The Baltimore HEARS Pilot Study: Hearing Health Care Equality Through Accessible Research & Solutions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE)-S at 3 Months
研究概览
简要总结
The primary purpose of the study is to develop and test the preliminary efficacy of a first-in-kind community-based intervention to provide affordable, accessible and effective hearing health care to low-income, minority older adults.
详细描述
Age-related hearing impairment is strongly associated with poorer communicative functioning and social isolation, but hearing impairment often goes undiagnosed and untreated, particularly among minority and low-income older adults. Novel interventions that translate research on social engagement, minority health, and hearing technology are needed to expand delivery of hearing health care to underserved older adults. The Baltimore Hearing Equality through Accessible Research and Solutions (HEARS) project will develop and pilot a first-in-kind community-based intervention to provide affordable, accessible, and effective hearing health care to minority and low-income older adults and their communication partners. The study will follow a mixed-methods approach that will incorporate quantitative and qualitative components throughout the formative and evaluative processes. Participants and their communication partners will be randomized to an immediate treatment group or a 3-month delayed treatment group. The investigators hypothesize that the intervention is associated with increased social engagement and communication, improved quality of life, and decreased loneliness and third-party disability in the immediate treatment compared to the delayed treatment group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 60 years or older
- •English-speaking
- •Aural-oral verbal communication as primary communication modality
- •Post-lingual hearing loss
- •Does not currently use a hearing amplification device or hearing aid
- •Signed informed consent to participate in baseline, 1 month, and 3 month assessments
- •Have a communication partner able to accompany them to all study-related appointments
排除标准
- •Individuals who do not fulfill inclusion criteria
- •Score ≤ 25 on the Montreal Cognitive Assessment
研究组 & 干预措施
Immediate Treatment Group
Immediate treatment with Baltimore HEARS intervention
干预措施: Baltimore HEARS (Behavioral)
Immediate Treatment Group
Immediate treatment with Baltimore HEARS intervention
干预措施: Baltimore HEARS (Device)
Delayed Treatment Group
3-month delayed treatment with Baltimore HEARS intervention
干预措施: Baltimore HEARS (Behavioral)
Delayed Treatment Group
3-month delayed treatment with Baltimore HEARS intervention
干预措施: Baltimore HEARS (Device)
结局指标
主要结局
Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE)-S at 3 Months
时间窗: 3 months
Mean change, Unpooled - comparing baseline to 3 month follow-up visit Measure Description: Measure was collected through a one-on-one interview with a trained data collector. Scoring: 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap
次要结局
- Change From Baseline in Revised QDS at 3 Months(3 months)
- Change From Baseline in Revised UCLA at 3 Months(3 months)
- Change From Baseline in SF-36 Mental Component at 3 Months(3 months)
- Change From Baseline in PHQ-9 at 3 Months(3 months)
- Change From Baseline in SF-36 Physical Component at 3 Months(3 months)