<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/NCT02976961</url>
  </required_header>
  <id_info>
    <org_study_id>31779</org_study_id>
    <nct_id>NCT02976961</nct_id>
  </id_info>
  <brief_title>A Personalized and Interactive Web-based Health Care Innovation to Advance the Quality of Care</brief_title>
  <acronym>ACQUIRE-ICD</acronym>
  <official_title>A Personalized and Interactive Web-based Health Care Innovation to AdvanCe the QualIty of Life and caRE of Patients With an Implantable Cardioverter Defibrillator</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Susanne Schmidt Pedersen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aalborg University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Gentofte, Copenhagen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zealand University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern Denmark</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>
      This study evaluates the clinical efficacy and cost-effectiveness of the ACQUIRE-ICD care&#xD;
      innovation as add-on to usual care as compared to usual care alone in patients with an&#xD;
      implantable cardioverter defibrillator.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2017</start_date>
  <completion_date type="Actual">May 8, 2023</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Device acceptance</measure>
    <time_frame>12 months</time_frame>
    <description>Measured with the Florida Patient Acceptance Survey (FPAS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health status (generic)</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>Measured with the Short Form Health Survey 12 items (SF-12)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient empowerment (ICD-EMPOWER)</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>Purpose-designed and disease-specific 14-item measure that measures patient empowerment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICD patient concerns (ICDC)</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>8-item ICD Patients' Concern questionnaire that taps into fear of shock as reported by the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of anxiety</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>Generalized Anxiety Disorder scale (GAD-7)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of depression</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>Patient Health Questionnaire (PHQ-9)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health status (heart failure specific)</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>Kansas City Cardiomyopathy Questionnaire (KCCQ-12)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to work</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>Purpose-designed questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first ICD therapy</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>Defined as ATP, cardioversion or shock</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first hospitalization due to a cardiac cause</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>Hospitalization due to a cardiac cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to mortality</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>Mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>Incremental cost gained per quality adjusted life year (QALY) and burden on health care professionals (physicians and nurses)). This will be measured with the EQ-5D-5L or captured from the patient's electronic health record (EHR; e.g. number of phone calls, emails, and consultations with patients), and purpose-designed questions.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">478</enrollment>
  <condition>Implantable Defibrillator User</condition>
  <condition>Distress</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implantable cardioverter defibrillator implant + usual care + supportive care given via an e-health platform. The supportive care consists of information, dialogue with a nurse or psychologist, CBT-based psychological intervention online, quizzes to increase knowledge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Implantable cardioverter defibrillator implant + usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supportive care</intervention_name>
    <description>Information, guidance, supportive care, and psychological intervention</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a first-time ICD or CRT-D&#xD;
&#xD;
          -  ≥18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subcutaneous ICD&#xD;
&#xD;
          -  Upgrade from a pacemaker to ICD or CRT&#xD;
&#xD;
          -  History of psychiatric illness other than affective/anxiety disorders&#xD;
&#xD;
          -  Cognitive impairments (e.g. dementia)&#xD;
&#xD;
          -  Left ventricular assist device (LVAD) or upcoming LVAD implant&#xD;
&#xD;
          -  Under evaluation or on the waiting list for heart transplantation&#xD;
&#xD;
          -  No e-mail address&#xD;
&#xD;
          -  Inability to manage or cope with computer technology&#xD;
&#xD;
          -  Insufficient knowledge of the Danish language&#xD;
&#xD;
          -  Participation in other randomized controlled trials unless of a technical nature&#xD;
&#xD;
          -  Irresponsible to ask patient to participate according to GCP&#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>Susanne S Pedersen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gentofte Hospital</name>
      <address>
        <city>Gentofte</city>
        <state>Hellerup</state>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aalborg University Hospital</name>
      <address>
        <city>Aalborg</city>
        <zip>9100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zealand University Hospital - Roskilde</name>
      <address>
        <city>Roskilde</city>
        <zip>4000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern Denmark</investigator_affiliation>
    <investigator_full_name>Susanne Schmidt Pedersen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Information</keyword>
  <keyword>Empowerment</keyword>
  <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/NCT02976961
org study id: 31779
nct id: NCT02976961
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the clinical efficacy and cost-effectiveness of the ACQUIRE-ICD care
      innovation as add-on to usual care as compared to usual care alone in patients with an
      implantable cardioverter defibrillator.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Device acceptance
time frame: 12 months
description: Measured with the Florida Patient Acceptance Survey (FPAS)
measure: Health status (generic)
time frame: 12 and 24 months
description: Measured with the Short Form Health Survey 12 items (SF-12)
measure: Patient empowerment (ICD-EMPOWER)
time frame: 12 and 24 months
description: Purpose-designed and disease-specific 14-item measure that measures patient empowerment
measure: ICD patient concerns (ICDC)
time frame: 12 and 24 months
description: 8-item ICD Patients' Concern questionnaire that taps into fear of shock as reported by the patient
measure: Symptoms of anxiety
time frame: 12 and 24 months
description: Generalized Anxiety Disorder scale (GAD-7)
measure: Symptoms of depression
time frame: 12 and 24 months
description: Patient Health Questionnaire (PHQ-9)
measure: Health status (heart failure specific)
time frame: 12 and 24 months
description: Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
measure: Return to work
time frame: 12 and 24 months
description: Purpose-designed questions
measure: Time to first ICD therapy
time frame: 12 and 24 months
description: Defined as ATP, cardioversion or shock
measure: Time to first hospitalization due to a cardiac cause
time frame: 12 and 24 months
description: Hospitalization due to a cardiac cause
measure: Time to mortality
time frame: 12 and 24 months
description: Mortality
measure: Cost-effectiveness
time frame: 12 and 24 months
description: Incremental cost gained per quality adjusted life year (QALY) and burden on health care professionals (physicians and nurses)). This will be measured with the EQ-5D-5L or captured from the patient's electronic health record (EHR; e.g. number of phone calls, emails, and consultations with patients), and purpose-designed questions.
arm group label: Intervention
arm group type: Experimental
description: Implantable cardioverter defibrillator implant + usual care + supportive care given via an e-health platform. The supportive care consists of information, dialogue with a nurse or psychologist, CBT-based psychological intervention online, quizzes to increase knowledge
arm group label: Usual care
arm group type: No Intervention
description: Implantable cardioverter defibrillator implant + usual care
intervention type: Other
intervention name: Supportive care
description: Information, guidance, supportive care, and psychological intervention
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Susanne S Pedersen, PhD
role: Principal Investigator
affiliation: University of Southern Denmark
facility: 
facility: 
facility: 
facility: 
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: University of Southern Denmark
investigator full name: Susanne Schmidt Pedersen
investigator title: Professor
sharing ipd: No