Age-related Hearing Impairment, Mild Cognitive Impairment, Personal Communication
Conditions
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.
Interventions
BEHAVIORALK-HEARS Intervention
Tailored aural rehabilitation for participant and care partner
Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to 100 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hearing Handicap Inventory for the Elderly (HHIE-S) score | Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group) | Score range 0-40. 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Revised UCLA Loneliness Scale | Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group) | 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. |
| Short Form-12 (SF-12) Mental Component Score | Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group) | 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. |
| Social Network size Measured by Lubben Social Network Index | Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group) | 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). |
Countries
United States
Outcome results
None listed