- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01843907
Patient Participation in Prevention of Loss of Functions
Cross-sectorial Patient Participation in Prevention of Loss of Functions in Older Short-stay Medical Patients
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
At baseline:
Nutritional status, BMI and weight, depression (GDS5), dementia (MMSE), pain (Verbal Ranking Scale), muscle strength (hand-grip strength, chair-to-stand-test), quality of life (EQ5D), coping (Sense of Coherence 13 item scale), patient experience (NORPEQ), medication management (MedMaide).
At follow-up three months after discharge:
BMI and weight, depression (GDS5), dementia (MMSE), pain (Verbal Ranking Scale), muscle strength (hand-grip strength, chair-to-stand-test) and EQ5D. In addition, need for initiated municipal assistance after discharge. Project employee who performs data collection is blinded to the group to which the patient is randomized.
The control group Patients in the control group undergo the same measurements and registrations at discharge and 3 - month follow-up, as the intervention groups, but receive otherwise usual treatment and care, and are discharged without further intervention. After six months control patients receive a report comprising the screening results, relevant information material and a cover letter. Patients' GP and municipality care section receive a summary of outcomes, as well as a cover letter.
Register data Information on mortality, readmissions and services in primary health care are obtained after 6 months from the National Patient Register, Population Register and municipalities.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Herlev, Dinamarca, 2730
- Herlev Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- 65 years or older
- Living in their own home with no contact to the Municipality, both before and after admission
- Discharged from Department o105 or the Acute Receiving Unit <48 hours from admission.
Exclusion Criteria:
- Patients with life-threatening disease in the terminal stage
- Patients who does not speak and understand Danish
- Patients who are not able to communicate and collaborate, with regards to the measurements
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Outro: Empowerment
Patients in the intervention group 1 receive a communication report which will also be sent to the physician and home care.
In communication report includes the results and interpretation and explanation of the measurements in layman's terms.
The report also includes relevant and targeted information on pain management, depression among the elderly, dementia and disability in old age and ways to maintain and improve functional capacity.
Links and addresses of relevant, local organizations, and networks are also included.
The information material is also included in the report sent to the General Practitioner (GP) and home care.
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To give patients the necessary resources to take care of their own health
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Outro: Conversation with Nurse
Patients in the intervention group 2 gets clarification and follow-up conversation with a nurse anchored in both medical department and municipalities.
The nurse is "blinded" in relation to the patient's screening results.
Problems identified in connection therewith are communicated to the GP and home care.
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To find out, if the nurse, using her ....
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Sem intervenção: Controle Group
Patients in the control group are undergoing the same measurements and records at discharge, as the intervention group, but are otherwise receiving treatment and care as usual without further intervention.
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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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Number of participants who have been readmitted to hospital
Prazo: 01.03.2013 - 12.31.2014
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Number of participants who have been readmitted to hospital.
Measured 6 months after admission.
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01.03.2013 - 12.31.2014
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mortality
Prazo: 01.04.2014 - 31.12.2014
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Mortality.
Number of participants, who have died.
Measured 6 months after admission.
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01.04.2014 - 31.12.2014
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Functional ability
Prazo: 31.12.2014
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Measured 3 months after discharge. Functional ability Handgrip-strength 4 second test: Hand- and forearm muscular strength in kg. and 30 second chair stand test: Lower-body muscle strength |
31.12.2014
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Primary Healthcare Services
Prazo: 01.04.2013 - 31.12.2014
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Delivered services in Primary Healthcare.
Measured 6 months after admission.
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01.04.2013 - 31.12.2014
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Tove L. Damsgaard, Herlev Hospital
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 (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
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
- H-1-2012-118
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