<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/NCT02235571</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00076067</org_study_id>
    <nct_id>NCT02235571</nct_id>
  </id_info>
  <brief_title>iChoose Decision Kidney Aid for End-Stage Renal Disease Patients</brief_title>
  <official_title>iChoose Kidney Decision Aid for Treatment Options Among End-Stage Renal Disease (ESRD) Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Satellite Healthcare</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norman S. Coplon Extramural Grant Program</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators developed iChoose Kidney -- a shared decision-making support tool&#xD;
      accessible through iPad, iPhone, or the web -- to provide ESRD patients and their providers&#xD;
      with a simple, standardized, easily accessible, statistically robust tool for use in the&#xD;
      clinic to guide patient education and healthcare decision-making about treatment options of&#xD;
      dialysis or kidney transplantation. The iChoose Kidney decision aid provides patients with&#xD;
      estimates of their individualized 1 and 3-year risks of mortality on dialysis vs.&#xD;
      transplantation, based on previous national data. The tool has the potential to improve&#xD;
      communication and decision-making between patients and their healthcare providers and improve&#xD;
      access to kidney transplantation among patients with ESRD.&#xD;
&#xD;
      This will be a two-arm, randomized study, and will be conducted at 3 large transplant centers&#xD;
      with diverse patient populations. One group of patients will receive standard education alone&#xD;
      during their scheduled transplant evaluation. The second group will receive the standard&#xD;
      education as well have the provider use the iChoose Kidney aid with them. The project&#xD;
      timeline will be a total of 24 months inclusive of enrollment, follow-up, data analysis, and&#xD;
      outcome evaluation.&#xD;
&#xD;
      This study will assess how well the iChoose decision aid works in improving patient&#xD;
      knowledge, preferences for treatment, and patient access to transplant. The study will also&#xD;
      assess whether providers find the tool useful for providing ways to share information with&#xD;
      patients about ways to treat their kidney disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effectiveness of the iChoose Kidney intervention to improve knowledge and shared decision-making between patients and physicians regarding ESRD treatment options.</measure>
    <time_frame>Up to 19 months</time_frame>
    <description>Patient knowledge of the survival benefit of transplant and the patient's individualized mortality risk</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient access to transplant</measure>
    <time_frame>Up to 19 months</time_frame>
    <description>Evaluation completion, waitlisting, transplant</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient treatment preferences</measure>
    <time_frame>Up to 19 months</time_frame>
    <description>Patient preference for transplant vs. dialysis</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">470</enrollment>
  <condition>End-Stage Kidney Disease</condition>
  <condition>Kidney Failure, Chronic</condition>
  <condition>Kidney Transplantation</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>These subjects are receiving standard patient education</description>
  </arm_group>
  <arm_group>
    <arm_group_label>iChoose Kidney Decision Aid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>These subjects receive iChoose Kidney Decision Aid along with standard patient education</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>iChoose Kidney Decision Aid</intervention_name>
    <description>Providers will use a shared decision making tool with patients via iPhone, iPad, or web which explains predicted individualized risk of mortality on dialysis vs. transplant during the evaluation appointment for kidney transplant.</description>
    <arm_group_label>iChoose Kidney Decision Aid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of end-stage renal disease (ESRD) and on dialysis for &lt; 1 year&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Subjects coming in for transplant medical evaluation&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cognitive or visual impairment&#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>Rachel Patzer, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory Transplant Center</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University (Kovler Transplant Center)</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 6, 2014</study_first_submitted>
  <study_first_submitted_qc>September 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>October 5, 2017</last_update_submitted>
  <last_update_submitted_qc>October 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Rachel Patzer, PhD</investigator_full_name>
    <investigator_title>Assistant Professor</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>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Renal Insufficiency</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/NCT02235571
org study id: IRB00076067
nct id: NCT02235571
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The investigators developed iChoose Kidney -- a shared decision-making support tool
      accessible through iPad, iPhone, or the web -- to provide ESRD patients and their providers
      with a simple, standardized, easily accessible, statistically robust tool for use in the
      clinic to guide patient education and healthcare decision-making about treatment options of
      dialysis or kidney transplantation. The iChoose Kidney decision aid provides patients with
      estimates of their individualized 1 and 3-year risks of mortality on dialysis vs.
      transplantation, based on previous national data. The tool has the potential to improve
      communication and decision-making between patients and their healthcare providers and improve
      access to kidney transplantation among patients with ESRD.

      This will be a two-arm, randomized study, and will be conducted at 3 large transplant centers
      with diverse patient populations. One group of patients will receive standard education alone
      during their scheduled transplant evaluation. The second group will receive the standard
      education as well have the provider use the iChoose Kidney aid with them. The project
      timeline will be a total of 24 months inclusive of enrollment, follow-up, data analysis, and
      outcome evaluation.

      This study will assess how well the iChoose decision aid works in improving patient
      knowledge, preferences for treatment, and patient access to transplant. The study will also
      assess whether providers find the tool useful for providing ways to share information with
      patients about ways to treat their kidney disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effectiveness of the iChoose Kidney intervention to improve knowledge and shared decision-making between patients and physicians regarding ESRD treatment options.
time frame: Up to 19 months
description: Patient knowledge of the survival benefit of transplant and the patient's individualized mortality risk
measure: Patient access to transplant
time frame: Up to 19 months
description: Evaluation completion, waitlisting, transplant
measure: Patient treatment preferences
time frame: Up to 19 months
description: Patient preference for transplant vs. dialysis
arm group label: Control
arm group type: No Intervention
description: These subjects are receiving standard patient education
arm group label: iChoose Kidney Decision Aid
arm group type: Experimental
description: These subjects receive iChoose Kidney Decision Aid along with standard patient education
intervention type: Behavioral
intervention name: iChoose Kidney Decision Aid
description: Providers will use a shared decision making tool with patients via iPhone, iPad, or web which explains predicted individualized risk of mortality on dialysis vs. transplant during the evaluation appointment for kidney transplant.
arm group label: iChoose Kidney Decision Aid
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rachel Patzer, PhD, MPH
role: Principal Investigator
affiliation: Emory University
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Rachel Patzer, PhD
investigator title: Assistant Professor
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
mesh term: Renal Insufficiency