<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/NCT04491565</url>
  </required_header>
  <id_info>
    <org_study_id>201909053</org_study_id>
    <nct_id>NCT04491565</nct_id>
  </id_info>
  <brief_title>An Interactive Video Educational Tool Improves the Quality of Bowel Preparation for Colonoscopy</brief_title>
  <official_title>An Interactive Video Educational Tool Improves the Quality of Bowel Preparation for Colonoscopy: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</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 aimed to determine whether an interactive, online educational platform&#xD;
      could improve procedure show rates and bowel preparation scores in an outpatient population&#xD;
      presenting for routine colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators performed a prospective, endoscopist-blinded, randomized controlled trial&#xD;
      at a hospital-based outpatient endoscopy center. Eligible patients were randomized to two&#xD;
      groups. Both groups received verbal and written instructions per standard care, while the&#xD;
      intervention group received access to an interactive, on-line video. Primary outcomes were&#xD;
      bowel preparation scores graded using the Boston Bowel Prep Score (BBPS), procedure show&#xD;
      rates, patient satisfaction, and pre-procedure anxiety. Secondary outcomes included adenoma&#xD;
      detection rate, mean bowel prep score per colonic segment, total number of polyps detected,&#xD;
      and complication rates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2019</start_date>
  <completion_date type="Actual">February 7, 2020</completion_date>
  <primary_completion_date type="Actual">February 7, 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>Screening</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adequacy of bowel prep</measure>
    <time_frame>intra procedure</time_frame>
    <description>adequacy of colonoscopy bowel prep was scored from 0 (worst) to 9 (best).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">270</enrollment>
  <condition>Colon Cancer Screening</condition>
  <arm_group>
    <arm_group_label>standard education</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>educational video</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>educational video</intervention_name>
    <description>an interactive educational video was viewed by participants in the intervention arm.</description>
    <arm_group_label>educational video</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Access to text messaging and the internet (mobile phone access alone was considered&#xD;
             sufficient)&#xD;
&#xD;
          -  Prescribed standard split-dose bowel preparation&#xD;
&#xD;
          -  Able to provide informed consent via telephone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Mentally impaired&#xD;
&#xD;
          -  Undergoing screening or surveillance for inflammatory bowel disease .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <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>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Washington University School of Medicine</investigator_affiliation>
    <investigator_full_name>Dayna Early</investigator_full_name>
    <investigator_title>Principle Investigator, Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>colonoscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>March 31, 2021</submitted>
    <returned>April 27, 2021</returned>
  </pending_results>
  <!-- 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/NCT04491565
org study id: 201909053
nct id: NCT04491565
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators aimed to determine whether an interactive, online educational platform
      could improve procedure show rates and bowel preparation scores in an outpatient population
      presenting for routine colonoscopy.
The investigators performed a prospective, endoscopist-blinded, randomized controlled trial
      at a hospital-based outpatient endoscopy center. Eligible patients were randomized to two
      groups. Both groups received verbal and written instructions per standard care, while the
      intervention group received access to an interactive, on-line video. Primary outcomes were
      bowel preparation scores graded using the Boston Bowel Prep Score (BBPS), procedure show
      rates, patient satisfaction, and pre-procedure anxiety. Secondary outcomes included adenoma
      detection rate, mean bowel prep score per colonic segment, total number of polyps detected,
      and complication rates.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Care Provider)
measure: Adequacy of bowel prep
time frame: intra procedure
description: adequacy of colonoscopy bowel prep was scored from 0 (worst) to 9 (best).
arm group label: standard education
arm group type: No Intervention
arm group label: educational video
arm group type: Active Comparator
intervention type: Other
intervention name: educational video
description: an interactive educational video was viewed by participants in the intervention arm.
arm group label: educational video
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Washington University School of Medicine
investigator full name: Dayna Early
investigator title: Principle Investigator, Professor of Medicine
mesh term: Colonic Neoplasms
submitted: March 31, 2021
returned: April 27, 2021