<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/NCT01691586</url>
  </required_header>
  <id_info>
    <org_study_id>UMCU.DHL.001</org_study_id>
    <nct_id>NCT01691586</nct_id>
  </id_info>
  <brief_title>Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices</brief_title>
  <acronym>REMOTE-CIED</acronym>
  <official_title>Remote Monitoring of Heart Failure Patients With Cardiovascular Implantable Electronic Device: The Patient Perspective</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UMC Utrecht</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tilburg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>UMC Utrecht</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>
      A relatively new and promising development in the area of cardiovascular implantable&#xD;
      electronic device therapy is remote patient monitoring (RPM). RPM systems can interrogate the&#xD;
      device automatically and send the data from the patients' home to the physician, thereby&#xD;
      reducing in-clinic follow-ups.&#xD;
&#xD;
      The purpose of this study is to evaluate the effect of RPM + in-clinic follow-up versus&#xD;
      in-clinic follow-up only on patient-reported health status and device-acceptance after&#xD;
      implantation with an implantable cardioverter defibrillator (ICD) or cardiac&#xD;
      resynchronization defibrillator (CRT-D).&#xD;
&#xD;
      Secondary objectives are (1) to identify subgroups of patients who prefer RPM over in-clinic&#xD;
      visits or vice versa due to specific clinical and psychological factors and (2) To&#xD;
      investigate the cost-effectiveness of RPM + in-clinic follow-up compared to in-clinic&#xD;
      follow-up only.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 13, 2013</start_date>
  <completion_date type="Actual">January 15, 2018</completion_date>
  <primary_completion_date type="Actual">January 15, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient-reported health status</measure>
    <time_frame>24 months</time_frame>
    <description>23-item Kansas City Cardiomyopathy Questionnaire (KCCQ)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-reported device acceptance</measure>
    <time_frame>24 months</time_frame>
    <description>12-item Florida Patient Acceptance Scale (FPAS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient-reported satisfaction with care</measure>
    <time_frame>24 months</time_frame>
    <description>Visual Analogue Scale ranging from 0-100 (with higher score representing more satisfaction with care)&#xD;
26-item self-made questionnaire to assess satisfaction with RPM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>24 months</time_frame>
    <description>Data regarding health care utilization is gathered from hospitals and patients.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">600</enrollment>
  <condition>Congestive Heart Failure</condition>
  <arm_group>
    <arm_group_label>Remote patient management</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Remote patient management system + yearly in-clinic follow-up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>In-Clinic follow-up</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In-clinic follow-up according to standard practice (every 3-6 months)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Remote patient monitoring</intervention_name>
    <description>Remote monitoring of ICD and heart failure data</description>
    <arm_group_label>Remote patient management</arm_group_label>
    <other_name>Boston Scientific LATITUDE system</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>In-Clinic check-ups</intervention_name>
    <description>Calender-based In-Clinic ICD check-up</description>
    <arm_group_label>In-Clinic follow-up</arm_group_label>
    <arm_group_label>Remote patient management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first time ICD/CRT-D implanted at one of the participating centers&#xD;
&#xD;
          -  left ventricular ejection fraction &lt;35%&#xD;
&#xD;
          -  NYHA functional class II or III symptoms&#xD;
&#xD;
          -  ICD/CRT-D device compatible with the LATITUDE(r) RPM system from Boston Scientific&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  On the waiting list for heart transplantation&#xD;
&#xD;
          -  History of psychiatric illness others than affective/anxiety disorders&#xD;
&#xD;
          -  Cognitive impairments&#xD;
&#xD;
          -  Insufficient knowledge of the language to fill in the questionnaires&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mathias Meine, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UMC Utrecht</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medical Center Utrecht</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>June 6, 2018</last_update_submitted>
  <last_update_submitted_qc>June 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>UMC Utrecht</investigator_affiliation>
    <investigator_full_name>M. Meine</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>implantable defibrillators</keyword>
  <keyword>remote patient monitoring</keyword>
  <keyword>patient-reported outcomes</keyword>
  <keyword>cost-effectiveness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <!-- 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/NCT01691586
org study id: UMCU.DHL.001
nct id: NCT01691586
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A relatively new and promising development in the area of cardiovascular implantable
      electronic device therapy is remote patient monitoring (RPM). RPM systems can interrogate the
      device automatically and send the data from the patients' home to the physician, thereby
      reducing in-clinic follow-ups.

      The purpose of this study is to evaluate the effect of RPM + in-clinic follow-up versus
      in-clinic follow-up only on patient-reported health status and device-acceptance after
      implantation with an implantable cardioverter defibrillator (ICD) or cardiac
      resynchronization defibrillator (CRT-D).

      Secondary objectives are (1) to identify subgroups of patients who prefer RPM over in-clinic
      visits or vice versa due to specific clinical and psychological factors and (2) To
      investigate the cost-effectiveness of RPM + in-clinic follow-up compared to in-clinic
      follow-up only.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Patient-reported health status
time frame: 24 months
description: 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ)
measure: Patient-reported device acceptance
time frame: 24 months
description: 12-item Florida Patient Acceptance Scale (FPAS)
measure: Patient-reported satisfaction with care
time frame: 24 months
description: Visual Analogue Scale ranging from 0-100 (with higher score representing more satisfaction with care)
26-item self-made questionnaire to assess satisfaction with RPM
measure: Cost-effectiveness
time frame: 24 months
description: Data regarding health care utilization is gathered from hospitals and patients.
arm group label: Remote patient management
arm group type: Experimental
description: Remote patient management system + yearly in-clinic follow-up
arm group label: In-Clinic follow-up
arm group type: Other
description: In-clinic follow-up according to standard practice (every 3-6 months)
intervention type: Device
intervention name: Remote patient monitoring
description: Remote monitoring of ICD and heart failure data
arm group label: Remote patient management
other name: Boston Scientific LATITUDE system
intervention type: Other
intervention name: In-Clinic check-ups
description: Calender-based In-Clinic ICD check-up
arm group label: In-Clinic follow-up
arm group label: Remote patient management
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Mathias Meine, MD, PhD
role: Principal Investigator
affiliation: UMC Utrecht
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: UMC Utrecht
investigator full name: M. Meine
investigator title: Principal Investigator
mesh term: Heart Failure