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

Study Overview
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Brief Summary
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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.

Official Title
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HEARS-SLP: Providing Speech Language Pathologist-Delivered Hearing Health Care to Individuals With Cognitive Impairment

Conditions
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Dementia, Hearing Loss, Cognitive Impairment

Intervention / Treatment
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* Device: HEARS-SLP device
* Behavioral: HEARS-SLP program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate treatment<br>immediate treatment | Device: HEARS-SLP device<br>* Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.<br>Behavioral: HEARS-SLP program<br>* Tailored aural rehabilitation for participant and communication partner<br>|
| Placebo Comparator: Delayed treatment<br>1 month delayed treatment | Device: HEARS-SLP device<br>* Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.<br>Behavioral: HEARS-SLP program<br>* Tailored aural rehabilitation for participant and communication partner<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group) | 
| 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. | Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group) |