Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT06068933
Status:
TERMINATED
Last Update Posted:
2025-04-06
First Post:
2023-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hearing Health for Korean American Older Adults With Mild Cognitive Impairment
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
K-HEARS MCI: Hearing Health Care for Korean American Older Adults With Mild Cognitive Impairment - Pilot
Status:
TERMINATED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study is being terminated due to insufficient participant recruitment within the projected timeframe
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
K-HEARS MCI
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R56DC019686 | NIH | None | https://reporter.nih.gov/quic… | View |