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| ID | Type | Description | Link |
|---|---|---|---|
| K23AG059900 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate treatment | Experimental | immediate treatment |
|
| Delayed treatment | Placebo Comparator | 1 month delayed treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEARS-SLP device | Device | Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation. |
|
| 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):
| Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esther Oh, MD, PhD | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Medicine | Baltimore | Maryland | 21224 | United States |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D003704 | Dementia |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| HEARS-SLP program | Behavioral | Tailored aural rehabilitation for participant and communication partner |
|
| 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) |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |