Health, health-related quality of life, and quality of life: what is the difference? Pharmacoeconomics. 2016;34(7):645-649. doi:10.1007/s40273-016-0389-9 - DOI - PubMed
    1. Haywood KL, Garratt AM, Fitzpatrick R. Quality of life in older people: a structured review of generic self-assessed health instruments. Qual Life Res. 2005;14(7):1651-1668. doi:10.1007/s11136-005-1743-0 - DOI - PubMed
    1. Phyo AZZ, Ryan J, Gonzalez-Chica DA, et al. ; ASPREE Investigator Group . Health-related quality of life and incident cardiovascular disease events in community-dwelling older people: a prospective cohort study. Int J Cardiol. 2021;339:170-178. doi:10.1016/j.ijcard.2021.07.004 - DOI - PMC - PubMed
    1. Phyo AZZ, Gonzalez-Chica DA, Stocks NP, et al. ; ASPREE Investigator Group . The utility of assessing health-related quality of life to predict cognitive decline and dementia. J Alzheimers Dis. 2021;80(2):895-904. doi:10.3233/JAD-201349 - DOI - PMC - PubMed

Publication types

Associated data