- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03327233
CONNECARE-Assuta-Case Study 1
Integrated Personalized Connected Care for Complex Chronic Patients - Community-based Management
The European Union's Horizon 2020 project issued a Call for Action [1] in December 2013 to design, develop, disseminate and evaluate new IT technologies for use in integrative treatment processes, with emphasis on complex adult patient. Assuta Hospital submitted a proposal for this call, as part of a broad consortium of 10 participants from various European countries.
The CONNECARE consortium has formulated a general model for integrative treatment, and is currently in the technological development stages, to create a smart (supportive decision) and adaptive system that supports integrative treatment processes both in the hospital and in the community for personalized treatment in complex chronic patients. The development includes a significant integrative component of self-care management by the patient and / or the primary caregiver.
Following the completion of the technological development, clinical trials will be held in four organizations throughout Europe - Assuta Hospital in Ashdod in cooperation with the Maccabi community in Ashdod, two centers in Catalonia and the Groningen region in the Netherlands. The purpose of the studies is to assess the impact of the implementation of the model, processes and digital tools that will be built during the project.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The intervention in this study consists of two parts:
- Integrative treatment in the community, which includes a close follow-up with a coordinating nurse for three months after discharge from the hospital.
- Empowering the patient to self-manage his or her health by using applications for smart devices.
The study protocol:
- Recruitment of participants during the patient's hospitalization after the patient is identified as a complex patient, explanation of the study and signing the consent form.
- Evaluation process for the patient, using valid questionnaires, in order to determine the baseline level at the entrance to the study.
- Distribution of research kit and related accessories and training.
- Close monitoring for three months in the community after discharge from the hospital and use of the research kit.
- Reassessment of the patient at the exit of the study.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- All Maccabi members who arrive at the ER in an unplanned manner
- Age over 65
- Living in a home and not in a nursing home
- LACE> 7
At least three of the following conditions:
- Multiple drugs - regular use of four or more drugs
- More than one case of hospitalization or visit to the ER in the past year
- Malnutrition
- Elements of low socio-economic status
- The patient and / or the main caregiver speak Hebrew, English or Russian
- The patient or primary caregiver has a password to the Maccabi Online website
- The patient and / or the primary caregiver have basic technological knowledge in the use of the applications
- The patient has wireless Internet access at home (via Wifi or through a cellular connection)
Exclusion Criteria:
- Patients with cognitive or dementia problems
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Intervention group
Implementing the Connecare system to support integrated care for complex patients with an unplanned admission to Assuta Ashdod who are discharged back to the community with an emphasis on Connecare self managment system for the patient and close follow up and coordination of all of the medical, health and social care in the community by a Maccabi integrated care nurse for a period of 3 months post discharge.
|
The CONNECARE SMS will rely on a hybrid solution that, besides being autonomous (the patient may use the SMS to monitor and access to her/his data and information), has also a collaborative component (through the interaction with the SACM) to allow participation by clinicians and to provide feedback to them.
In so doing, the patient may control her/his activity, receiving recommendations to improve the treatment and to be encouraged in following it.
|
Sem intervenção: Matched control group
The control group will be selected from Maccabi's database and will be patients who are matched 1:1 with the intervention sample and live in another community similar to Ashdod in socioeconomic characteristics who undergo the same elective major surgery in other hospitals
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Re-Hospitalizations and emergency room visits in the short term after discharge from the hospital
Prazo: One month
|
Number of hospitalizations and emergency room visits after discharge
|
One month
|
Re-Hospitalizations and emergency room visits in the long term after discharge from the hospital
Prazo: One year
|
Number of hospitalizations and emergency room visits after discharge
|
One year
|
Length of hospitalization
Prazo: Less then one month
|
In days
|
Less then one month
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Compliance with the assignments in the discharge program guidelines
Prazo: One year
|
At the time of discharge from the hospital, the patient receives a list of tasks to be performed as part of the release letter.
We would like to know how many out of this tasks were carried out
|
One year
|
Community health services use
Prazo: One year
|
Number of appointments made by the patient during the follow up time for primary physician, professionals, laboratory tests and imaging, physiotherapy and nutritionist.
|
One year
|
Evaluation of usability of the technology systems developed
Prazo: One year
|
Using questionnaires for nurses and patients to express their opinion on the use of the technology systems in the project and how much these systems assisted them
|
One year
|
Cost-benefits evaluation for the intervention
Prazo: One year
|
Economic evaluation of tests and services saved as a result of active and orderly monitoring of the patient
|
One year
|
Assessment of satisfaction of patients from all the projects components (The follow up and the technology systems)
Prazo: One year
|
Using satisfaction questionnaires to be passed at the end of the study
|
One year
|
Assessment of satisfaction of medical staff from all the projects components (The follow up and the technology systems)
Prazo: One year
|
Using satisfaction questionnaires to be passed at the end of the study
|
One year
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Bella Azaria, Doctor, Assuta Medical Center
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Antecipado)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 0033-17-ASMC
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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