- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02545374
Medico-economic Evaluation of a Project of Wounds by a Remote Network (DOMOPLAIES)
Medico-economic Evaluation of the DOMOPLAIES Project by the CICAT-LR Network
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Montpellier, França, 34295
- Wound healing Department
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Being adult
- Taken up residence on the Languedoc-Roussillon
- Patient carrying a wound with healing or improvement objective (wound closure or the appearance of 40% of granulation)
- Informed consent signed,
- Patient member of the Security Social
- Patient having a visiting nurse.
Exclusion Criteria:
- Patient in vital or functional emergency situation during the first call or during the consultation
- Tumoral wound
- dialysis patient
- Arteritis of stage 4 and not revascularizable
- Absence of regular doctor and visiting nurse
- patient refusal
- Refusal of one of the health professionals participating in the pathology care
- Anybody incapable to communicate and to answer the questions
- Pregnant or nursing woman
- Subject deprived of freedom by court or administrative order
- Major subject protected by the law
- For the patients in telemedicine: refusal of the collaboration agreement
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 |
|---|---|
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Experimental: Telemedicine
In the telemedicine arm, all patients will be supported by Telemedicine protocol according to the development of telemedicine in the region. The use of teleconsultation allows the couple expert doctor / nurse expert to perform a complex of wound assessment consultation and / or chronic. The use of telemedicine allows for acts of telecare, when the nurse applicant sought a remote support of an expert nurse (under the responsibility of a doctor) for the realization of an act. The use of tele-expertise enables physicians to remotely bring special expertise to improve patient care. |
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Comparador Ativo: Control
In the control arm, patient care depend on his home, as is currently the case:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Rate of healed chronic wounds during a telemedicine care
Prazo: Six months after inclusion
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Rate of healed chronic wounds during a telemedicine care versus during a usual medical care
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Six months after inclusion
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Rate of healed chronic wounds during a usual medical care
Prazo: Six months after inclusion
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Rate of healed chronic wounds during a telemedicine care versus during a usual medical care
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Six months after inclusion
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Result to the questionnaire on the quality of life: EQ-5D
Prazo: Six months after inclusion
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Compare the quality of life of patients with chronic wounds during a telemedicine coverage versus during a usual medical care, thanks to the EQ-5D quality life scale.
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Six months after inclusion
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A measure of the costs of the management of the disease
Prazo: Seven months after the inclusion of the last patient
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A measure of the costs of the management of the disease (consumer care, hospitalization, transport ...)
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Seven months after the inclusion of the last patient
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A measure of the costs of the intervention assessed
Prazo: Seven months after the inclusion of the last patient
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A measure of the costs of the intervention assessed (investment, maintenance, training ...).
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Seven months after the inclusion of the last patient
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The total healing time
Prazo: Six months after inclusion
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Six months after inclusion
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The decrease in centimeters of the wound surface to 6 months
Prazo: Six months after inclusion
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Six months after inclusion
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The response time between making an appointment and support
Prazo: Six months after inclusion
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Six months after inclusion
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The mortality rate within 6 months
Prazo: Six months after inclusion
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Six months after inclusion
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimado)
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
- 9250
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