HEARS Neuropsychiatric Symptoms & Hearing Loss: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Distress as assessed by the Neuropsychiatric Inventory (NPI-Q)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Distress as assessed by the Neuropsychiatric Inventory (NPI-Q)
时间窗: 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
次要结局
- 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))