Hearing Health Equity Through Accessible Research and Solutions for Korean Americans
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Johns Hopkins University
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- Hearing Handicap Inventory for the Elderly (HHIE-S) score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •PARTICIPANT CRITERIA Participant inclusion criteria
- •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
- •Hearing handicap as measured by HHIE-S score >=8 Participant
Exclusion Criteria
- •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
- •COMMUNICATION PARTNER CRITERIA Communication Partner inclusion criteria
- •Age 18 years or older
- •Able to read and speak Korean
- •Lives with the older adult or has at least weekly interactions Communication Partner exclusion criteria
- •Plan to move from the area within 6 months
- •Active treatment for a terminal illness or in hospice
Arms & Interventions
Immediate Treatment Site
Study site assigned to immediate treatment of K-HEARS intervention
Intervention: K-HEARS Intervention (Behavioral)
Immediate Treatment Site
Study site assigned to immediate treatment of K-HEARS intervention
Intervention: K-HEARS Sound Amplifier Intervention (Device)
Delayed Treatment Site
Study site assigned to 6-month delayed treatment of K-HEARS intervention
Intervention: K-HEARS Intervention (Behavioral)
Delayed Treatment Site
Study site assigned to 6-month delayed treatment of K-HEARS intervention
Intervention: K-HEARS Sound Amplifier Intervention (Device)
Outcomes
Primary Outcomes
Hearing Handicap Inventory for the Elderly (HHIE-S) score
Time Frame: 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 Outcomes
- 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))