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Baltimore HEARS: Hearing Health Equity Through Accessible Research & Solutions

NCT03442296 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2022-10-04

Study results available
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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.

Conditions

  • Age-related Hearing Impairment 1
  • Personal Communication

Interventions

BEHAVIORAL

Baltimore HEARS

Tailored aural rehabilitation for participant and communication partner (if applicable)

DEVICE

Baltimore HEARS

Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.

Sponsors & Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Frank R Lin, MD, PhD · Johns Hopkins University

  • Carrie L Nieman, MD, MPH · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-18
Primary Completion
2020-06-17
Completion
2021-07-14

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03442296 on ClinicalTrials.gov