<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/NCT03294811</url>
  </required_header>
  <id_info>
    <org_study_id>Cardiocoach</org_study_id>
    <nct_id>NCT03294811</nct_id>
  </id_info>
  <brief_title>A Two-way Communication System to Coach Elderly Patients With Heart Failure</brief_title>
  <acronym>CardioCoach</acronym>
  <official_title>CARDIOCOACH: Development of an Intelligent Two-way Communication System to Coach Elderly Patients With Heart Failure in Their Home Situation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hasselt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ziekenhuis Oost-Limburg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jessa Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hasselt University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open randomized clinical trial with two study arms. One group, receiving usual&#xD;
      care for heart failure, will be compared to another group, receiving usual care plus active&#xD;
      telemonitoring interference.&#xD;
&#xD;
      When leaving the hospital, the usual care arm receives a document with a predefined&#xD;
      medication scheme and advice for the general practitioner (like it is currently done in usual&#xD;
      care).&#xD;
&#xD;
      The telemonitoring interference in the other study arm consists of a smartphone application&#xD;
      to register medication intake and to transmit the data of an automatic blood pressure device&#xD;
      and a balance to a central platform. The goal is to improve medication uptitration&#xD;
      (angiotensin-converting-enzyme inhibitor (ACE-I) and bètablockers (BB)) in heart failure&#xD;
      patients and to improve medication compliance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2014</start_date>
  <completion_date type="Actual">April 4, 2018</completion_date>
  <primary_completion_date type="Actual">December 15, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean medication doses</measure>
    <time_frame>3 months</time_frame>
    <description>Mean daily doses of ACE-inhibitors/ARB's, β blokkers and Aldosteron antagonists after 3 months. This is estimated by registration of the types of medication, the corresponding doses and the frequency of intake.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medication titration</measure>
    <time_frame>after month 6</time_frame>
    <description>Mean daily doses of ACE-inhibitors/ARB's, β blokkers and Aldosteron antagonists after 6 months. This is estimated by registration of the types of medication, the corresponding doses and the frequency of intake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>up to month 6</time_frame>
    <description>All-cause mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All cardio related hospitalizations (number and time)</measure>
    <time_frame>up to month 6</time_frame>
    <description>Arrythmogenic nature&#xD;
Ischemic nature&#xD;
Heart failure nature&#xD;
Valvular/surgical nature&#xD;
Elektrofysiological nature (implantation ICD, CRT,…)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All heart failure hospitalizations</measure>
    <time_frame>up to month 6</time_frame>
    <description>Treatment with (whether or not intravenous) diuretic therapy&#xD;
Treatment with hemodynamic guided therapy (vasodilators)&#xD;
Treatment with intravenous inotropics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of medical practitioner-patient contacts</measure>
    <time_frame>up to month 6</time_frame>
    <description>In hospital (medical record)&#xD;
General practitioner&#xD;
At patient home (Remedus)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of (telephone) contacts, registered by the heart failure nurse</measure>
    <time_frame>up to month 6</time_frame>
    <description>Number of (telephone) contacts, registered by the heart failure nurse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of (telephone) contacts for the encouragement of medication compliance and parameter (Remedus)</measure>
    <time_frame>up to month 6</time_frame>
    <description>Number of (telephone) contacts for the encouragement of medication compliance (Remedus)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of heart failure and comorbidities</measure>
    <time_frame>up to month 6</time_frame>
    <description>Blood collection with: kidney function determinations, electrolytes&#xD;
Echo parameters (cardiac output, LVEF, diameters end systolic and diastolic)&#xD;
Weight, length, blood pressure, ECG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life according to the HeartQoL questionnaire</measure>
    <time_frame>day 1, month 6</time_frame>
    <description>Quality of life according to the HeartQoL questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction survey</measure>
    <time_frame>month 6</time_frame>
    <description>Satisfaction survey about the received care (anonymous) for the cardiocoach group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Telemonitoring group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Recieve a smartphone with an application to coach them, a blood pressure monitor and scale.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group (usual care, without telemonitoring)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Telemonitoring</intervention_name>
    <description>The telemonitoring interference in the telemonitoring arm consists of a smartphone application that helps the patient to take their medication in time and to take their blood pressure and weight on a daily basis in order to improve the medication uptitration and medication compliance.</description>
    <arm_group_label>Telemonitoring group</arm_group_label>
    <other_name>Telemedicine</other_name>
    <other_name>remote monitoring</other_name>
    <other_name>remote follow-up</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 60&#xD;
&#xD;
          -  Patient has to be followed in Ziekenhuis Oost-Limburg or Jessa Ziekenhuis Hasselt and&#xD;
             has to live in the region Genk - Hasselt&#xD;
&#xD;
          -  The patient has to be cognitive strong enough and speak enough Dutch to communicate&#xD;
             about their health situation and to understand the smartphone application&#xD;
&#xD;
          -  The diagnosis of systolic heart failure or severe myocardial infarction has to be done&#xD;
             during consultation or hospitalization&#xD;
&#xD;
          -  Left ventricular ejection fraction (LVEF) &lt;45%&#xD;
&#xD;
          -  Treatment minimally with ACE-I and BB On the basis of an interview between the heart&#xD;
             failure nurse and patient, one will decide if the patient is eligible to join the&#xD;
             study. The patient also needs to speak sufficient Dutch to be communicative about&#xD;
             his/her medical condition.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Reversible form of heart failure&#xD;
&#xD;
          -  Heart failure due to severe aortic stenosis&#xD;
&#xD;
          -  At the time of inclusion a eGFR less than 30ml/min/kg&#xD;
&#xD;
          -  Presence of a cardiac resynchronization therapy (CRT) device&#xD;
&#xD;
          -  Active treatment with either ACE-I/ARB or BB&#xD;
&#xD;
          -  Patient that are subscribed in a cardiac revalidation program when leaving the&#xD;
             hospital&#xD;
&#xD;
          -  Patients with severe form of COPD (GOLD III)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vandervoort Pieter, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Ziekenhuis Oost-Limburg</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paul Dendale, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Jessa Ziekenhuis, Hasselt, Belgium</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jo Ravelingen</last_name>
    <role>Study Director</role>
    <affiliation>Remedus, Aartselaar, Belgium</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Van Vooren</last_name>
    <role>Study Director</role>
    <affiliation>Fifthplay, Antwerpen, Belgium</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Valerie Storms, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Mobile Health Unit, Hasselt University, Hasselt, Belgium</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lars Grieten, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mobile Health Unit, Hasselt University, Hasselt, Belgium</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christophe Smeets, PhD student</last_name>
    <role>Study Chair</role>
    <affiliation>Mobile Health Unit, Hasselt University, Hasselt, Belgium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ziekenhuis Oost-Limburg</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jessa Ziekenhuis</name>
      <address>
        <city>Hasselt</city>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>May 20, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>May 10, 2019</last_update_submitted>
  <last_update_submitted_qc>May 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hasselt University</investigator_affiliation>
    <investigator_full_name>Pieter Vandervoort</investigator_full_name>
    <investigator_title>prof. dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</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/NCT03294811
org study id: Cardiocoach
nct id: NCT03294811
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This is an open randomized clinical trial with two study arms. One group, receiving usual
      care for heart failure, will be compared to another group, receiving usual care plus active
      telemonitoring interference.

      When leaving the hospital, the usual care arm receives a document with a predefined
      medication scheme and advice for the general practitioner (like it is currently done in usual
      care).

      The telemonitoring interference in the other study arm consists of a smartphone application
      to register medication intake and to transmit the data of an automatic blood pressure device
      and a balance to a central platform. The goal is to improve medication uptitration
      (angiotensin-converting-enzyme inhibitor (ACE-I) and bètablockers (BB)) in heart failure
      patients and to improve medication compliance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Mean medication doses
time frame: 3 months
description: Mean daily doses of ACE-inhibitors/ARB's, β blokkers and Aldosteron antagonists after 3 months. This is estimated by registration of the types of medication, the corresponding doses and the frequency of intake.
measure: Medication titration
time frame: after month 6
description: Mean daily doses of ACE-inhibitors/ARB's, β blokkers and Aldosteron antagonists after 6 months. This is estimated by registration of the types of medication, the corresponding doses and the frequency of intake.
measure: All-cause mortality
time frame: up to month 6
description: All-cause mortality
measure: All cardio related hospitalizations (number and time)
time frame: up to month 6
description: Arrythmogenic nature
Ischemic nature
Heart failure nature
Valvular/surgical nature
Elektrofysiological nature (implantation ICD, CRT,…)
measure: All heart failure hospitalizations
time frame: up to month 6
description: Treatment with (whether or not intravenous) diuretic therapy
Treatment with hemodynamic guided therapy (vasodilators)
Treatment with intravenous inotropics
measure: Number of medical practitioner-patient contacts
time frame: up to month 6
description: In hospital (medical record)
General practitioner
At patient home (Remedus)
measure: Number of (telephone) contacts, registered by the heart failure nurse
time frame: up to month 6
description: Number of (telephone) contacts, registered by the heart failure nurse
measure: Number of (telephone) contacts for the encouragement of medication compliance and parameter (Remedus)
time frame: up to month 6
description: Number of (telephone) contacts for the encouragement of medication compliance (Remedus)
measure: Evolution of heart failure and comorbidities
time frame: up to month 6
description: Blood collection with: kidney function determinations, electrolytes
Echo parameters (cardiac output, LVEF, diameters end systolic and diastolic)
Weight, length, blood pressure, ECG
measure: Quality of life according to the HeartQoL questionnaire
time frame: day 1, month 6
description: Quality of life according to the HeartQoL questionnaire
measure: Satisfaction survey
time frame: month 6
description: Satisfaction survey about the received care (anonymous) for the cardiocoach group.
arm group label: Telemonitoring group
arm group type: Experimental
description: Recieve a smartphone with an application to coach them, a blood pressure monitor and scale.
arm group label: Control group
arm group type: No Intervention
description: Control group (usual care, without telemonitoring)
intervention type: Device
intervention name: Telemonitoring
description: The telemonitoring interference in the telemonitoring arm consists of a smartphone application that helps the patient to take their medication in time and to take their blood pressure and weight on a daily basis in order to improve the medication uptitration and medication compliance.
arm group label: Telemonitoring group
other name: Telemedicine
other name: remote monitoring
other name: remote follow-up
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Vandervoort Pieter, MD, PhD
role: Study Director
affiliation: Ziekenhuis Oost-Limburg
last name: Paul Dendale, MD, PhD
role: Study Director
affiliation: Jessa Ziekenhuis, Hasselt, Belgium
last name: Jo Ravelingen
role: Study Director
affiliation: Remedus, Aartselaar, Belgium
last name: Peter Van Vooren
role: Study Director
affiliation: Fifthplay, Antwerpen, Belgium
last name: Valerie Storms, PhD
role: Study Director
affiliation: Mobile Health Unit, Hasselt University, Hasselt, Belgium
last name: Lars Grieten, PhD
role: Principal Investigator
affiliation: Mobile Health Unit, Hasselt University, Hasselt, Belgium
last name: Christophe Smeets, PhD student
role: Study Chair
affiliation: Mobile Health Unit, Hasselt University, Hasselt, Belgium
facility: 
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Hasselt University
investigator full name: Pieter Vandervoort
investigator title: prof. dr.
mesh term: Heart Failure
sharing ipd: Undecided