Clinical trial NCT06068933: Hearing Health for Korean American Older Adults With Mild Cognitive Impairment
Official title: K-HEARS MCI: Hearing Health Care for Korean American Older Adults With Mild Cognitive Impairment - Pilot
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Age-related Hearing Impairment
Personal Communication
Mild Cognitive Impairment
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2023-10-05
Enrollment: 1
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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.

Detailed 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 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

Primary outcomes:
measure: Hearing Handicap Inventory for the Elderly (HHIE-S) score
timeFrame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Secondary outcomes:
measure: Revised UCLA Loneliness Scale
timeFrame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
measure: Short Form-12 (SF-12) Mental Component Score
timeFrame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
measure: Social Network size Measured by Lubben Social Network Index
timeFrame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Nursing
state: Maryland
Study officials:
affiliation: JHU School Of Nursing
name: Hae-Ra Han, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: