Hearing Health for Korean American Older Adults With Mild Cognitive Impairment

Last updated: April 2, 2025
Sponsor: Johns Hopkins University
Overall Status: Terminated

Phase

N/A

Condition

Mild Cognitive Impairment

Memory Loss

Hearing Impairment

Treatment

K-HEARS Intervention

K-HEARS Sound Amplifier Intervention

Clinical Study ID

NCT06068933
IRB00249500
R56DC019686
  • Ages 60-100
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

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

Study Design

Total Participants: 1
Treatment Group(s): 2
Primary Treatment: K-HEARS Intervention
Phase:
Study Start date:
December 12, 2023
Estimated Completion Date:
November 27, 2024

Study 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: randomized, controlled pilot study with study participants randomized to an immediate treatment group, versus a 6-month delayed treatment group of an intervention specific for individuals with MCI, 3) Phase 2B: a non-randomized pragmatic-focused trial of community-dwelling older KAs with hearing loss but without MCI, and 4) Phase 3: qualitative evaluation of the experience and supplemental feedback through exploratory focus groups and/or semi-structured interviews.

Connect with a study center

  • Johns Hopkins School of Nursing

    Baltimore, Maryland 21205
    United States

    Site Not Available

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