Protocol for Implementation of Collaborative Self-management Services to Promote Physical Activity
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
Control group of the prehabilitation trial
Citizens & mild disease_Intervention
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 group of the prehabilitation trial
干预措施: PreHabilitation (Behavioral)
Chronic patients_Intervention
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
Control group of the Rehabilitation in chronic stable patients in primary care trial
Citizens & mild disease_Control
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
Josep Roca
Consultor senior
Hospital Clinic of Barcelona
