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- Ensaio Clínico NCT04284865
Optimizing Maintenance for Patients With COPD Via a Web Platform - Case Study
Optimizing Maintenance for Patients With Chronic Obstructive Pulmonary Disease Following Pulmonary Rehabilitation Via a Web Platform - Case Study
Visão geral do estudo
Descrição detalhada
Introduction: By 2020, chronic obstructive pulmonary disease (COPD) is projected to become the 3rd leading cause of death in the world. Pulmonary rehabilitation (PR) has been shown to improve quality of life of people with COPD by decreasing their symptoms. However, the benefits obtained during PR tend to decrease within six months to one year after PR.
The objective of this study is to implement a web platform following PR programs in order to improve COPD patients' adherence to self-management techniques. Specifically, the investigators will 1) evaluate the adherence to the use of the web platform and 2) the effects on exercise capacity, quality of life, the number of hospitalizations and exacerbations. Therefore, the investigators want to verify whether the addition of a tele-management tool allows the gains obtained during PR to be retained over 3, 6 and 12 months. The hypothesis is that patients will maintain their PR gains if they use the platform.
Methods: Participants with COPD will be selected in a PR group at CHUS Hôtel-Dieu de Sherbrooke. Their initial 10-week rehabilitation program will be followed by the use of a web-based tele-management platform for 12 months. Data will be collected at the beginning of PR (T1), end of the PR (T2), after three months of using the web platform (T3), after six months (Q4) and after 12 months (T5). To measure adherence, the research team will have access to a) the number of connections made on the site, b) the number of exercises performed, c) the duration and type of cardiorespiratory exercises as well as the muscular exercises filled in the logbook and d) the number of exercises performed (breathing, cardiorespiratory and muscular exercises) self-reported by the participants at the time of assessment. For the second objective, the measures used will be FEV1 for lung function, the 6-minutes walk test for exercise capacity, COPD Assessment Test for quality of life, modified BORG scale (0-10) and the medical research center (MRC) for the feeling of dyspnea, the number of hospitalizations over 3, 6 and 12 months (self-reported) and the number of exacerbations via medication taken from their pharmacist.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Quebec
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Sherbrooke, Quebec, Canadá, J1H 5N4
- Université de Sherbrooke
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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:
- Complete the PR program at CIUSSSS of Estrie-CHUS in Sherbrooke and finishing after December 2019
- To have a mild to very severe diagnosis of COPD (mild: forced expiratory volume in 1 second (FEV1) ) ≥ 80%, very severe: FEV1 <30% and Tiffeneau score <0.7)
- Have a score ≥2 on the Medical Research Council (MRC) dyspnea scale
- Have access to a computer, laptop or cell phone at home with an high speed internet service.
Exclusion Criteria:
- Inability to give informed consent
- Instable condition in the 4 weeks prior to the study (change in medication and symptoms such as dyspnea and sputum (colour and quantity)).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Intervention group
The web platform includes three respiratory exercises: diaphragmatic breathing, thoracic expansion exercise and thoracic expansion exercise assisted upper limbs.
It is suggested to do each of the three exercises once a day (AM and PM), four repetitions each.
An electronic logbook is also available on the platform to record the duration and the type of others cardiorespiratory exercise of their choice (cycling, walking, using stairs, etc.) as well as strengthening (upper and lower body).
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The intervention involves the use of the web platform for 12 months combined with a monthly phone follow-up.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change in Adherence of each participant
Prazo: 3 months, 6 months and 12 months
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The number of connections made on the site
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3 months, 6 months and 12 months
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Change in Adherence of each participant
Prazo: 3 months, 6 months and 12 months
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the number of exercises performed on the platform web
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3 months, 6 months and 12 months
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Change in Adherence of each participant
Prazo: 3 months, 6 months and 12 months
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Number of entry/week in the logbook on the platform web
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3 months, 6 months and 12 months
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Change in Adherence of each participant
Prazo: 3 months, 6 months and 12 months
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the number of exercises performed (breathing, cardiorespiratory and muscular exercises) self-reported by the participants
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3 months, 6 months and 12 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change in Exercise capacity
Prazo: pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months
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six minute walk test (distance reach (m) by walking for 6 minutes)
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pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months
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Change of the Quality of life
Prazo: pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months
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COPD assessment test (CAT) (measure the impact of COPD on a person's life, and how this changes over time)
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pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months
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Change in dyspnea
Prazo: pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months
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Borg Scale and the medical research center (MRC) scale (scale of 0 to 10 where 0 is no effort and 10 , maximum effort)
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pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months
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Change of Number of hospitalizations
Prazo: pre-pulmonary rehabilitation, 0 months, 6 months and 12 months
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Self-reported
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pre-pulmonary rehabilitation, 0 months, 6 months and 12 months
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Change of Number of exacerbations
Prazo: pre-pulmonary rehabilitation, 0 months, 6 months and 12 months
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We will be able to know to number of exacerbations by the medication taken from the pharmacist of each participant
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pre-pulmonary rehabilitation, 0 months, 6 months and 12 months
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (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
Palavras-chave
Outros números de identificação do estudo
- 2020-3607
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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