NCT06803394

Brief Summary

The objective of this study is to test the effect of a community-delivered, affordable, and accessible hearing care intervention on improving communication function and health-related quality of life among older Korean Americans (KA) and the older Korean American's care partners that integrates a low-cost over-the-counter amplification device and hearing rehabilitation in comparison to a 6-month delayed treatment group through a cluster randomized controlled study.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Feb 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Feb 2025Sep 2028

First Submitted

Initial submission to the registry

January 27, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

February 9, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

January 27, 2025

Last Update Submit

March 11, 2026

Conditions

Age-related Hearing ImpairmentPersonal CommunicationHearing ImpairmentHearing LossCommunity-dwelling SeniorsKorean

Outcome Measures

Primary Outcomes (1)

  • Hearing Handicap Inventory for the Elderly (HHIE-S) score

    Score range 0-40. 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap.

    Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)

Secondary Outcomes (2)

  • Third Party Disability as assessed by the Significant Other Scale for Hearing Disability (SOS-HEAR)

    Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)

  • Relationship Quality as assessed by the Mutuality Scale

    Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)

Study Arms (2)

Immediate Treatment Site

EXPERIMENTAL

Study site assigned to immediate treatment of K-HEARS intervention

Behavioral: K-HEARS InterventionDevice: K-HEARS Sound Amplifier Intervention

Delayed Treatment Site

PLACEBO COMPARATOR

Study site assigned to 6-month delayed treatment of K-HEARS intervention

Behavioral: K-HEARS InterventionDevice: K-HEARS Sound Amplifier Intervention

Interventions

K-HEARS InterventionBEHAVIORAL

Tailored aural rehabilitation for participant and care partner

Delayed Treatment SiteImmediate Treatment Site
K-HEARS Sound Amplifier InterventionDEVICE

Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.

Delayed Treatment SiteImmediate Treatment Site

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identified as first-generation KA in the target region
  • Age 60 years or older
  • Has a communication partner who lives in the same household or has at least weekly interactions
  • Screening audiometry Pure-tone audiometry (PTA)1,2,4 kilohertz (kHz) \>25 decibel (dB) hearing loss (HL) in better ear

You may not qualify if:

  • Current use of hearing aid
  • Medical contraindications to use amplification device (e.g., draining ear)
  • Plan to move from the area within 6 months
  • Active treatment for a terminal illness or in hospice
  • Age 18 years or older
  • Able to read and speak Korean
  • Plan to move from the area within 6 months
  • Active treatment for a terminal illness or in hospice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

CommunicationHearing Loss

Condition Hierarchy (Ancestors)

BehaviorHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hae-Ra Han, PhD,RN

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2025

First Posted

January 31, 2025

Study Start

February 9, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations

US(1)