K-HEARS Interventions for Age-Related Hearing Loss

(K-HEARS Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Hae-Ra Han, PhD,RN

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Johns Hopkins University

Trial Summary

What is the purpose of this trial?

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.

Research Team

Hae-Ra Han, PhD,RN

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for older Korean Americans and their care partners who are experiencing age-related hearing loss. Participants should be community-dwelling seniors interested in improving communication function and quality of life through a new hearing intervention.

Inclusion Criteria

Self-identified as first-generation KA in the target region

I have someone who lives with me or sees me weekly to help communicate.

Screening audiometry Pure-tone audiometry (PTA) 1,2,4 kilohertz (kHz) >25 decibel (dB) hearing loss (HL) in better ear

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

Treatment Details

Interventions

• K-HEARS Intervention (Behavioral Intervention)
• K-HEARS Sound Amplifier Intervention (Device)

Trial Overview The study tests the 'K-HEARS Intervention,' which includes an affordable over-the-counter sound amplifier and hearing rehabilitation, against a delayed treatment group to see if it improves communication and life quality.

Participant Groups

Group I: Immediate Treatment Site Experimental Treatment 2 Interventions

Study site assigned to immediate treatment of K-HEARS intervention

Group II: Delayed Treatment Site Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Joshua M. Levy

National Institute on Deafness and Other Communication Disorders (NIDCD)

Chief Medical Officer

MD, MPH, MS

Debara L. Tucci

National Institute on Deafness and Other Communication Disorders (NIDCD)

Chief Executive Officer since 2019

MD, MS, MBA