Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

22 de enero de 2019 actualizado 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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

2300

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

      • Barcelona, España, 08036
        • Reclutamiento
        • Hospital Clinic de Barcelona
        • Contacto:
          • Anael Barberan Garcia, PhD
          • Número de teléfono: +34 932775540
          • Correo electrónico: anaelbg@gmail.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
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.

Sin intervención: 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.

Sin intervención: 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.

Sin intervención: Citizens & mild disease_Control
Control group of the Rehabilitation in mild chronic patients and citizens at risk trial

¿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)
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
Periodo de tiempo: 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
Periodo de tiempo: Baseline - Six months - 12 months
Primary outcome for arms 5 & 6 - Short-form 36 survey
Baseline - Six months - 12 months

Medidas de resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de abril de 2016

Finalización primaria (Actual)

1 de enero de 2019

Finalización del estudio (Anticipado)

1 de junio de 2020

Fechas de registro del estudio

Enviado por primera vez

22 de noviembre de 2016

Primero enviado que cumplió con los criterios de control de calidad

24 de noviembre de 2016

Publicado por primera vez (Estimar)

29 de noviembre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de enero de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

22 de enero de 2019

Última verificación

1 de enero de 2019

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • NEXTCARE-PA

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

3
Suscribir