<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/NCT04443114</url>
  </required_header>
  <id_info>
    <org_study_id>IRB18-1378</org_study_id>
    <nct_id>NCT04443114</nct_id>
  </id_info>
  <brief_title>Informing American Muslims About Living Donation</brief_title>
  <official_title>Assessing the Feasibility of Peer-Led Educational Workshops on Increasing Awareness Among American Muslims About Living Donation in Mosque Communities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</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>
      The purpose of this projects is to test the effectiveness of a tailored educational&#xD;
      intervention in increasing knowledge about organ donation among Muslim Americans. More&#xD;
      specifically, using the theory of planned behavior (TPB) as a conceptual framework, the&#xD;
      workshop's goal is to enhance attendee knowledge of the benefits and risks (behavioral&#xD;
      beliefs and attitude), understanding of religious arguments for and against (normative&#xD;
      beliefs and subjective norm), and procedural knowledge about the process and types of&#xD;
      (control beliefs and perceived control) living organ donation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study consists of two workshops (control and experimental) and an optional follow-up&#xD;
      interview.&#xD;
&#xD;
      The study contains 2 intervention arms based on the order in which the organ donation&#xD;
      workshop is delivered at the mosque: early and late. The early arm will receive the&#xD;
      experimental organ donation workshop first, followed by the control workshop (on end-of-life&#xD;
      care). The late arm will receive the workshops in the opposite order (end-of-life care&#xD;
      workshop followed by the organ donation workshop).&#xD;
&#xD;
      To address varied adult learning styles, the workshops will incorporate didactic teaching,&#xD;
      moderated panel presentations, and facilitated small group discussions led by a trained peer&#xD;
      educator. Workshops will also involve self-administered surveys.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 10, 2018</start_date>
  <completion_date type="Actual">August 3, 2019</completion_date>
  <primary_completion_date type="Actual">August 3, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Islamic knowledge of living organ donation</measure>
    <time_frame>2 weeks</time_frame>
    <description>Islamic Knowledge of Living Donation [IK-LOD] Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in living organ donation knowledge</measure>
    <time_frame>2 weeks</time_frame>
    <description>Living Donation subscale of the Rotterdam Renal Transplant Knowledge Test (R3K-T)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">337</enrollment>
  <condition>Living Organ Donation</condition>
  <arm_group>
    <arm_group_label>Early Arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The early arm will receive the experimental organ donation workshop first, followed by the control workshop on end-of-life care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Late Arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The late arm will receive the control workshop on end-of-life care first, followed by the experimental organ donation workshop.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Organ Donation Workshop</intervention_name>
    <description>Discussion Moderated by Peer Educators Didactic Session 1: Biomedical Aspects of Living Donation Didactic Session 2: Organ Donation and Transplantation in the US- Statistics and Procedures Moderated Debate: Living Organ Donation: Halal or Haram? Facilitated Group Discussions with Peer Educators</description>
    <arm_group_label>Early Arm</arm_group_label>
    <arm_group_label>Late Arm</arm_group_label>
    <other_name>Experimental</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>End of Life Care Workshop</intervention_name>
    <description>Discussion Moderated by Peer Educators Didactic Session 1: Critical Theological Concepts about Sickness and Health in Islamic Bioethics Didactic Session 2: Islamic Rulings about Brain Death, and Withdrawing/Withholding Life Support Moderated Panel Discussion: End-of-life Decision Making Facilitated Group Discussions with Peer Educators</description>
    <arm_group_label>Early Arm</arm_group_label>
    <arm_group_label>Late Arm</arm_group_label>
    <other_name>Control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-identified Muslim men and women&#xD;
&#xD;
          -  Fluent in English&#xD;
&#xD;
          -  Adult&#xD;
&#xD;
          -  Availability to attend workshop sessions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No personal or immediate family history of organ transplant&#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>Michael Quinn, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>October 15, 2020</last_update_submitted>
  <last_update_submitted_qc>October 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04443114
org study id: IRB18-1378
nct id: NCT04443114
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this projects is to test the effectiveness of a tailored educational
      intervention in increasing knowledge about organ donation among Muslim Americans. More
      specifically, using the theory of planned behavior (TPB) as a conceptual framework, the
      workshop's goal is to enhance attendee knowledge of the benefits and risks (behavioral
      beliefs and attitude), understanding of religious arguments for and against (normative
      beliefs and subjective norm), and procedural knowledge about the process and types of
      (control beliefs and perceived control) living organ donation.
The study consists of two workshops (control and experimental) and an optional follow-up
      interview.

      The study contains 2 intervention arms based on the order in which the organ donation
      workshop is delivered at the mosque: early and late. The early arm will receive the
      experimental organ donation workshop first, followed by the control workshop (on end-of-life
      care). The late arm will receive the workshops in the opposite order (end-of-life care
      workshop followed by the organ donation workshop).

      To address varied adult learning styles, the workshops will incorporate didactic teaching,
      moderated panel presentations, and facilitated small group discussions led by a trained peer
      educator. Workshops will also involve self-administered surveys.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in Islamic knowledge of living organ donation
time frame: 2 weeks
description: Islamic Knowledge of Living Donation [IK-LOD] Scale
measure: Change in living organ donation knowledge
time frame: 2 weeks
description: Living Donation subscale of the Rotterdam Renal Transplant Knowledge Test (R3K-T)
arm group label: Early Arm
arm group type: Other
description: The early arm will receive the experimental organ donation workshop first, followed by the control workshop on end-of-life care.
arm group label: Late Arm
arm group type: Other
description: The late arm will receive the control workshop on end-of-life care first, followed by the experimental organ donation workshop.
intervention type: Other
intervention name: Organ Donation Workshop
description: Discussion Moderated by Peer Educators Didactic Session 1: Biomedical Aspects of Living Donation Didactic Session 2: Organ Donation and Transplantation in the US- Statistics and Procedures Moderated Debate: Living Organ Donation: Halal or Haram? Facilitated Group Discussions with Peer Educators
arm group label: Early Arm
arm group label: Late Arm
other name: Experimental
intervention type: Other
intervention name: End of Life Care Workshop
description: Discussion Moderated by Peer Educators Didactic Session 1: Critical Theological Concepts about Sickness and Health in Islamic Bioethics Didactic Session 2: Islamic Rulings about Brain Death, and Withdrawing/Withholding Life Support Moderated Panel Discussion: End-of-life Decision Making Facilitated Group Discussions with Peer Educators
arm group label: Early Arm
arm group label: Late Arm
other name: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Quinn, PhD
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No