N/A
N=151
Baltimore HEARS: Hearing Health Equity Through Accessible Research & Solutions
Age-related Hearing Impairment 1 · Personal Communication
Bottom Line
View on ClinicalTrials.gov: NCT03442296 ↗Enrolled (actual)
151
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S) — -13.2; .06 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Baltimore HEARS (Behavioral); Baltimore HEARS (Device)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S) |
-10.3; -8.2 | — |
| SECONDARY Change From Baseline in Revised UCLA Loneliness Scale |
-1.3; -1.9 | — |
| SECONDARY Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9) |
-0.3; -1.1 | — |
| SECONDARY Change From Baseline in Short Form-12 (SF-12) Mental Component Score |
1.1; -1.4 | — |
| SECONDARY Change From Baseline in Short Form -12 (SF-12) Physical Component Score |
1.0; 1.7 | — |
| SECONDARY Change From Baseline in Cohen Social Network Index (SNI): Network Diversity |
0.3; -0.0 | — |
| SECONDARY Change From Baseline in Cohen Social Network Index (SNI): Social Network Size |
-1.5; -3.7 | — |
| SECONDARY Change From Baseline in Valuation of Life |
-1.9; -1.0 | — |
| SECONDARY Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy |
0.3; 0.2 | — |
| SECONDARY Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy |
-0.6; -0.4 | — |
| SECONDARY Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest |
0.9; 0.1 | — |
| SECONDARY Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score |
8.3; 8.2 | — |
| SECONDARY Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening |
4.0; 4.8 | — |
| SECONDARY Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening |
2.8; 2.5 | — |
| SECONDARY Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet |
1.5; 0.8 | — |
| SECONDARY Change From Baseline in Hearing Knowledge |
0.2; 0.0 | — |
| SECONDARY Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S) |
-10.3; -8.2 | — |
| SECONDARY Change From Baseline in Revised UCLA Loneliness Scale |
-1.3; -1.9 | — |
| SECONDARY Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9) |
-0.3; -1.1 | — |
| SECONDARY Change From Baseline in Short Form -12 (SF-12) Mental Component Score |
0.5; 0.7 | — |
| SECONDARY Change From Baseline in Short Form -12 (SF-12) Physical Component Score |
1.0; 1.7 | — |
| SECONDARY Change From Baseline in Cohen (Social Network Index) SNI: Network Diversity |
-0.1; -0.2 | — |
| SECONDARY Change From Baseline in Cohen Social Network Index (SNI): Social Network Size |
-1.5; -3.7 | — |
| SECONDARY Change From Baseline in Valuation of Life |
-1.9; -1.0 | — |
| SECONDARY Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy |
-0.6; -0.4 | — |
| SECONDARY Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy |
0.3; 0.2 | — |
| SECONDARY Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest |
0.9; 0.1 | — |
| SECONDARY Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score |
8.3; 8.2 | — |
| SECONDARY Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening |
4.0; 4.8 | — |
| SECONDARY Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening |
2.8; 2.5 | — |
| SECONDARY Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet |
1.5; 0.8 | — |
| SECONDARY Change From Baseline in Hearing Knowledge |
0.2; 0.0 | — |
Summary
Age-related hearing loss is highly prevalent and hearing health care is underutilized. The primary objective of the proposed randomized controlled trial is to investigate the efficacy of a community health worker (CHW)-delivered hearing loss intervention program. A preceding pilot study demonstrated preliminary effectiveness of the intervention program in reducing self-reported hearing handicap, and highlighted its acceptability among the target demographic. The proposed trial will now expand upon lessons learned through previous pilot studies and expand to other affordable residences for low-to-moderate income older adults in Baltimore. Primary outcome measurements will investigate intervention effects on hearing handicap, with secondary measurements investigating effects on domains such as social isolation and quality of life. This trial is a first-in-kind investigation of a novel community-based intervention that addresses hearing loss in a vulnerable, urban population.
Eligibility Criteria
Inclusion Criteria
- Age 60 years or older
- English-speaking
- Aural-oral verbal communication as primary communication modality
- Post-lingual hearing loss (Audiometric pure tone averages [0.5-4kHz] in both ears >25 dB)
- Does not currently use a hearing amplification device or hearing aid
- Signed informed consent to participate in all study related activities
- Willing to regularly use listening device once provided for the remainder of their time in the study
- Hearing handicap as measured by HHIE-S score >8
- Able to follow study instructions
Exclusion Criteria
- Individuals who do not fulfill inclusion criteria
- Evidence of ear disease or pathology requiring further medical evaluation
Data sourced from ClinicalTrials.gov (NCT03442296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.