Overview
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.
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