NCT06068933

Hearing Health for Korean American Older Adults With Mild Cognitive Impairment

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 60 Years – 100 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-12-12
• Primary completion: 2024-08-08
• Completion: 2024-11-27
• First posted: 2023-10-05
• Last updated: 2025-04-06

Locations

1 site across 1 country: United States