跳至主要内容
临床试验/NCT03338751
NCT03338751撤回不适用

Determine the Effect on Cognitive Impairment Measures by Providing Hearing-Assistance to Skilled Nursing Facility Residents

NYU Langone Health1 个研究点 分布在 1 个国家开始时间: 2018年1月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Measure of Cognitive function using Mini-Cog

研究概览

简要总结

The purpose of the study is to see if a commercially available hearing assistance device called the PockeTalker has an effect on performance on cognitive (memory and thinking) tests among skilled nursing facility residents.

Investigators are asking residents to perform cognitive tests with and without hearing assistance equipment known as PockeTalkers. This study will be conducted at one urban Skilled Nursing Facility (SNF) with the goal of understanding the extent to which hearing impairment impacts commonly used cognitive impairment measures for clinical assessment. Cognitive performance will be measured, cerumen occlusion, and perceived hearing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

入选标准

  • admitted to unit of intervention
  • ability to communicate and follow simple commands
  • capacity to consent assessed with standard questions used to assess capacity or having a surrogate who can provide consent.

排除标准

  • not on the unit of intervention
  • obtunded or comatose state
  • inability to communicate verbally
  • inability to consent and without surrogate
  • non-English speaking

结局指标

主要结局

Measure of Cognitive function using Mini-Cog

时间窗: 20 Minutes

three-item recall and a clock draw test. 24 Medical assistants have been trained and have employed this test successfully in primary care practices. The Mini-Cog has test characteristics that are comparable to any other brief instrument and exceeds most in accuracy or predictive quality.

Perceived Hearing measured by Hearing Handicap Inventory for the Elderly-Screening Version (HHIE)

时间窗: 20 Minutes

HHIE-S is a valid, robust test for identifying hearing-impaired elderly, irrespective of the audiometric definition used to finally diagnose hearing difficulties.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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