Hearing Health Equity Through Accessible Research and Solutions for Korean Americans
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Hearing Handicap Inventory for the Elderly (HHIE-S) score
研究概览
简要总结
The objective of this study is to test the effect of a community-delivered, affordable, and accessible hearing care intervention on improving communication function and health-related quality of life among older Korean Americans (KA) and the older Korean American's care partners that integrates a low-cost over-the-counter amplification device and hearing rehabilitation in comparison to a 6-month delayed treatment group through a cluster randomized controlled study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PARTICIPANT CRITERIA Participant inclusion criteria
- •Self-identified as first-generation KA in the target region
- •Age 60 years or older
- •Has a communication partner who lives in the same household or has at least weekly interactions
- •Screening audiometry Pure-tone audiometry (PTA)1,2,4 kilohertz (kHz) >25 decibel (dB) hearing loss (HL) in better ear
- •Hearing handicap as measured by HHIE-S score >=8 Participant
排除标准
- •Current use of hearing aid
- •Medical contraindications to use amplification device (e.g., draining ear)
- •Plan to move from the area within 6 months
- •Active treatment for a terminal illness or in hospice
- •COMMUNICATION PARTNER CRITERIA Communication Partner inclusion criteria
- •Age 18 years or older
- •Able to read and speak Korean
- •Lives with the older adult or has at least weekly interactions Communication Partner exclusion criteria
- •Plan to move from the area within 6 months
- •Active treatment for a terminal illness or in hospice
研究组 & 干预措施
Immediate Treatment Site
Study site assigned to immediate treatment of K-HEARS intervention
干预措施: K-HEARS Intervention (Behavioral)
Immediate Treatment Site
Study site assigned to immediate treatment of K-HEARS intervention
干预措施: K-HEARS Sound Amplifier Intervention (Device)
Delayed Treatment Site
Study site assigned to 6-month delayed treatment of K-HEARS intervention
干预措施: K-HEARS Intervention (Behavioral)
Delayed Treatment Site
Study site assigned to 6-month delayed treatment of K-HEARS intervention
干预措施: K-HEARS Sound Amplifier Intervention (Device)
结局指标
主要结局
Hearing Handicap Inventory for the Elderly (HHIE-S) score
时间窗: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Score range 0-40. 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap.
次要结局
- Third Party Disability as assessed by the Significant Other Scale for Hearing Disability (SOS-HEAR)(Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group))
- Relationship Quality as assessed by the Mutuality Scale(Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group))