<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/NCT02234245</url>
  </required_header>
  <id_info>
    <org_study_id>CEIC-AL 53/2012</org_study_id>
    <nct_id>NCT02234245</nct_id>
  </id_info>
  <brief_title>Economic Evaluation in Cardiology: Remote Monitoring of Pacemakers</brief_title>
  <official_title>Economic Evaluation in Cardiology: Remote Monitoring of Pacemakers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Almeria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Almeria</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to estimate the outcomes in health and cost of the follow-up&#xD;
      of patients with pacemakers.&#xD;
&#xD;
      The initial hypothesize of this study is that remote monitoring of pacemaker will show a best&#xD;
      relation of outcomes in costs and effectiveness than the conventional follow-up in hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiovascular Diseases are a major cause of global morbidity and mortality, being&#xD;
      responsible according to the World Health Organization of the 30% of overall mortality.&#xD;
&#xD;
      Since 2001 that the first pacemaker of remote monitoring was implanted in Europe, more than&#xD;
      300,000 pacemaker have been implanted around the world. Despite this sharp expansion, the&#xD;
      scientific evidence on economic evaluations of pacemaker with remote monitoring is very&#xD;
      limited, and in our knowledge, studies including informal costs have not been conducted.&#xD;
&#xD;
      In the field of cardiology, telemedicine allows consultations with patients through&#xD;
      monitoring systems and remote communication analyzing the ongoing heart rates of people with&#xD;
      pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy and&#xD;
      subcutaneous Holter. The use of remote monitoring may save time and efforts to both&#xD;
      healthcare professionals and patients, including their informal caregivers, reducing the&#xD;
      number of follow up visits to the hospital and reducing the associated costs with patient&#xD;
      follow-up, which will help to improve sustainability of healthcare services.&#xD;
&#xD;
      During the 12 months of study, the patients with implant of pacemakers of both groups will be&#xD;
      assessed of the same parameters, in 4 different moments (pre-implant and months 1, 6, 12 and&#xD;
      5 years post-implantation).&#xD;
&#xD;
      The study will estimate: 1) The Clinical features of the patients. 2) The effectiveness&#xD;
      through of administration of health-related quality of life, functional capacity&#xD;
      questionnaires and 3) Finally, the hospital and informal costs of patients with pacemakers&#xD;
      will be estimated by the researches.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">November 2013</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical features</measure>
    <time_frame>12 months</time_frame>
    <description>Selected variables from the medical history records:&#xD;
gender&#xD;
age&#xD;
indication for the implantation of the pacemaker.&#xD;
comorbidities&#xD;
pharmacological treatment&#xD;
vital signs&#xD;
pacemaker parameters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health-Related Quality of Life</measure>
    <time_frame>5 years</time_frame>
    <description>EuroQol-5Dimensions (EQ-5D)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional capacity</measure>
    <time_frame>5 years</time_frame>
    <description>Duke Activity Status Index (DASI).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Direct costs</measure>
    <time_frame>5 years</time_frame>
    <description>Direct costs taken into account:&#xD;
pacemakers' costs´(device implanted)&#xD;
hospitalizations' costs&#xD;
consultations' costs (hospital)&#xD;
prescribed medical transport's cost&#xD;
health personnel costs&#xD;
pharmaceutical costs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indirect cost</measure>
    <time_frame>5 years</time_frame>
    <description>Maintenance of the medical consultation (hospital):&#xD;
electricity&#xD;
cleaning&#xD;
furniture&#xD;
Health fungible&#xD;
equipment investment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Informal costs</measure>
    <time_frame>5 years</time_frame>
    <description>Costs related to the care and displacements of patients to hospital:&#xD;
displacement costs to hospital&#xD;
Accommodation costs&#xD;
Cost of meals&#xD;
Costs for caregivers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with Adverse Events</measure>
    <time_frame>5 years</time_frame>
    <description>Number of patients with Adverse Events&#xD;
- type of Adverse Events diagnosed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consultations and Hospitalizations unscheduled</measure>
    <time_frame>5 years</time_frame>
    <description>- number of unscheduled visits and hospitalizations</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">83</enrollment>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Hospital monitoring of pacemakers</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients have to go to the hospital to be monitorized</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Remote monitoring of pacemakers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telemedicine System:&#xD;
Patients have not to go to the hospital to be monitorized</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Telemedicine System</intervention_name>
    <description>Telemedicine System is used in remote monitoring group</description>
    <arm_group_label>Remote monitoring of pacemakers</arm_group_label>
    <other_name>Patients are monitorized from hospital</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be 18 years of age&#xD;
&#xD;
          -  Have a pacemaker implanted&#xD;
&#xD;
          -  Understand and be able to properly perform self-monitoring at home&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Be participating in another study&#xD;
&#xD;
          -  Refuse to participate in the study&#xD;
&#xD;
          -  Have implanted a different cardiac device to the pacemaker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital de Poniente</name>
      <address>
        <city>El Ejido</city>
        <state>Almeria</state>
        <zip>04700</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Almeria</investigator_affiliation>
    <investigator_full_name>Antonio Lopez Villegas</investigator_full_name>
    <investigator_title>PhD student</investigator_title>
  </responsible_party>
  <keyword>Follow-Up studies</keyword>
  <keyword>Biological Pacemakers</keyword>
  <keyword>Telemedicine</keyword>
  <keyword>Efficiency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</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/NCT02234245
org study id: CEIC-AL 53/2012
nct id: NCT02234245
lead sponsor: 
has dmc: Yes
The purpose of this research is to estimate the outcomes in health and cost of the follow-up
      of patients with pacemakers.

      The initial hypothesize of this study is that remote monitoring of pacemaker will show a best
      relation of outcomes in costs and effectiveness than the conventional follow-up in hospital.
Cardiovascular Diseases are a major cause of global morbidity and mortality, being
      responsible according to the World Health Organization of the 30% of overall mortality.

      Since 2001 that the first pacemaker of remote monitoring was implanted in Europe, more than
      300,000 pacemaker have been implanted around the world. Despite this sharp expansion, the
      scientific evidence on economic evaluations of pacemaker with remote monitoring is very
      limited, and in our knowledge, studies including informal costs have not been conducted.

      In the field of cardiology, telemedicine allows consultations with patients through
      monitoring systems and remote communication analyzing the ongoing heart rates of people with
      pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy and
      subcutaneous Holter. The use of remote monitoring may save time and efforts to both
      healthcare professionals and patients, including their informal caregivers, reducing the
      number of follow up visits to the hospital and reducing the associated costs with patient
      follow-up, which will help to improve sustainability of healthcare services.

      During the 12 months of study, the patients with implant of pacemakers of both groups will be
      assessed of the same parameters, in 4 different moments (pre-implant and months 1, 6, 12 and
      5 years post-implantation).

      The study will estimate: 1) The Clinical features of the patients. 2) The effectiveness
      through of administration of health-related quality of life, functional capacity
      questionnaires and 3) Finally, the hospital and informal costs of patients with pacemakers
      will be estimated by the researches.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Clinical features
time frame: 12 months
description: Selected variables from the medical history records:
gender
age
indication for the implantation of the pacemaker.
comorbidities
pharmacological treatment
vital signs
pacemaker parameters
measure: Health-Related Quality of Life
time frame: 5 years
description: EuroQol-5Dimensions (EQ-5D)
measure: Functional capacity
time frame: 5 years
description: Duke Activity Status Index (DASI).
measure: Direct costs
time frame: 5 years
description: Direct costs taken into account:
pacemakers' costs´(device implanted)
hospitalizations' costs
consultations' costs (hospital)
prescribed medical transport's cost
health personnel costs
pharmaceutical costs
measure: Indirect cost
time frame: 5 years
description: Maintenance of the medical consultation (hospital):
electricity
cleaning
furniture
Health fungible
equipment investment
measure: Informal costs
time frame: 5 years
description: Costs related to the care and displacements of patients to hospital:
displacement costs to hospital
Accommodation costs
Cost of meals
Costs for caregivers
measure: Number of patients with Adverse Events
time frame: 5 years
description: Number of patients with Adverse Events
- type of Adverse Events diagnosed
measure: Consultations and Hospitalizations unscheduled
time frame: 5 years
description: - number of unscheduled visits and hospitalizations
arm group label: Hospital monitoring of pacemakers
arm group type: No Intervention
description: Patients have to go to the hospital to be monitorized
arm group label: Remote monitoring of pacemakers
arm group type: Experimental
description: Telemedicine System:
Patients have not to go to the hospital to be monitorized
intervention type: Device
intervention name: Telemedicine System
description: Telemedicine System is used in remote monitoring group
arm group label: Remote monitoring of pacemakers
other name: Patients are monitorized from hospital
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad de Almeria
investigator full name: Antonio Lopez Villegas
investigator title: PhD student
mesh term: Cardiovascular Diseases