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

January 22, 2019 updated by: Josep Roca, Hospital Clinic of Barcelona

Protocol for Implementation of Collaborative Self-management Services to Promote Physical Activity

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clínic de Barcelona
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PreHab_Intervention
Experimental group of the prehabilitation trial
Behavioral: PreHabilitation
  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.
No Intervention: PreHab_Control
Control group of the prehabilitation trial
Experimental: Chronic patients_Intervention
Experimental group of the Rehabilitation in chronic stable patients in primary care trial
Behavioral: Rehabilitation in chronic stable patients in primary care
  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.
No Intervention: Chronic patients_Control
Control group of the Rehabilitation in chronic stable patients in primary care trial
Experimental: Citizens & mild disease_Intervention
Experimental group of the Rehabilitation in mild chronic patients and citizens at risk trial
Behavioral: Rehabilitation in mild chronic patients and citizens at risk
  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.
No Intervention: Citizens & mild disease_Control
Control group of the Rehabilitation in mild chronic patients and citizens at risk trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications during hospitalization
Time Frame: Postoperative hospitalization period (up to 90 days)
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
Time Frame: Life-span of the project (12 months)
Primary outcome for arms 3 & 4
Life-span of the project (12 months)
Changes in Health-related quality of life
Time Frame: Baseline - Six months - 12 months
Primary outcome for arms 5 & 6 - Short-form 36 survey
Baseline - Six months - 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Aerobic capacity
Time Frame: Baseline - Six months - 12 months
Six-minute walking test
Baseline - Six months - 12 months
Hospital length of stay
Time Frame: Postoperative hospitalization period (up to 90 days)
Days of hospital stay
Postoperative hospitalization period (up to 90 days)
Intensive care unit length of stay
Time Frame: Postoperative hospitalization period (up to 90 days)
Days of ICU stay
Postoperative hospitalization period (up to 90 days)
Changes in Physical activity
Time Frame: Baseline - Six months - 12 months
Accelerometry
Baseline - Six months - 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Collaborators

Institut de Recerca Biomèdica de Lleida
Badalona Serveis Assistencials

Investigators

  • Principal Investigator: Josep Roca, Prof, Hospital Clinic de Barcelona - IDIBAPS - University of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

January 1, 2019

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

November 22, 2016

First Submitted That Met QC Criteria

November 24, 2016

First Posted (Estimate)

November 29, 2016

Study Record Updates

Last Update Posted (Actual)

January 24, 2019

Last Update Submitted That Met QC Criteria

January 22, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEXTCARE-PA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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