Baltimore HEARS: Hearing Health Equity Through Accessible Research & Solutions

Johns Hopkins University

Status: Completed

Conditions: Age-related Hearing Impairment 1; Personal Communication

Treatments: Device: Baltimore HEARS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03442296

R33DC015062-03 (U.S. NIH Grant/Contract)

IRB00144968

Details and patient eligibility

About

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.

Enrollment: 151 patients

Sex: All

Ages: 60 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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151 participants in 2 patient groups, including a placebo group

Immediate Treatment Group

Experimental group

Description:

Immediate treatment with Baltimore HEARS intervention

Treatment:

Device: Baltimore HEARS

Device: Baltimore HEARS

Delayed Treatment Group

Placebo Comparator group

Description:

3-month delayed treatment with Baltimore HEARS intervention

Treatment:

Device: Baltimore HEARS

Device: Baltimore HEARS