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

Mild Cognitive Impairment Clinical Trial

— K-HEARS MCI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06068933
• Other study ID #: IRB00249500
• Secondary ID: R56DC019686
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2023
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: Carrie L Nieman, MD, MPH
• Phone: 410-502-6965
• Email: cnieman1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

PARTICIPANT INCLUSION CRITERIA FOR PHASE 2A: MCI-Pilot Trial

• Age = 60 years

• Self-identified as first-generation Korean American

• Self-reported ability to read and speak Korean

• Hearing loss identified by screening audiometry pure-tone-average (PTA) 1, 2, 4 kilohertz > 25 decibel hearing loss in better hearing ear

• Mild cognitive impairment (CDR=0.5 and/or Korean Montreal Cognitive Assessment (MoCA-K) <23)

• Report not currently using a hearing aid

• Has a care partner able to participate in the study

• Stable medication regimen. Stable (for 2 weeks or longer) dosing of medication (e.g. antidepressants, antipsychotics) for neuropsychiatric symptoms

PARTICIPANT INCLUSION CRITERIA FOR PHASE 2B: KA Older Adult-focused Trial:

• Age = 60 years

• Self-identified as first-generation Korean American

• Self-reported ability to read and speak Korean

• Hearing loss identified by screening audiometry pure-tone-average (PTA) 1, 2, 4 kilohertz >= 35 decibel Hearing Loss in better hearing ear

• Report not currently using a hearing aid

• Has a care partner able to participate in the study

CARE PARTNER INCLUSION CRITERIA (same for both Phase 2A and 2B)

• Age 18 years or older

• Able to read and speak Korean

• Lives in the same household with the participant or has at least daily interactions

• Aural-oral verbal communication as primary communication modality

• Able to accompany participant to all study visits

EXCLUSION CRITERIA (same for both Phase 2A and 2B)

Participant exclusion criteria

• Residence in an assisted living facility (ALF) or nursing home (NH)

• Medical contraindication to use of amplification device (e.g., draining ear)

• Currently using a hearing aid or listening device

Care partner exclusion criteria

• Individuals who do not fulfill inclusion criteria

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Deafness
• Hearing Loss
• Mild Cognitive Impairment
• Personal Communication

Intervention

Behavioral:
• K-HEARS Intervention
Tailored aural rehabilitation for participant and care partner

Device:
• K-HEARS Sound Amplifier Intervention
Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.

Locations

Country	Name	City	State
United States	Johns Hopkins School of Nursing	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Revised UCLA Loneliness Scale	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.	Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Secondary	Short Form-12 (SF-12) Mental Component Score	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.	Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Secondary	Social Network size Measured by Lubben Social Network Index	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).	Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)