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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Age-related Hearing Impairment, Personal Communication, Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: K-HEARS Intervention
* Device: K-HEARS Sound Amplifier Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants in Phase 2-A MCI Focused Trial will be randomized into a two arms: immediate intervention and delayed intervention. Participants in Phase 2-B KA Older Adult Focused Trial will not be randomized.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 2A -MCI Pilot Trial Immediate Treatment Group<br>Immediate treatment with K-HEARS intervention | Behavioral: K-HEARS Intervention<br>* Tailored aural rehabilitation for participant and care partner<br>Device: K-HEARS Sound Amplifier Intervention<br>* Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.<br>|
| Placebo Comparator: Phase 2A -MCI Pilot Trial Delayed Treatment Group<br>6-month delayed treatment with K-HEARS intervention | Behavioral: K-HEARS Intervention<br>* Tailored aural rehabilitation for participant and care partner<br>Device: K-HEARS Sound Amplifier Intervention<br>* Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.<br>|
| Other: Phase 2B -KA Older Adult Focused Trial (non-randomized)<br>Immediate treatment with K-HEARS intervention | Behavioral: K-HEARS Intervention<br>* Tailored aural rehabilitation for participant and care partner<br>Device: K-HEARS Sound Amplifier Intervention<br>* Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) |