Skip to content

Hearing Health Equity Through Accessible Research and Solutions for Korean Americans

Hearing Health Equity Through Accessible Research and Solutions for Korean Americans

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06803394
Acronym
K-HEARS
Enrollment
800
Registered
2025-01-31
Start date
2025-02-09
Completion date
2028-09-30
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

Tailored aural rehabilitation for participant and care partner

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

Sponsors

Johns Hopkins University
Lead SponsorOTHER
National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Hearing Handicap Inventory for the Elderly (HHIE-S) scoreBaseline, 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.

Secondary

MeasureTime frameDescription
Third Party Disability as assessed by the Significant Other Scale for Hearing Disability (SOS-HEAR)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.
Relationship Quality as assessed by the Mutuality ScaleBaseline, 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORHae-Ra Han, PhD,RN

Johns Hopkins University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026