Hearing Health for Korean American Older Adults With Mild Cognitive Impairment (K-HEARS MCI)

Johns Hopkins University

Status: Terminated

Conditions: Mild Cognitive Impairment; Age-related Hearing Impairment; Personal Communication

Treatments: Behavioral: K-HEARS Intervention; Device: K-HEARS Sound Amplifier Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06068933

R56DC019686 (U.S. NIH Grant/Contract)

IRB00249500

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 60 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 3 patient groups, including a placebo group

Phase 2A -MCI Pilot Trial Immediate Treatment Group

Experimental group

Description:

Immediate treatment with K-HEARS intervention

Treatment:

Device: K-HEARS Sound Amplifier Intervention

Behavioral: K-HEARS Intervention

Phase 2A -MCI Pilot Trial Delayed Treatment Group

Placebo Comparator group

Description:

6-month delayed treatment with K-HEARS intervention

Treatment:

Device: K-HEARS Sound Amplifier Intervention

Behavioral: K-HEARS Intervention

Phase 2B -KA Older Adult Focused Trial (non-randomized)

Other group

Description:

Immediate treatment with K-HEARS intervention

Treatment:

Device: K-HEARS Sound Amplifier Intervention

Behavioral: K-HEARS Intervention