Educational Program for Hearing Aid Users With Internet Support
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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Vastra Gotalandsregion
-
Boras、Vastra Gotalandsregion、スウェーデン、501 82
- Hearing Clinic, Hearing Organization
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ: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.
|
|
実験的:Intervention group
Professional support via Internet
|
The control group only had access to reading material.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The Hearing Handicap Inventory for the Elderly (HHIE)
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
International Outcome Inventory for Hearing Aids (IOI-HA)
時間枠: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)
時間枠: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)
時間枠: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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Gerhard Andersson, Professor、Department of Clinical and Experimental Medicine, Division of Technical Audiology, Linkoping University, Sweden; Department of Behavioral Sciences and Learning, Swedish Institute.
- 主任研究者:Thomas Lunner, Professor、Department of Clinical and Experimental Medicine, Division of Technical Audiology, Linkoping University, Sweden; Oticon A/S, Research Centre Eriksholm, Snekkersten, Denmark.
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。