Aging, Cognition, and Hearing Evaluation in Elders Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Hearing Handicap Inventory for the Elderly (HHIE)
研究概览
简要总结
The investigators will conduct a small pilot study that will randomize ~ 40 70-84 year-old adults with hearing loss to best-practices hearing rehabilitative treatment (hearing assessment, counseling, fitting of amplification devices) versus a successful aging intervention (one-on-one counseling/education sessions on successful aging topics). Participants will be followed for 6 months, and outcomes will focus on communication, quality of life, cognition, and other functional surveys. This pilot study is in preparation for a larger planned trial to investigate if hearing loss treatment can reduce cognitive decline and dementia in older adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 84 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 70-84 years.
- •Community-dwelling.
- •Fluent English-speaker.
- •Residency. Participants must plan to reside in the local area for the study duration (6 months).
- •Audiometric hearing impairment. Participants must have adult-onset hearing impairment with a pure tone average (0.5, 1, and 2 kHz) in the better-hearing ear of ≥ 30 decibels and <70 dB.
- •Word Recognition in Quiet score >60% bilaterally.
- •Mini-Mental State Exam (MMSE) score ≥ 23 for individuals with high-school degree or less; Mini-Mental State Exam (MMSE) score ≥ 25 for individuals with some college or more
- •Willingness to participate. Participants must be willing and able to consent to participate in the study, be willing to be randomized to either the Hearing intervention or to the Successful Aging intervention, and be willing to follow the study protocol for the duration of the trial.
排除标准
- •Potential candidates for enrollment who meet one or more of t he following criteria are excluded from participation in the study:
- •Self-reported disability in ≥ 2 or more Activities of Daily Living (ADL)
- •Self-reported hearing aid use in the past year (>5 hours/week).
- •Vision impairment (worse than 20/40 on MN Near Vision Card).
- •Medical contraindication to use of hearing aids (e.g., draining ear).
- •Conductive hearing impairment as determined by a difference in air audiometry and bone audiometry ("air-bone gap") greater than 15 dB in 2 or more contiguous frequencies in both ears.
- •Unwilling to wear hearing aids on a regular (i.e., daily or near daily) basis
- •No participants are excluded based on race or sex
研究组 & 干预措施
Hearing intervention
Best practices hearing rehabilitative treatment
干预措施: Best practices hearing rehabilitative treatment (Other)
Successful aging intervention
Successful aging intervention
干预措施: Successful aging intervention (Other)
结局指标
主要结局
Hearing Handicap Inventory for the Elderly (HHIE)
时间窗: 6 month follow-up
次要结局
- Neurocognitive test battery including Trail Making Test, Delayed Word Recall, and other tests(6 months)