<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/NCT03803423</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00146922</org_study_id>
    <nct_id>NCT03803423</nct_id>
  </id_info>
  <brief_title>Dissemination of the Donor Application: Utilizing Social Media to Identify Potential Live Organ Donors</brief_title>
  <official_title>Dissemination of the Donor Application: Utilizing Social Media to Identify Potential Live Organ Donors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MaineHealth</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Scripps Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</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>
      This study utilizes a web-based application to help patients on the organ transplant waitlist&#xD;
      communicate patient's need for a living donor via social media and provide interested&#xD;
      potential donors the opportunity to engage with the evaluation process.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Barriers to identifying a live donor include lack of education and hesitance to initiate a&#xD;
      conversation about live donation. For these reasons, many transplant candidates are hesitant&#xD;
      to discuss candidate's illness and are therefore reluctant to pursue live donor&#xD;
      transplantation. The investigators hypothesize that utilization of social media to spread&#xD;
      awareness about candidate's illness and candidate's need for a live donor will enable many&#xD;
      transplant candidates to successfully identify live donors. In this study, participants will&#xD;
      use a novel web-based application, called the &quot;Donor App&quot;, to create and share candidate's&#xD;
      story via Facebook and other social networks to assist in the search for a live donor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 27, 2017</start_date>
  <completion_date type="Anticipated">November 27, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 27, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>All participants will be invited to use the Donor App.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Potential donors identified</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Number of potential live donors that come forward to the transplant center on behalf of the participant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Live donor transplantation</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Number of participants that receive a live donor transplant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>App utilization as assessed by number of participants with story completion and posting in the donor app</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>The extent of a participants story completion and posting will be recorded internally by the Donor App. The number of participants that complete stories and post will be counted to assess app utilization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Donor App Implementation</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Success of the Donor App across multiple institutions will be tracked by the number of participants enrolled and invited to use the app at each institution.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>End Stage Renal Disease</condition>
  <condition>End Stage Liver Disease</condition>
  <arm_group>
    <arm_group_label>The Donor App</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Select physicians and research staff from about 15 transplant hospitals will be given access to distribute the application to patients who the above people feel could benefit from the application. After obtaining informed consent, an approved member of the study team will enter the participant's name, contact info, and organ needed into the Donor App's secure management portal to send an email or text message with a unique and protected invitation link to the participant. Using this link the participant will be allowed to use the Donor App indefinitely.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The Donor App</intervention_name>
    <description>The Donor app is a web-based application that helps transplant candidates tell the candidate's story via social media in the hopes of identifying an appropriate living donor. Sample stories created using the Donor App can be found at www.thedonorapp.com.</description>
    <arm_group_label>The Donor App</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  On the kidney-only or liver-only transplant waiting list at a collaborating center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 18 years of age&#xD;
&#xD;
          -  Not on the kidney or liver transplant waiting list&#xD;
&#xD;
          -  On multiple organ transplant waiting lists&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Cameron, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andrew Cameron, MD PhD</last_name>
    <phone>4432870134</phone>
    <email>donorapp@jhu.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Scripps Green Hospital</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Enrolling by invitation</status>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Enrolling by invitation</status>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Sherri Loeb, BSN</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Maine Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Maine</state>
        <zip>04102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Enrolling by invitation</status>
  </location>
  <location>
    <facility>
      <name>The Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21218</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrew Cameron, MD PhD</last_name>
      <phone>443-287-0134</phone>
      <email>donorapp@jhu.edu</email>
    </contact>
    <investigator>
      <last_name>Andrew Cameron, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Washington University in St. Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Enrolling by invitation</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.thedonorapp.com/</url>
    <description>The Donor App Homepage</description>
  </link>
  <reference>
    <citation>Kumar K, King EA, Muzaale AD, Konel JM, Bramstedt KA, Massie AB, Segev DL, Cameron AM. A Smartphone App for Increasing Live Organ Donation. Am J Transplant. 2016 Dec;16(12):3548-3553. doi: 10.1111/ajt.13961. Epub 2016 Aug 10.</citation>
    <PMID>27402293</PMID>
  </reference>
  <reference>
    <citation>Bramstedt KA, Cameron AM. Beyond the Billboard: The Facebook-Based Application, Donor, and Its Guided Approach to Facilitating Living Organ Donation. Am J Transplant. 2017 Feb;17(2):336-340. doi: 10.1111/ajt.14004. Epub 2016 Sep 7.</citation>
    <PMID>27501516</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>November 15, 2022</last_update_submitted>
  <last_update_submitted_qc>November 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Live Donor Transplant</keyword>
  <keyword>Social Media</keyword>
  <keyword>Advocacy</keyword>
  <keyword>Education</keyword>
  <keyword>Living Donation</keyword>
  <keyword>The Donor App</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>End Stage Liver Disease</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03803423
org study id: IRB00146922
nct id: NCT03803423
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study utilizes a web-based application to help patients on the organ transplant waitlist
      communicate patient's need for a living donor via social media and provide interested
      potential donors the opportunity to engage with the evaluation process.
Barriers to identifying a live donor include lack of education and hesitance to initiate a
      conversation about live donation. For these reasons, many transplant candidates are hesitant
      to discuss candidate's illness and are therefore reluctant to pursue live donor
      transplantation. The investigators hypothesize that utilization of social media to spread
      awareness about candidate's illness and candidate's need for a live donor will enable many
      transplant candidates to successfully identify live donors. In this study, participants will
      use a novel web-based application, called the "Donor App", to create and share candidate's
      story via Facebook and other social networks to assist in the search for a live donor.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All participants will be invited to use the Donor App.
primary purpose: Other
masking: None (Open Label)
measure: Potential donors identified
time frame: Up to 5 years
description: Number of potential live donors that come forward to the transplant center on behalf of the participant.
measure: Live donor transplantation
time frame: Up to 5 years
description: Number of participants that receive a live donor transplant.
measure: App utilization as assessed by number of participants with story completion and posting in the donor app
time frame: Up to 5 years
description: The extent of a participants story completion and posting will be recorded internally by the Donor App. The number of participants that complete stories and post will be counted to assess app utilization.
measure: The Donor App Implementation
time frame: Up to 5 years
description: Success of the Donor App across multiple institutions will be tracked by the number of participants enrolled and invited to use the app at each institution.
arm group label: The Donor App
arm group type: Experimental
description: Select physicians and research staff from about 15 transplant hospitals will be given access to distribute the application to patients who the above people feel could benefit from the application. After obtaining informed consent, an approved member of the study team will enter the participant's name, contact info, and organ needed into the Donor App's secure management portal to send an email or text message with a unique and protected invitation link to the participant. Using this link the participant will be allowed to use the Donor App indefinitely.
intervention type: Other
intervention name: The Donor App
description: The Donor app is a web-based application that helps transplant candidates tell the candidate's story via social media in the hopes of identifying an appropriate living donor. Sample stories created using the Donor App can be found at www.thedonorapp.com.
arm group label: The Donor App
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Andrew Cameron, MD PhD
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Andrew Cameron, MD PhD
phone: 4432870134
email: donorapp@jhu.edu
facility: 
status: Enrolling by invitation
facility: 
status: Enrolling by invitation
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Enrolling by invitation
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Enrolling by invitation
country: United States
url: https://www.thedonorapp.com/
description: The Donor App Homepage
citation: Kumar K, King EA, Muzaale AD, Konel JM, Bramstedt KA, Massie AB, Segev DL, Cameron AM. A Smartphone App for Increasing Live Organ Donation. Am J Transplant. 2016 Dec;16(12):3548-3553. doi: 10.1111/ajt.13961. Epub 2016 Aug 10.
PMID: 27402293
citation: Bramstedt KA, Cameron AM. Beyond the Billboard: The Facebook-Based Application, Donor, and Its Guided Approach to Facilitating Living Organ Donation. Am J Transplant. 2017 Feb;17(2):336-340. doi: 10.1111/ajt.14004. Epub 2016 Sep 7.
PMID: 27501516
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: End Stage Liver Disease
mesh term: Kidney Failure, Chronic
sharing ipd: No