<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/NCT03229811</url>
  </required_header>
  <id_info>
    <org_study_id>831500</org_study_id>
    <nct_id>NCT03229811</nct_id>
  </id_info>
  <brief_title>Integrating Conservative Kidney Management Options and Advance Care Planning Into a Pre-Dialysis Educational Program</brief_title>
  <official_title>Integrating Conservative Kidney Management Options and Advance Care Planning Into a Pre-Dialysis Educational Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goals of this work will be to evaluate the preliminary efficacy of a comprehensive&#xD;
      pre-dialysis education program on increased knowledge of conservative kidney management and&#xD;
      advance care planning among patients with advanced CKD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This intervention will be randomized among patients with advanced chronic kidney disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The PI left academic practice&#xD;
  </why_stopped>
  <start_date type="Actual">October 24, 2021</start_date>
  <completion_date type="Actual">December 14, 2021</completion_date>
  <primary_completion_date type="Actual">December 14, 2021</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>
    <intervention_model_description>Comprehensive pre-dialysis program incorporating conservative and advance care planning education</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knowledge of conservative kidney management and advance care planning</measure>
    <time_frame>Baseline and Day 1 post-intervention</time_frame>
    <description>Change in knowledge of conservative kidney management and advance care planning (mean score)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Communication of EOL preferences with healthcare providers and family members</measure>
    <time_frame>12 weeks post-intervention</time_frame>
    <description>Binary outcome (yes/no)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Completion of healthcare proxy forms, living wills, and POLST forms</measure>
    <time_frame>Day 1 post intervention and 12 weeks post-intervention</time_frame>
    <description>Binary outcome (yes/no)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Advance Care Planning</condition>
  <condition>Chronic Kidney Diseases</condition>
  <condition>Conservative Kidney Management</condition>
  <arm_group>
    <arm_group_label>Standard pre-dialysis education</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard pre-dialysis options education including hemodialysis, peritoneal dialysis, and kidney transplantation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ESRD education + ACP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard ESRD education + conservative kidney management and advance care planning education</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ESRD education + conservative kidney management and ACP education</intervention_name>
    <description>Targeted conservative kidney management and advance care planning education delivered in person by trained healthcare providers</description>
    <arm_group_label>ESRD education + ACP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stage 4 or 5 CKD (defined by the CKD-EPI estimation of GFR &lt; 30 ml/min/1.73m2)&#xD;
&#xD;
          -  Age 65 years or greater or frail&#xD;
&#xD;
          -  self-reported Black or White race&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of dementia&#xD;
&#xD;
          -  History of legal blindness&#xD;
&#xD;
          -  Listed for kidney transplantation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>October 6, 2022</last_update_submitted>
  <last_update_submitted_qc>October 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
    <investigator_full_name>Nwamaka Eneanya, MD, MPH</investigator_full_name>
    <investigator_title>Attending Nephrologist</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>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>November 8, 2022</submitted>
    <returned>September 15, 2023</returned>
  </pending_results>
  <!-- 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/NCT03229811
org study id: 831500
nct id: NCT03229811
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The goals of this work will be to evaluate the preliminary efficacy of a comprehensive
      pre-dialysis education program on increased knowledge of conservative kidney management and
      advance care planning among patients with advanced CKD.
This intervention will be randomized among patients with advanced chronic kidney disease.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Comprehensive pre-dialysis program incorporating conservative and advance care planning education
primary purpose: Health Services Research
masking: Single (Investigator)
measure: Knowledge of conservative kidney management and advance care planning
time frame: Baseline and Day 1 post-intervention
description: Change in knowledge of conservative kidney management and advance care planning (mean score)
measure: Communication of EOL preferences with healthcare providers and family members
time frame: 12 weeks post-intervention
description: Binary outcome (yes/no)
measure: Completion of healthcare proxy forms, living wills, and POLST forms
time frame: Day 1 post intervention and 12 weeks post-intervention
description: Binary outcome (yes/no)
arm group label: Standard pre-dialysis education
arm group type: No Intervention
description: Standard pre-dialysis options education including hemodialysis, peritoneal dialysis, and kidney transplantation
arm group label: ESRD education + ACP
arm group type: Active Comparator
description: Standard ESRD education + conservative kidney management and advance care planning education
intervention type: Other
intervention name: ESRD education + conservative kidney management and ACP education
description: Targeted conservative kidney management and advance care planning education delivered in person by trained healthcare providers
arm group label: ESRD education + ACP
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: Nwamaka Eneanya, MD, MPH
investigator title: Attending Nephrologist
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: No
submitted: November 8, 2022
returned: September 15, 2023