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| ID | Type | Description | Link |
|---|---|---|---|
| R56DC019686 | U.S. NIH Grant/Contract | View source |
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This study is being terminated due to insufficient participant recruitment within the projected timeframe
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 2A -MCI Pilot Trial Immediate Treatment Group | Experimental | Immediate treatment with K-HEARS intervention |
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| Phase 2A -MCI Pilot Trial Delayed Treatment Group | Placebo Comparator | 6-month delayed treatment with K-HEARS intervention |
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| Phase 2B -KA Older Adult Focused Trial (non-randomized) | Other | Immediate treatment with K-HEARS intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| K-HEARS Intervention | Behavioral | Tailored aural rehabilitation for participant and care partner |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group) |
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PARTICIPANT INCLUSION CRITERIA FOR PHASE 2A: MCI-Pilot Trial
PARTICIPANT INCLUSION CRITERIA FOR PHASE 2B: KA Older Adult-focused Trial:
CARE PARTNER INCLUSION CRITERIA (same for both Phase 2A and 2B)
EXCLUSION CRITERIA (same for both Phase 2A and 2B)
Participant exclusion criteria
Care partner exclusion criteria
• Individuals who do not fulfill inclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Hae-Ra Han, PhD, RN | JHU School Of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins School of Nursing | Baltimore | Maryland | 21205 | United States |
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| ID | Term |
|---|---|
| D003142 | Communication |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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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.
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| K-HEARS Sound Amplifier Intervention | Device | Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation. |
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| 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. | 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). | Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group) |