Clinical trial NCT02976064: Implementation of Collaborative Self-management Services to Promote Physical Activity
Official title: Protocol for Implementation of Collaborative Self-management Services to Promote Physical Activity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Disease
Keywords: physical activity
lifestyle
adaptive case management
telemedicine
integrated care
collaborative self-management
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Badalona Serveis Assistencials
name: Institut de Recerca Biomèdica de Lleida
First posted: 2016-11-29
Enrollment: 2300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative complications during hospitalization
timeFrame: Postoperative hospitalization period (up to 90 days)
measure: Determinants of adoption of the PA service
timeFrame: Life-span of the project (12 months)
measure: Changes in Health-related quality of life
timeFrame: Baseline - Six months - 12 months
Secondary outcomes:
measure: Changes in Aerobic capacity
timeFrame: Baseline - Six months - 12 months
measure: Hospital length of stay
timeFrame: Postoperative hospitalization period (up to 90 days)
measure: Intensive care unit length of stay
timeFrame: Postoperative hospitalization period (up to 90 days)
measure: Changes in Physical activity
timeFrame: Baseline - Six months - 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
affiliation: Hospital Clinic de Barcelona - IDIBAPS - University of Barcelona
name: Josep Roca, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barberan-Garcia A, Gimeno-Santos E, Blanco I, Cano I, Martinez-Palli G, Burgos F, Miralles F, Coca M, Murillo S, Sanz M, Steblin A, Ubre M, Benavent J, Vidal J, Sitges M, Roca J. Protocol for regional implementation of collaborative self-management services to promote physical activity. BMC Health Serv Res. 2018 Jul 17;18(1):560. doi: 10.1186/s12913-018-3363-8.