<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/NCT01662323</url>
  </required_header>
  <id_info>
    <org_study_id>TOPHU01</org_study_id>
    <nct_id>NCT01662323</nct_id>
  </id_info>
  <brief_title>Study to Improve the Treatment of Patients With Heart Failure by General Practitioners</brief_title>
  <acronym>TOPHU</acronym>
  <official_title>Therapy OPtimization Heart Failure Utrecht</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Julius Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agis Zorgverzekeringen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Julius Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether it is possible to improve the care of&#xD;
      general practitioners for patients with heart failure. The investigators try to reach that&#xD;
      goal by training the GP's for 90 minutes in uptitrating the recommended medication according&#xD;
      the guidelines. After 6 month the investigators ask the patients to fill out a questionary.&#xD;
      The investigators ask them about their quality of live.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2009</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>proportion recommended medication for patients with heart failure</measure>
    <time_frame>up to 6 months</time_frame>
    <description>the proportion patient who got at the end of the study the tree medicaments which should be prescribed to a patient with heart failure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>QoL</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Measurement of quality of live six months after uptitration of the recommended medication.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">683</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Training of the GP's, intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>General practitioners are trained to diagnose and treat heart failure according the recommendations of the NHG-standard.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controle</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>General practitioners giving care as usual to their heart failure patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>GP's treating HF according the dutch guidelines</intervention_name>
    <arm_group_label>Controle</arm_group_label>
    <arm_group_label>Training of the GP's, intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Do have a general practitioners diagnosis heart failure mentioned twice in the&#xD;
             electronical medical file.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incapacitated patients with a life expectancy of less than 2 months&#xD;
&#xD;
          -  Seniles&#xD;
&#xD;
          -  Patients who do not speak the Dutch language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>August 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>November 13, 2012</last_update_submitted>
  <last_update_submitted_qc>November 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Julius Center</investigator_affiliation>
    <investigator_full_name>Drs. Mark M J Valk</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <keyword>Heart failure, general practitioner, medical therapy, quality of live</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/NCT01662323
org study id: TOPHU01
nct id: NCT01662323
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether it is possible to improve the care of
      general practitioners for patients with heart failure. The investigators try to reach that
      goal by training the GP's for 90 minutes in uptitrating the recommended medication according
      the guidelines. After 6 month the investigators ask the patients to fill out a questionary.
      The investigators ask them about their quality of live.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: proportion recommended medication for patients with heart failure
time frame: up to 6 months
description: the proportion patient who got at the end of the study the tree medicaments which should be prescribed to a patient with heart failure.
measure: QoL
time frame: up to 1 year
description: Measurement of quality of live six months after uptitration of the recommended medication.
arm group label: Training of the GP's, intervention
arm group type: Active Comparator
description: General practitioners are trained to diagnose and treat heart failure according the recommendations of the NHG-standard.
arm group label: Controle
arm group type: Active Comparator
description: General practitioners giving care as usual to their heart failure patients.
intervention type: Behavioral
intervention name: GP's treating HF according the dutch guidelines
arm group label: Controle
arm group label: Training of the GP's, intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Julius Center
investigator full name: Drs. Mark M J Valk
investigator title: assistant professor
mesh term: Heart Failure