<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/NCT01696890</url>
  </required_header>
  <id_info>
    <org_study_id>TEMAHF2</org_study_id>
    <nct_id>NCT01696890</nct_id>
  </id_info>
  <brief_title>Integration of Follow-up by First and Second Line Practitioners by Telemonitoring in Heart Failure.</brief_title>
  <acronym>TEMA-HF2</acronym>
  <official_title>Integration of Follow-up by First and Second Line Practitioners Facilitated by Telemonitoring Versus Stand-alone Telemonitoring in Patients With Severe Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jessa Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jessa Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate this model of telemonitoring-assisted close supervision&#xD;
      and interaction between first and second line health professionals versus a model of&#xD;
      telemonitoring without this integrated approach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The incidence of acute decompensated heart failure is increasing. Patients with severe heart&#xD;
      failure are rehospitalised for decompensation several times each year, increasing the cost&#xD;
      for health care. In these cases of recurrent decompensation, the medical intervention in&#xD;
      hospital is often limited to increasing the dosage of diuretics or vasodilators until the&#xD;
      patient reaches a compensated state. After discharge, a readmission can be expected within a&#xD;
      few months. A multidisciplinary approach by primary physician, heart failure nurse,&#xD;
      rehabilitation team and cardiologist has been shown to decrease rehospitalisation rate and&#xD;
      increase quality of life.&#xD;
&#xD;
      Very recently, our study group showed that an intense collaboration between first line&#xD;
      practitioner and heart failure clinic, facilitated by the use of telemonitoring, can reduce&#xD;
      mortality and hospitalisation rate. This study was a RIZIV sponsored trial of 6 months&#xD;
      follow-up in patients with chronic heart failure. However, a large randomised multicentre&#xD;
      trial investigating the use of telemonitoring in a population of heart failure (NYHA II-III)&#xD;
      patients did not find any difference between telemonitoring and usual care (Chaudry et al&#xD;
      NEJM 2010). In contradiction with this study, a Cochrane meta-analysis (Ingliss 2010) in more&#xD;
      than 5000 patients confirmed our finding with a reduction in mortality and morbidity. The&#xD;
      question therefore remains which factors are responsible for success or failure of the use of&#xD;
      telemonitoring. Based on our previous experience, the approach of close monitoring by&#xD;
      telemonitoring, with first line intervention by the patient's general practitioner (GP) and&#xD;
      supervision by the heart failure clinic, might be the critical success factor.&#xD;
&#xD;
      Therefore, the aim of this study is to evaluate this model of telemonitoring-assisted close&#xD;
      supervision and interaction between first and second line health professionals versus a model&#xD;
      of telemonitoring without this integrated approach.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    lack of inclusions, sudden withdrawal of study coordinator&#xD;
  </why_stopped>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>Phase 2</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>overall mortality</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>number of rehospitalizations</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>time investment by HF nurses</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>appearance of renal failure (glomerular filtration rate (GFR) &lt;60 mL/min/1.73 m2)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Chronic Heart Failure</condition>
  <arm_group>
    <arm_group_label>integrated care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>telemonitoring-assisted follow-up with intensive collaboration between general practitioner and specialized Heart failure clinic.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>telemonitoring- assisted follow-up with usual care by general practitioner, without supervision of heart failure clinic</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>integrated follow-up</intervention_name>
    <description>close interaction between HF clinic and general practitioner in response to telemonitoring alerts. All subjects will be monitored daily for heart rate, blood pressure, and body weight, after which these data are transferred automatically to the general practitioner. This device is custom-made.</description>
    <arm_group_label>integrated care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>standard care</intervention_name>
    <description>no interaction between HF clinic and general practitioner in response to telemonitoring alerts. General practitioner is responsible for adaptations to therapy according to clinical presentation of the patient.</description>
    <arm_group_label>standard care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients hospitalized for decompensation of systolic heart failure&#xD;
&#xD;
          -  LVEF &lt; 40% during hospitalization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  reversible forms of acute heart failure (acute ischemia, myocarditis,..)&#xD;
&#xD;
          -  heart failure due to severe aortic stenosis&#xD;
&#xD;
          -  participation in cardiac rehabilitation after discharge&#xD;
&#xD;
          -  previous or actual residency in a nursing home&#xD;
&#xD;
          -  creatinine clearance &lt;15 ml/min&#xD;
&#xD;
          -  planned dialysis in the next 6 months&#xD;
&#xD;
          -  planned biventricular pacemaker or cardiac surgery&#xD;
&#xD;
          -  life expectancy of less than 1 year due to other diseases&#xD;
&#xD;
          -  severe obstructive pulmonary disease (Gold III)&#xD;
&#xD;
          -  significant mental or cognitive problems interfering with the daily measurements or&#xD;
             intake of medication.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>paul dendale, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jessa Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Middelheim Ziekenhuis</name>
      <address>
        <city>Antwerp</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Brussel</name>
      <address>
        <city>Brussel</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Oost-Limburg</name>
      <address>
        <city>Genk</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Maria Middelares</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jessa Hospital</name>
      <address>
        <city>Hasselt</city>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Groeninge</name>
      <address>
        <city>Kortrijk</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chr.Citadelle</name>
      <address>
        <city>Liege</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>March 29, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>April 6, 2015</last_update_submitted>
  <last_update_submitted_qc>April 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jessa Hospital</investigator_affiliation>
    <investigator_full_name>Paul Dendale</investigator_full_name>
    <investigator_title>Prof Dr</investigator_title>
  </responsible_party>
  <keyword>chronic heart failure</keyword>
  <keyword>telemonitoring</keyword>
  <keyword>first line practitioners</keyword>
  <keyword>integrated approach</keyword>
  <keyword>efficacy</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/NCT01696890
org study id: TEMAHF2
nct id: NCT01696890
lead sponsor: 
has dmc: Yes
The aim of this study is to evaluate this model of telemonitoring-assisted close supervision
      and interaction between first and second line health professionals versus a model of
      telemonitoring without this integrated approach.
The incidence of acute decompensated heart failure is increasing. Patients with severe heart
      failure are rehospitalised for decompensation several times each year, increasing the cost
      for health care. In these cases of recurrent decompensation, the medical intervention in
      hospital is often limited to increasing the dosage of diuretics or vasodilators until the
      patient reaches a compensated state. After discharge, a readmission can be expected within a
      few months. A multidisciplinary approach by primary physician, heart failure nurse,
      rehabilitation team and cardiologist has been shown to decrease rehospitalisation rate and
      increase quality of life.

      Very recently, our study group showed that an intense collaboration between first line
      practitioner and heart failure clinic, facilitated by the use of telemonitoring, can reduce
      mortality and hospitalisation rate. This study was a RIZIV sponsored trial of 6 months
      follow-up in patients with chronic heart failure. However, a large randomised multicentre
      trial investigating the use of telemonitoring in a population of heart failure (NYHA II-III)
      patients did not find any difference between telemonitoring and usual care (Chaudry et al
      NEJM 2010). In contradiction with this study, a Cochrane meta-analysis (Ingliss 2010) in more
      than 5000 patients confirmed our finding with a reduction in mortality and morbidity. The
      question therefore remains which factors are responsible for success or failure of the use of
      telemonitoring. Based on our previous experience, the approach of close monitoring by
      telemonitoring, with first line intervention by the patient's general practitioner (GP) and
      supervision by the heart failure clinic, might be the critical success factor.

      Therefore, the aim of this study is to evaluate this model of telemonitoring-assisted close
      supervision and interaction between first and second line health professionals versus a model
      of telemonitoring without this integrated approach.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: overall mortality
time frame: 6 months
measure: number of rehospitalizations
time frame: 6 months
measure: time investment by HF nurses
time frame: 6 months
measure: quality of life
time frame: 6 months
measure: appearance of renal failure (glomerular filtration rate (GFR) <60 mL/min/1.73 m2)
time frame: 6 months
arm group label: integrated care
arm group type: Active Comparator
description: telemonitoring-assisted follow-up with intensive collaboration between general practitioner and specialized Heart failure clinic.
arm group label: standard care
arm group type: Active Comparator
description: telemonitoring- assisted follow-up with usual care by general practitioner, without supervision of heart failure clinic
intervention type: Device
intervention name: integrated follow-up
description: close interaction between HF clinic and general practitioner in response to telemonitoring alerts. All subjects will be monitored daily for heart rate, blood pressure, and body weight, after which these data are transferred automatically to the general practitioner. This device is custom-made.
arm group label: integrated care
intervention type: Device
intervention name: standard care
description: no interaction between HF clinic and general practitioner in response to telemonitoring alerts. General practitioner is responsible for adaptations to therapy according to clinical presentation of the patient.
arm group label: standard care
criteria: 
gender: All
minimum age: 60 Years
maximum age: 90 Years
healthy volunteers: No
last name: paul dendale, MD, PhD
role: Principal Investigator
affiliation: Jessa Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Jessa Hospital
investigator full name: Paul Dendale
investigator title: Prof Dr
mesh term: Heart Failure