<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/NCT02251899</url>
  </required_header>
  <id_info>
    <org_study_id>HN-AHS-HS-2</org_study_id>
    <nct_id>NCT02251899</nct_id>
  </id_info>
  <brief_title>A Disease Management Study Targeted to Reduce Health Care Utilization for Patients With Congestive Heart Failure</brief_title>
  <official_title>A Disease Management Study Targeted to Reduce Health Care Utilization for Patients With Congestive Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Health Navigator</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Region Stockholm</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ostergotland County Council, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vastra Gotaland Region</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Uppsala County Council, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Health Navigator</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine whether a nurse-managed telephone-based&#xD;
      disease-management intervention can reduce healthcare utilization and improve self-assessed&#xD;
      health status in patients with congestive heart failure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2010</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>Phase 3</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>Number of hospitalizations</measure>
    <time_frame>From randomization for up to 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of outpatient visits to medical doctor</measure>
    <time_frame>From randomization for up to 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>From randomization for up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stays</measure>
    <time_frame>From randomization for up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total health care cost</measure>
    <time_frame>From randomization for up to 2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>The Focus is to Investigate Effects of a Disease Management Intervention for Patients With Congestive Heart Failure</condition>
  <arm_group>
    <arm_group_label>Disease-Management intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Behavioral: Disease-Management intervention The participants in the intervention group receive a nurse-managed disease-management intervention that is regularly delivered by telephone or, when necessary, in person</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Intervention: Control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group not receiving any in</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Disease-Management intervention</intervention_name>
    <description>The participants in the intervention group receive a nurse-managed disease-management intervention that is regularly delivered by telephone or, when necessary, in person</description>
    <arm_group_label>Disease-Management intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with ≥1 unplanned inpatient occasion with primary diagnosis of heart failure&#xD;
             ( I50) during the last 12 months&#xD;
&#xD;
          -  Heart failure grade NYHA II- III&#xD;
&#xD;
          -  Accurate heart failure diagnosis&#xD;
&#xD;
          -  Living in one of four Swedish counties where the trial is ongoing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Deceased&#xD;
&#xD;
          -  In a moribund state&#xD;
&#xD;
          -  Significant cognitive loss and therefore cannot provide consent&#xD;
&#xD;
          -  Psychosis diagnosis&#xD;
&#xD;
          -  Severe hearing impairment&#xD;
&#xD;
          -  Language difficulties&#xD;
&#xD;
          -  Participants in another study&#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>Gustaf Edgren</last_name>
    <role>Principal Investigator</role>
    <affiliation>gustaf@pheph.se</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gustaf Edgren</last_name>
    <email>gustaf@pheph.se</email>
  </overall_contact>
  <location>
    <facility>
      <name>Stockholms Läns Landsting</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gustaf Edgren, MD PhD</last_name>
      <phone>+46708186862</phone>
      <email>gustaf@pheph.se</email>
    </contact>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <results_reference>
    <citation>Reinius P, Johansson M, Fjellner A, Werr J, Ohlen G, Edgren G. A telephone-based case-management intervention reduces healthcare utilization for frequent emergency department visitors. Eur J Emerg Med. 2013 Oct;20(5):327-34. doi: 10.1097/MEJ.0b013e328358bf5a.</citation>
    <PMID>22960802</PMID>
  </results_reference>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>March 26, 2015</last_update_submitted>
  <last_update_submitted_qc>March 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02251899
org study id: HN-AHS-HS-2
nct id: NCT02251899
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The aim of this study is to determine whether a nurse-managed telephone-based
      disease-management intervention can reduce healthcare utilization and improve self-assessed
      health status in patients with congestive heart failure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of hospitalizations
time frame: From randomization for up to 2 years
measure: Number of outpatient visits to medical doctor
time frame: From randomization for up to 2 years
measure: Mortality
time frame: From randomization for up to 2 years
measure: Length of hospital stays
time frame: From randomization for up to 2 years
measure: Total health care cost
time frame: From randomization for up to 2 years
arm group label: Disease-Management intervention
arm group type: Experimental
description: Behavioral: Disease-Management intervention The participants in the intervention group receive a nurse-managed disease-management intervention that is regularly delivered by telephone or, when necessary, in person
arm group label: No Intervention: Control arm
arm group type: No Intervention
description: Control group not receiving any in
intervention type: Behavioral
intervention name: Disease-Management intervention
description: The participants in the intervention group receive a nurse-managed disease-management intervention that is regularly delivered by telephone or, when necessary, in person
arm group label: Disease-Management intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gustaf Edgren
role: Principal Investigator
affiliation: gustaf@pheph.se
last name: Gustaf Edgren
email: gustaf@pheph.se
facility: 
status: Recruiting
contact: 
country: Sweden
citation: Reinius P, Johansson M, Fjellner A, Werr J, Ohlen G, Edgren G. A telephone-based case-management intervention reduces healthcare utilization for frequent emergency department visitors. Eur J Emerg Med. 2013 Oct;20(5):327-34. doi: 10.1097/MEJ.0b013e328358bf5a.
PMID: 22960802
responsible party type: Sponsor
mesh term: Heart Failure