<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/NCT03009084</url>
  </required_header>
  <id_info>
    <org_study_id>S57777</org_study_id>
    <nct_id>NCT03009084</nct_id>
  </id_info>
  <brief_title>Multidisciplinary Care for Patients With Chronic Kidney Disease to Increase Their Self-management.</brief_title>
  <official_title>Nephrocare: Multidisciplinary Care for Patients With Chronic Kidney Disease: an Increase of Patient Empowerment and Self-management by Using Interactive and Communication Tools and Nursing Interventions.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the communication and data sharing between the&#xD;
      primary care physician and the nephrologist about patients with chronic kidney disease. Also&#xD;
      therapeutic interventions that change behavior and telemonitoring of the blood pressure will&#xD;
      be explored and compared to the usual care. The most important aim of this study is to&#xD;
      improve the quality of care for the patient with chronic kidney disease in cooperation with&#xD;
      the primary care physician and the nephrologist.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Through questionnaires with primary care physicians, nephrologists from the University&#xD;
      Hospitals of Leuven and patients with chronic kidney disease, the problems will be known.&#xD;
&#xD;
      After the exploration there will be an intervention with patients who meet the in- and&#xD;
      exclusion criteria. Around 150-200 patients will be included with a 1:2 randomisation in the&#xD;
      control and intervention group. The relevant clinical data and the factors of lifestyle will&#xD;
      be questioned at the baseline.&#xD;
&#xD;
      The intervention group will receive individualized therapy by a nurse, for example to quit&#xD;
      smoking, to eat healthier and to do more physical activities. This therapy is based on the&#xD;
      most important risk factors and will be determined before the start of the therapy. Further&#xD;
      on, these patients will also be motivated to take their blood pressure more frequently by&#xD;
      using a telemonitoring system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 17, 2015</start_date>
  <completion_date type="Actual">March 31, 2017</completion_date>
  <primary_completion_date type="Actual">March 31, 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BMI change</measure>
    <time_frame>one year</time_frame>
    <description>BMI change in kg/m²</description>
  </primary_outcome>
  <primary_outcome>
    <measure>smoking cessation</measure>
    <time_frame>one year</time_frame>
    <description>percentage of smoking cessation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in Estimated Glomerular Filtration Rate (eGFR)</measure>
    <time_frame>one year</time_frame>
    <description>Estimated Glomerular Filtration Rate (eGFR) in mL/min/1.73m²</description>
  </primary_outcome>
  <primary_outcome>
    <measure>lipid control</measure>
    <time_frame>one year</time_frame>
    <description>LDL in mmol/l</description>
  </primary_outcome>
  <primary_outcome>
    <measure>blood pressure under control</measure>
    <time_frame>one year</time_frame>
    <description>percentage of patients with blood pressure within target limits</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Communication between primary care physicians and the nephrologists.</measure>
    <time_frame>6 months</time_frame>
    <description>Improved communication between primary care physicians and nephrologists measured by a questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relevant clinical data: systolic and diastolic blood pressure</measure>
    <time_frame>one year</time_frame>
    <description>Improved or stable clinical data that are taken at the consultation of nephrology (systolic and diastolic blood pressure).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Chronic Kidney Diseases</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lifestyle counseling of modifiable risk factors of chronic kidney disease: telemonitoring of blood pressure, counseling for smoking cessation, losing weight and increasing the physical activity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle counseling</intervention_name>
    <description>Lifestyle counseling of modifiable risk factors of chronic kidney disease: telemonitoring of blood pressure, counseling for smoking cessation, losing weight and increasing the physical activity.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Predialysis, hemodialysis, peritoneal dialysis, transplantation&#xD;
&#xD;
          -  Included in the care program of chronic kidney diseases&#xD;
&#xD;
          -  Dutch-speaking&#xD;
&#xD;
          -  Signed and approved informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No Dutch-speaking&#xD;
&#xD;
          -  Impaired cognitive condition or medically unstable&#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>Kathleen Claes, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitaire Ziekenhuizen KU Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospitals Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>April 11, 2015</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>October 13, 2018</last_update_submitted>
  <last_update_submitted_qc>October 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitaire Ziekenhuizen KU Leuven</investigator_affiliation>
    <investigator_full_name>Kathleen Claes</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03009084
org study id: S57777
nct id: NCT03009084
lead sponsor: 
has dmc: Yes
The purpose of this study is to investigate the communication and data sharing between the
      primary care physician and the nephrologist about patients with chronic kidney disease. Also
      therapeutic interventions that change behavior and telemonitoring of the blood pressure will
      be explored and compared to the usual care. The most important aim of this study is to
      improve the quality of care for the patient with chronic kidney disease in cooperation with
      the primary care physician and the nephrologist.
Through questionnaires with primary care physicians, nephrologists from the University
      Hospitals of Leuven and patients with chronic kidney disease, the problems will be known.

      After the exploration there will be an intervention with patients who meet the in- and
      exclusion criteria. Around 150-200 patients will be included with a 1:2 randomisation in the
      control and intervention group. The relevant clinical data and the factors of lifestyle will
      be questioned at the baseline.

      The intervention group will receive individualized therapy by a nurse, for example to quit
      smoking, to eat healthier and to do more physical activities. This therapy is based on the
      most important risk factors and will be determined before the start of the therapy. Further
      on, these patients will also be motivated to take their blood pressure more frequently by
      using a telemonitoring system.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: BMI change
time frame: one year
description: BMI change in kg/m²
measure: smoking cessation
time frame: one year
description: percentage of smoking cessation.
measure: change in Estimated Glomerular Filtration Rate (eGFR)
time frame: one year
description: Estimated Glomerular Filtration Rate (eGFR) in mL/min/1.73m²
measure: lipid control
time frame: one year
description: LDL in mmol/l
measure: blood pressure under control
time frame: one year
description: percentage of patients with blood pressure within target limits
measure: Communication between primary care physicians and the nephrologists.
time frame: 6 months
description: Improved communication between primary care physicians and nephrologists measured by a questionnaire.
measure: Relevant clinical data: systolic and diastolic blood pressure
time frame: one year
description: Improved or stable clinical data that are taken at the consultation of nephrology (systolic and diastolic blood pressure).
arm group label: Intervention group
arm group type: Experimental
description: Lifestyle counseling of modifiable risk factors of chronic kidney disease: telemonitoring of blood pressure, counseling for smoking cessation, losing weight and increasing the physical activity.
arm group label: Control group
arm group type: No Intervention
description: Usual care.
intervention type: Behavioral
intervention name: Lifestyle counseling
description: Lifestyle counseling of modifiable risk factors of chronic kidney disease: telemonitoring of blood pressure, counseling for smoking cessation, losing weight and increasing the physical activity.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kathleen Claes, Prof. Dr.
role: Principal Investigator
affiliation: Universitaire Ziekenhuizen KU Leuven
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Universitaire Ziekenhuizen KU Leuven
investigator full name: Kathleen Claes
investigator title: Prof. Dr.
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: Undecided