- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Maria Sánchez
- Número de teléfono: 34932275747
- Correo electrónico: masanchezm@clinic.cat
Ubicaciones de estudio
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Barcelona, España, 08036
- Reclutamiento
- Hospital Clinic de Barcelona
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Contacto:
- Anael Barberan Garcia, PhD
- Número de teléfono: +34 932775540
- Correo electrónico: anaelbg@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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. |
Sin intervención: 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. |
Sin intervención: 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. |
Sin intervención: Citizens & mild disease_Control
Control group of the Rehabilitation in mild chronic patients and citizens at risk trial
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Postoperative complications during hospitalization
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Changes in Aerobic capacity
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NEXTCARE-PA
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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