Hearing Health for Korean American Older Adults With Mild Cognitive Impairment (NCT06068933) | Clinical Trial Compass
TerminatedNot Applicable
Hearing Health for Korean American Older Adults With Mild Cognitive Impairment
Stopped: This study is being terminated due to insufficient participant recruitment within the projected timeframe
United States1 participantsStarted 2023-12-12
Plain-language summary
The objective of this study is to develop and assess the feasibility, acceptability, and preliminary efficacy of a community-delivered, affordable, and accessible hearing care intervention tailored to the needs of community-dwelling Korean American (KA) older adults with mild cognitive impairment (MCI) and their care partners that integrates a low-cost over-the-counter amplification device and hearing rehabilitation through a randomized controlled pilot study. Each dyad will consist of the study participant and their care partner.
Who can participate
Age range
60 Years – 100 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 INCLUSION CRITERIA FOR PHASE 2A: MCI-Pilot Trial
* Age ≥ 60 years
* Self-identified as first-generation Korean American
* Self-reported ability to read and speak Korean
* Hearing loss identified by screening audiometry pure-tone-average (PTA) 1, 2, 4 kilohertz \> 25 decibel hearing loss in better hearing ear
* Mild cognitive impairment (CDR=0.5 and/or Korean Montreal Cognitive Assessment (MoCA-K) \<23)
* Report not currently using a hearing aid
* Has a care partner able to participate in the study
* Stable medication regimen. Stable (for 2 weeks or longer) dosing of medication (e.g. antidepressants, antipsychotics) for neuropsychiatric symptoms
PARTICIPANT INCLUSION CRITERIA FOR PHASE 2B: KA Older Adult-focused Trial:
* Age ≥ 60 years
* Self-identified as first-generation Korean American
* Self-reported ability to read and speak Korean
* Hearing loss identified by screening audiometry pure-tone-average (PTA) 1, 2, 4 kilohertz \>= 35 decibel Hearing Loss in better hearing ear
* Report not currently using a hearing aid
* Has a care partner able to participate in the study
CARE PARTNER INCLUSION CRITERIA (same for both Phase 2A and 2B)
* Age 18 years or older
* Able to read and speak Korean
* Lives in the same household with the participant or has at least daily interactions
* Aural-oral verbal communication as primary communication modality
* Able to accompany participant to all study visits
EXCLUSION CRITERIA (same for both Phase 2A and 2B)
Participant exclu…
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