Implementation of Collaborative Self-management Services to Promote Physical Activity
- Conditions
- Chronic Disease
- Interventions
- Behavioral: Rehabilitation in chronic stable patients in primary careBehavioral: Rehabilitation in mild chronic patients and citizens at riskBehavioral: PreHabilitation
- Registration Number
- NCT02976064
- Lead Sponsor
- Hospital Clinic of Barcelona
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2300
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chronic patients_Intervention Rehabilitation in chronic stable patients in primary care Experimental group of the Rehabilitation in chronic stable patients in primary care trial Citizens & mild disease_Intervention Rehabilitation in mild chronic patients and citizens at risk Experimental group of the Rehabilitation in mild chronic patients and citizens at risk trial PreHab_Intervention PreHabilitation Experimental group of the prehabilitation trial
- Primary Outcome Measures
Name Time Method Postoperative complications during hospitalization 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 Life-span of the project (12 months) Primary outcome for arms 3 \& 4
Changes in Health-related quality of life Baseline - Six months - 12 months Primary outcome for arms 5 \& 6 - Short-form 36 survey
- Secondary Outcome Measures
Name Time Method Changes in Aerobic capacity Baseline - Six months - 12 months Six-minute walking test
Hospital length of stay Postoperative hospitalization period (up to 90 days) Days of hospital stay
Intensive care unit length of stay Postoperative hospitalization period (up to 90 days) Days of ICU stay
Changes in Physical activity Baseline - Six months - 12 months Accelerometry
Trial Locations
- Locations (1)
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain