<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/NCT04420858</url>
  </required_header>
  <id_info>
    <org_study_id>1500909-1</org_study_id>
    <nct_id>NCT04420858</nct_id>
  </id_info>
  <brief_title>Effect of Video Education on Patients' Knowledge and Attitudes of Privacy in Prenatal Genetics</brief_title>
  <official_title>Effect of Video Education on Patients' Knowledge and Attitudes of Privacy in Prenatal Genetics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Women and Infants Hospital of Rhode Island</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Women and Infants Hospital of Rhode Island</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 investigators propose a randomized controlled trial to assess baseline maternal knowledge&#xD;
      of and attitudes toward commercial prenatal genetic testing laboratories' genetic privacy&#xD;
      practices, and to determine whether a brief educational intervention alters these attitudes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose a randomized controlled trial to assess baseline maternal knowledge&#xD;
      of and attitudes toward commercial prenatal genetic testing laboratories' genetic privacy&#xD;
      practices, and to determine whether a brief educational intervention alters these attitudes.&#xD;
      Pregnant women undergoing specialized fetal anatomic ultrasound surveys at Women and Infants'&#xD;
      maternal fetal medicine prenatal diagnostic imaging centers will be recruited to participate.&#xD;
      Volunteers will be randomized to receive either standard education about prenatal genetic&#xD;
      testing or standard education plus additional education about federal genetic privacy&#xD;
      protections. Next, the participants view the educational materials to which they were&#xD;
      randomized. Finally, all volunteers will take the same survey, which will assess baseline&#xD;
      demographic variables as well as their knowledge of and attitudes toward broad sharing of&#xD;
      data obtained from prenatal genetic testing. Once finished with the survey, volunteers will&#xD;
      have completed their participation in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 21, 2020</start_date>
  <completion_date type="Actual">October 16, 2020</completion_date>
  <primary_completion_date type="Actual">October 16, 2020</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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knowledge about broad sharing of genetic data for non-clinical research purposes</measure>
    <time_frame>This outcome will be assessed immediately after exposure to education (day 0)</time_frame>
    <description>Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What is patient knowledge about the potential sharing of their genetic data for non-clinical research purposes? Outcome will be measured on the Likert scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of broad sharing of genetic data for non-clinical research purposes</measure>
    <time_frame>This outcome will be assessed immediately after exposure to education (day 0)</time_frame>
    <description>Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What is patient acceptance of laboratory-initiated sharing of their de-identified genetic data for non-clinical purposes? Outcome will be measured on the Likert scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability of retention of genetic data for non-clinical purposes</measure>
    <time_frame>This outcome will be assessed immediately after exposure to education (day 0)</time_frame>
    <description>Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What is patient acceptance of retaining their de-identified genetic data to potentially use it for non-clinical purposes? Outcome will be measured on the Likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability of use of genetic data for non-clinical purposes</measure>
    <time_frame>This outcome will be assessed immediately after exposure to education (day 0)</time_frame>
    <description>Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What is patient acceptance of using their de-identified genetic data for non-clinical purposes such as research and development? Outcome will be measured on the Likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge and understanding of aneuploidy screening and results</measure>
    <time_frame>This outcome will be assessed immediately after exposure to education (day 0)</time_frame>
    <description>Are patients aware that they underwent aneuploidy screening with cell-free fetal DNA (cfDNA)? Are they aware of their results? Outcome will be measured on the Likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge and understanding of carrier testing and results</measure>
    <time_frame>This outcome will be assessed immediately after exposure to education (day 0)</time_frame>
    <description>Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: Are patients aware that they underwent carrier testing? Are they aware of their results? Outcome will be measured on the Likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability of retention, use, and broad sharing of fetal genetic data for non-clinical research purposes</measure>
    <time_frame>This outcome will be assessed immediately after exposure to education (day 0)</time_frame>
    <description>Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: Assess maternal acceptance of each of these outcomes. Outcome will be measured on the Likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal rationale for pursuing cfDNA</measure>
    <time_frame>This outcome will be assessed immediately after exposure to education (day 0)</time_frame>
    <description>Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What prompted patient to pursue cfDNA testing? Outcome will be measured on the Likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal knowledge of different commercial cfDNA providers</measure>
    <time_frame>This outcome will be assessed immediately after exposure to education (day 0)</time_frame>
    <description>Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: Are patents who have undergone cfDNA testing aware that multiple companies offer this service? Outcome will be measured on the Likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal knowledge pertaining to Down Syndrome and the genetics of trisomies.</measure>
    <time_frame>This outcome will be assessed immediately after exposure to education (day 0)</time_frame>
    <description>Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: To what extent do mothers who have undergone cfDNA screening and are participating in this study understand these topics? Outcome will be measured on the Likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal perceptions of the de-identifiability of genetic data</measure>
    <time_frame>This outcome will be assessed immediately after exposure to education (day 0)</time_frame>
    <description>Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: To what extent do mothers who have undergone cfDNA screening believe that deidentified genetic information is not re-identifiable? Outcome will be measured on the Likert scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">162</enrollment>
  <condition>Aneuploidy</condition>
  <condition>Genetic Disease</condition>
  <condition>Pregnancy Related</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The control arm will receive standard education about cell-free DNA screening that would typically be presented during a prenatal visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental arm will receive additional education about federal legislation that protects the privacy of genetic information (Genetic Information Nondiscrimination Act, GINA).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced (experimental) education</intervention_name>
    <description>See arm description.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard (control) education.</intervention_name>
    <description>See arm description.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant patients undergoing a scheduled L2 ultrasound at the Women and Infants&#xD;
             Prenatal Diagnosis Center (PDC)&#xD;
&#xD;
          -  Singleton pregnancies&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Results available from cell-free DNA screening for this pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior L2 ultrasound at the PDC during the current pregnancy (to avoid test-retest or&#xD;
             multiple approach)&#xD;
&#xD;
          -  Prior participation in this study&#xD;
&#xD;
          -  Gestational age &lt;17'0 weeks or &gt;23'6 weeks&#xD;
&#xD;
          -  Suboptimally dated pregnancies (i.e. dated by ultrasound after 22 weeks gestation)&#xD;
&#xD;
          -  Unscheduled / add-on L2 ultrasounds&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>Christian Parobek</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of OB/GYN, Women and Infants Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Women and Infants Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Genetic privacy</keyword>
  <keyword>Aneuploidy screening</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>Data use</keyword>
  <keyword>Data sharing</keyword>
  <keyword>Protected health information</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Genetic Diseases, Inborn</mesh_term>
    <mesh_term>Aneuploidy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Non-identifiable data will be freely shared with other researchers upon request for facilitate reproducibility or future systemic review, pending approval from local institutional review board.</ipd_description>
    <ipd_time_frame>De-identified study data will be available after publication and for a time period of 6 years after enrollment of the final volunteer.</ipd_time_frame>
    <ipd_access_criteria>De-identified study data will be shared with researchers upon request.</ipd_access_criteria>
  </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/NCT04420858
org study id: 1500909-1
nct id: NCT04420858
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators propose a randomized controlled trial to assess baseline maternal knowledge
      of and attitudes toward commercial prenatal genetic testing laboratories' genetic privacy
      practices, and to determine whether a brief educational intervention alters these attitudes.
The investigators propose a randomized controlled trial to assess baseline maternal knowledge
      of and attitudes toward commercial prenatal genetic testing laboratories' genetic privacy
      practices, and to determine whether a brief educational intervention alters these attitudes.
      Pregnant women undergoing specialized fetal anatomic ultrasound surveys at Women and Infants'
      maternal fetal medicine prenatal diagnostic imaging centers will be recruited to participate.
      Volunteers will be randomized to receive either standard education about prenatal genetic
      testing or standard education plus additional education about federal genetic privacy
      protections. Next, the participants view the educational materials to which they were
      randomized. Finally, all volunteers will take the same survey, which will assess baseline
      demographic variables as well as their knowledge of and attitudes toward broad sharing of
      data obtained from prenatal genetic testing. Once finished with the survey, volunteers will
      have completed their participation in this study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Knowledge about broad sharing of genetic data for non-clinical research purposes
time frame: This outcome will be assessed immediately after exposure to education (day 0)
description: Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What is patient knowledge about the potential sharing of their genetic data for non-clinical research purposes? Outcome will be measured on the Likert scale.
measure: Acceptability of broad sharing of genetic data for non-clinical research purposes
time frame: This outcome will be assessed immediately after exposure to education (day 0)
description: Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What is patient acceptance of laboratory-initiated sharing of their de-identified genetic data for non-clinical purposes? Outcome will be measured on the Likert scale.
measure: Acceptability of retention of genetic data for non-clinical purposes
time frame: This outcome will be assessed immediately after exposure to education (day 0)
description: Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What is patient acceptance of retaining their de-identified genetic data to potentially use it for non-clinical purposes? Outcome will be measured on the Likert scale.
measure: Acceptability of use of genetic data for non-clinical purposes
time frame: This outcome will be assessed immediately after exposure to education (day 0)
description: Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What is patient acceptance of using their de-identified genetic data for non-clinical purposes such as research and development? Outcome will be measured on the Likert scale.
measure: Knowledge and understanding of aneuploidy screening and results
time frame: This outcome will be assessed immediately after exposure to education (day 0)
description: Are patients aware that they underwent aneuploidy screening with cell-free fetal DNA (cfDNA)? Are they aware of their results? Outcome will be measured on the Likert scale.
measure: Knowledge and understanding of carrier testing and results
time frame: This outcome will be assessed immediately after exposure to education (day 0)
description: Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: Are patients aware that they underwent carrier testing? Are they aware of their results? Outcome will be measured on the Likert scale.
measure: Acceptability of retention, use, and broad sharing of fetal genetic data for non-clinical research purposes
time frame: This outcome will be assessed immediately after exposure to education (day 0)
description: Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: Assess maternal acceptance of each of these outcomes. Outcome will be measured on the Likert scale.
measure: Maternal rationale for pursuing cfDNA
time frame: This outcome will be assessed immediately after exposure to education (day 0)
description: Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What prompted patient to pursue cfDNA testing? Outcome will be measured on the Likert scale.
measure: Maternal knowledge of different commercial cfDNA providers
time frame: This outcome will be assessed immediately after exposure to education (day 0)
description: Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: Are patents who have undergone cfDNA testing aware that multiple companies offer this service? Outcome will be measured on the Likert scale.
measure: Maternal knowledge pertaining to Down Syndrome and the genetics of trisomies.
time frame: This outcome will be assessed immediately after exposure to education (day 0)
description: Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: To what extent do mothers who have undergone cfDNA screening and are participating in this study understand these topics? Outcome will be measured on the Likert scale.
measure: Maternal perceptions of the de-identifiability of genetic data
time frame: This outcome will be assessed immediately after exposure to education (day 0)
description: Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: To what extent do mothers who have undergone cfDNA screening believe that deidentified genetic information is not re-identifiable? Outcome will be measured on the Likert scale.
arm group label: Control
arm group type: Other
description: The control arm will receive standard education about cell-free DNA screening that would typically be presented during a prenatal visit.
arm group label: Experimental
arm group type: Experimental
description: The experimental arm will receive additional education about federal legislation that protects the privacy of genetic information (Genetic Information Nondiscrimination Act, GINA).
intervention type: Behavioral
intervention name: Enhanced (experimental) education
description: See arm description.
arm group label: Experimental
intervention type: Behavioral
intervention name: Standard (control) education.
description: See arm description.
arm group label: Control
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Christian Parobek
role: Principal Investigator
affiliation: Department of OB/GYN, Women and Infants Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Genetic Diseases, Inborn
mesh term: Aneuploidy
sharing ipd: Yes
ipd description: Non-identifiable data will be freely shared with other researchers upon request for facilitate reproducibility or future systemic review, pending approval from local institutional review board.
ipd time frame: De-identified study data will be available after publication and for a time period of 6 years after enrollment of the final volunteer.
ipd access criteria: De-identified study data will be shared with researchers upon request.