- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00128765
Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease in General Practice
Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease (COPD) in General Practice. A Randomized Controlled Trial Comparing Regular Practice Nurse Review, Self-management Education and Usual Care
In this randomized controlled trial, three contemporary modes for chronic obstructive pulmonary disease (COPD) management in Dutch general practices are compared for costs and effects:
- usual general practitioner (GP) care (at patient's initiative);
- regular practice nurse review; and
- integrated self-management education.
All three interventions are based on existing guidelines, materials, and field experiences.
Visão geral do estudo
Status
Condições
Descrição detalhada
Considering the ageing of the Dutch population and the current and increasing shortage of general practitioners (GPs), the capacity of primary healthcare is a major and growing concern. Delegation of care normally provided by GPs with care provided by trained practice nurses is now rapidly emerging for patients with chronic respiratory disease, i.e. asthma and chronic obstructive pulmonary disease (COPD). However, most general practices still provide care at initiative of the patient self, because of the lack in scientific evidence and the costs of implementing a regular care structure. Self-care by patients may be an alternative to alleviate the growing load on primary health care.
The following two main research questions are addressed in this study.
- Does an integrated self-management education intervention for patients with COPD in general practice contribute to attaining long-term treatment targets, compared to regular monitoring by a practice nurse and usual GP care?
- What is the cost-effectiveness of an integrated self-management education intervention for patients with COPD, compared to regular monitoring by a practice nurse and usual GP care?
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Nijmegen, Holanda, 6500 HB
- Radboud University, Department of General Medicine
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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:
- Registered in one of the general practices participating in the study
- Diagnosis of COPD, with Global Initiative for Chronic Obstructive Lung Diseases (GOLD) stage I, II or III
- Age ≥35 years
- Willing to provide written informed consent
Exclusion Criteria:
- Very poor prognosis with regard to respiratory condition (GOLD stage IV)
- Severe co-morbid conditions with a reduced life expectancy
- Unable to communicate in the Dutch language
- Objections to one or more of the disease management modes in the study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: usual care
usual care, i.e.
COPD care at patient's own initiative, mostly for medical help during exacerbations
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care at initiative of the patient (usual GP care)
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Experimental: monitoring controls
regular COPD care (monitoring) provided by practice nurse according to current COPD guidelines
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protocol based on existing Guidelines: Dutch College of General Practitioners (NHG) Global Initiative for Chronic Obstructive Lung Disease (GOLD)
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Experimental: self-management
disease specific self-management program 'Living Well with COPD'
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disease specific self-management program 'Living Well with COPD', developed in Montreal, Canada
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
disease-specific health-related quality of life (HRQoL)
Prazo: two years
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two years
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Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
the number of exacerbations
Prazo: two years
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two years
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generic quality of life
Prazo: two years
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two years
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decline post- and pre-bronchodilator (BD) lung function indices
Prazo: two years
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two years
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level of respiratory symptoms
Prazo: two years
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two years
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satisfaction with the health care received
Prazo: two years
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two years
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compliance with (non-) pharmaceutical treatment
Prazo: two years
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two years
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direct and indirect medical costs
Prazo: two years
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two years
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COPD related self-efficacy
Prazo: two years
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two years
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COPD coping styles
Prazo: two years
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two years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Chris van Weel, FRCP, Department of General Practice, Radboud University, Nijmegen, The Netherlands
- Diretor de estudo: Tjard Schermer, PhD, Department of General Practice, Radboud University, Nijmegen, The Netherlands
- Investigador principal: Erik Bischoff, MD, Department of General Practice, Radboud University, Nijmegen, The Netherlands
Publicações e links úteis
Publicações Gerais
- Bourbeau J, Julien M, Maltais F, Rouleau M, Beaupre A, Begin R, Renzi P, Nault D, Borycki E, Schwartzman K, Singh R, Collet JP; Chronic Obstructive Pulmonary Disease axis of the Respiratory Network Fonds de la Recherche en Sante du Quebec. Reduction of hospital utilization in patients with chronic obstructive pulmonary disease: a disease-specific self-management intervention. Arch Intern Med. 2003 Mar 10;163(5):585-91. doi: 10.1001/archinte.163.5.585.
- Monninkhof E, van der Valk P, van der Palen J, van Herwaarden C, Partridge MR, Zielhuis G. Self-management education for patients with chronic obstructive pulmonary disease: a systematic review. Thorax. 2003 May;58(5):394-8. doi: 10.1136/thorax.58.5.394.
- Bourbeau J, Nault D, Dang-Tan T. Self-management and behaviour modification in COPD. Patient Educ Couns. 2004 Mar;52(3):271-7. doi: 10.1016/S0738-3991(03)00102-2.
- Bischoff EW, Akkermans R, Bourbeau J, van Weel C, Vercoulen JH, Schermer TR. Comprehensive self management and routine monitoring in chronic obstructive pulmonary disease patients in general practice: randomised controlled trial. BMJ. 2012 Nov 28;345:e7642. doi: 10.1136/bmj.e7642.
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MONC95582
- ZonMw grant: 945.04.230 (Número de outro subsídio/financiamento: ZonMw)
- Picasso grant: 005.2004 (Número de outro subsídio/financiamento: Picasso)
- CMO: 2004/249 (Outro identificador: Medical Ethics Committee)
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