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

Primary Purpose

Age-related Hearing Impairment, Personal Communication, Mild Cognitive Impairment

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
K-HEARS Intervention
K-HEARS Sound Amplifier Intervention
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Age-related Hearing Impairment

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA Participant inclusion criteria: 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 Care partner inclusion criteria: 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 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Immediate Treatment Group

    Delayed Treatment Group

    Arm Description

    Immediate treatment with K-HEARS intervention

    6-month delayed treatment with K-HEARS intervention

    Outcomes

    Primary Outcome Measures

    Change from Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S)
    Score range 0-40. 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap.

    Secondary Outcome Measures

    Change From Baseline in 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.
    Change From Baseline in 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.
    Change in Social Network 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).

    Full Information

    First Posted
    September 29, 2023
    Last Updated
    September 29, 2023
    Sponsor
    Johns Hopkins University
    Collaborators
    National Institute on Deafness and Other Communication Disorders (NIDCD)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06068933
    Brief Title
    K-HEARS MCI: Hearing Health Care for Korean American Older Adults With Mild Cognitive Impairment
    Acronym
    K-HEARS MCI
    Official Title
    K-HEARS MCI: Hearing Health Care for Korean American Older Adults With Mild Cognitive Impairment - Pilot
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University
    Collaborators
    National Institute on Deafness and Other Communication Disorders (NIDCD)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Age-related Hearing Impairment, Personal Communication, Mild Cognitive Impairment

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Immediate Treatment Group
    Arm Type
    Experimental
    Arm Description
    Immediate treatment with K-HEARS intervention
    Arm Title
    Delayed Treatment Group
    Arm Type
    Placebo Comparator
    Arm Description
    6-month delayed treatment with K-HEARS intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    K-HEARS Intervention
    Intervention Description
    Tailored aural rehabilitation for participant and care partner
    Intervention Type
    Device
    Intervention Name(s)
    K-HEARS Sound Amplifier Intervention
    Intervention Description
    Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
    Primary Outcome Measure Information:
    Title
    Change from Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S)
    Description
    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)
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Revised UCLA Loneliness Scale
    Description
    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)
    Title
    Change From Baseline in Short Form-12 (SF-12) Mental Component Score
    Description
    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)
    Title
    Change in Social Network Measured by Lubben Social Network Index
    Description
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    INCLUSION CRITERIA Participant inclusion criteria: 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 Care partner inclusion criteria: 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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carrie L Nieman, MD, MPH
    Phone
    410-502-6965
    Email
    cnieman1@jhmi.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hae-Ra Han, PhD, RN
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hae-Ra Han, PhD, RN
    Organizational Affiliation
    JHU School Of Nursing
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    K-HEARS MCI: Hearing Health Care for Korean American Older Adults With Mild Cognitive Impairment

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