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Hearing Care Program for Mild Cognitive Impairment (K-HEARS MCI Trial)

N/A
Waitlist Available
Led By Hae-Ra Han, PhD, RN
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older
Age ≥ 60 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months post-intervention (immediate group). 6 months post-baseline (delayed group)

Summary

This trial aims to create and test a hearing care program for older Korean American adults with mild cognitive impairment and their caregivers. The program will include a low-cost hearing device and rehabilitation. A pilot study will

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves non-invasive interventions like sound amplifiers and rehabilitation exercises, side effects are minimal but may include discomfort from wearing the device or frustration if difficulties in communication persist.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am 60 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months post-intervention (immediate group). 6 months post-baseline (delayed group)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months post-intervention (immediate group). 6 months post-baseline (delayed group) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hearing Handicap Inventory for the Elderly (HHIE-S) score
Secondary study objectives
Revised UCLA Loneliness Scale
Short Form-12 (SF-12) Mental Component Score
Social Network size Measured by Lubben Social Network Index

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase 2B -KA Older Adult Focused Trial (non-randomized)Experimental Treatment2 Interventions
Immediate treatment with K-HEARS intervention
Group II: Phase 2A -MCI Pilot Trial Immediate Treatment GroupExperimental Treatment2 Interventions
Immediate treatment with K-HEARS intervention
Group III: Phase 2A -MCI Pilot Trial Delayed Treatment GroupPlacebo Group2 Interventions
6-month delayed treatment with K-HEARS intervention

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,321 Previous Clinical Trials
14,873,888 Total Patients Enrolled
2 Trials studying Personal Communication
166 Patients Enrolled for Personal Communication
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
352 Previous Clinical Trials
181,139 Total Patients Enrolled
1 Trials studying Personal Communication
151 Patients Enrolled for Personal Communication
Hae-Ra Han, PhD, RNPrincipal InvestigatorJHU School Of Nursing
3 Previous Clinical Trials
347 Total Patients Enrolled
~11 spots leftby Mar 2025
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