Hearing Health for Korean American Older Adults With Mild Cognitive Impairment (K-HEARS MCI)

April 2, 2025 updated by: Johns Hopkins University

K-HEARS MCI: Hearing Health Care for Korean American Older Adults With Mild Cognitive Impairment - Pilot

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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: 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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 2A -MCI Pilot Trial Immediate Treatment Group
Immediate treatment with K-HEARS intervention
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.
Placebo Comparator: Phase 2A -MCI Pilot Trial Delayed Treatment Group
6-month delayed treatment with K-HEARS intervention
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.
Other: Phase 2B -KA Older Adult Focused Trial (non-randomized)
Immediate treatment with K-HEARS intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing Handicap Inventory for the Elderly (HHIE-S) score
Time Frame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Score range 0-40. 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap.
Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Revised UCLA Loneliness Scale
Time Frame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)

Score is the sum of 20-item self-reported measure. Scores range from 20 to 80.

Score ranges:

20-34 - Low degree of loneliness 35-49 - Moderate degree of loneliness 50-64 - Moderately high degree of loneliness 65-80 - High degree of loneliness.
Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Short Form-12 (SF-12) Mental Component Score
Time Frame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Score ranges from 0-100 with higher scores indicating better mental health functioning.
Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Social Network size Measured by Lubben Social Network Index
Time Frame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Measures social network size for both family and friends and also the frequency of interaction with them. Higher scores indicate higher level of social engagement. Score range (0-30).
Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Hae-Ra Han, PhD, RN, JHU School Of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2023

Primary Completion (Actual)

August 8, 2024

Study Completion (Actual)

November 27, 2024

Study Registration Dates

First Submitted

September 29, 2023

First Submitted That Met QC Criteria

September 29, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00249500
  • R56DC019686 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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