<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/NCT03290157</url>
  </required_header>
  <id_info>
    <org_study_id>ColoprAPP Study</org_study_id>
    <nct_id>NCT03290157</nct_id>
  </id_info>
  <brief_title>Improvement of Colonoscopy Preparation by Using a SPA</brief_title>
  <acronym>ColoprAPP</acronym>
  <official_title>Evaluation of Improvement of Colonoscopy Preparation by Using a SPA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Ulm</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Ulm</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 study evaluates the impact of a SPA on Quality of bowel preparation for colonoscopy.&#xD;
      Half of the patients receive regular paper based information on colonoscopy preparation&#xD;
      (control), while the other half will use an additional SPA for colonoscopy preparation&#xD;
      (coloprAPP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preparation for colonoscopy is perceived as a major impediment to participate in CRC&#xD;
      screening colonoscopy. Hence, inadequate bowel preparation is reported in up to 25% of all&#xD;
      patients undergoing colonoscopy.&#xD;
&#xD;
      Although the quality of bowel preparation is influenced by various factors, it largely&#xD;
      depends on patient´s compliance regarding instructions on purgatives and diet. Therefore&#xD;
      reinforced education and guidance is a valuable tool to improve bowel preparation.&#xD;
&#xD;
      A rapidly increasing number of individuals worldwide use smartphones in their daily life.&#xD;
      Application of this new technology into patient education could facilitate and empower the&#xD;
      patient guidance. In this study patients either receive regular information on colonoscopy&#xD;
      preparation (paper-based) or download a SPA for reinforced reminding of the steps of&#xD;
      colonoscopy preparation. Objective of this study is to measure the impact of a SPA on quality&#xD;
      of bowel preparation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Anticipated">May 28, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 30, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Bowel preparation</measure>
    <time_frame>During colonoscopy procedure</time_frame>
    <description>Measurement of bowel cleanliness by Boston Bowel preparation Scale (BBPS) with special regard on percentage of insufficient results of bowel preparation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adenoma detection rate</measure>
    <time_frame>histological analysis after colonoscopy up to 10 days (d10)</time_frame>
    <description>Rate of adenoma detected and resected during colonoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptance of patients towards bowel preparation procedure</measure>
    <time_frame>at colonoscopy appointment (day 0)</time_frame>
    <description>Measurement of patient satisfaction and acceptance with colonoscopy preparation procedure rated by numeric Rating scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Colonoscopy Preparation</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Regular colonoscopy preparation paper based information provided</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ColoprAPP group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Regular colonoscopy preparation paper based information provided plus usage of a downloaded SPA (ColoprAPP) as a reminder system for colonoscopy preparation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ColoprAPP</intervention_name>
    <description>Additional downloaded SPA for reminding the crucial steps of colonoscopy preparation</description>
    <arm_group_label>ColoprAPP group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  smartphone&#xD;
&#xD;
          -  outpatient appointment for colonoscopy&#xD;
&#xD;
          -  CRC Screening, surveillance&#xD;
&#xD;
          -  &lt;ASA 3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no smartphone&#xD;
&#xD;
          -  &gt;ASA 3 (no possibility for outpatient colonoscopy)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benjamin M Walter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinikum Ulm</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Benjamin M Walter, MD</last_name>
    <phone>0049-731-500-44818</phone>
    <email>Benjamin.walter@uniklinik-ulm.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Gastroenterologische Praxis Dornstadt</name>
      <address>
        <city>Dornstadt</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leopold Ludwig, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Landshut-Achdorf</name>
      <address>
        <city>Landshut</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bruno Neu, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Ludwigsburg</name>
      <address>
        <city>Ludwigsburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benjamin Meier, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benjamin M Walter, MD</last_name>
      <phone>0049-731-500-44818</phone>
      <email>Benjamin.walter@uniklinik-ulm.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>February 4, 2019</last_update_submitted>
  <last_update_submitted_qc>February 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Ulm</investigator_affiliation>
    <investigator_full_name>Alexander Meining</investigator_full_name>
    <investigator_title>Head of Endoscopy department</investigator_title>
  </responsible_party>
  <keyword>Colonoscopy</keyword>
  <keyword>preparation</keyword>
  <keyword>new media</keyword>
  <keyword>SPA</keyword>
  <keyword>APP</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03290157
org study id: ColoprAPP Study
nct id: NCT03290157
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the impact of a SPA on Quality of bowel preparation for colonoscopy.
      Half of the patients receive regular paper based information on colonoscopy preparation
      (control), while the other half will use an additional SPA for colonoscopy preparation
      (coloprAPP).
Preparation for colonoscopy is perceived as a major impediment to participate in CRC
      screening colonoscopy. Hence, inadequate bowel preparation is reported in up to 25% of all
      patients undergoing colonoscopy.

      Although the quality of bowel preparation is influenced by various factors, it largely
      depends on patient´s compliance regarding instructions on purgatives and diet. Therefore
      reinforced education and guidance is a valuable tool to improve bowel preparation.

      A rapidly increasing number of individuals worldwide use smartphones in their daily life.
      Application of this new technology into patient education could facilitate and empower the
      patient guidance. In this study patients either receive regular information on colonoscopy
      preparation (paper-based) or download a SPA for reinforced reminding of the steps of
      colonoscopy preparation. Objective of this study is to measure the impact of a SPA on quality
      of bowel preparation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Investigator)
measure: Quality of Bowel preparation
time frame: During colonoscopy procedure
description: Measurement of bowel cleanliness by Boston Bowel preparation Scale (BBPS) with special regard on percentage of insufficient results of bowel preparation
measure: Adenoma detection rate
time frame: histological analysis after colonoscopy up to 10 days (d10)
description: Rate of adenoma detected and resected during colonoscopy
measure: Acceptance of patients towards bowel preparation procedure
time frame: at colonoscopy appointment (day 0)
description: Measurement of patient satisfaction and acceptance with colonoscopy preparation procedure rated by numeric Rating scale
arm group label: Control group
arm group type: No Intervention
description: Regular colonoscopy preparation paper based information provided
arm group label: ColoprAPP group
arm group type: Other
description: Regular colonoscopy preparation paper based information provided plus usage of a downloaded SPA (ColoprAPP) as a reminder system for colonoscopy preparation
intervention type: Device
intervention name: ColoprAPP
description: Additional downloaded SPA for reminding the crucial steps of colonoscopy preparation
arm group label: ColoprAPP group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Benjamin M Walter, MD
role: Principal Investigator
affiliation: Universitätsklinikum Ulm
last name: Benjamin M Walter, MD
phone: 0049-731-500-44818
email: Benjamin.walter@uniklinik-ulm.de
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Ulm
investigator full name: Alexander Meining
investigator title: Head of Endoscopy department
sharing ipd: Undecided