Effect of a Community Health Worker-Delivered Personal Sound Amplification Device on Self-Perceived Communication Function in Older Adults With Hearing Loss: A Randomized Clinical Trial.

Importance: Age-related hearing loss that impairs daily communication is associated with adverse health outcomes, but use of hearing aids by older adults is low and disparities exist. Objective: To test whether an affordable, accessible hearing care intervention, delivered by community health workers using over-the-counter hearing technology, could improve self-perceived communication function among older adults with hearing loss compared with a wait-list control. Design, Setting, and Participants: Open-label randomized clinical trial conducted between April 2018 and October 2019 with 3-month data collection completed in June 2020. The trial took place at 13 community sites, including affordable independent housing complexes (n = 10), senior centers (n = 2), and an older adult social club (n = 1) in Baltimore, Maryland. A total of 151 participants aged 60 years or older with hearing loss were randomized. Interventions: Participants were randomized to receive a community health worker-delivered hearing care intervention (n = 78) or to a wait-list control group (n = 73). The 2-hour intervention consisted of fitting a low-cost amplification device and instruction. Main Outcomes and Measures: The primary outcome was change in self-perceived communication function (Hearing Handicap Inventory for the Elderly-Screening Version [HHIE-S]; score range, 0-40; higher scores indicate poorer function) from baseline to 3 months postrandomization. The average treatment effect was estimated using the doubly robust weighted least squares estimator, which uses an outcome regression model weighted by the inverse probability of attrition to account for baseline covariate imbalance and missing data. Results: Among 151 participants randomized (mean age, 76.7 [SD, 8.0] years; 101 [67.8%] women; 65 [43%] self-identified as African American; 96 [63.6%] with low income [<$25 000 annual household income]), 136 (90.1%) completed 3-month follow-up for the primary outcome. In the intervention group, 90.5% completed the intervention session and reported at least 1 hour of daily amplification use at 3 months postrandomization. Mean scores for the HHIE-S were 21.7 (SD, 9.4) at baseline and 7.9 (SD, 9.2) at 3 months (change of -13.2 [SD, 10.3]) in the intervention group, and 20.1 (SD, 10.1) at baseline and 21 (SD, 9.1) at 3 months (change of 0.6 [SD, 7.1]) in the control group. Self-perceived communication function significantly improved in the intervention group compared with the control group, with an estimated average treatment effect of the intervention of a -12.98-point HHIE-S change (95% CI, -15.51 to -10.42). No study-related adverse events were reported. Conclusions and Relevance: Among older adults with hearing loss, a community health worker-delivered personal sound amplification device intervention, compared with a wait-list control, significantly improved self-perceived communication function at 3 months. Findings are limited by the absence of a sham control, and further research is needed to understand effectiveness compared with other types of care delivery models and amplification devices. Trial Registration: ClinicalTrials.gov Identifier: NCT03442296.