<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/NCT04475146</url>
  </required_header>
  <id_info>
    <org_study_id>PREPAVIDEO</org_study_id>
    <nct_id>NCT04475146</nct_id>
  </id_info>
  <brief_title>Impact of Visualisation an Explanatory Video on the Quality of Bowel Preparation</brief_title>
  <official_title>Impact de la Visualisation d'Une vidéo Explicative Sur la qualité de la préparation Intestinale</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Intercommunal Creteil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Intercommunal Creteil</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 research hypothesis is that video visualization improves the quality of bowel preparation&#xD;
      and the patients' understanding of the modalities of bowel preparation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prescription of colonoscopy is performed by a gastroenterologist, who chooses the type of&#xD;
      bowel preparation. During this consultation, the doctor explains to the patient the bowel&#xD;
      preparation, then gives the patient the prescription with the type of product and a sheet&#xD;
      explaining the diet without residues.&#xD;
&#xD;
      The time between this consultation and the colonoscopy is sometimes long. The idea of this&#xD;
      study is to accompany this information on intestinal preparation with a video that details&#xD;
      the different stages of intestinal preparation by MOVIPREP. Indeed, studies have in the past&#xD;
      shown an improvement in the quality of intestinal preparation with the help of better&#xD;
      information to patients (educational booklet, or smartphone application)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of colonoscopy percentage with a Boston score of 7 or higher and a score of 2 or higher in each segment, in group 1 &quot;standard information and video visualization&quot; versus in group 2 &quot;standard information.&quot;</measure>
    <time_frame>Immediately after the colonoscopy</time_frame>
    <description>Boston score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>A scale of understanding and satisfaction in relation to the quality of Information on intestinal preparation.</measure>
    <time_frame>2 hours after the colonoscopy</time_frame>
    <description>Satisfaction and Understanding Questionnaires (Likert Scale)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">282</enrollment>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>Standard information and video visualization</arm_group_label>
    <description>Standard information and video visualization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard information, no video</arm_group_label>
    <description>Standard information, no video</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>video vizualisation</intervention_name>
    <description>video vizualisation</description>
    <arm_group_label>Standard information and video visualization</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All major patients, without legal protection measures, understanding French and having&#xD;
        access to the internet and an email address. Patient having a first outpatient colonoscopy&#xD;
        with preparation by MOVIPREP.&#xD;
&#xD;
        The study will be proposed by the investigator to patients followed for colonoscopy in the&#xD;
        department of Hepato-gastroenterology. If patients accepted to participate in the protocol&#xD;
        and the informed consent form is signed, patients will be included in the protocol.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Major patient&#xD;
&#xD;
          -  Patient with first indication of colonoscopy&#xD;
&#xD;
          -  Colonoscopy performed in outpatient with preparation by MOVIPREP&#xD;
&#xD;
          -  Patient affiliated with Social Security&#xD;
&#xD;
          -  Informed consent signed by the patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hospitalized patients&#xD;
&#xD;
          -  With no Internet access, or no access to the email&#xD;
&#xD;
          -  Blind patients&#xD;
&#xD;
          -  Patient who don't speak French&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Severe constipation (3 stools/week) or long-term laxatives&#xD;
&#xD;
          -  History of partial or total colectomy&#xD;
&#xD;
          -  Other preparation product&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mathias VIDON, MD</last_name>
    <phone>01 57 02 27 30</phone>
    <email>mathias.vidon@chicreteil.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Laurent COSTES, MD</last_name>
    <phone>01 57 02 27 34</phone>
    <email>Laurent.costes@chicreteil.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre hospitalier intercommunal de Créteil</name>
      <address>
        <city>Créteil</city>
        <zip>94100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mathias VIDON, MD</last_name>
      <phone>01 57 02 27 30</phone>
      <email>mathias.vidon@chicreteil.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHI Villeneuve St George</name>
      <address>
        <city>Villeneuve-Saint-Georges</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Julia ROUX</last_name>
      <email>julia.roux@chiv.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>June 6, 2023</last_update_submitted>
  <last_update_submitted_qc>June 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>video of bowel preparation</keyword>
  <!-- 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/NCT04475146
org study id: PREPAVIDEO
nct id: NCT04475146
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The research hypothesis is that video visualization improves the quality of bowel preparation
      and the patients' understanding of the modalities of bowel preparation.
The prescription of colonoscopy is performed by a gastroenterologist, who chooses the type of
      bowel preparation. During this consultation, the doctor explains to the patient the bowel
      preparation, then gives the patient the prescription with the type of product and a sheet
      explaining the diet without residues.

      The time between this consultation and the colonoscopy is sometimes long. The idea of this
      study is to accompany this information on intestinal preparation with a video that details
      the different stages of intestinal preparation by MOVIPREP. Indeed, studies have in the past
      shown an improvement in the quality of intestinal preparation with the help of better
      information to patients (educational booklet, or smartphone application)
observational model: Other
time perspective: Prospective
measure: Comparison of colonoscopy percentage with a Boston score of 7 or higher and a score of 2 or higher in each segment, in group 1 "standard information and video visualization" versus in group 2 "standard information."
time frame: Immediately after the colonoscopy
description: Boston score
measure: A scale of understanding and satisfaction in relation to the quality of Information on intestinal preparation.
time frame: 2 hours after the colonoscopy
description: Satisfaction and Understanding Questionnaires (Likert Scale)
arm group label: Standard information and video visualization
description: Standard information and video visualization
arm group label: Standard information, no video
description: Standard information, no video
intervention type: Other
intervention name: video vizualisation
description: video vizualisation
arm group label: Standard information and video visualization
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mathias VIDON, MD
phone: 01 57 02 27 30
email: mathias.vidon@chicreteil.fr
last name: Laurent COSTES, MD
phone: 01 57 02 27 34
email: Laurent.costes@chicreteil.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: France
responsible party type: Sponsor