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Enrolling by Invitation

NCT Number: NCT06803394

Hearing Health Equity Through Accessible Research and Solutions for Korean Americans

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.

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Key information

Conditions

Age-related Hearing Impairment Behavior Communication Community-dwelling Seniors Ear Diseases Hearing Disorders Hearing Impairment Hearing Loss Korean Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Personal Communication Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

K-HEARS Intervention

Behavioral

Tailored aural rehabilitation for participant and care partner

K-HEARS Sound Amplifier Intervention

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Acronym: K-HEARS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 31, 2025
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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