Hearing Health Equity Through Accessible Research and Solutions for Korean Americans
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: K-HEARS Intervention, K-HEARS Sound Amplifier Intervention.
- Who it may be relevant to
- Registry conditions: Age-related Hearing Impairment, Personal Communication, Hearing Impairment, Hearing Loss. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Behavioral K-HEARS Intervention
Tailored aural rehabilitation for participant and care partner - Device K-HEARS Sound Amplifier Intervention
Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Primary outcome measures
- Hearing Handicap Inventory for the Elderly (HHIE-S) score [Time frame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)]
Secondary outcome measures (2)
- 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)]
- Relationship Quality as assessed by the Mutuality Scale [Time frame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Johns Hopkins School of Nursing — Baltimore
Identifiers
NCT: NCT06803394 · IRB00406742 · R01DC019686