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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
1
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.
Johns Hopkins School of Nursing
Baltimore, Maryland, United States
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.
Time frame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.