- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02976064
Implementation of Collaborative Self-management Services to Promote Physical Activity (NEXTCARE-PA)
Protocol for Implementation of Collaborative Self-management Services to Promote Physical Activity
Background: The growing awareness on the health burden generated by insufficient levels of physical activity has prompted the interest for deploying community-based initiatives aiming at fostering active healthy living. It is of note, however, that, to our knowledge, none of the interventions evaluated so far have reached large scale adoption. The current protocol relies on the general hypothesis that properly tailored self-management programs, fully integrated in the patient's action plan with remote off-line professional support, may induce sustained behavioral changes resulting in exercise health behavior. Accordingly, the current manuscript addresses those unmet requirements, namely: i) Workflow design of the PA services engaging both patients and health professionals; ii) Enhanced information and communication technologies (ICT)-support; iii) Evaluation strategies including structured indicators; and, iv) Implementation of innovative business models. The main outcome of the current protocol will be a roadmap for large scale deployment and assessment of novel collaborative self-management PA services in the region of Catalonia (7.5 million citizens).
Methods: The protocol has been designed as part of the regional deployment of integrated care services in Catalonia (2016-2020). It has been conceived has a two-year (2017-2018) test bed period.
Aims: The protocol uses a population-health approach to addresses the four aims: i) Prehabilitation for high risk candidates to major surgery; ii) Community-based rehabilitation for clinical stable chronic patients with moderate to severe disease; and, iii) Promotion of physical activity and healthy lifestyles for citizens at risk and patients with mild disease.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Barcelona, Espanha, 08036
- Recrutamento
- Hospital Clinic De Barcelona
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Contato:
- Anael Barberan Garcia, PhD
- Número de telefone: +34 932775540
- E-mail: anaelbg@gmail.com
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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:
Arms 1 & 2:
- Candidates to major elective surgical procedures in the following specialties: abdominal, gynecology, cardiovascular, urology and thoracic
- Patients presenting high surgical risk because they are they are aged > 70 years and/or show an American Society of Anesthesiologist (ASA) score of III/IV
- A tentative surgical schedule allowing for at least 4 weeks for the pre-habilitation intervention.
Arms 3 & 4:
- Patients suffering one or more targeted chronic conditions (cardiovascular diseases, chronic obstructive pulmonary disease and type 2 diabetes mellitus)
- Moderate-to-severe disease (main disorder)
- High user of healthcare resources assessed by history of past hospital-related events (admissions and/or emergency room visits).
Arms 5 & 6:
- Citizens at risk for chronic conditions and patients showing mild target disease(s) recruited through advertisements, primary care centers or pharmacy offices.
Exclusion Criteria:
Arms 1 & 2:
- Emergency surgery
- Unstable cardiac or respiratory disease
- Locomotor limitations precluding the practice of exercise
- Cognitive deterioration impeding the adherence to the program.
Arms 3-6:
- Unstable cardiovascular or respiratory disorders
- Locomotor limitations precluding the practice of exercise
- Cognitive deterioration impeding the adherence to the program.
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: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: PreHab_Intervention
Experimental group of the prehabilitation trial
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6-Discharge: Patient will be discharged from prehabilitation and moved to rehabilitation. |
Sem intervenção: PreHab_Control
Control group of the prehabilitation trial
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Experimental: Chronic patients_Intervention
Experimental group of the Rehabilitation in chronic stable patients in primary care trial
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6-Discharge: The patient will be discharged or moved to the PA service addressed to citizens at risk & patients with mild disease. |
Sem intervenção: Chronic patients_Control
Control group of the Rehabilitation in chronic stable patients in primary care trial
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Experimental: Citizens & mild disease_Intervention
Experimental group of the Rehabilitation in mild chronic patients and citizens at risk trial
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6-Discharge: The basic version of the promotion of PA program is conceived for a timeless duration. However, the different modules included in the service portfolio will have specific agendas and associated costs. |
Sem intervenção: Citizens & mild disease_Control
Control group of the Rehabilitation in mild chronic patients and citizens at risk trial
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Postoperative complications during hospitalization
Prazo: Postoperative hospitalization period (up to 90 days)
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Primary outcome for arms 1 & 2 - Percentage of patients suffering postoperative complications during hospitalization
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Postoperative hospitalization period (up to 90 days)
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Determinants of adoption of the PA service
Prazo: Life-span of the project (12 months)
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Primary outcome for arms 3 & 4
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Life-span of the project (12 months)
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Changes in Health-related quality of life
Prazo: Baseline - Six months - 12 months
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Primary outcome for arms 5 & 6 - Short-form 36 survey
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Baseline - Six months - 12 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Changes in Aerobic capacity
Prazo: Baseline - Six months - 12 months
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Six-minute walking test
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Baseline - Six months - 12 months
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Hospital length of stay
Prazo: Postoperative hospitalization period (up to 90 days)
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Days of hospital stay
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Postoperative hospitalization period (up to 90 days)
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Intensive care unit length of stay
Prazo: Postoperative hospitalization period (up to 90 days)
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Days of ICU stay
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Postoperative hospitalization period (up to 90 days)
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Changes in Physical activity
Prazo: Baseline - Six months - 12 months
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Accelerometry
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Baseline - Six months - 12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Josep Roca, Prof, Hospital Clinic de Barcelona - IDIBAPS - University of Barcelona
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
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 (Real)
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
- NEXTCARE-PA
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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