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Implementation of Collaborative Self-management Services to Promote Physical Activity (NEXTCARE-PA)

22 de janeiro de 2019 atualizado por: Josep Roca, Hospital Clinic of Barcelona

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

Tipo de estudo

Intervencional

Inscrição (Antecipado)

2300

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Barcelona, Espanha, 08036
        • Recrutamento
        • Hospital Clinic De Barcelona
        • Contato:
          • Anael Barberan Garcia, PhD
          • Número de telefone: +34 932775540
          • E-mail: anaelbg@gmail.com

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

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

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

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
  1. Case identification: Candidates fulfilling the inclusion criteria will be identified by the anesthesiologist.
  2. Case evaluation: Candidates will be assessed to identify the overall needs and perform a baseline evaluation.
  3. Personalized Work plan definition: Personalization of the plan involves a calendar and planning of face to face visits and remote contacts; intensity of the supervised exercise training program; threshold of steps per day; nutritional intervention; psychological intervention; and integration of the intervention into the overall work plan.
  4. Work plan execution & 5-Follow-up+event handling: Involve the follow-up tasks, including non-scheduled interactions through the personal health folder (PHF)

6-Discharge: Patient will be discharged from prehabilitation and moved to rehabilitation.

Sem intervenção: PreHab_Control
Control group of the prehabilitation trial
Experimental: Chronic patients_Intervention
Experimental group of the Rehabilitation in chronic stable patients in primary care trial
  1. Case identification: Candidates fulfilling the inclusion criteria will be identified by the general practitioner.
  2. Case evaluation: The primary care team will characterize the candidates, covering: i) patient requirements defining the work plan; ii) aerobic capacity and physical activity; iii) identification of factors modulating adherence.
  3. Personalized work plan definition: The community-based intervention will include reassessment of the patient's work plan aiming at optimization of both pharmacological and non-pharmacological therapies. Consist of a motivational interview and a physical activity (PA) intervention (6-month duration) based on supervised endurance training, promotion of PA and empowerment for self-management using the PHF.
  4. Work plan execution & 5-Follow-up+event handling: The ICT-support will facilitate the program follow up.

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
Experimental: Citizens & mild disease_Intervention
Experimental group of the Rehabilitation in mild chronic patients and citizens at risk trial
  1. Case identification: Candidates fulfilling the inclusion criteria will be identified by the GP.
  2. Case evaluation: i) patient requirements defining the work plan; ii) aerobic capacity and PA; iii) identification of factors modulating adherence.
  3. Personalized work plan definition: i) motivational interview; ii) training for the use of the PHF for self-management; and iii) assign one case manager for off-line remote surveillance. The following optional modules are envisaged: i) basic service (above); ii) endurance training programs; iii) community physical activity group sessions; and/or, iv) upgraded PA program including sensors and close off-line supervision.
  4. Work plan execution & 5-Follow-up+event handling: The ICT-support will facilitate the program follow up.

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)
Primary outcome for arms 1 & 2 - Percentage of patients suffering postoperative complications during hospitalization
Postoperative hospitalization period (up to 90 days)
Determinants of adoption of the PA service
Prazo: Life-span of the project (12 months)
Primary outcome for arms 3 & 4
Life-span of the project (12 months)
Changes in Health-related quality of life
Prazo: Baseline - Six months - 12 months
Primary outcome for arms 5 & 6 - Short-form 36 survey
Baseline - Six months - 12 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Changes in Aerobic capacity
Prazo: Baseline - Six months - 12 months
Six-minute walking test
Baseline - Six months - 12 months
Hospital length of stay
Prazo: Postoperative hospitalization period (up to 90 days)
Days of hospital stay
Postoperative hospitalization period (up to 90 days)
Intensive care unit length of stay
Prazo: Postoperative hospitalization period (up to 90 days)
Days of ICU stay
Postoperative hospitalization period (up to 90 days)
Changes in Physical activity
Prazo: Baseline - Six months - 12 months
Accelerometry
Baseline - Six months - 12 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Josep Roca, Prof, Hospital Clinic de Barcelona - IDIBAPS - University of Barcelona

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de abril de 2016

Conclusão Primária (Real)

1 de janeiro de 2019

Conclusão do estudo (Antecipado)

1 de junho de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

22 de novembro de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de novembro de 2016

Primeira postagem (Estimativa)

29 de novembro de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de janeiro de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de janeiro de 2019

Última verificação

1 de janeiro de 2019

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • NEXTCARE-PA

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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