- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01837550
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
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Vastra Gotalandsregion
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Boras, Vastra Gotalandsregion, Швеция, 501 82
- Hearing Clinic, Hearing Organization
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: 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.
|
|
Экспериментальный: Intervention group
Professional support via Internet
|
The control group only had access to reading material.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
The Hearing Handicap Inventory for the Elderly (HHIE)
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
International Outcome Inventory for Hearing Aids (IOI-HA)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Gerhard Andersson, Professor, Department of Clinical and Experimental Medicine, Division of Technical Audiology, Linkoping University, Sweden; Department of Behavioral Sciences and Learning, Swedish Institute.
- Главный следователь: Thomas Lunner, Professor, Department of Clinical and Experimental Medicine, Division of Technical Audiology, Linkoping University, Sweden; Oticon A/S, Research Centre Eriksholm, Snekkersten, Denmark.
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- HörNet VGR
Планирование данных отдельных участников (IPD)
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