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

Not Applicable

Terminated

• Conditions: Age-related Hearing Impairment; Personal Communication; Mild Cognitive Impairment
• Interventions: Behavioral: K-HEARS Intervention; Device: K-HEARS Sound Amplifier Intervention

• Registration Number: NCT06068933
• Lead Sponsor: Johns Hopkins University

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.

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 Timeline

• Study First Submitted: 2023-09-29
• Study First Submitted QC: 2023-09-29
• Study First Posted: 2023-10-05
• Study Start: 2023-12-12
• Primary Completion: 2024-08-08
• Study Completion: 2024-11-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 2A -MCI Pilot Trial Immediate Treatment Group	K-HEARS Intervention	Immediate treatment with K-HEARS intervention
Phase 2B -KA Older Adult Focused Trial (non-randomized)	K-HEARS Intervention	Immediate treatment with K-HEARS intervention
Phase 2A -MCI Pilot Trial Delayed Treatment Group	K-HEARS Intervention	6-month delayed treatment with K-HEARS intervention
Phase 2A -MCI Pilot Trial Immediate Treatment Group	K-HEARS Sound Amplifier Intervention	Immediate treatment with K-HEARS intervention
Phase 2A -MCI Pilot Trial Delayed Treatment Group	K-HEARS Sound Amplifier Intervention	6-month delayed treatment with K-HEARS intervention
Phase 2B -KA Older Adult Focused Trial (non-randomized)	K-HEARS Sound Amplifier Intervention	Immediate treatment with K-HEARS intervention

Primary Outcome Measures

Name	Time	Method
Hearing Handicap Inventory for the Elderly (HHIE-S) score	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.

Secondary Outcome Measures

Name	Time	Method
Revised UCLA Loneliness Scale	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.
Short Form-12 (SF-12) Mental Component Score	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.
Social Network size Measured by Lubben Social Network Index	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).

Trial Locations

Locations (1)

Johns Hopkins School of Nursing; 🇺🇸 Baltimore, Maryland, United States