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Randomized Controlled Trial
. 2024 Dec;72(12):3784-3799.
doi: 10.1111/jgs.19185. Epub 2024 Sep 12.

Effect of hearing intervention on communicative function: A secondary analysis of the ACHIEVE randomized controlled trial

Affiliations
Randomized Controlled Trial

Effect of hearing intervention on communicative function: A secondary analysis of the ACHIEVE randomized controlled trial

Victoria A Sanchez et al. J Am Geriatr Soc. 2024 Dec.

Abstract

Background: The Aging and Cognitive Health Evaluation in Elders (ACHIEVE) Study was designed to determine the effects of a best-practice hearing intervention on cognitive decline among community-dwelling older adults. Here, we conducted a secondary analysis of the ACHIEVE Study to investigate the effect of hearing intervention on self-reported communicative function.

Methods: The ACHIEVE Study is a parallel-group, unmasked, randomized controlled trial of adults aged 70-84 years with untreated mild-to-moderate hearing loss and without substantial cognitive impairment. Participants were randomly assigned (1:1) to a hearing intervention (audiological counseling 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 semiannually for 3 years. Self-reported communicative function was measured with the Hearing Handicap Inventory-Elderly Screening version (HHIE-S, range 0-40, higher scores indicate greater impairment). Effect of hearing intervention versus control on HHIE-S was analyzed through an intention-to-treat model controlling for known covariates.

Results: HHIE-S improved after 6-months with hearing intervention compared to control, and continued to be better through 3-year follow-up. We estimated a difference of -8.9 (95% CI: -10.4, -7.5) points between intervention and control groups in change in HHIE-S score from baseline to 6 months, -9.3 (95% CI: -10.8, -7.9) to Year 1, -8.4 (95% CI: -9.8, -6.9) to Year 2, and - 9.5 (95% CI: -11.0, -8.0) to Year 3. Other prespecified sensitivity analyses that varied analytical parameters did not change the observed results.

Conclusions: Hearing intervention improved self-reported communicative function compared to a control intervention within 6 months and with effects sustained through 3 years. These findings suggest that clinical recommendations for older adults with hearing loss should encourage hearing intervention that could benefit communicative function and potentially have positive downstream effects on other aspects of health.

Keywords: clinical trial; cognition; functional disability; hearing handicap; hearing loss.

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Conflict of interest statement

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. Dr. Reed reported serving on the scientific advisory boards of Neosensory. Dr. Schrack is a consultant to Edwards Lifesciences. 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. All other authors report no relevant disclosures.

Figures

FIGURE 1
FIGURE 1
Modified consort flow diagram showing how many participants were enrolled (n = 977); randomized to either the hearing intervention (n = 490) or the health education control intervention (n = 487); and the complete datasets from baseline through Year 3 follow‐up. Hearing Handicap Inventory for the Elderly—Screening version (HHIE‐S) was the primary outcome of interest and detailed completed, incomplete or missing scores are noted at all assessment time points.
FIGURE 2
FIGURE 2
(A and B) Blue represents the control intervention while red represents the hearing intervention group. In the top panel (A), Hearing Handicap Inventory for the Elderly—Screening version (HHIE‐S) score for each group is shown at Baseline (gray) and at 6 months (6 M) and Years 1–3 (Y1, Y2, Y3). Clinical scaling of the HHIE‐S is shown with gray horizontal lines indicating No Handicap (0–8), Mild–Moderate (10–24), and Severe (26–40). The bottom panel (B) shows a waterfall plot for each participant indicating their starting HHIE‐S score at baseline to their final HHIE‐S score at Year 3.
FIGURE 3
FIGURE 3
Proportion of participants with clinically significant Hearing Handicap Inventory for the Elderly—Screening version (HHIE‐S) scores (greater than mild handicap, score ≥10) by intervention assignment. Blue represents the control intervention while red represents the hearing intervention group. *p < 0.001.

References

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