- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02836665
Application of Telemedicine for Dermatological Emergency Patients (Telederm)
After admission to the emergency room each dermatological patient is routinely assessed to Manchester Triage System (MTS) by the nursing staff. Thereby data are collected for anamnesis followed by randomization in two equal study groups.
Patients of group A (control group) wait routinely until the dermatological investigator in charge arrives at the emergency room. Once the dermatological investigator is on site, he gives a diagnosis and proposes a therapy.
For Patients of group B (teledermatology) study-related photographs of the skin lesion and anamnesis data are uploaded to the hospital information system "medico". Those data can directly be processed by the dermatological investigator in charge who enters his diagnosis and his therapy proposal.
Subsequently an internal control is carried out as the same investigator comes personally to the emergency room to check its telemedical diagnosis and therapy proposal.
Finally both time periods patients have to wait in the emergency room for their diagnosis and therapy are compared with each other.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
After admission to the emergency room each dermatological patient is routinely assessed to Manchester Triage System (MTS) by the nursing staff. Thereby data are collected for anamnesis (duration of symptoms, allergies, self-medication, medical history) followed by randomization in two equal study groups.
Patients of group A (control group) wait routinely until the dermatological investigator in charge arrives at the emergency room. Once the dermatological investigator is on site, he gives a diagnosis and proposes a therapy.
Time is measured from the patients admission to the emergency room up to the personnel diagnosis and therapy by the dermatological investigator in charge.
For Patients of group B (teledermatology) first of all study-related photographs of the skin lesions are taken with a tablet. After that the registration of the consult "teledermatology" is carried out by the emergency investigator in charge, who uploads the photographs as well as the data for anamnesis to the hospital information system "medico". The consult "teledermatology" can directly be processed by the dermatological investigator in charge who enters his diagnosis and his therapy proposal.
Time is measured from admission to the emergency room up to the telemedical diagnosis and therapy by the dermatological investigator in charge.
Subsequently an internal control is carried out as the same investigator comes personally to the emergency room to check its telemedical diagnosis and therapy proposal.
Finally both time measurements are compared with each other.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
-
Aachen, Германия, 52074
- Uniklinik RWTH Aachen
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Male or female aged ≥ 18 years
- Written informed consent prior to study participation
- Adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel.
- Dermatological emergency patient
Exclusion Criteria:
- Male or female aged < 18 years
- Missing informed consent prior to study participation
- Patient has been committed to an institution by legal or regulatory order
- Persons in dependence from the sponsor or working with the sponsor
- Participation in another clinical trial within the previous 2 months
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Без вмешательства: A: Control group
Patients of group A wait routinely until the dermatological investigator in charge arrives at the emergency room.
Once the dermatological investigator is on site, he gives a diagnosis and proposes a therapy.
|
|
|
Экспериментальный: B: Telemedicine for dermatological emergency patients
For Patients of group B study-related photographs of the skin lesion and anamnesis data are uploaded to the hospital information system "medico".
Those data can directly be processed by the dermatological investigator in charge who enters his diagnosis and his therapy proposal.
|
Study-related photographs of the skin lesion made by a tablet and anamnesis data are uploaded to the hospital information system "medico".
Those data can directly be processed by the dermatological investigator in charge who enters his diagnosis and his therapy proposal without being on site.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Waiting time [min]
Временное ограничение: 1 emergency visit [approximately 2 hours]
|
Time is measured from the patients admission to the emergency room up to the personnel/telemedical diagnosis and therapy by the dermatological investigator in charge.
|
1 emergency visit [approximately 2 hours]
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Number of differences between the personally and the telemedical diagnosis and therapy proposal
Временное ограничение: 1 emergency visit [approximately 2 hours]
|
An internal control is carried out as the same investigator comes personally to the emergency room to check its telemedical diagnosis and therapy proposal.
|
1 emergency visit [approximately 2 hours]
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Luigi Villa, Dr. med., RWTH Aachen University
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
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 (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 16-033
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
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