HEARS Neuropsychiatric Symptoms & Hearing Loss: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Johns Hopkins University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Distress as assessed by the Neuropsychiatric Inventory (NPI-Q)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Immediate treatment
Intervention: HEARS-NPS device (Device)
Immediate treatment
Intervention: HEARS-NPS program (Behavioral)
Delayed treatment
Intervention: HEARS-NPS device (Device)
Delayed treatment
Intervention: HEARS-NPS program (Behavioral)
Outcomes
Primary Outcomes
Distress as assessed by the Neuropsychiatric Inventory (NPI-Q)
Time Frame: 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 Outcomes
- 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))
- 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))
- 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))