Hearing Health Equity Through Accessible Research and Solutions for Korean Americans

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06803394
Status
Enrolling By Invitation

Conditions

  • Age-related Hearing Impairment
  • Community-dwelling Seniors
  • Hearing Impairment
  • Hearing Loss
  • Korean
  • Personal Communication

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • K-HEARS Intervention — BEHAVIORAL
    Tailored aural rehabilitation for participant and care partner
  • K-HEARS Sound Amplifier Intervention — DEVICE
    Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.

Study Details

The objective of this study is to test the effect of a community-delivered, affordable, and accessible hearing care intervention on improving communication function and health-related quality of life among older Korean Americans (KA) and the older Korean American's care partners that integrates a low-cost over-the-counter amplification device and hearing rehabilitation in comparison to a 6-month delayed treatment group through a cluster randomized controlled study.

Key Dates

Start date
Feb 9, 2025
Status verified
Mar 2026
Primary completion
Feb 1, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Immediate Treatment Site
    Study site assigned to immediate treatment of K-HEARS intervention
  • Placebo Comparator: Delayed Treatment Site
    Study site assigned to 6-month delayed treatment of K-HEARS intervention

Primary Outcome Measure

Hearing Handicap Inventory for the Elderly (HHIE-S) score [ Time Frame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins School of NursingBaltimoreMaryland21205-

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By research site
Johns Hopkins School of Nursing· Baltimore, MD

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