Hearing Health Equity Through Accessible Research and Solutions for Korean Americans

NCT ID: NCT06803394

Last Updated: 2025-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-09

Study Completion Date

2028-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Immediate Treatment Site

Study site assigned to immediate treatment of K-HEARS intervention

Group Type EXPERIMENTAL

K-HEARS Intervention

Intervention Type BEHAVIORAL

Tailored aural rehabilitation for participant and care partner

K-HEARS Sound Amplifier Intervention

Intervention Type DEVICE

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

Delayed Treatment Site

Study site assigned to 6-month delayed treatment of K-HEARS intervention

Group Type PLACEBO_COMPARATOR

K-HEARS Intervention

Intervention Type BEHAVIORAL

Tailored aural rehabilitation for participant and care partner

K-HEARS Sound Amplifier Intervention

Intervention Type DEVICE

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

Interventions

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K-HEARS Intervention

Tailored aural rehabilitation for participant and care partner

Intervention Type BEHAVIORAL

K-HEARS Sound Amplifier Intervention

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

Intervention Type DEVICE

Eligibility Criteria

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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

* Age 18 years or older
* Able to read and speak Korean

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

* Plan to move from the area within 6 months
* Active treatment for a terminal illness or in hospice
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hae-Ra Han, PhD,RN

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins School of Nursing

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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R01DC019686

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00406742

Identifier Type: -

Identifier Source: org_study_id

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