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Improvement of Colonoscopy Preparation by New Media (APP) (PERICLESAPPI)

Primary Purpose

Gastrointestinal Neoplasms

Status
Unknown status
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
APP supported colonoscopy preparation
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastrointestinal Neoplasms focused on measuring Colonoscopy, new media, APP, colonoscopy preparation, SPA, smartphone application

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • outpatient colonoscopy
  • smartphone owner with android system

Exclusion Criteria:

  • chronic renal failure
  • anticoagulants
  • pregnancy
  • diabetes mellitus (IDDM)

Sites / Locations

  • 2nd Medical Department, Klinikum rechts der IsarRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Regular colonoscopy preparation

APP supported colonoscopy preparation

Arm Description

Comparison group. Regular colonoscopy preparation

APP as additional device for colonoscopy preparation

Outcomes

Primary Outcome Measures

Feasibility
feasibility of app supported colonoscopy preparation (stable working and function of software on smartphone)

Secondary Outcome Measures

Bowel preparation
Evaluation of bowel preparation during colonoscopy by BostenBowelPreparation Scale
patient´s satification
Evaluation of patient´s satisfication by a questionaire

Full Information

First Posted
February 24, 2015
Last Updated
July 27, 2015
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT02512328
Brief Title
Improvement of Colonoscopy Preparation by New Media (APP)
Acronym
PERICLESAPPI
Official Title
First Experiences With an Offline App (SPA; Smartphone Application) for Colonoscopy Preparation- PERICLES-I APP; Prospective Evaluations of Improvement of Colonocopy Preparation by Optimized Visualization (PERICLES)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technical University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Feasibility of an newly programmed offline application for smartphones (SPA, APP) for colonoscopy preparation offering a 5 day guidance prior colonoscopy containing dietary- and behavioral recommendation.
Detailed Description
First feasibility testing of a newly programmed app/SPA for android system named Colopr-APP. It is an strictly offline working, autonomous system downloaded to the smartphone. It creates an 5-day guidance prior outpatient colonoscopy with dietary and behavior recommendations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Neoplasms
Keywords
Colonoscopy, new media, APP, colonoscopy preparation, SPA, smartphone application

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regular colonoscopy preparation
Arm Type
No Intervention
Arm Description
Comparison group. Regular colonoscopy preparation
Arm Title
APP supported colonoscopy preparation
Arm Type
Experimental
Arm Description
APP as additional device for colonoscopy preparation
Intervention Type
Device
Intervention Name(s)
APP supported colonoscopy preparation
Intervention Description
additional usage of an app for colonoscopy preparation
Primary Outcome Measure Information:
Title
Feasibility
Description
feasibility of app supported colonoscopy preparation (stable working and function of software on smartphone)
Time Frame
at day 0 colonoscopy after colonoscopy preparation
Secondary Outcome Measure Information:
Title
Bowel preparation
Description
Evaluation of bowel preparation during colonoscopy by BostenBowelPreparation Scale
Time Frame
at day 0 after colonoscopy
Title
patient´s satification
Description
Evaluation of patient´s satisfication by a questionaire
Time Frame
day 1 after colonoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: outpatient colonoscopy smartphone owner with android system Exclusion Criteria: chronic renal failure anticoagulants pregnancy diabetes mellitus (IDDM)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin M Walter, MD
Phone
0049-89-4140-2251
Email
Benjamin.Walter@lrz.tum.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin M Walter, MD
Organizational Affiliation
Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
2nd Medical Department, Klinikum rechts der Isar
City
Munich
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin M Walter, MD
Phone
+49-89-4140-2223
Email
Benjamin.Walter@lrz.tum.de
First Name & Middle Initial & Last Name & Degree
Benjamin Walter, MD
First Name & Middle Initial & Last Name & Degree
von Delius Stefan, MD
First Name & Middle Initial & Last Name & Degree
Katharina Strehle
First Name & Middle Initial & Last Name & Degree
Peter Klare, MD
First Name & Middle Initial & Last Name & Degree
Neu Bruno, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
28931498
Citation
Walter B, Schmid R, von Delius S. A Smartphone App for Improvement of Colonoscopy Preparation (ColoprAPP): Development and Feasibility Study. JMIR Mhealth Uhealth. 2017 Sep 20;5(9):e138. doi: 10.2196/mhealth.7703.
Results Reference
derived

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Improvement of Colonoscopy Preparation by New Media (APP)

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