Hearing Health Equity Through Accessible Research and Solutions for Korean Americans (NCT06803394) | Clinical Trial Compass
By InvitationNot Applicable
Hearing Health Equity Through Accessible Research and Solutions for Korean Americans
United States800 participantsStarted 2025-02-09
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hearing Handicap Inventory for the Elderly (HHIE-S) score