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

Johns Hopkins University

Status: Invitation-only

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

Treatments: Behavioral: K-HEARS Intervention; Device: K-HEARS Sound Amplifier Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06803394

R01DC019686 (U.S. NIH Grant/Contract)

IRB00406742

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 exclusion criteria
• Plan to move from the area within 6 months
• Active treatment for a terminal illness or in hospice

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups, including a placebo group

Immediate Treatment Site

Experimental group

Description:

Study site assigned to immediate treatment of K-HEARS intervention

Treatment:

Device: K-HEARS Sound Amplifier Intervention

Behavioral: K-HEARS Intervention

Delayed Treatment Site

Placebo Comparator group

Description:

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

Treatment:

Device: K-HEARS Sound Amplifier Intervention

Behavioral: K-HEARS Intervention