使用非处方助听器进行基于自我效能的听力康复
基于自我效能的听力康复,通过非处方助听器优化现实世界的结果:一项试点研究
本研究的目的是了解一种称为基于自我效能的听觉康复 (SEBAR) 的新听力学治疗过程是否可以提高使用非处方 (OTC) 助听器的信心和成功率。
它旨在回答的主要问题是:
- SEBAR 能否提高参与者管理非处方助听器的信心?
- SEBAR 能否提高参与者采用非处方助听器的意愿、满意度、生活质量和情绪状态? 研究人员将比较佩戴和不佩戴 OTC 助听器时 SEBAR 的这些结果。
参与者将:
- 无需 OTC 助听器即可进行一次预约来完成几份调查问卷
- 佩戴 ITC 助听器一周,并使用应用程序回答有关其体验的问题
- 进行第二次预约,使用 OTC 助听器完成相同的调查问卷。
研究概览
详细说明
拟议的研究将采用单臂前后干预研究设计来实现这两个目标。 参与者将完成两项预约。 第一次预约的评估将作为基线(独立)。 随后将在自然聆听情况下使用 OTC HA 并实施 SEBAR 一周,结果测量将在预约 2(辅助)中再次完成,以反映佩戴 OTC HA 的影响。 将比较无辅助和有辅助条件下的结果测量分数,以回答这两个目标。 拟议研究中的两项任命将在阿肯色医学大学健康专业学院听力学和言语病理学系的共享和专用研究空间中完成。 研究计划将提交给大学机构审查委员会批准。抵达后,参与者将完成同意程序,其中 PI 将详细描述所有研究程序、研究的风险和益处,以及参与者选择时不会产生负面后果在数据收集期间退出研究或停止参与。 签署同意书后,参与者将完成两次预约。
预约 1:对于每位感兴趣的参与者,将完成标准听力测试程序以确认其资格。 一旦符合资格的参与者同意,初步措施将完成。 然后,参与者将完成助听器自我效能、采用 HA 的意愿、预期 HA 满意度、当前情绪状态和生活质量的无辅助基线结果测量。 此时,OTC HA 将为参与者安装,并且他们将收到 SEBAR。 参与者将被要求在下周每天使用 HA 至少 4 小时。 最后,EMA 应用程序将安装在他们的手机上,研究人员将演示其在家里的使用。
预约 2:在此预约时,将存储为期一周的现场试验期间来自 EMA 应用程序的数据。 HA 将使用 Verifit 2 进行测试,以验证它们是否在参与者的首选设置下提供所需的放大量。 将重复进行的所有结果测量,以反映使用 OTC HA 一周后的结果。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Arkansas
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Little Rock、Arkansas、美国、72204
- Department of Audiology, University of Arkansas for Medical Sciences
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
纳入标准:
18-85岁之间
- 非波动性、成人发病、双侧轻度至中度感音神经性听力损失(500-3000Hz 的平均听力阈值在 25 至 60 dB HL 之间,两耳之间的差异不超过 10 dB)。
- 以前没有使用助听器的经验
- 以英语为第一语言且自我报告健康状况良好
排除标准:
- 任何报告的外耳或中耳病变史 • 不会因性别、种族/民族而将参与者排除在外。
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:前置单臂设计
参与者将在收到 SEBAR 的同时佩戴助听器一周。
将评估使用或不使用助听器的结果。
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非处方药设备一周
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Total Confidence
大体时间:1 week
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The Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA), referred to as MARSHA, is a 24-item, validated, self-report questionnaire used to assess an individual's confidence (self-efficacy) in their ability to use and manage hearing aids.
Participants rated their confidence for each item (0 - 100%) and the average percentage across all items was calculated as the percentage of total confidence.
Scores between pre- and post-conditions were compared and reported here.
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1 week
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Total Readiness Score on the URICA Scale
大体时间:1 week
|
Participants' readiness to adopt HAs was assessed using the 32-item modified University of Rhode Island Change Assessment (URICA).
Each item presents a statement that asks about how ready a person is to move along in their hearing-health journey and adopt a treatment such as HAs.
Participants respond to each item using a 5-point scale ranging from strongly disagree (1 point) to strongly agree (5 points).
Items represent the stages of change (precontemplation, contemplation, preparation, action).
Total readiness score (Readiness for change) is calculated by adding the scores representing the stages contemplation, preparation, action and subtracting this from scores on the items representing the precontemplation stage.
The range of total readiness for change score is -2 to 14. Higher score represents higher readiness to adopt HAs, with scores of 11 or more is considered appropriate for someone to have the readiness to taken action to get hearing aids.
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1 week
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Hearing Aid Satisfaction on SADL Average Score
大体时间:1 week
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The Satisfaction with Amplification in Daily Life (SADL) Scale is a standardized, self-report instrument used to assess patient satisfaction with hearing aid use, including perceived benefit, usability, and psychosocial impact.
It has 15 items in 4 subscales (Positive Effect, Service and Cost, Negative Features, Personal Image).
For this study, only average score across all items was calculated.
For each item participants respond the frequency (how frequently the said outcome in the item happens with them or true for them).
Average frequency score (ranging from 1-5) across all items is used for analysis.
The range of possible score is 1 to 7. Higher scores indicate greater satisfaction with hearing aids (better outcome).
Lower scores indicate lower satisfaction or greater perceived difficulty with hearing aids (poorer outcomes).
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1 week
|
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Emotional State Total Score
大体时间:1 week
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Participants' change in emotional state will be assessed using the, 20-item, Positive and Negative Affect Schedule-Short Form (PANAS-SF).
Participants respond to each item on a 5-point Likert scale ranging from "very slightly or not at all" to "extremely."
Participants are asked to read each word and indicate the extent (intensity) to which they feel that way before/after wearing HAs.
Positive and negative affective scores will be computed by calculating the sum of the items included for each of these two subscales.
For this study, the final emotional state average score was calculated by subtracting the negative state score from the positive state score for each participant.
Total possible range of scores would be -40 to +40.
A positive emotional state total score indicated that the participant reported greater positive emotional states than negative emotional states.
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1 week
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Hearing-related Quality of Life Total Score
大体时间:1 week
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A one-item hearing-related quality of life question wase used.
The question asked about participants' current quality of life compared to before.
The scale ranges from "a very great deal worse" (-7) to "a very great deal better" (7).
An absolute change of 2 or more is considered clinically relevant in audiology.
Higher positive values indicate improvements in hearing- related QOL and higher negative values indicate reduced hearing related QOL.
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1 week
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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