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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AG076525-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This randomized controlled trial study aims to evaluate a revised hearing care intervention for older adults with Alzheimer's Disease and Related Dementias (ADRD). The community-delivered hearing care intervention utilizes tailored strategies to assess impact on communication, neuropsychiatric symptoms (NPS), and care partner distress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate treatment | Experimental |
| |
| Delayed treatment | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEARS-NPS device | Device | Tailored fitting and programming of a personal sound amplifier accompanied by an aural rehabilitation component. |
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| Measure | Description | Time Frame |
|---|---|---|
| Distress 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 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. Higher score is worse SEVERITY of the symptom (how it affects the patient):
| Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group) |
| Measure | Description | Time Frame |
|---|---|---|
| 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, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esther Oh, MD, Ph.D. | Contact | 410-550-0925 | eoh9@jhmi.edu | |
| Jami Trumbo, MSPH | Contact | jami.trumbo@jhu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Esther Oh, MD, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Memory and Alzheimer's Treatment Center | Recruiting | Baltimore | Maryland | 21224 | United States |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D034381 | Hearing Loss |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| HEARS-NPS program | Behavioral | Tailored aural rehabilitation for participant and care partner. |
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| Relationship Quality as assessed by the Patient-Caregiver Closeness Scale (CG-CR) | The scale assesses the closeness of the caregiver-care recipient relationship with six items. The total score ranges from 14 to 70. A higher total score reflects a better relationship quality. | Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group) |
| International Outcome Inventory for Hearing Aids (IOI-HA) Survey | The hearing inventory survey is used to evaluate the effectiveness of alternative interventions such as assistive devices and communication strategies. The total score ranges from 7-35 where higher scores indicate a better outcome. | Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group) |
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |