跳至主要内容
临床试验/NCT02976064
NCT02976064Unknown不适用

Protocol for Implementation of Collaborative Self-management Services to Promote Physical Activity

Hospital Clinic of Barcelona1 个研究点 分布在 1 个国家目标入组 2,300 人开始时间: 2016年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
2,300
试验地点
1
主要终点
Postoperative complications during hospitalization

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Care Provider)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.
  • •Unstable cardiovascular or respiratory disorders
  • •Locomotor limitations precluding the practice of exercise
  • •Cognitive deterioration impeding the adherence to the program.

研究组 & 干预措施

PreHab_Control

No Intervention

Control group of the prehabilitation trial

Citizens & mild disease_Intervention

Experimental

Experimental group of the Rehabilitation in mild chronic patients and citizens at risk trial

干预措施: Rehabilitation in mild chronic patients and citizens at risk (Behavioral)

PreHab_Intervention

Experimental

Experimental group of the prehabilitation trial

干预措施: PreHabilitation (Behavioral)

Chronic patients_Intervention

Experimental

Experimental group of the Rehabilitation in chronic stable patients in primary care trial

干预措施: Rehabilitation in chronic stable patients in primary care (Behavioral)

Chronic patients_Control

No Intervention

Control group of the Rehabilitation in chronic stable patients in primary care trial

Citizens & mild disease_Control

No Intervention

Control group of the Rehabilitation in mild chronic patients and citizens at risk trial

结局指标

主要结局

Postoperative complications during hospitalization

时间窗: Postoperative hospitalization period (up to 90 days)

Primary outcome for arms 1 \& 2 - Percentage of patients suffering postoperative complications during hospitalization

Determinants of adoption of the PA service

时间窗: Life-span of the project (12 months)

Primary outcome for arms 3 \& 4

Changes in Health-related quality of life

时间窗: Baseline - Six months - 12 months

Primary outcome for arms 5 \& 6 - Short-form 36 survey

次要结局

  • Changes in Aerobic capacity(Baseline - Six months - 12 months)
  • Hospital length of stay(Postoperative hospitalization period (up to 90 days))
  • Intensive care unit length of stay(Postoperative hospitalization period (up to 90 days))
  • Changes in Physical activity(Baseline - Six months - 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Josep Roca

Consultor senior

Hospital Clinic of Barcelona

研究点 (1)

Loading locations...

相似试验