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HEARS-SLP: Providing SLP-Delivered Hearing Health Care to Individuals With Cognitive Impairment

Primary Purpose

Hearing Loss, Dementia, Cognitive Impairment

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

About this trial

This is an interventional other trial for Hearing Loss

Eligibility Criteria

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

Inclusion Criteria: Age 60 - 100 years old English-speaking Lives at home Diagnosis of probable Alzheimer's Disease or other related dementia according to the core clinical criteria outlined in the National Institute on Aging (NIA) and Alzheimer's Association Guidelines Availability of caregiver/study partner to participate in all study-related visits and who provides ≥8 hours of weekly oversight/care Speech frequency pure tone average (0.5- 4 kHz) >25 db in the better-hearing ear; adult onset hearing loss Stable (for 2 weeks or longer) dosing of medication (e.g. antidepressants, antipsychotics) for neuropsychiatric symptoms Exclusion Criteria: Current self-reported use of hearing aid or amplification device Medical contraindication to use hearing aids ( e.g. draining ears) Inability to participate in the 1-month follow up

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Immediate treatment

    Delayed treatment

    Arm Description

    immediate treatment

    1 month delayed treatment

    Outcomes

    Primary Outcome Measures

    Change from Baseline in Neuropsychiatric Symptoms as assessed by the Neuropsychiatric Inventory (NPI-Q)
    Scoring: Each of the 12 NPI-Q domains contains a survey question that reflects symptoms of that domain. Initial responses to each domain question are "Yes" or "No". If the response to the question is "No", the informant goes to the next question. If "Yes", the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale and the associated impact of the symptom manifestations on them using a 5-point scale. The NPI-Q provides symptom Severity and Distress ratings for each symptom reported, and total Severity and Distress scores reflecting the sum of individual domain scores. Total NPI-Q severity score is the sum of individual symptom scores, ranges from 0 to 36. SEVERITY of the symptom (how it affects the patient): = Mild (noticeable, but not a significant change) = Moderate (significant, but not a dramatic change) = Severe

    Secondary Outcome Measures

    Change from Baseline in Health-related Quality of Life as assessed by the Quality of Life in Alzheimer's Disease (QOL-AD) scale
    Scoring for QOL-AD: Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4. The total score is the sum of all 13 items. Total scores range from 13 to 52.
    Change From Baseline in Hearing Specific Quality of life as assessed by the Hearing Handicap Inventory for the Elderly (HHIE-S)
    Higher scores indicate increased hearing handicap. Scoring: 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap An increase in the score from baseline (a positive number) indicates a worsening in hearing handicap.

    Full Information

    First Posted
    August 18, 2023
    Last Updated
    September 28, 2023
    Sponsor
    Johns Hopkins University
    Collaborators
    National Institute on Aging (NIA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06008782
    Brief Title
    HEARS-SLP: Providing SLP-Delivered Hearing Health Care to Individuals With Cognitive Impairment
    Official Title
    HEARS-SLP: Providing Speech Language Pathologist-Delivered Hearing Health Care to Individuals With Cognitive Impairment
    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
    March 2024 (Anticipated)
    Study Completion Date
    September 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University
    Collaborators
    National Institute on Aging (NIA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Building upon the HEARS audiologist-community health worker (CHW) model, this study intervention will be delivered by a speech-language pathologist (SLP). The primary objective of the study is to develop and test an affordable and accessible hearing rehabilitative intervention that will be delivered by a SLP to individuals with cognitive impairment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hearing Loss, Dementia, Cognitive Impairment

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Immediate treatment
    Arm Type
    Experimental
    Arm Description
    immediate treatment
    Arm Title
    Delayed treatment
    Arm Type
    Placebo Comparator
    Arm Description
    1 month delayed treatment
    Intervention Type
    Device
    Intervention Name(s)
    HEARS-SLP device
    Intervention Description
    Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
    Intervention Type
    Behavioral
    Intervention Name(s)
    HEARS-SLP program
    Intervention Description
    Tailored aural rehabilitation for participant and communication partner
    Primary Outcome Measure Information:
    Title
    Change from Baseline in Neuropsychiatric Symptoms as assessed by the Neuropsychiatric Inventory (NPI-Q)
    Description
    Scoring: Each of the 12 NPI-Q domains contains a survey question that reflects symptoms of that domain. Initial responses to each domain question are "Yes" or "No". If the response to the question is "No", the informant goes to the next question. If "Yes", the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale and the associated impact of the symptom manifestations on them using a 5-point scale. The NPI-Q provides symptom Severity and Distress ratings for each symptom reported, and total Severity and Distress scores reflecting the sum of individual domain scores. Total NPI-Q severity score is the sum of individual symptom scores, ranges from 0 to 36. SEVERITY of the symptom (how it affects the patient): = Mild (noticeable, but not a significant change) = Moderate (significant, but not a dramatic change) = Severe
    Time Frame
    Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)
    Secondary Outcome Measure Information:
    Title
    Change from Baseline in Health-related Quality of Life as assessed by the Quality of Life in Alzheimer's Disease (QOL-AD) scale
    Description
    Scoring for QOL-AD: Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4. The total score is the sum of all 13 items. Total scores range from 13 to 52.
    Time Frame
    Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)
    Title
    Change From Baseline in Hearing Specific Quality of life as assessed by the Hearing Handicap Inventory for the Elderly (HHIE-S)
    Description
    Higher scores indicate increased hearing handicap. Scoring: 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap An increase in the score from baseline (a positive number) indicates a worsening in hearing handicap.
    Time Frame
    Baseline and 1 month post-intervention (immediate group). 1 month 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: Age 60 - 100 years old English-speaking Lives at home Diagnosis of probable Alzheimer's Disease or other related dementia according to the core clinical criteria outlined in the National Institute on Aging (NIA) and Alzheimer's Association Guidelines Availability of caregiver/study partner to participate in all study-related visits and who provides ≥8 hours of weekly oversight/care Speech frequency pure tone average (0.5- 4 kHz) >25 db in the better-hearing ear; adult onset hearing loss Stable (for 2 weeks or longer) dosing of medication (e.g. antidepressants, antipsychotics) for neuropsychiatric symptoms Exclusion Criteria: Current self-reported use of hearing aid or amplification device Medical contraindication to use hearing aids ( e.g. draining ears) Inability to participate in the 1-month follow up
    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
    Roxanne Clement-Rorick, MPH
    Phone
    410-955-0920
    Email
    rcleme10@jh.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Esther Oh, MD, PhD
    Organizational Affiliation
    Johns Hopkins School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    6626295
    Citation
    Ventry IM, Weinstein BE. Identification of elderly people with hearing problems. ASHA. 1983 Jul;25(7):37-42. No abstract available.
    Results Reference
    background
    PubMed Identifier
    2307305
    Citation
    Tuley MR, Mulrow CD, Aguilar C, Velez R. A critical reevaluation of the Quantified Denver Scale of Communication Function. Ear Hear. 1990 Feb;11(1):56-61. doi: 10.1097/00003446-199002000-00011.
    Results Reference
    background

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    HEARS-SLP: Providing SLP-Delivered Hearing Health Care to Individuals With Cognitive Impairment

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