Hearing Health Equity Through Accessible Research and Solutions for Korean Americans (K-HEARS)

March 11, 2026 updated by: Johns Hopkins University
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

PARTICIPANT CRITERIA Participant inclusion criteria

  • Self-identified as first-generation KA in the target region
  • Age 60 years or older
  • Has a communication partner who lives in the same household or has at least weekly interactions
  • Screening audiometry Pure-tone audiometry (PTA)1,2,4 kilohertz (kHz) >25 decibel (dB) hearing loss (HL) in better ear
  • Hearing handicap as measured by HHIE-S score >=8 Participant exclusion criteria
  • Current use of hearing aid
  • Medical contraindications to use amplification device (e.g., draining ear)
  • Plan to move from the area within 6 months
  • Active treatment for a terminal illness or in hospice

COMMUNICATION PARTNER CRITERIA Communication Partner inclusion criteria

  • Age 18 years or older
  • Able to read and speak Korean
  • Lives with the older adult or has at least weekly interactions Communication Partner exclusion criteria
  • Plan to move from the area within 6 months
  • Active treatment for a terminal illness or in hospice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Treatment Site
Study site assigned to immediate treatment of K-HEARS intervention
Behavioral: K-HEARS Intervention
Tailored aural rehabilitation for participant and care partner
Device: K-HEARS Sound Amplifier Intervention
Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Placebo Comparator: Delayed Treatment Site
Study site assigned to 6-month delayed treatment of K-HEARS intervention
Behavioral: K-HEARS Intervention
Tailored aural rehabilitation for participant and care partner
Device: K-HEARS Sound Amplifier Intervention
Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing Handicap Inventory for the Elderly (HHIE-S) score
Time Frame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Score range 0-40. 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap.
Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Third Party Disability as assessed by the Significant Other Scale for Hearing Disability (SOS-HEAR)
Time Frame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Third-party disability will be measured in communication partners using the Significant Other Scale for Hearing Disability (SOS-HEAR). Score range 0-104, with higher score more disability.
Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Relationship Quality as assessed by the Mutuality Scale
Time Frame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Relationship quality will be measured using the Mutuality Scale among participants and communication partners. Score range 0-60, with higher score better relationship quality.
Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Hae-Ra Han, PhD,RN, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

September 30, 2028

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

January 31, 2025

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00406742
  • R01DC019686 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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