HEARS-SLP: Providing Speech Language Pathologist-Delivered Hearing Health Care to Individuals With Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from Baseline in Neuropsychiatric Symptoms as assessed by the Neuropsychiatric Inventory (NPI-Q)
研究概览
简要总结
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.
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
- •Lives at home
- •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
- •Availability of caregiver/study partner to participate in all study-related visits and who provides ≥8 hours of weekly oversight/care
- •Speech frequency pure tone average (0.5- 4 kHz) >25 db in the better-hearing ear; adult onset hearing loss
- •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
研究组 & 干预措施
Immediate treatment
immediate treatment
干预措施: HEARS-SLP program (Behavioral)
Delayed treatment
1 month delayed treatment
干预措施: HEARS-SLP program (Behavioral)
Delayed treatment
1 month delayed treatment
干预措施: HEARS-SLP device (Device)
Immediate treatment
immediate treatment
干预措施: HEARS-SLP device (Device)
结局指标
主要结局
Change from Baseline in Neuropsychiatric Symptoms as assessed by the Neuropsychiatric Inventory (NPI-Q)
时间窗: Baseline and 1 month post-intervention (immediate group). 1 month 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 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): 1. = Mild (noticeable, but not a significant change) 2. = Moderate (significant, but not a dramatic change) 3. = Severe
次要结局
- Change From Baseline in Hearing Specific Quality of life as assessed by the Hearing Handicap Inventory for the Elderly (HHIE-S)(Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group))
- Change from Baseline in Health-related Quality of Life as assessed by the Quality of Life in Alzheimer's Disease (QOL-AD) scale(Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group))