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Implementation of Collaborative Self-management Services to Promote Physical Activity (NEXTCARE-PA)

Primary Purpose

Chronic Disease

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PreHabilitation
Rehabilitation in chronic stable patients in primary care
Rehabilitation in mild chronic patients and citizens at risk
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Disease focused on measuring physical activity, lifestyle, adaptive case management, telemedicine, integrated care, collaborative self-management

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Clínic de BarcelonaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Experimental

No Intervention

Arm Label

PreHab_Intervention

PreHab_Control

Chronic patients_Intervention

Chronic patients_Control

Citizens & mild disease_Intervention

Citizens & mild disease_Control

Arm Description

Experimental group of the prehabilitation trial

Control group of the prehabilitation trial

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

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

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

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

Outcomes

Primary Outcome Measures

Postoperative complications during hospitalization
Primary outcome for arms 1 & 2 - Percentage of patients suffering postoperative complications during hospitalization
Determinants of adoption of the PA service
Primary outcome for arms 3 & 4
Changes in Health-related quality of life
Primary outcome for arms 5 & 6 - Short-form 36 survey

Secondary Outcome Measures

Changes in Aerobic capacity
Six-minute walking test
Hospital length of stay
Days of hospital stay
Intensive care unit length of stay
Days of ICU stay
Changes in Physical activity
Accelerometry

Full Information

First Posted
November 22, 2016
Last Updated
January 22, 2019
Sponsor
Hospital Clinic of Barcelona
Collaborators
Badalona Serveis Assistencials, Institut de Recerca Biomèdica de Lleida
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1. Study Identification

Unique Protocol Identification Number
NCT02976064
Brief Title
Implementation of Collaborative Self-management Services to Promote Physical Activity
Acronym
NEXTCARE-PA
Official Title
Protocol for Implementation of Collaborative Self-management Services to Promote Physical Activity
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Badalona Serveis Assistencials, Institut de Recerca Biomèdica de Lleida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
physical activity, lifestyle, adaptive case management, telemedicine, integrated care, collaborative self-management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
2300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PreHab_Intervention
Arm Type
Experimental
Arm Description
Experimental group of the prehabilitation trial
Arm Title
PreHab_Control
Arm Type
No Intervention
Arm Description
Control group of the prehabilitation trial
Arm Title
Chronic patients_Intervention
Arm Type
Experimental
Arm Description
Experimental group of the Rehabilitation in chronic stable patients in primary care trial
Arm Title
Chronic patients_Control
Arm Type
No Intervention
Arm Description
Control group of the Rehabilitation in chronic stable patients in primary care trial
Arm Title
Citizens & mild disease_Intervention
Arm Type
Experimental
Arm Description
Experimental group of the Rehabilitation in mild chronic patients and citizens at risk trial
Arm Title
Citizens & mild disease_Control
Arm Type
No Intervention
Arm Description
Control group of the Rehabilitation in mild chronic patients and citizens at risk trial
Intervention Type
Behavioral
Intervention Name(s)
PreHabilitation
Intervention Description
Case identification: Candidates fulfilling the inclusion criteria will be identified by the anesthesiologist. Case evaluation: Candidates will be assessed to identify the overall needs and perform a baseline evaluation. 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. 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.
Intervention Type
Behavioral
Intervention Name(s)
Rehabilitation in chronic stable patients in primary care
Intervention Description
Case identification: Candidates fulfilling the inclusion criteria will be identified by the general practitioner. 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. 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. 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.
Intervention Type
Behavioral
Intervention Name(s)
Rehabilitation in mild chronic patients and citizens at risk
Intervention Description
Case identification: Candidates fulfilling the inclusion criteria will be identified by the GP. Case evaluation: i) patient requirements defining the work plan; ii) aerobic capacity and PA; iii) identification of factors modulating adherence. 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. 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.
Primary Outcome Measure Information:
Title
Postoperative complications during hospitalization
Description
Primary outcome for arms 1 & 2 - Percentage of patients suffering postoperative complications during hospitalization
Time Frame
Postoperative hospitalization period (up to 90 days)
Title
Determinants of adoption of the PA service
Description
Primary outcome for arms 3 & 4
Time Frame
Life-span of the project (12 months)
Title
Changes in Health-related quality of life
Description
Primary outcome for arms 5 & 6 - Short-form 36 survey
Time Frame
Baseline - Six months - 12 months
Secondary Outcome Measure Information:
Title
Changes in Aerobic capacity
Description
Six-minute walking test
Time Frame
Baseline - Six months - 12 months
Title
Hospital length of stay
Description
Days of hospital stay
Time Frame
Postoperative hospitalization period (up to 90 days)
Title
Intensive care unit length of stay
Description
Days of ICU stay
Time Frame
Postoperative hospitalization period (up to 90 days)
Title
Changes in Physical activity
Description
Accelerometry
Time Frame
Baseline - Six months - 12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Sánchez
Phone
34932275747
Email
masanchezm@clinic.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep Roca, Prof
Organizational Affiliation
Hospital Clinic de Barcelona - IDIBAPS - University of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anael Barberan Garcia, PhD
Phone
+34 932775540
Email
anaelbg@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30016944
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.
Results Reference
derived

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Implementation of Collaborative Self-management Services to Promote Physical Activity

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