Hearing Care Program for Mild Cognitive Impairment

(K-HEARS MCI Trial)

Overseen By Hae-Ra Han, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Assisted living, Draining ear, Hearing aid

Compensation: Varies

Number of Visits: 12

Trial Summary

What is the purpose of this trial?

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.

Research Team

Hae-Ra Han, PhD, RN

Principal Investigator

JHU School Of Nursing

Eligibility Criteria

This trial is for Korean American adults over 60 with mild cognitive impairment and hearing loss, who can read and speak Korean. They must not be using a hearing aid but have a care partner willing to join the study. Participants should also be on stable medication regimens.

Inclusion Criteria

You identify as a first-generation Korean American.

You have a hearing loss of at least 25 decibels in the better ear tested across 1, 2 and 4 kHz frequencies.

My medication doses for mental health have been stable for at least 2 weeks.

Timeline

Development

Development of the intervention through exploratory focus groups and/or semi-structured interviews and prototyping via open-labeled trial

Not specified

Randomized Controlled Pilot Study

Randomized, controlled pilot study with participants randomized to an immediate treatment group versus a 6-month delayed treatment group

6 months

Baseline, 6 months post-intervention

Non-randomized Pragmatic-focused Trial

Non-randomized pragmatic-focused trial of community-dwelling older Korean Americans with hearing loss but without MCI

Not specified

Qualitative Evaluation

Qualitative evaluation of the experience and supplemental feedback through exploratory focus groups and/or semi-structured interviews

Not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

6 months post-intervention

Treatment Details

Interventions

• K-HEARS Intervention
• K-HEARS Sound Amplifier Intervention

Trial Overview The K-HEARS intervention being tested includes an affordable sound amplifier device and hearing rehabilitation tailored for first-generation Korean American older adults with MCI. The study will assess its feasibility, acceptability, and preliminary effectiveness through a randomized pilot study.

Participant Groups

Group I: Phase 2B -KA Older Adult Focused Trial (non-randomized) Experimental Treatment 2 Interventions

Immediate treatment with K-HEARS intervention

Group II: Phase 2A -MCI Pilot Trial Immediate Treatment Group Experimental Treatment 2 Interventions

Immediate treatment with K-HEARS intervention

Group III: Phase 2A -MCI Pilot Trial Delayed Treatment Group Placebo Group 2 Interventions

6-month delayed treatment with K-HEARS intervention

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+