<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/NCT03816423</url>
  </required_header>
  <id_info>
    <org_study_id>00035994</org_study_id>
    <nct_id>NCT03816423</nct_id>
  </id_info>
  <brief_title>Use of Videos to Improve Patient Knowledge on Prenatal Genetics</brief_title>
  <acronym>VPE</acronym>
  <official_title>The Use of Videos for Informed Consent for Prenatal Genetic Screening: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tampa General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of South Florida</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 is a randomized controlled trial of a low income and low health literacy population of&#xD;
      pregnant women from a diverse racial and ethnic background to assess the effectiveness of a&#xD;
      pre-visit educational video on prenatal genetic screening and testing options.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During pregnancy, women are routinely counseled about the risks of their offspring to have a&#xD;
      chromosomal abnormality or birth defects. Both prenatal screening and diagnostic testing&#xD;
      options to exclude aneuploidy should be offered to all pregnant women early in their&#xD;
      pregnancy. A standardized educational video on prenatal screening may enhance a patient's&#xD;
      understanding and knowledge of testing and support more informed decisions.&#xD;
&#xD;
      The objective of this study is to evaluate and compare patient knowledge scores on prenatal&#xD;
      genetic screening before and after a standard prenatal care visit compared to the addition of&#xD;
      a pre-appointment educational video.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 30, 2019</start_date>
  <completion_date type="Actual">May 12, 2020</completion_date>
  <primary_completion_date type="Actual">January 24, 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>
    <intervention_model_description>Primary purpose: assess and compare patient knowledge on prenatal genetic screening before and after a standard prenatal care visit compared to the addition of a pre-appointment educational video.&#xD;
All participants will complete a 15-item questionnaire on prenatal genetic screening options at baseline and after routine prenatal care visit.&#xD;
Participants randomized to the control group, will have a routine prenatal care appoinment, while the intervention group will watch a pre-appointment 4.5 minute educational video entitled &quot;How to decide about prenatal genetic testing&quot;.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knowledge score</measure>
    <time_frame>same day for both groups</time_frame>
    <description>Evaluate the participants' baseline and post-visit knowledge scores on prenatal genetic screening for both groups using the &quot;Maternal Serum Screening Knowledge Score Questionnaire&quot; (MSSKQ)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knowledge score change</measure>
    <time_frame>same day for both groups</time_frame>
    <description>Compare the knowledge score change for both groups using the Maternal Serum Screening Knowledge Score Questionnaire&quot; (MSSKQ)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Aneuploidy</condition>
  <condition>Birth Defect</condition>
  <arm_group>
    <arm_group_label>Traditional counseling</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will undergo routine prenatal care visit with clinical practicioner only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>video group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to the intervention group (video education) will view the prenatal screening video &quot;How to Decide About Prenatal Genetic Testing,&quot; followed by a routine prenatal appointment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>video</intervention_name>
    <description>Participants randomized to the intervention group, will wacth a pre-appointment video, followed by a routine prenatal care visit.</description>
    <arm_group_label>video group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnancy, english or spanish-speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  minors &lt;18 years old,&#xD;
&#xD;
          -  &gt; 21 completed weeks of gestational age,&#xD;
&#xD;
          -  prior genetic counseling during current pregnancy&#xD;
&#xD;
          -  fetus with known ultrasound abnormality&#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>Karla Leavitt, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of South Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Genesis Healthpark- TGH</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>May 15, 2020</last_update_submitted>
  <last_update_submitted_qc>May 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>patient education</keyword>
  <keyword>genetic counseling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</mesh_term>
    <mesh_term>Aneuploidy</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/NCT03816423
org study id: 00035994
nct id: NCT03816423
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized controlled trial of a low income and low health literacy population of
      pregnant women from a diverse racial and ethnic background to assess the effectiveness of a
      pre-visit educational video on prenatal genetic screening and testing options.
During pregnancy, women are routinely counseled about the risks of their offspring to have a
      chromosomal abnormality or birth defects. Both prenatal screening and diagnostic testing
      options to exclude aneuploidy should be offered to all pregnant women early in their
      pregnancy. A standardized educational video on prenatal screening may enhance a patient's
      understanding and knowledge of testing and support more informed decisions.

      The objective of this study is to evaluate and compare patient knowledge scores on prenatal
      genetic screening before and after a standard prenatal care visit compared to the addition of
      a pre-appointment educational video.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Primary purpose: assess and compare patient knowledge on prenatal genetic screening before and after a standard prenatal care visit compared to the addition of a pre-appointment educational video.
All participants will complete a 15-item questionnaire on prenatal genetic screening options at baseline and after routine prenatal care visit.
Participants randomized to the control group, will have a routine prenatal care appoinment, while the intervention group will watch a pre-appointment 4.5 minute educational video entitled "How to decide about prenatal genetic testing".
primary purpose: Other
masking: None (Open Label)
measure: Knowledge score
time frame: same day for both groups
description: Evaluate the participants' baseline and post-visit knowledge scores on prenatal genetic screening for both groups using the "Maternal Serum Screening Knowledge Score Questionnaire" (MSSKQ)
measure: Knowledge score change
time frame: same day for both groups
description: Compare the knowledge score change for both groups using the Maternal Serum Screening Knowledge Score Questionnaire" (MSSKQ)
arm group label: Traditional counseling
arm group type: No Intervention
description: Patients will undergo routine prenatal care visit with clinical practicioner only
arm group label: video group
arm group type: Experimental
description: Participants randomized to the intervention group (video education) will view the prenatal screening video "How to Decide About Prenatal Genetic Testing," followed by a routine prenatal appointment.
intervention type: Other
intervention name: video
description: Participants randomized to the intervention group, will wacth a pre-appointment video, followed by a routine prenatal care visit.
arm group label: video group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Karla Leavitt, MD, MPH
role: Principal Investigator
affiliation: University of South Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Congenital Abnormalities
mesh term: Aneuploidy
sharing ipd: No