Status:
TERMINATED
Hearing Health for Korean American Older Adults With Mild Cognitive Impairment
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions:
Age-related Hearing Impairment
Personal Communication
Eligibility:
All Genders
60-100 years
Phase:
NA
Brief 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...
Detailed Description
The study consists of three phases: 1) Phase 1: development of the intervention through exploratory focus groups and/or semi-structured interviews and prototyping via open-labeled trial 2) Phase 2A: r...
Eligibility Criteria
Inclusion
- 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 exclusion criteria
- Residence in an assisted living facility (ALF) or nursing home (NH)
- Medical contraindication to use of amplification device (e.g., draining ear)
- Currently using a hearing aid or listening device
- Care partner exclusion criteria
- • Individuals who do not fulfill inclusion criteria
Exclusion
Key Trial Info
Start Date :
December 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2024
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT06068933
Start Date
December 12 2023
End Date
November 27 2024
Last Update
April 6 2025
Active Locations (1)
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1
Johns Hopkins School of Nursing
Baltimore, Maryland, United States, 21205