Key Points
Question
Does a hearing care intervention consisting of a community health worker–delivered personal sound amplification device improve communication function among older adults with hearing loss?
Findings
In this randomized clinical trial that included 151 participants, the hearing care intervention, compared with a wait-list control, resulted in significant improvement in self-perceived communication function (measured by change in the Hearing Handicap Inventory for the Elderly–Screening Version score; range, 0-40 [higher scores are worse]) at 3 months (estimated average treatment effect of –12.98 points).
Meaning
Among older adults with hearing loss, a community health worker–delivered intervention that included a personal sound amplification device intervention, compared with a wait-list control, significantly improved self-perceived communication function at 3 months.
Abstract
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
This randomized clinical trial assesses the effect of a community health worker–delivered personal sound amplification device intervention vs a wait-list control condition on self-perceived communication function at 3 months among older adults with hearing loss.
Introduction
Clinically significant hearing loss that can impair daily communication was prevalent in 64% of Americans aged 70 years or older based on nationally representative data from 2001 to 2010.1 Age-related hearing loss was independently associated with adverse health outcomes as highlighted by recent meta-analyses, including dementia (2018 and 2020),2,3 falls (2016),4 and depression (2020).5 Rehabilitative modalities that address hearing loss and strengthen communication function, such as through hearing aid use, may help mitigate these outcomes. However, hearing aid uptake among older Americans remained low based on nationally representative data from 1999 to 2006,6 and substantive disparities in hearing aid use persisted from 2005 to 2018.7,8 Disparities exist in part because hearing care is predominantly delivered through a clinic-based model that can include barriers to care, such as high out-of-pocket costs, a lack of or limited insurance coverage, availability of clinicians, and required multiple clinician visits.9
The incorporation of community health worker (CHW)–partnered models, including peer mentors, is an approach that reduces barriers and addresses disparities.10,11 Within hearing care, particularly for older adults, CHW-partnered models have received limited study,12,13 despite national and international recommendations.9,14 The HEARS (Hearing Health Equity Through Accessible Research and Solutions) intervention was designed as a structured hearing care program delivered by CHWs in a community setting that incorporates provision of a low-cost amplification device with education and counseling on age-related hearing loss.15 An initial pilot study of the intervention demonstrated feasibility and acceptability.15 To assess the efficacy of CHW-delivered hearing care when provided to older adults, a randomized clinical trial was conducted to test the hypothesis that the intervention improves self-perceived communication function at 3 months postintervention compared with a wait-list control.
Methods
Study Design
This randomized clinical trial was an open-label, 2-group, parallel-group trial. Participants were randomized 1:1 to the intervention vs wait-list control. The primary end point was assessed at 3 months postrandomization. All participants in the wait-list control were also offered the intervention after they reached the 3-month trial end point, and 12-month postintervention data were collected for both groups. Eligible participants provided informed consent and the trial was approved by the institutional review board of the Johns Hopkins University School of Medicine. The trial protocol was reviewed by the lead study investigators and the study’s scientific advisory board. The statistical analysis plan was prespecified by the lead statistician before being unblinded to study data. The study protocol was amended in March 2020 to incorporate telephone-based collection of all outcome measures in response to COVID-19–related safety measures. No further amendments were made. The trial protocol and statistical analysis plan are available in Supplement 1 and Supplement 2, respectively.
Study Setting and Participants
This community-engaged trial took place in Baltimore, Maryland, in partnership with a community advisory board established in 2014 with representation from local nonprofit housing organizations (Weinberg Senior Living and Catholic Charities) and community aging services leaders. Potential study sites were identified by the community advisory board and prioritized based on potential unmet hearing care needs, including buildings with a higher percentage of low-income older adult residents. A total of 13 local sites were identified, including affordable independent housing complexes for older adults (n = 10), senior centers (n = 2), and an older adult social club (n = 1).
Eligible trial participants were aged 60 years or older, had acquired hearing loss (audiometric pure tone average [PTA] across speech frequencies [0.5-4 kHz] in the better-hearing ear >25-dB hearing level), were not currently using a hearing aid or amplification device, and self-reported functional communication impairment (score ≥8 on the Hearing Handicap Inventory for the Elderly–Screening Version [HHIE-S]16,17). The HHIE-S measures the influence of hearing loss on daily communicative function, including restrictions in participation in daily life and the social and emotional effects secondary to communication difficulties related to hearing loss, such as feeling embarrassed meeting new people, feeling frustrated when talking to others, or limiting one’s social life.17,18 An HHIE-S score of 0 to 8 indicates no communication impairment; 10 to 24, mild to moderate communication impairment; and 26 to 40, significant communication impairment.17,18 In clinical practice, patients with a score above 8 are typically referred for further evaluation. Participants were excluded if they were unable to complete study instructions, including an automated hearing screening protocol, or had symptoms or signs of ear disease requiring medical evaluation prior to enrollment. Eligibility screening included self-report questions related to sudden change in hearing, asymmetric hearing loss, otalgia, otorrhea, and vertigo. If participants responded with a report of current or recent otologic symptoms within the past 3 to 6 months, they were advised to consult with their primary care clinician for further evaluation and possible referral to a specialist. After potential participants were cleared by their clinician, eligibility was reassessed. Data related to race and ethnicity were collected given known disparities in hearing care, particularly among African American older adults. Racial and ethnic identification was determined by participants and based on fixed categories.
Recruitment, Randomization, and Blinding
All recruitment events and study visits took place at the 13 community sites. Study personnel screened potential participants, and audiological testing was completed with an automated protocol on a calibrated tablet-based audiometer (Shoebox) with TDH-59 supra-aural headphones (Telephonics). Eligible participants provided written informed consent, completed baseline assessments with study personnel, and were randomly assigned 1:1 to the intervention group or the wait-list control. The “blockrand” package in R (R Foundation for Statistical Computing) was used to create randomization lists of permuted blocks of size 4 and 6, stratified by site to increase within-site balance in treatment allocation. The random seed choice and list generation was performed by another analyst outside the study team. Allocations were concealed using sealed, opaque envelopes, filled by volunteers outside the study team. Participants were enrolled by the study team, who provided the envelopes for participants to open at randomization. The lead investigators and statistician were blinded to participant group assignments and outcome data. Data collectors were unblinded to participant group assignments due to participants in the intervention group often wearing their amplification device to their follow-up visits.
Intervention and Interventionists
The intervention was a theory-driven, community-delivered approach to hearing care designed for older adults that incorporated fitting and orientation to a low-cost amplification device and hearing rehabilitation.15 The intervention focused on enhancing participants’ self-efficacy as related to incorporating communication strategies and using an amplification device in their daily routines as the intervention’s primary behavioral change mechanism of action15 and was designed to be delivered via a CHW-partnered model of care. The intervention was delivered by trained older adult CHWs who received indirect supervision by audiologist supervisors, consisting of weekly one-on-one calls and monthly continuing education meetings with fellow CHWs, supervisors, and study team members. The intervention was designed to be delivered in 1 to 2 sessions over less than 2 hours. Participants selected an amplification device, each of which is commercially available as a personal sound amplification product.19 The 2 device options were (1) a monaural ear-level device similar in form to a conventional behind-the-ear hearing aid that includes in situ fitting and verification via a smartphone-/tablet-based application (Sidekick; Sound World Solutions; retail price of approximately $450) or (2) a body-worn amplifier with a wired headset (SuperEar SE9000, Sonic Technology; retail price of approximately $100). Devices were selected based on their amplification quality, rechargeability, lack of reliance on a smartphone for daily use, and usability by older adults (eg, larger buttons or dials).19,20 All participants were provided the device at no cost as part of remuneration. All intervention sessions delivered by the CHWs were audio recorded for study purposes (eg, quality assurance, protocol fidelity monitoring).
Older adult CHWs delivered all aspects of the intervention. Potential CHWs were identified by community partners, interviewed by the study team, and invited to complete formal training. Potential CHWs were recognized leaders within their communities, able to read at a sixth-grade reading level, and willing to learn to use a tablet device. Two audiologist supervisors trained 10 CHWs. Training consisted of 8 weekly interactive sessions, each 1.5 hours, and culminated in certification that entailed delivering the intervention. A total of 9 older adult CHWs were certified. The CHWs received a quarterly remuneration of $135, the recommended amount by the community advisory board, and all transportation for CHWs was provided through a ride-sharing service business account.
Outcomes
Demographic data along with a health literacy screen (Rapid Estimate of Adult Literacy in Medicine–Short Form)21 and cognitive screen (Montreal Cognitive Assessment),22 self-reported prior hearing aid use, and technology ownership and use were collected at baseline. The primary outcome was change in self-perceived communication function from baseline to 3 months postrandomization as measured by the HHIE-S.17 Secondary outcomes included 3-month change from baseline in health-related quality of life, for which participants were instructed to consider hearing as part of their physical health (12-Item Short Form Health Survey; score range, 0-100; higher scores indicate better quality of life),23 depression (Patient Health Questionnaire 9; score range, 0-27; higher scores indicate worse depression; 0-4, minimal depression; 5-9, mild depression; 10-14, moderate depression; 15-19, moderately severe depression; 20-27, severe depression),24 social isolation (Social Network Index; score range, 0-103; higher scores indicate better social network),25 loneliness (UCLA Loneliness Scale; score range, 20-80, higher scores indicate worse loneliness),26 valuation of life (score range, 13-65; higher scores indicate better valuation),27 and technology and amplification device interest and self-efficacy (investigator adapted from subscales of the Attitudes Toward Computers Questionnaire; score range on each subscale, 5-25; higher scores indicate better attitudes).28 Listening self-efficacy was assessed as an indicator of the intervention’s underlying mechanism of action and measured using the Listening Self-Efficacy Questionnaire, specifically selecting items from the Dialogue in Quiet, Directed Listening, and Complex Listening subscales (score range on each item, 0-10; higher scores indicate better listening self-efficacy).29 The selected items from the Listening Self-Efficacy Questionnaire were totaled and considered a secondary outcome, while the individual subscales were exploratory outcomes. An investigator-developed hearing loss knowledge questionnaire was also administered as an exploratory measure (eTable 1 in Supplement 3; score range, 0-8; higher scores indicate better knowledge). There were no changes in trial outcomes after the trial commenced. All primary, secondary, and exploratory outcomes were prespecified. Outcome scores that could not be obtained due to missed items or “don’t know”/“refused” responses were treated as missing when no published methods were available to address such responses, and baseline change was considered missing if either the baseline or follow-up assessment did not yield a score.
Data Collection
Data were collected at baseline and at the 3-month end point, which was the primary time point. After the 3-month end point, the wait-list control group was also offered the intervention. Data were then collected at 12 months postintervention for both groups. Most data at the 3-month end point were collected in-person via interviewer-administered questionnaires in quiet, private spaces at each community site. The primary outcome measure was administered via telephone for participants who were (1) more than 3 months beyond the 3-month end point and unable or unwilling to meet the interviewer in person or (2) unable to meet the interviewer in person due to social distancing restrictions associated with the COVID-19 pandemic beginning in March 2020. Due to COVID-19 restrictions, the majority of 12-month data were collected virtually, either via telephone or videoconferencing, and all participants received printed questionnaires to accompany interviewer-provided oral prompts.
Sample Size Calculation
Based on the pilot study that demonstrated a large effect size on the HHIE-S (Cohen d = –0.74; n = 15),15 the investigators hypothesized an effect size of 0.60 with an attrition rate of 20%. The investigators aimed to enroll a total of 150 participants to achieve 90% power while maintaining a type I error rate of 0.05 using a 2-sample t test.
Statistical Analysis
All analyses were preplanned, prespecified, and conducted using the doubly robust weighted least squares estimator to reduce potential bias and improve precision.30,31 This method estimates the average treatment effect of the intervention, the comparison in population average outcomes between all individuals being assigned to the treatment group and all individuals being assigned to the wait-list control group. The doubly robust weighted least squares estimator uses an outcome regression model with weights to account for imbalance in baseline covariates between treatment groups and missing data. The analytic weights involve a propensity score weight and an inverse probability of attrition weight (IPAW). Code for the estimator was written by J.B. and validated by E.E.G.M. A sensitivity analysis repeated the analysis with exclusion of outcomes obtained more than 30 days outside of the study window to assess the influence of outcomes obtained outside the protocol window. A post hoc sensitivity analysis assessed the influence of imputation by using the screening HHIE-S scores to impute missing baseline HHIE-S scores. All randomized participants were included in analyses, including the primary analysis, and were analyzed according to how they were randomized irrespective of the treatment they received. An additional secondary analysis estimated the complier average causal effect by including weights from a propensity model to account for differences in baseline HHIE-S, age, and PTA between those who did and did not adhere to the intervention.32 Adherence was defined as attending all intervention sessions and reporting at least 1 hour per day of amplification device use 3 months postintervention.
In each analysis, the propensity score models, IPAW models, and outcome models included the baseline value of the outcome, age, and PTA in the better-hearing ear as linear terms, and estimates are valid under the assumption that data are missing at random given this information and treatment assignment.
Means and their differences at 3 months postrandomization and 12 months postintervention were estimated using IPAW to account for missing data. Specification of IPAW models was identical to the inverse-weight models in the primary and secondary analyses. Twelve-month postintervention IPAW models additionally included 3-month postrandomization change in the outcome as a covariate.
Ninety-five percent confidence intervals were obtained using bias-corrected and accelerated bootstrap resampling procedure with 10 000 replicates. Mean or mode imputation of any missing baseline covariates was performed within each bootstrap sample. All analyses conducted were reported, and confidence intervals for secondary and exploratory analyses were not adjusted for multiplicity. Statistical significance was assessed at the .05 level using 2-sided testing. Because of the potential for type I error due to multiple comparisons, findings for analyses of secondary end points should be interpreted as exploratory. Given the low-risk nature of the intervention, no interim analyses and stopping guidelines were applied. Analyses were completed using Stata version SE 16.0 (StataCorp) and R version 4.2.0.
Results
Trial Population and Baseline Characteristics
A total of 348 individuals underwent screening, 188 individuals were deemed eligible, and 151 individuals enrolled and were randomized, with 78 assigned to the intervention and 73 randomized to wait-list control (Figure 1). Recruitment efforts occurred from April 2018 to October 2019, interventions were delivered from May 2018 to February 2020, and data collection for the 3-month end point occurred from August 2018 to June 2020. Data for the 12-month end point were collected from June 2019 to July 2021. Complete data for change from baseline to the 3-month end point for the HHIE-S were available for 136 participants (90.1%) for the primary outcome. In the intervention group, 93.6% (73/78) completed the intervention, and 90.5% (57/63) completed the intervention session and reported at least 1 hour of daily amplification use at 3 months postrandomization. At the 12-month end point, complete data for the change from baseline to 12 months postintervention were available for 105 participants (69.5%), and 75% (72/96) reported at least 1 hour of daily amplification use.
Figure 1. Participant Flow in the HEARS Trial.
HEARS indicates Hearing Health Equity Through Accessible Research and Solutions; HHIE-S, Hearing Handicap Inventory for the Elderly–Screening Version (range, 0-40; scores of 0-8 indicate no communication impairment; 10-24, mild to moderate communication impairment; and 26-40, significant communication impairment)16,17; PTA, speech-frequency pure tone average (includes 0.5 to 4 kHz in the better-hearing ear).
aIndividuals who reported a potentially concerning otologic symptom (eg, sudden change in hearing, asymmetric hearing, otalgia, otorrhea, vertigo) in the past 3 to 6 months. Individuals were advised to see their primary care clinician or specialist before continuing with the study. These individuals were either not cleared by their clinician or did not reach back out to the study team to indicate that the symptom(s) resolved.
bAll analyses used inverse probability of attrition weights (IPAW) to account for missing data. Models for IPAW included participant age, pure tone average, and the outcome score at baseline, and were fit using all randomized participants. Missing baseline outcomes were imputed. IPAW models for 12 months postintervention additionally included 3-month postrandomization change.
Among the 151 participants, the mean age was 76.7 years (SD, 8.0 years), 67.8% self-identified as female, and 43% self-identified as Black or African American (Table 1). Most participants (63.6%) reported less than $25 000 in annual household income, had a mean health literacy level of seventh grade to eighth grade, and had a mean Montreal Cognitive Assessment score of 23.0. Participants’ mean speech-frequency PTA was a 42.0-dB hearing level (SD, 12.0 dB), and 78.1% reported no prior hearing aid or amplification device use. Approximately half of the participants neither owned nor used a computer (50.3%), and 45.3% did not own a smartphone.
Table 1. Baseline Participant Characteristics.
| Characteristics | Intervention (n = 78) | Control (n = 73) |
|---|---|---|
| Age, mean (SD), y | 75.7 (7.0) | 77.7 (8.9) |
| Self-identified sex, No./total (%) | ||
| Female | 47/78 (60.3) | 54/71 (76.1) |
| Male | 31/78 (39.7) | 17/71 (23.9) |
| Self-identified race and ethnicity, No. (%) | ||
| Black | 40 (51.3) | 25 (34.2) |
| Hispanic | 1 (1.3) | 2 (2.7) |
| Non-Hispanic White | 37 (47.4) | 39 (53.4) |
| Othera | 0 | 7 (9.6) |
| Education, No. (%) | ||
| Less than high school | 21 (26.9) | 21 (28.8) |
| High school or equivalent | 20 (25.6) | 22 (30.1) |
| More than high school | 37 (47.4) | 30 (41.1) |
| REALM-SF score, mean (SD)b | 6.1 (1.7) | 6.1 (1.8) |
| Annual household income, $, No./total (%) | ||
| <25 000 | 48/73 (65.8) | 48/71 (67.6) |
| 25 000-49 999 | 16/73 (21.9) | 16/71 (22.5) |
| 50 000-74 999 | 7/73 (9.6) | 4/71 (5.6) |
| 75 000-99 999 | 2/73 (2.7) | 2/71 (2.8) |
| 100 000-149 999 | 0/73 | 1/71 (1.4) |
| Living alone, No. (%) | 53 (67.9) | 56 (76.7) |
| MoCA score, mean (SD)c | 22.6 (4.4) | 23.5 (3.9) |
| Speech-frequency pure tone average, mean (SD), dB hearing leveld | 41.5 (12.8) | 42.6 (11.2) |
| Hearing loss categorization, No. (%) | ||
| Mild (>25- to 40-dB hearing level) | 43 (55.1) | 35 (47.9) |
| Moderate or greater (>40-dB hearing level) | 35 (44.9) | 38 (52.1) |
| Prior hearing aid or amplification device use, No. (%) | ||
| No prior device use | 66 (84.6) | 52 (71.2) |
| Prior device use | 11 (14.1) | 21 (28.8) |
| Don’t know | 1 (1.3) | 0 |
| Owns smartphone, No. (%) | 42/78 (53.8) | 40/72 (55.6) |
| Computer use within past month, No. (%) | ||
| Does not have or use a computer | 38 (48.7) | 38 (52.1) |
| Has or uses a computer but did not use the internet | 9 (11.5) | 6 (8.2) |
| Has or uses a computer and used the internet | 31 (39.7) | 29 (39.7) |
| Text or email use within past month, No. (%) | ||
| Not within the past month | 33 (42.3) | 26 (35.6) |
| Some days or rarely | 18 (23.1) | 23 (31.5) |
| Most days | 27 (34.6) | 24 (32.9) |
Other includes individuals who self-identified as American Indian or Alaska Native, Asian, or other race.
Rapid Estimate of Adult Literacy in Medicine–Short Form (REALM-SF): score range, 0-7 (higher scores indicate better literacy); 0, third-grade reading level or below; 1-3, fourth- to sixth-grade reading level; 4-6, seventh- to eighth-grade reading level; 7: high school reading level.
Montreal Cognitive Assessment (MoCA): score range, 0-30 (higher scores indicate better cognition); 30-26, normal cognition; 25-18, mild cognitive impairment; 17-10, moderate cognitive impairment; <10, severe cognitive impairment.
Speech-frequency pure tone average includes 0.5 to 4 kHz in the better-hearing ear.
Primary Outcome
The primary outcome, 3-month change in self-perceived communication function as measured by the HHIE-S, demonstrated significant improvement among the intervention group compared with control (Table 2 and Figure 2). Mean (SD) 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. The average treatment effect of the intervention on 3-month change from baseline in self-perceived communication function as measured by the HHIE-S was –12.98 (95% CI, –15.51 to –10.42) (Table 2; see eTable 5 in Supplement 3 for unadjusted analyses).
Table 2. Primary and Select Secondary Trial Outcomes at 3 Months by Treatment Group.
| Outcome measure | Intervention group (n = 78) | Control group (n = 73) | Between-group change difference (95% CI)a | Average treatment effect of intervention (95% CI) | ||||
|---|---|---|---|---|---|---|---|---|
| Baseline, mean (SD) | 3 Months, mean (SD) | 3-Month change, mean (SD) | Baseline, mean (SD) | 3 Months, mean (SD) | 3-Month change, mean (SD) | |||
| Primary outcome | ||||||||
| HHIE-S score (communication function)b | 21.7 (9.4) [n = 76] | 7.9 (9.2) [n = 70] | –13.2 (10.3) [n = 68] | 20.1 (10.1) [n = 71] | 21.0 (9.1) [n = 70] | 0.6 (7.1) [n = 68] | –13.79 (–16.79 to –10.82) | –12.98 (–15.51 to –10.42)c |
| Selected secondary outcomes | ||||||||
| Health-related quality of life | ||||||||
| SF-12 mental component scored | 48.5 (10.1) [n = 75] | 49.2 (10.1) [n = 62] | 1.1 (11.2) [n = 59] | 49.4 (9.9) [n = 70] | 48.1 (9.5) [n = 68] | –1.4 (10.0) [n = 66] | 2.62 (–1.14 to 6.37) | 2.38 (–0.87 to 5.61) |
| SF-12 physical component scored,e | 39.0 (11.0) [n = 75] | 43.6 (11.7) [n = 62] | 4.4 (10.4) [n = 59] | 39.4 (11.1) [n = 70] | 38.8 (10.7) [n = 68] | –0.4 (10.1) [n = 66] | 4.80 (1.09 to 8.36) | 4.58 (0.70 to 7.91) |
| Psychosocial | ||||||||
| UCLA Loneliness Scale scoref | 23.3 (10.0) [n = 75] | 21.1 (9.0) [n = 61] | –2.8 (8.7) [n = 59] | 20.6 (9.2) [n = 71] | 20.2 (8.5) [n = 65] | –0.6 (7.0) [n = 63] | –2.26 (–5.25 to 0.40) | –0.71 (–3.11 to 1.58) |
| PHQ-9 scoreg | 6.0 (4.5) [n = 75] | 5.1 (4.8) [n = 63] | –1.0 (4.3) [n = 61] | 5.9 (4.5) [n = 68] | 5.7 (5.6) [n = 67] | –0.2 (4.0) [n = 63] | –0.75 (–2.07 to 0.74) | –0.69 (–2.04 to 0.74) |
| SNI network diversityh | 4.7 (1.9) [n = 75] | 5.0 (1.9) [n = 60] | 0.3 (1.2) [n = 58] | 4.9 (1.7) [n = 71] | 4.9 (1.8) [n = 65] | 0.0 (1.2) [n = 63] | 0.33 (–0.08 to 0.74) | 0.25 (–0.14 to 0.66) |
| SNI network size, median (IQR)h | 19.0 (13.0 to 27.0) [n = 75] | 21.0 (11.0 to 31.2) [n = 60] | 0.0 (–5.0 to 8.0) [n = 58] | 20.0 (11.0 to 27.0) [n = 71] | 20.0 (12.0 to 29.0) [n = 65] | 0.0 (–4.0 to 5.5) [n = 63] | 0.94 (–2.22 to 4.20) | 1.02 (–2.10 to 4.31) |
| Valuation of life scorei | 53.6 (8.0) [n = 75] | 54.1 (7.3) [n = 63] | 0.1 (6.9) [n = 60] | 53.7 (6.4) [n = 69] | 53.3 (6.3) [n = 69] | –0.6 (5.1) [n = 65] | 0.71 (–1.36 to 2.96) | 0.39 (–1.44 to 2.33) |
| Listening self-efficacy | ||||||||
| LSEQ adapted total scorej | 28.9 (10.3) [n = 78] | 39.3 (10.1) [n = 61] | 10.8 (11.3) [n = 61] | 28.9 (9.1) [n = 71] | 28.2 (8.2) [n = 70] | –0.7 (8.1) [n = 68] | 11.51 (8.13 to 14.99) | 11.31 (8.37 to 14.14) |
Difference in mean change from baseline between intervention and control. Absolute difference, the difference in mean outcomes between the intervention and control groups, can be found in eTable 5 in Supplement 3.
Hearing Handicap Inventory for the Elderly–Screening Version (HHIE-S): range, 0-40; scores of 0-8 indicate no communication impairment; 10-24, mild to moderate communication impairment; and 26-40, significant communication impairment.16,17 Primary outcome data were unavailable for 15 individuals, 7 who had items that were missing or incomplete at either the baseline or the 3-month end point, 1 who obtained hearing aids prior to receiving the intervention and withdrew, 1 who withdrew consent, 2 who were lost to follow-up, and 4 who died of causes unrelated to the study as determined by the study investigators (reported to the institutional review board).
Primary outcome.
12-Item Short Form Health Survey (SF-12): range, 0-100 (higher scores indicate better quality of life).23
Participants were instructed to consider hearing loss as part of their physical health when completing the SF-12.
UCLA Loneliness Scale: range, 20-80 (higher scores indicate worse loneliness).26
Patient Health Questionnaire 9 (PHQ-9): range, 0-27 (higher scores indicate worse depression); 0-4, minimal depression; 5-9, mild depression; 10-14, moderate depression; 15-19, moderately severe depression; 20-27, severe depression.24
Social Network Index (SNI): range, 0-103 (higher scores indicate better social network).25
Valuation of life: range, 13-65 (higher scores indicate better valuation).27
Listening Self-Efficacy Questionnaire (LSEQ) adapted total score includes select items from the Dialogue in Quiet, Directed Listening, and Complex Listening subscales; score range on each item, 0-10 (higher scores indicate better listening self-efficacy).29
Figure 2. HHIE-S Scores at Baseline and 3 Months Postrandomization.
HHIE-S indicates Hearing Handicap Inventory for the Elderly–Screening Version (range, 0-40; scores of 0-8 indicate no communication impairment; 10-24, mild to moderate communication impairment; and 26-40, significant communication impairment).16,17 In panels A and B, boxes vertically extend from the 75th to the 25th percentile. The median is indicated by the horizontal line in the box. The vertical length of the box is the interquartile IQR. The whiskers extend from quartile 3 to the largest observed value between quartile 3 and (quartile 3 + 1.5 × IQR) and from quartile 1 to the smallest observed value between (quartile 1 − 1.5 × IQR) and quartile 1. The violin plot overlaid on the box plot represents the distribution of the observed values, similar to a histogram that is made symmetric around the vertical axis.
In a prespecified sensitivity analysis, results were not sensitive to treating HHIE-S data collected outside of the 3-month follow-up window as missing (estimated average treatment effect, –13.75; 95% CI, –16.22 to –11.07). Results were similar in a post hoc sensitivity analysis that used screening HHIE-S scores to impute missing baseline HHIE-S scores (estimated average treatment effect, –12.96; 95% CI, –15.48 to –10.33). Results were also comparable with the complier average causal effect, the estimated effect of the intervention among those who would adhere to the intervention if it were offered to them (complier average causal effect, –13.92; 95% CI, –16.50 to –11.05).
Secondary Outcomes
Among the secondary outcomes, participants who completed the intervention reported significant improvements in the physical component of the 12-Item Short Form Health Survey health-related quality of life score, with an average treatment effect of 4.58 (95% CI, 0.70-7.91) (Table 2). An adapted measure of listening self-efficacy demonstrated significant improvement in self-efficacy among the intervention group (mean score, 10.8 [SD, 11.3]) compared with the control group (mean score, –0.7 [SD, 8.1]), with an average treatment effect of 11.31 (95% CI, 8.37-14.14) (Table 2). Additional secondary outcomes related to loneliness, depression, valuation of life, social isolation, and technology-related self-efficacy were not significantly different between the intervention and control groups (summarized in Table 2 and eTables 2 and 5 in Supplement 3).
12-Month Postintervention Outcomes
Participants in the wait-list control group were offered the intervention after the 3-month end point, and 12-month postintervention outcomes were assessed in all participants. Both groups demonstrated significant, sustained, and comparable improvements in self-perceived communication function as measured by the HHIE-S at the 12-month postintervention end point, with a mean HHIE-S score of 10.77 (95% CI, 8.43-13.57) and a mean change in HHIE-S score of –10.25 (95% CI, –13.11 to –7.56) in participants randomized to the intervention group, and a mean HHIE-S score of 11.40 (95% CI, 9.11-13.99) and mean change in HHIE-S score of –9.45 (95% CI, –13.03 to –5.96) in participants randomized to the wait-list control group who received the intervention at 3 months (eTables 3, 4, and 5 in Supplement 3). The difference in HHIE-S mean scores between the 2 groups at 12 months postintervention was –0.64 (95% CI, –4.19 to 2.81).
Adverse Events
There were 4 non–study-related deaths that occurred during the study. No other serious or nonserious adverse events occurred.
Discussion
Among older adults with hearing loss, a community health worker–delivered intervention, including a personal sound amplification device and hearing rehabilitation, compared with a wait-list control condition, significantly improved self-perceived communication function at 3 months. The results support the potential for CHW-partnered models within hearing care as an additional care model needed to address the growing burden of age-related hearing loss.
To the authors’ knowledge, this randomized clinical trial was the first of a CHW-delivered hearing care intervention designed for older adults that included provision of amplification.33 The improvements in self-perceived communication function were comparable in magnitude with improvements documented for older adults who received conventional clinic-based hearing care with provision of hearing aids by audiologists.34,35,36,37 Hearing aid users in one study had a comparable mean baseline score of 18.7 with an improvement in self-perceived communication function of –7.96 on the HHIE-S 6 months following receipt of hearing aids fit by audiologists in a US-based academic audiology practice.34 A 2017 Cochrane review of hearing aids included a study that used the full-length HHIE (score range, 0-100) and found a mean difference of –10.54 in a community-based sample with hearing aid use.35,36 In addition, the improvement in self-perceived communication function was maintained through 12 months postintervention and was comparable with findings of hearing aid users 12 months after fitting.34
Consistent with another study that demonstrated that hearing aids can improve overall health-related quality of life in a clinic-based sample within the Veterans Administration,35,38 the secondary outcome analyses suggest that the CHW-delivered hearing care intervention significantly improved physical health-related quality of life when hearing was considered part of physical health.35 However, these findings were not significant at 12 months postintervention. Regarding additional secondary outcomes at 3 and 12 months, analyses did not demonstrate a significant change in loneliness, depression, or social isolation.
To the authors’ knowledge, this trial was the largest trial to date of a hearing care intervention in the US of African American older adults and low-income older adults with hearing loss.39 Unlike prior hearing-related trials, the cohort reflected populations underrepresented within hearing care who have largely gone unserved by existing care models.7,8,39 The cohort’s low baseline use of technology, including smartphone ownership, underscored the need for diverse approaches to enable a spectrum of older adults to benefit from hearing technologies, many of which require some degree of technology access and literacy. Hence, although more affordable hearing aids are available directly over the counter to US consumers as directed by the US Food and Drug Administration,40 many older adults may still not be able to benefit from such technologies without the concurrent availability of hearing care services.
Limitations
This study has several limitations. First, the study team who collected outcomes were unblinded and were aware of group assignments given that many participants in the intervention group wore their amplification devices to follow-up visits. Second, the study cohort may have limited generalizability to other populations given the focus on a primarily urban-dwelling population of individuals who identify as low income, most of whom were recruited in partnership with affordable independent housing complexes. Third, the wait-list control group condition in this trial has limitations and did not include an active comparison, such as hearing aids obtained through an audiologist or inclusion of a sham device. Fourth, potential spillover effects may have occurred because some of the community sites included independent housing complexes and senior centers, and it is unknown how potential improvements in one participant’s self-perceived communication function may have influenced another’s self-perceived communication function. Community health workers may vary in intervention delivery. Fifth, the provision of an amplification device at no cost as a form of renumeration may have biased participants’ responses.
Conclusions
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 Protocol
Statistical Analysis Plan
eTable 1. Hearing Loss Knowledge Questionnaire – Investigator-Developed Survey
eTable 2. Additional Secondary & Exploratory Trial Outcomes 3-Months Post-Randomization by Treatment Group
eTable 3. Primary and Select Secondary Trial Outcomes 12-Months Post-Intervention by Treatment Group
eTable 4. Additional Secondary & Exploratory Trial Outcomes 12-Months Post-Intervention by Treatment Group
eTable 5. Means & Confidence Intervals for Outcomes at Baseline, 3-Months Post-Randomization, and 12-Months Post-Intervention
eReferences
Data Sharing Statement
References
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Trial Protocol
Statistical Analysis Plan
eTable 1. Hearing Loss Knowledge Questionnaire – Investigator-Developed Survey
eTable 2. Additional Secondary & Exploratory Trial Outcomes 3-Months Post-Randomization by Treatment Group
eTable 3. Primary and Select Secondary Trial Outcomes 12-Months Post-Intervention by Treatment Group
eTable 4. Additional Secondary & Exploratory Trial Outcomes 12-Months Post-Intervention by Treatment Group
eTable 5. Means & Confidence Intervals for Outcomes at Baseline, 3-Months Post-Randomization, and 12-Months Post-Intervention
eReferences
Data Sharing Statement