Self-care Program in the Prevention of Admissions of Patients (AUTOCUID)
Effectiveness of an Self-care Program in the Prevention of Admissions of Patients With Hospitalizations Potentially Avoidable: Randomized Clinical Trial
One of the most cost effective intervention is to avoid unnecessary hospitalizations in the national health system. These unnecessary admissions are increasing for several years, reaching rates of over 30% in patients with chronic obstructive pulmonary disease (COPD) or heart failure at two months of hospital discharge. There is scientific evidence suggesting that a multidisciplinary intervention consisting in controling disease and stress associated with disease, and modifying eating habits could reduce the number of hospitalizations due to disease decompensation.
The main objective of the study is to assess the rate of readmissions at year of multidisciplinary intervention in patients with COPD and / or heart failure.
We will select 144 patients who will be randomized to two groups (control and intervention group) and they will be followed for 12 months through 4 visits (1 month, 3 months, 6 months and 12 months of hospital discharge).
Patients assigned to the intervention group will be receive three educational sessions (one of them will be imparted by nursing, another by the nutritionist and the last one by the psychologist). In addition, patients with a BMI <20 and / or> 30 will receive a closer monitoring by the nutritionist).
Patients assigned to the control group will receive usual care in clinical practice.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Alava
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Vitoria-Gasteiz, Alava, Espanha, 01009
- Recrutamento
- Araba Universitary Hospital (Txagorritxu)
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Contato:
- Naiara Parraza, PhD
- Número de telefone: 945007413
- E-mail: naiara.parrazadiez@osakidetza.net
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- COPD
- Heart failure: heart failure in clinically stable with ≥ II degree of NYHA . 1 or more emergency admissions for the same diagnosis in the prior year
Exclusion Criteria:
- Mental states that make difficult the self-care: Class 295, 296, 297, 298, 300, 301, 304 and 316 (schizophrenic disorders, episodic mood, delusional other nonorganic psychosis, anxiety, dissociative and somatoform, personality, alcohol and drug dependencies)
- Congenital respiratory diseases or presence of other obstructive pulmonary diseases
- Patients participating in other research studies.
- Other diseases that can affect patients' medium-term survival
- Moderate to severe cognitive impairment.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: Control group
Habitual Clinical Practice
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Experimental: Intervention Group
Multidisciplinary intervention consisting in controlling disease and stress associated to it, and modifying eating habits.
A Nurse, nutritionist and a psychologist will be the responsible of these educational sessions.
it will be three educational sessions.
Patients with a BMI lower than 20 or bigger than 30 will be receive a closer follow up by nutritionist.
In addition, patients with a score of 9 or more in the Patients Health Questionnaire-9 questionnaire will be also a closer follow up with the psychologist.
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Health education sessions consisting in controlling disease and stress asociated to it, and modifying eating habits
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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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Readmission rate
Prazo: 12 months
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in the twelve months following the intervention, according to the electronic record of the hospital
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12 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of admissions to emergency service or number of visits to general practitioner's office or number of visits to emergency service
Prazo: 12 months
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12 months
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time until the first admission to the hospital
Prazo: it wil be measured at 12 months
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it wil be measured at 12 months
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time until first visit to general practitioner's office
Prazo: it will be measured at 12 months
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it will be measured at 12 months
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time until the first visit to emergency service
Prazo: it will be measured at 12 months
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it will be measured at 12 months
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Health related quality of life through several questionnaires
Prazo: At month, 3, 6 and 12 months after discharge
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COPD Assessment Test (CAT), self efficacy scale in COPD patients, SORT Form-36, Patient Health Questionnaire-9, Minnesota Living with Heart Failure Questionnaire (MLHFQ), Physical Activity Questionnaire (IPAQ), Barthel Index, European heart failure self-care behaviour scale.
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At month, 3, 6 and 12 months after discharge
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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HbA1c
Prazo: at month, 3, 6 and 12 months
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glycated hemoglobin
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at month, 3, 6 and 12 months
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Type B natriuretic peptide (BNP), blood pressure
Prazo: At month, 3, 6 and 12 months of discharge
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At month, 3, 6 and 12 months of discharge
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APACHE III INDEX, Functional Category of New York Heart Association (NYHA)
Prazo: 1 day
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1 day
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (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
- AC-01
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