NCT01809496终止不适用
Auditory Rehabilitation From the Perspective of the Significant Other
VA National Center for Rehabilitative Auditory Research2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2013年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- post-use subjective opinions regarding the hearing aids
研究概览
简要总结
The purpose of this study is to examine the effect of enhanced patient-centered counseling (PCC) and the influence of spousal involvement in pre-fitting counseling on hearing-aid outcomes.
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both men and women with hearing loss and their live-in partners will serve as subjects in this study. The subjects with hearing loss will have a mild to moderately-severe hearing loss in both of the ears, will have word recognition scores of 40% or better bilaterally, and will be about to get new hearing aids. Live-in partners may also have up to a moderately-severe degree of hearing loss but cannot have prior experience with hearing aids nor have plans to get hearing aids during the course of their participation in this study. Their word recognition scores should also be 40% or better bilaterally. All subjects also will meet the following additional inclusion criteria:
- •Age 20-85 years;
- •Intact mental status as assessed by the Mini-Mental State Examination (MMSE; Folstein, Folstein & McHugh, 1975);
- •No evidence of any major medical illness requiring long-term assistive care, as determined by the Katz Index of Independence in Activities of Daily Living (Katz, Down, Cash &Grotz, 1970);
- •Able to read and respond to English; and
- •Willing and able to give written informed consent to participate in this investigation.
排除标准
- •Failure to satisfy any of the requirements listed above or if their live-in partner fails to meet the criteria.
结局指标
主要结局
post-use subjective opinions regarding the hearing aids
时间窗: 4-6 weeks after the hearing aid fitting
questionnaires
次要结局
- pre-use hearing aid expectations(immediately after the intervention at Visit #2 (Day 0))
研究者
M. Samantha Lewis, Ph.D.
Principal Investigator
VA National Center for Rehabilitative Auditory Research
研究点 (2)
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