Hearing Health for Korean American Older Adults With Mild Cognitive Impairment

NCT06068933 | Terminated DMC

• 2 other identifiers: IRB00249500R56DC019686
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Age-related Hearing Impairment; Personal Communication; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Hearing Handicap Inventory for the Elderly (HHIE-S) score

  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 Outcomes (3)

• Revised UCLA Loneliness Scale

  Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)

• Short Form-12 (SF-12) Mental Component Score

  Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)

• Social Network size Measured by Lubben Social Network Index

  Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)

Study Arms (3)

Phase 2A -MCI Pilot Trial Immediate Treatment Group

EXPERIMENTAL

Immediate treatment with K-HEARS intervention

Behavioral: K-HEARS Intervention; Device: K-HEARS Sound Amplifier Intervention

Phase 2A -MCI Pilot Trial Delayed Treatment Group

PLACEBO COMPARATOR

6-month delayed treatment with K-HEARS intervention

Behavioral: K-HEARS Intervention; Device: K-HEARS Sound Amplifier Intervention

Phase 2B -KA Older Adult Focused Trial (non-randomized)

OTHER

Immediate treatment with K-HEARS intervention

Behavioral: K-HEARS Intervention; Device: K-HEARS Sound Amplifier Intervention

Interventions

K-HEARS Intervention BEHAVIORAL

Tailored aural rehabilitation for participant and care partner

Phase 2A -MCI Pilot Trial Delayed Treatment Group; Phase 2A -MCI Pilot Trial Immediate Treatment Group; Phase 2B -KA Older Adult Focused Trial (non-randomized)

K-HEARS Sound Amplifier Intervention DEVICE

Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.

Phase 2A -MCI Pilot Trial Delayed Treatment Group; Phase 2A -MCI Pilot Trial Immediate Treatment Group; Phase 2B -KA Older Adult Focused Trial (non-randomized)

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Age 18 years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Communication; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Hae-Ra Han, PhD, RN

  JHU School Of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants in Phase 2-A MCI Focused Trial will be randomized into a two arms: immediate intervention and delayed intervention. Participants in Phase 2-B KA Older Adult Focused Trial will not be randomized.

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 5, 2023
• Study Start: December 12, 2023
• Primary Completion: August 8, 2024
• Study Completion: November 27, 2024
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

US (1)