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Educational Program for Hearing Aid Users With Internet Support

2016年3月22日 更新者:Milijana Malmberg、Sodra Alvsborgs Hospital

A Randomized, Controlled Trial Evaluating the Short- and Long-term Effects of an Internet-based Aural Rehabilitation Program for Hearing Aid Users Implemented in a General Clinical Practice

The purpose of this study is to examine the short-term effects of complementing an educational program for hearing aid users with Internet support.

研究概览

详细说明

Aural rehabilitation aims to improve communication for people with hearing impairment. Education is widely regarded as an integral part of rehabilitation, but the effect of the delivery method of an educational program on the experience of hearing problems has rarely been investigated in controlled trials. Internet as a complement to aural rehabilitation has been tested in different studies with promising results. Though, until now not applied clinically as a part of an aural rehabilitation, focusing on hearing aid users with persistent self- reported hearing problems.

The purpose of this study was to evaluate the effect of an internet-based aural rehabilitation for hearing aid users from a clinical population.

Participants were randomly assigned to an intervention or control group. The intervention group followed a five-week program that consisted of reading material, home training assignments, online and telephone interaction with an audiologist, and participation in a discussion forum. The control group only had access to reading material.

The Hearing Handicap Inventory for the Elderly (HHIE), the Hospital Anxiety and Depression Scale (HADS) and the Communication Strategies Scale (CSS) were used to measure the outcomes of this study; and were recorded before and directly after the intervention as well as 6 months post-intervention.

研究类型

介入性

注册 (实际的)

74

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Vastra Gotalandsregion
      • Boras、Vastra Gotalandsregion、瑞典、501 82
        • Hearing Clinic, Hearing Organization

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • the hearing aid users to be between 20 and 80 yr of age,
  • the hearing aid users to have conductive or sensorineural hearing loss of mild to moderate degree (20-60 decibel Hearing Level pure-tone average measured across 500, 1000, and 2000 Hertz),
  • the hearing aid users to have completed a hearing aid fitting at least 3 months before the study began (regardless of hearing aid manufacturer, model, or hearing aid outcomes),
  • the hearing aid users to have a Hearing Handicap Inventory for the Elderly (HHIE) score of >20 points (indicative of some residual self-reported hearing problems),
  • the hearing aid users to provide informed consent to participate

Exclusion Criteria:

  • the hearing aid users who are not fulfilling the conditions to participate

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Control group
no professional support
The intervention group followed a five-week program that consisted of reading material, home training assignments, online and telephone interaction with an audiologist, and participation in a discussion forum.
实验性的:Intervention group
Professional support via Internet
The control group only had access to reading material.

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
The Hearing Handicap Inventory for the Elderly (HHIE)
大体时间:5 weeks, 6 months
The HHIE measures the experience of hearing loss in older people by focusing on the psycosocial and emotional effects of hearing loss. Higher score reflects a higher self-reported hearing problem. Minimum score for the total scale (reported) is 0 and maximum score is 100 points.
5 weeks, 6 months

次要结果测量

结果测量
措施说明
大体时间
International Outcome Inventory for Hearing Aids (IOI-HA)
大体时间:pre-measurement
The IOI-HA measures hearing aid outcomes. The IOI-HA includes seven questions, measuring specific dimensions of hearing aid outcomes: daily use, benefits, remaining activity limitations, satisfaction, remaining participation restrictions, impact on the environment, and quality of life. Each question is scored from 1 to 5 (reported), where a higher score indicates a better outcome.
pre-measurement
Hospital Anxiety and Depression Scale (HADS)
大体时间:5 weeks, 6 months
The HADS contains 14 items. Responses are scored from 0 to 3 and a higher score indicates more symptoms of anxiety and depression. Minimum score for the total scale (reported) is 0 and maximum score for the total scale is 42.
5 weeks, 6 months
Communication Strategies Scale (CSS)
大体时间:5 weeks, 6 months
CSS is designed to analyze participants' behavior in various communication situations. Scoring for CSS ranges from 1 almost never to 5 almost always for subscales Verbal- and Nonverbal Strategies and conversely for Maladaptive Behaviors; indicating how frequent a specific situation or behavior occurs. Minimum score for the total scale (reported) is 0 and maximum score for the total scale is 125.
5 weeks, 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Gerhard Andersson, Professor、Department of Clinical and Experimental Medicine, Division of Technical Audiology, Linkoping University, Sweden; Department of Behavioral Sciences and Learning, Swedish Institute.
  • 首席研究员:Thomas Lunner, Professor、Department of Clinical and Experimental Medicine, Division of Technical Audiology, Linkoping University, Sweden; Oticon A/S, Research Centre Eriksholm, Snekkersten, Denmark.

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年4月1日

初级完成 (实际的)

2013年12月1日

研究完成 (实际的)

2014年6月1日

研究注册日期

首次提交

2013年4月18日

首先提交符合 QC 标准的

2013年4月22日

首次发布 (估计)

2013年4月23日

研究记录更新

最后更新发布 (估计)

2016年4月25日

上次提交的符合 QC 标准的更新

2016年3月22日

最后验证

2016年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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