Alzheimer Disease, Cognitive Impairment, Dementia, Hearing Loss
Conditions
Brief summary
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.
Interventions
DEVICEHEARS-NPS device
Tailored fitting and programming of a personal sound amplifier accompanied by an aural rehabilitation component.
BEHAVIORALHEARS-NPS program
Tailored aural rehabilitation for participant and care partner.
Sponsors
National Institute on Aging (NIA)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 60 - 100 years old * English-speaking * 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 * Speech frequency pure tone average (0.5- 4 kHz) \>25 db in the better-hearing ear; adult onset hearing loss * Availability of caregiver/study partner who is 18+ to participate in all study-related visits and who provides care supervision * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distress as assessed by the Neuropsychiatric Inventory (NPI-Q) | Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group) | 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): 1. = Mild (noticeable, but not a significant change) 2. = Moderate (significant, but not a dramatic change) 3. = Severe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hearing Handicap Inventory for the Elderly (HHIE-S) | Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group) | 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. |
| Relationship Quality as assessed by the Patient-Caregiver Closeness Scale (CG-CR) | Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group) | 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. |
| International Outcome Inventory for Hearing Aids (IOI-HA) Survey | Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group) | 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. |
Countries
United States
Contacts
Primary ContactEsther Oh, MD, Ph.D.
Backup ContactJami Trumbo, MSPH
Outcome results
None listed