<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/NCT03038685</url>
  </required_header>
  <id_info>
    <org_study_id>UHAntwerp</org_study_id>
    <nct_id>NCT03038685</nct_id>
  </id_info>
  <brief_title>A Personalized, Digital Coaching Program After Stroke</brief_title>
  <acronym>STROKECOACH</acronym>
  <official_title>A Personalized, Digital Coaching Program With Teleconsultancy to Improve Secondary Prevention After Ischemic Stroke: a Pilot, Multicenter Pre/Post Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Antwerp</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sint-Lucashospital, Bruges, Belgium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AZ Sint-Jan AV</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Groeningehospital, Kortrijk, Belgium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Belgian Stroke Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Interuniversity Centre For Health Economics Research, VUB, Brussels, Belgium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Antwerp</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The Belgian Stroke Council initiated a project to improve risk factor control and medication&#xD;
      adherence in ischemic stroke patients by developing an individualized in-hospital initiated&#xD;
      and post- discharge, digital coaching program addition to standard practice (strokecoach.be).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall aim of this project is to further improve subacute and chronic stroke care in the&#xD;
      Belgian context with main focus on the patients' quality of life, stroke recurrence and&#xD;
      secondary cardiovascular prevention. Main focuses are on patient-empowerment, shared-decision&#xD;
      making and health literacy, as these items are linked with better therapeutic adherence and&#xD;
      self-care for chronic diseases.&#xD;
&#xD;
      In case of a positive result, implementation of this individualized chronic stroke care&#xD;
      program executed by a personal stroke coach, initiated during hospitalization and using a&#xD;
      web-based intervention program, can easily be unrolled in other Belgian stroke units. The&#xD;
      program can be cost-effective if better clinical outcome, stroke recurrence rates, number of&#xD;
      in-hospital consultations, number of rehospitalisations are reduced. This will be evaluated&#xD;
      in a in-depth healt-economic analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">February 28, 2018</completion_date>
  <primary_completion_date type="Actual">February 28, 2018</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>Single Group Assignment</intervention_model>
    <intervention_model_description>A pilot, double-arm, pre/post study design with compirason between historical, monocenter cohort (Sint-Janhospital, 2011) and prospective, multicenter cohort (4 Belgian Stroke centers, 2017)</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cardiovascular risk factor control</measure>
    <time_frame>6 months</time_frame>
    <description>The primary endpoint is the impact of the intervention on the cardiovascular risk factor control by assessing the evolution of the SCORE (Systematic COronary Risk Evaluation: High &amp; Low cardiovascular Risk Charts) risk pre- and postintervention. An official program to analyze these parameter will be used (AOST©, Crethsoft).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality-of-life</measure>
    <time_frame>3-6months</time_frame>
    <description>The impact on the quality-of-life will be evaluated by using the dutch version of the EQ-5D questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical outcome</measure>
    <time_frame>6 months</time_frame>
    <description>The impact on the clinical outcome will be assessed by the modified Rankin Score (0-6, mRS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke recurrence rate</measure>
    <time_frame>0.5-1-2-3-6 months</time_frame>
    <description>At every teleconsultancy contact stroke recurrences will be demanded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic adherence</measure>
    <time_frame>0.5-1-2-3-6 months</time_frame>
    <description>A selfreport of the therapeutic adherence will be checked at every consultation by asking them if any medication had been skipped during last 10 days.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>Stroke, Ischemic</condition>
  <arm_group>
    <arm_group_label>prospective, multicenter cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A group of 175 patients will be recruited in 4 Belgian stroke centers during the six months period. All data will be collected prospectively and patients will be treated during six months period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>historical, single center cohort</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>A historical cohort of Sint-Janhospital (2011 - Bruges, Belgium) with prospectively collected data will be used as comparator for the experimental arm. These data were published in Vanacker P, Couvreur T, Vanhooren G. Can we improve cerebrovascular risk reduction in real-life? A single centre's experience. Cerebrovasc Dis 2011;31(suppl 2):289</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Strokecoach.be - digital coaching program for stroke patients</intervention_name>
    <description>The stroke coach gives patients two education sessions during hospitalization (risk factor management, review of medications and clinical evolution). During these sessions, study participation will be proposed. Eligibility will partially depend on their historical use of the internet and e-mail. The aim is to have the digital platform personalized for his/her individual needs, risk factors and remaining neurologic signs/symptoms. Tips and tricks to deal with lifestyle modification will be delivered on regular basis. Meanwhile, patients will be asked to complete on a pre-specified frequency their data regarding their cardiovascular risk profile. Additionally, participants will be contacted at 0.5-1-2 and 6 months by phone calls or videoconsultancy. To standardize, an adapted, digital version of the standardized WSO Post-Stroke Checklist shall be used as a decision-support flowchart. A report of the consultation will be derived after the videoconsultancy.</description>
    <arm_group_label>prospective, multicenter cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with an acute ischemic stroke hospitalized at a participating stroke center can be&#xD;
        included during hospitalisation if fulfilling following three criteria: - they will return&#xD;
        back home or be discharged to a rehabilitation center&#xD;
&#xD;
          -  have a life expectancy of more than 6 months&#xD;
&#xD;
          -  have experience with internet use (at least weekly checking emails) or a caregiver&#xD;
             accepts to help with the digital platform.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Patients unable or unwilling to be followed post-discharge for 6 months&#xD;
&#xD;
          -  Patients with a major neurologic post-stroke and no caregiver participation&#xD;
&#xD;
          -  Cognitive impairment limiting use of digital platform and no caregiver participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Vanacker, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Antwerp</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sint-Janhospital</name>
      <address>
        <city>Brugge</city>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sint-Lucashospital</name>
      <address>
        <city>Brugge</city>
        <zip>8310</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Antwerp</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groeningehospital</name>
      <address>
        <city>Kortrijk</city>
        <zip>8500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/31701472/</url>
    <description>Related Info</description>
  </link>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>January 11, 2021</last_update_submitted>
  <last_update_submitted_qc>January 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Antwerp</investigator_affiliation>
    <investigator_full_name>PVanacker</investigator_full_name>
    <investigator_title>neurovascular consultant</investigator_title>
  </responsible_party>
  <keyword>Secondary prevention</keyword>
  <keyword>Web-based intervention</keyword>
  <keyword>Strokecoach</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03038685
org study id: UHAntwerp
nct id: NCT03038685
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The Belgian Stroke Council initiated a project to improve risk factor control and medication
      adherence in ischemic stroke patients by developing an individualized in-hospital initiated
      and post- discharge, digital coaching program addition to standard practice (strokecoach.be).
The overall aim of this project is to further improve subacute and chronic stroke care in the
      Belgian context with main focus on the patients' quality of life, stroke recurrence and
      secondary cardiovascular prevention. Main focuses are on patient-empowerment, shared-decision
      making and health literacy, as these items are linked with better therapeutic adherence and
      self-care for chronic diseases.

      In case of a positive result, implementation of this individualized chronic stroke care
      program executed by a personal stroke coach, initiated during hospitalization and using a
      web-based intervention program, can easily be unrolled in other Belgian stroke units. The
      program can be cost-effective if better clinical outcome, stroke recurrence rates, number of
      in-hospital consultations, number of rehospitalisations are reduced. This will be evaluated
      in a in-depth healt-economic analysis.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: A pilot, double-arm, pre/post study design with compirason between historical, monocenter cohort (Sint-Janhospital, 2011) and prospective, multicenter cohort (4 Belgian Stroke centers, 2017)
primary purpose: Prevention
masking: None (Open Label)
measure: cardiovascular risk factor control
time frame: 6 months
description: The primary endpoint is the impact of the intervention on the cardiovascular risk factor control by assessing the evolution of the SCORE (Systematic COronary Risk Evaluation: High & Low cardiovascular Risk Charts) risk pre- and postintervention. An official program to analyze these parameter will be used (AOST©, Crethsoft).
measure: Quality-of-life
time frame: 3-6months
description: The impact on the quality-of-life will be evaluated by using the dutch version of the EQ-5D questionnaire
measure: Clinical outcome
time frame: 6 months
description: The impact on the clinical outcome will be assessed by the modified Rankin Score (0-6, mRS).
measure: Stroke recurrence rate
time frame: 0.5-1-2-3-6 months
description: At every teleconsultancy contact stroke recurrences will be demanded.
measure: Therapeutic adherence
time frame: 0.5-1-2-3-6 months
description: A selfreport of the therapeutic adherence will be checked at every consultation by asking them if any medication had been skipped during last 10 days.
arm group label: prospective, multicenter cohort
arm group type: Experimental
description: A group of 175 patients will be recruited in 4 Belgian stroke centers during the six months period. All data will be collected prospectively and patients will be treated during six months period.
arm group label: historical, single center cohort
arm group type: No Intervention
description: A historical cohort of Sint-Janhospital (2011 - Bruges, Belgium) with prospectively collected data will be used as comparator for the experimental arm. These data were published in Vanacker P, Couvreur T, Vanhooren G. Can we improve cerebrovascular risk reduction in real-life? A single centre's experience. Cerebrovasc Dis 2011;31(suppl 2):289
intervention type: Behavioral
intervention name: Strokecoach.be - digital coaching program for stroke patients
description: The stroke coach gives patients two education sessions during hospitalization (risk factor management, review of medications and clinical evolution). During these sessions, study participation will be proposed. Eligibility will partially depend on their historical use of the internet and e-mail. The aim is to have the digital platform personalized for his/her individual needs, risk factors and remaining neurologic signs/symptoms. Tips and tricks to deal with lifestyle modification will be delivered on regular basis. Meanwhile, patients will be asked to complete on a pre-specified frequency their data regarding their cardiovascular risk profile. Additionally, participants will be contacted at 0.5-1-2 and 6 months by phone calls or videoconsultancy. To standardize, an adapted, digital version of the standardized WSO Post-Stroke Checklist shall be used as a decision-support flowchart. A report of the consultation will be derived after the videoconsultancy.
arm group label: prospective, multicenter cohort
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Vanacker, MD PhD
role: Principal Investigator
affiliation: University Hospital, Antwerp
facility: 
facility: 
facility: 
facility: 
country: Belgium
url: https://pubmed.ncbi.nlm.nih.gov/31701472/
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Antwerp
investigator full name: PVanacker
investigator title: neurovascular consultant
mesh term: Stroke
mesh term: Ischemic Stroke
sharing ipd: No