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临床试验/NCT01843777
NCT01843777已完成不适用

Applying the Use of Motivational Tools to Auditory Rehabilitation

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Difference in Hours of Hearing Aid Use Between Pre-intervention and Post-intervention

研究概览

简要总结

The purpose of this study is to compare two different ways of helping first-time hearing-aid users get the most out of their hearing aids and determine if one method is better than the other. One method provides the patient with routine information regarding the care and use of hearing aids the other method uses tools to address patient-specific barriers against and motivators for hearing-aid use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • be aged between 20 and 89 years
  • be a first-time hearing-aid user
  • air-conduction pure-tone averages (mean thresholds at 500 Hz, 1000 Hz, and 2000 Hz) of 70 dB HL or less in both ears
  • word-recognition scores of 40% or better in each ear
  • English as their first language
  • have sufficient vision and reading ability
  • have the appropriate cognitive skills to participate in the study as determined by the Mini Mental State Exam, 2nd Edition - Brief Version (Folstein et al., 2010)
  • have been fit by the VA Portland Health Care System Audiology and Speech Pathology Service (ASPS) with two hearing aids which have datalogging capabilities
  • be independent in their completion of activities in daily living, as determined by their score on the Katz Index of Independence in Activities of Daily Living (Katz et al., 1970)
  • have poor adoption of their hearing aids
  • be free of a documented diagnosis in the VA Computerized Patient Record System (CPRS) record of neurological or psychological disorder, such as Alzheimer's disease, schizophrenia, or uncontrolled substance abuse, which would interfere with the completion of the study. Vulnerable populations are not being studied.

排除标准

  • Failure to satisfy any of the requirements listed as inclusion criteria

结局指标

主要结局

Difference in Hours of Hearing Aid Use Between Pre-intervention and Post-intervention

时间窗: Collected pre-intervention and again at post-intervention appointment occurring between four and six weeks after the intervention date

Hearing aid use was measured by the number of hours of use recorded in the hearing-aid software. This was measured on up to four occasions: Visit #1 to #3 (pre-intervention), and Visit #4 (post-intervention). Average daily hours of hearing aid use was documented at each time point, so that the Visit #4 observation is a measure of the average daily use between the start of intervention (Visit #3) and visit #4. Data logger results were averaged between the left and right hearing aids at each time point and across all three pre-intervention time points.

次要结局

  • Difference Between Pre-intervention and Post-intervention Total Score on International Outcome Inventory for Hearing Aids(Collected twice once at pre-intervention visit and once at a post-intervention visit occurring four to six weeks following the intervention)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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