<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02976064</url>
  </required_header>
  <id_info>
    <org_study_id>NEXTCARE-PA</org_study_id>
    <nct_id>NCT02976064</nct_id>
  </id_info>
  <brief_title>Implementation of Collaborative Self-management Services to Promote Physical Activity</brief_title>
  <acronym>NEXTCARE-PA</acronym>
  <official_title>Protocol for Implementation of Collaborative Self-management Services to Promote Physical Activity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Badalona Serveis Assistencials</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut de Recerca Biomèdica de Lleida</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Clinic of Barcelona</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: The growing awareness on the health burden generated by insufficient levels of&#xD;
      physical activity has prompted the interest for deploying community-based initiatives aiming&#xD;
      at fostering active healthy living. It is of note, however, that, to our knowledge, none of&#xD;
      the interventions evaluated so far have reached large scale adoption. The current protocol&#xD;
      relies on the general hypothesis that properly tailored self-management programs, fully&#xD;
      integrated in the patient's action plan with remote off-line professional support, may induce&#xD;
      sustained behavioral changes resulting in exercise health behavior. Accordingly, the current&#xD;
      manuscript addresses those unmet requirements, namely: i) Workflow design of the PA services&#xD;
      engaging both patients and health professionals; ii) Enhanced information and communication&#xD;
      technologies (ICT)-support; iii) Evaluation strategies including structured indicators; and,&#xD;
      iv) Implementation of innovative business models. The main outcome of the current protocol&#xD;
      will be a roadmap for large scale deployment and assessment of novel collaborative&#xD;
      self-management PA services in the region of Catalonia (7.5 million citizens).&#xD;
&#xD;
      Methods: The protocol has been designed as part of the regional deployment of integrated care&#xD;
      services in Catalonia (2016-2020). It has been conceived has a two-year (2017-2018) test bed&#xD;
      period.&#xD;
&#xD;
      Aims: The protocol uses a population-health approach to addresses the four aims: i)&#xD;
      Prehabilitation for high risk candidates to major surgery; ii) Community-based rehabilitation&#xD;
      for clinical stable chronic patients with moderate to severe disease; and, iii) Promotion of&#xD;
      physical activity and healthy lifestyles for citizens at risk and patients with mild disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Actual">January 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative complications during hospitalization</measure>
    <time_frame>Postoperative hospitalization period (up to 90 days)</time_frame>
    <description>Primary outcome for arms 1 &amp; 2 - Percentage of patients suffering postoperative complications during hospitalization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determinants of adoption of the PA service</measure>
    <time_frame>Life-span of the project (12 months)</time_frame>
    <description>Primary outcome for arms 3 &amp; 4</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Health-related quality of life</measure>
    <time_frame>Baseline - Six months - 12 months</time_frame>
    <description>Primary outcome for arms 5 &amp; 6 - Short-form 36 survey</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Aerobic capacity</measure>
    <time_frame>Baseline - Six months - 12 months</time_frame>
    <description>Six-minute walking test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>Postoperative hospitalization period (up to 90 days)</time_frame>
    <description>Days of hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensive care unit length of stay</measure>
    <time_frame>Postoperative hospitalization period (up to 90 days)</time_frame>
    <description>Days of ICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Physical activity</measure>
    <time_frame>Baseline - Six months - 12 months</time_frame>
    <description>Accelerometry</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">2300</enrollment>
  <condition>Chronic Disease</condition>
  <arm_group>
    <arm_group_label>PreHab_Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental group of the prehabilitation trial</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PreHab_Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group of the prehabilitation trial</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic patients_Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental group of the Rehabilitation in chronic stable patients in primary care trial</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic patients_Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group of the Rehabilitation in chronic stable patients in primary care trial</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Citizens &amp; mild disease_Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental group of the Rehabilitation in mild chronic patients and citizens at risk trial</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Citizens &amp; mild disease_Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group of the Rehabilitation in mild chronic patients and citizens at risk trial</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PreHabilitation</intervention_name>
    <description>Case identification: Candidates fulfilling the inclusion criteria will be identified by the anesthesiologist.&#xD;
Case evaluation: Candidates will be assessed to identify the overall needs and perform a baseline evaluation.&#xD;
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.&#xD;
Work plan execution &amp; 5-Follow-up+event handling: Involve the follow-up tasks, including non-scheduled interactions through the personal health folder (PHF)&#xD;
6-Discharge: Patient will be discharged from prehabilitation and moved to rehabilitation.</description>
    <arm_group_label>PreHab_Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Rehabilitation in chronic stable patients in primary care</intervention_name>
    <description>Case identification: Candidates fulfilling the inclusion criteria will be identified by the general practitioner.&#xD;
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.&#xD;
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.&#xD;
Work plan execution &amp; 5-Follow-up+event handling: The ICT-support will facilitate the program follow up.&#xD;
6-Discharge: The patient will be discharged or moved to the PA service addressed to citizens at risk &amp; patients with mild disease.</description>
    <arm_group_label>Chronic patients_Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Rehabilitation in mild chronic patients and citizens at risk</intervention_name>
    <description>Case identification: Candidates fulfilling the inclusion criteria will be identified by the GP.&#xD;
Case evaluation: i) patient requirements defining the work plan; ii) aerobic capacity and PA; iii) identification of factors modulating adherence.&#xD;
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.&#xD;
Work plan execution &amp; 5-Follow-up+event handling: The ICT-support will facilitate the program follow up.&#xD;
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.</description>
    <arm_group_label>Citizens &amp; mild disease_Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Arms 1 &amp; 2:&#xD;
&#xD;
          -  Candidates to major elective surgical procedures in the following specialties:&#xD;
             abdominal, gynecology, cardiovascular, urology and thoracic&#xD;
&#xD;
          -  Patients presenting high surgical risk because they are they are aged &gt; 70 years&#xD;
             and/or show an American Society of Anesthesiologist (ASA) score of III/IV&#xD;
&#xD;
          -  A tentative surgical schedule allowing for at least 4 weeks for the pre-habilitation&#xD;
             intervention.&#xD;
&#xD;
        Arms 3 &amp; 4:&#xD;
&#xD;
          -  Patients suffering one or more targeted chronic conditions (cardiovascular diseases,&#xD;
             chronic obstructive pulmonary disease and type 2 diabetes mellitus)&#xD;
&#xD;
          -  Moderate-to-severe disease (main disorder)&#xD;
&#xD;
          -  High user of healthcare resources assessed by history of past hospital-related events&#xD;
             (admissions and/or emergency room visits).&#xD;
&#xD;
        Arms 5 &amp; 6:&#xD;
&#xD;
          -  Citizens at risk for chronic conditions and patients showing mild target disease(s)&#xD;
             recruited through advertisements, primary care centers or pharmacy offices.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Arms 1 &amp; 2:&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Unstable cardiac or respiratory disease&#xD;
&#xD;
          -  Locomotor limitations precluding the practice of exercise&#xD;
&#xD;
          -  Cognitive deterioration impeding the adherence to the program.&#xD;
&#xD;
        Arms 3-6:&#xD;
&#xD;
          -  Unstable cardiovascular or respiratory disorders&#xD;
&#xD;
          -  Locomotor limitations precluding the practice of exercise&#xD;
&#xD;
          -  Cognitive deterioration impeding the adherence to the program.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Josep Roca, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinic de Barcelona - IDIBAPS - University of Barcelona</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maria Sánchez</last_name>
    <phone>34932275747</phone>
    <email>masanchezm@clinic.cat</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Clínic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anael Barberan Garcia, PhD</last_name>
      <phone>+34 932775540</phone>
      <email>anaelbg@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Clinic of Barcelona</investigator_affiliation>
    <investigator_full_name>Josep Roca</investigator_full_name>
    <investigator_title>Consultor senior</investigator_title>
  </responsible_party>
  <keyword>physical activity</keyword>
  <keyword>lifestyle</keyword>
  <keyword>adaptive case management</keyword>
  <keyword>telemedicine</keyword>
  <keyword>integrated care</keyword>
  <keyword>collaborative self-management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02976064
org study id: NEXTCARE-PA
nct id: NCT02976064
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Care Provider)
measure: Postoperative complications during hospitalization
time frame: Postoperative hospitalization period (up to 90 days)
description: Primary outcome for arms 1 & 2 - Percentage of patients suffering postoperative complications during hospitalization
measure: Determinants of adoption of the PA service
time frame: Life-span of the project (12 months)
description: Primary outcome for arms 3 & 4
measure: Changes in Health-related quality of life
time frame: Baseline - Six months - 12 months
description: Primary outcome for arms 5 & 6 - Short-form 36 survey
measure: Changes in Aerobic capacity
time frame: Baseline - Six months - 12 months
description: Six-minute walking test
measure: Hospital length of stay
time frame: Postoperative hospitalization period (up to 90 days)
description: Days of hospital stay
measure: Intensive care unit length of stay
time frame: Postoperative hospitalization period (up to 90 days)
description: Days of ICU stay
measure: Changes in Physical activity
time frame: Baseline - Six months - 12 months
description: Accelerometry
arm group label: PreHab_Intervention
arm group type: Experimental
description: Experimental group of the prehabilitation trial
arm group label: PreHab_Control
arm group type: No Intervention
description: Control group of the prehabilitation trial
arm group label: Chronic patients_Intervention
arm group type: Experimental
description: Experimental group of the Rehabilitation in chronic stable patients in primary care trial
arm group label: Chronic patients_Control
arm group type: No Intervention
description: Control group of the Rehabilitation in chronic stable patients in primary care trial
arm group label: Citizens & mild disease_Intervention
arm group type: Experimental
description: Experimental group of the Rehabilitation in mild chronic patients and citizens at risk trial
arm group label: Citizens & mild disease_Control
arm group type: No Intervention
description: Control group of the Rehabilitation in mild chronic patients and citizens at risk trial
intervention type: Behavioral
intervention name: PreHabilitation
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.
arm group label: PreHab_Intervention
intervention type: Behavioral
intervention name: Rehabilitation in chronic stable patients in primary care
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.
arm group label: Chronic patients_Intervention
intervention type: Behavioral
intervention name: Rehabilitation in mild chronic patients and citizens at risk
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.
arm group label: Citizens & mild disease_Intervention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Josep Roca, Prof
role: Principal Investigator
affiliation: Hospital Clinic de Barcelona - IDIBAPS - University of Barcelona
last name: Maria Sánchez
phone: 34932275747
email: masanchezm@clinic.cat
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Clinic of Barcelona
investigator full name: Josep Roca
investigator title: Consultor senior
mesh term: Chronic Disease
sharing ipd: Undecided