Implementation of Collaborative Self-management Services to Promote Physical Activity
NEXTCARE-PA
Protocol for Implementation of Collaborative Self-management Services to Promote Physical Activity
1 other identifier
interventional
2,300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 22, 2016
CompletedFirst Posted
Study publicly available on registry
November 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJanuary 24, 2019
January 1, 2019
2.8 years
November 22, 2016
January 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Postoperative complications during hospitalization
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
Primary outcome for arms 3 \& 4
Life-span of the project (12 months)
Changes in Health-related quality of life
Primary outcome for arms 5 \& 6 - Short-form 36 survey
Baseline - Six months - 12 months
Secondary Outcomes (4)
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
Study Arms (6)
PreHab_Intervention
EXPERIMENTALExperimental group of the prehabilitation trial
PreHab_Control
NO INTERVENTIONControl group of the prehabilitation trial
Chronic patients_Intervention
EXPERIMENTALExperimental group of the Rehabilitation in chronic stable patients in primary care trial
Chronic patients_Control
NO INTERVENTIONControl group of the Rehabilitation in chronic stable patients in primary care trial
Citizens & mild disease_Intervention
EXPERIMENTALExperimental group of the Rehabilitation in mild chronic patients and citizens at risk trial
Citizens & mild disease_Control
NO INTERVENTIONControl group of the Rehabilitation in mild chronic patients and citizens at risk trial
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Clinic of Barcelonalead
- Badalona Serveis Assistencialscollaborator
- Institut de Recerca Biomèdica de Lleidacollaborator
Study Sites (1)
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Related Publications (1)
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.
PMID: 30016944DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Josep Roca, Prof
Hospital Clinic de Barcelona - IDIBAPS - University of Barcelona
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultor senior
Study Record Dates
First Submitted
November 22, 2016
First Posted
November 29, 2016
Study Start
April 1, 2016
Primary Completion
January 1, 2019
Study Completion
June 1, 2020
Last Updated
January 24, 2019
Record last verified: 2019-01