<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/NCT03819686</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00098952</org_study_id>
    <secondary_id>R01DK114891</secondary_id>
    <nct_id>NCT03819686</nct_id>
  </id_info>
  <brief_title>Reducing Disparities in Living Donor Transplant Among African Americans</brief_title>
  <official_title>Reducing Disparities in Living Donor Transplant Among African Americans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</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>
      For most of the patients in the United States with end stage renal disease (ESRD), kidney&#xD;
      transplantation represents the optimal treatment, and living donor kidney transplantation&#xD;
      (LDKT) is preferable. Nevertheless, there are pervasive racial disparities in access to LDKT.&#xD;
      The main outcome of this study is change in the proportion of study participants who have at&#xD;
      least one living donor inquiry by friends/family over study period.The long-term objective is&#xD;
      to understand the combined effect of a systems-level intervention (Transplant Referral&#xD;
      EXchange or T-REX) and a culturally-sensitive individual-level educational intervention&#xD;
      (web-based Living ACTS: About Choices in Transplantation and Sharing) on racial disparities&#xD;
      in access to LDKT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For most of the patients in the United States with end stage renal disease (ESRD), kidney&#xD;
      transplantation represents the optimal treatment. Moreover, living donor kidney&#xD;
      transplantation (LDKT) offers numerous advantages such as better kidney quality, increased&#xD;
      short- and long-term graft survival, lower rates of acute rejection, and reduced health care&#xD;
      cost. Nevertheless, there are pervasive racial disparities in access to LDKT, with white ESRD&#xD;
      patients four times more likely to receive a LDKT than African American ESRD patients. The&#xD;
      main outcome of this study is change in the proportion of study participants who have at&#xD;
      least one living donor inquiry by friends/family over 12 months from baseline.The long-term&#xD;
      objective is to understand the combined effect of a systems-level intervention that enhances&#xD;
      communication between dialysis facility and transplant center clinicians (Transplant Referral&#xD;
      EXchange or T-REX) and a culturally-sensitive individual-level educational intervention&#xD;
      (web-based Living ACTS: About Choices in Transplantation and Sharing) on racial disparities&#xD;
      in access to LDKT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Anticipated">January 26, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 26, 2024</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in percent of patients with at least one inquiry from a potential living donor</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Data collection form that captures potential recipient ID (i.e. study participant), date of living donor inquiry, and donor inquiry ID, will be securely obtained from each transplant center following a 12 month period from enrollment. Data will be collected electronically for all study participants through a secure, HIPAA-compliant data server (QualityNet). The percent of patients with at least one inquiry from a potential living donor among patients who receive Living ACTS will be compared to those who receive a control website with embedded educational video.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in knowledge and understanding of donation/transplantation assessment score</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Scale includes 13 true/False questions, score ranges from 0 to 13, 0 Min-12 Maximum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in motivation scale score to ask a family member to be a living donor</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>9-item scale assesses motivation to ask a family member to be a living donor. Potential responses range from 1 to 5 with higher values indicate stronger agreement with the statement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in confidence in initiating a conversation about LDKT</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>10-item behavioral skills scale measures confidence in initiating a conversation about LDKT. Potential responses range from 1 to 5 with higher values indicate stronger confidence.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Comprehensive and final list of website modifications.</measure>
    <time_frame>12 months post-baseline</time_frame>
    <description>A series of individual interviews with participants will be conducted to obtain feedback on the web-based version of Living ACTS. All facilitators will meet to compare findings and to compose a comprehensive and final list of website modifications. Participant feedback will be used to refine and finalize the web-based intervention.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in intention to discuss LDKT with family members</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>1-item behavioral intentions scale measures intention to discuss LDKT with family members, score ranges 1-5 (1-extremely unlikely, 5 - extremely likely)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">416</enrollment>
  <condition>Kidney Transplant</condition>
  <arm_group>
    <arm_group_label>Living ACTS website</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to the provision of standard transplant education procedures, a patient will watch the Living ACTS video (embedded in the Living ACTS website) along with any family members or friends who are accompanying a patient. Plus minimum of 5 minutes navigating the website (aside from watching the 20-minute video).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard transplant education procedures</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Usual Care, which involves the provision of standard transplant education procedures at each transplant center, which entail reviewing a packet of information with the pre-transplant coordinator. The packet serves to inform transplant candidates and their families about the option living donor kidney transplantation (LDKT). In addition, participants will be provided an iPad/tablet to watch two 10-minute National Kidney Foundation videos about kidney disease and transplantation in their private room during their regularly scheduled KT evaluation. This video discusses information about transplant, but does not specifically address LDKT and is not culturally-sensitive to African American population.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Living ACTS website</intervention_name>
    <description>Living ACTS: About Choices in Transplantation and Sharing video that draws from the Information-Motivation-Behavioral Skills Model of individual level behavior change. A patient will watch the Living ACTS video (embedded in the Living ACTS website) along with any family members or friends who are accompanying a patient. Plus minimum of 5 minutes navigating the website (aside from watching ~20-minutes of videos from the website)</description>
    <arm_group_label>Living ACTS website</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard transplant education procedures</intervention_name>
    <description>Review of a packet of information with the pre-transplant coordinator. The packet serves to inform transplant candidates and their families about the option living donor kidney transplantation (LDKT). In addition, participants will be provided an iPad/tablet to watch two ~10-minute National Kidney Foundation videos about kidney disease and transplantation in their private room during their regularly scheduled KT evaluation. This video discusses information about transplant, but does not specifically address LDKT and is not culturally-sensitive to African American population.</description>
    <arm_group_label>Living ACTS website</arm_group_label>
    <arm_group_label>Standard transplant education procedures</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients referred (from dialysis facility, chronic kidney disease clinic, or self)&#xD;
             and scheduled for an evaluation at one of the four study sites within the study time&#xD;
             period.&#xD;
&#xD;
          -  African American or Black&#xD;
&#xD;
          -  age 18 to 70 years&#xD;
&#xD;
          -  BMI &lt; 39&#xD;
&#xD;
          -  English-speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachel Patzer, PhD, MPH, FAST</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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>April 27, 2023</last_update_submitted>
  <last_update_submitted_qc>April 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Rachel Patzer</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>end stage renal disease</keyword>
  <keyword>ESRD</keyword>
  <keyword>living donor kidney transplantation</keyword>
  <keyword>LDKT</keyword>
  <keyword>African American</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 23, 2023</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT03819686/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03819686
org study id: IRB00098952
secondary id: R01DK114891
nct id: NCT03819686
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
For most of the patients in the United States with end stage renal disease (ESRD), kidney
      transplantation represents the optimal treatment, and living donor kidney transplantation
      (LDKT) is preferable. Nevertheless, there are pervasive racial disparities in access to LDKT.
      The main outcome of this study is change in the proportion of study participants who have at
      least one living donor inquiry by friends/family over study period.The long-term objective is
      to understand the combined effect of a systems-level intervention (Transplant Referral
      EXchange or T-REX) and a culturally-sensitive individual-level educational intervention
      (web-based Living ACTS: About Choices in Transplantation and Sharing) on racial disparities
      in access to LDKT.
For most of the patients in the United States with end stage renal disease (ESRD), kidney
      transplantation represents the optimal treatment. Moreover, living donor kidney
      transplantation (LDKT) offers numerous advantages such as better kidney quality, increased
      short- and long-term graft survival, lower rates of acute rejection, and reduced health care
      cost. Nevertheless, there are pervasive racial disparities in access to LDKT, with white ESRD
      patients four times more likely to receive a LDKT than African American ESRD patients. The
      main outcome of this study is change in the proportion of study participants who have at
      least one living donor inquiry by friends/family over 12 months from baseline.The long-term
      objective is to understand the combined effect of a systems-level intervention that enhances
      communication between dialysis facility and transplant center clinicians (Transplant Referral
      EXchange or T-REX) and a culturally-sensitive individual-level educational intervention
      (web-based Living ACTS: About Choices in Transplantation and Sharing) on racial disparities
      in access to LDKT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in percent of patients with at least one inquiry from a potential living donor
time frame: Baseline, 12 months
description: Data collection form that captures potential recipient ID (i.e. study participant), date of living donor inquiry, and donor inquiry ID, will be securely obtained from each transplant center following a 12 month period from enrollment. Data will be collected electronically for all study participants through a secure, HIPAA-compliant data server (QualityNet). The percent of patients with at least one inquiry from a potential living donor among patients who receive Living ACTS will be compared to those who receive a control website with embedded educational video.
measure: Change in knowledge and understanding of donation/transplantation assessment score
time frame: Baseline, 12 months
description: Scale includes 13 true/False questions, score ranges from 0 to 13, 0 Min-12 Maximum
measure: Change in motivation scale score to ask a family member to be a living donor
time frame: Baseline, 12 months
description: 9-item scale assesses motivation to ask a family member to be a living donor. Potential responses range from 1 to 5 with higher values indicate stronger agreement with the statement.
measure: Change in confidence in initiating a conversation about LDKT
time frame: Baseline, 12 months
description: 10-item behavioral skills scale measures confidence in initiating a conversation about LDKT. Potential responses range from 1 to 5 with higher values indicate stronger confidence.
measure: Comprehensive and final list of website modifications.
time frame: 12 months post-baseline
description: A series of individual interviews with participants will be conducted to obtain feedback on the web-based version of Living ACTS. All facilitators will meet to compare findings and to compose a comprehensive and final list of website modifications. Participant feedback will be used to refine and finalize the web-based intervention.
measure: Change in intention to discuss LDKT with family members
time frame: Baseline, 12 months
description: 1-item behavioral intentions scale measures intention to discuss LDKT with family members, score ranges 1-5 (1-extremely unlikely, 5 - extremely likely)
arm group label: Living ACTS website
arm group type: Experimental
description: In addition to the provision of standard transplant education procedures, a patient will watch the Living ACTS video (embedded in the Living ACTS website) along with any family members or friends who are accompanying a patient. Plus minimum of 5 minutes navigating the website (aside from watching the 20-minute video).
arm group label: Standard transplant education procedures
arm group type: Other
description: Usual Care, which involves the provision of standard transplant education procedures at each transplant center, which entail reviewing a packet of information with the pre-transplant coordinator. The packet serves to inform transplant candidates and their families about the option living donor kidney transplantation (LDKT). In addition, participants will be provided an iPad/tablet to watch two 10-minute National Kidney Foundation videos about kidney disease and transplantation in their private room during their regularly scheduled KT evaluation. This video discusses information about transplant, but does not specifically address LDKT and is not culturally-sensitive to African American population.
intervention type: Behavioral
intervention name: Living ACTS website
description: Living ACTS: About Choices in Transplantation and Sharing video that draws from the Information-Motivation-Behavioral Skills Model of individual level behavior change. A patient will watch the Living ACTS video (embedded in the Living ACTS website) along with any family members or friends who are accompanying a patient. Plus minimum of 5 minutes navigating the website (aside from watching ~20-minutes of videos from the website)
arm group label: Living ACTS website
intervention type: Behavioral
intervention name: Standard transplant education procedures
description: Review of a packet of information with the pre-transplant coordinator. The packet serves to inform transplant candidates and their families about the option living donor kidney transplantation (LDKT). In addition, participants will be provided an iPad/tablet to watch two ~10-minute National Kidney Foundation videos about kidney disease and transplantation in their private room during their regularly scheduled KT evaluation. This video discusses information about transplant, but does not specifically address LDKT and is not culturally-sensitive to African American population.
arm group label: Living ACTS website
arm group label: Standard transplant education procedures
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Rachel Patzer, PhD, MPH, FAST
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Rachel Patzer
investigator title: Principal Investigator
sharing ipd: No
provided document: 