- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Aachen, Alemanha, 52074
- Uniklinik RWTH Aachen
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Sem intervenção: 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.
|
|
Experimental: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Waiting time [min]
Prazo: 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]
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Number of differences between the personally and the telemedical diagnosis and therapy proposal
Prazo: 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]
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Luigi Villa, Dr. med., RWTH Aachen University
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 16-033
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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