Improvement of Colonoscopy Preparation by Using a SPA (ColoprAPP)

Evaluation of Improvement of Colonoscopy Preparation by Using a SPA

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).

Study Overview

• Status: Unknown
• Conditions: Colonoscopy Preparation
• Intervention / Treatment: Device: ColoprAPP

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benjamin M Walter, MD; Phone Number: 0049-731-500-44818; Email: Benjamin.walter@uniklinik-ulm.de

Study Locations

• Germany
  • Dornstadt, Germany
    • Recruiting
    • Gastroenterologische Praxis Dornstadt
    • Contact: Leopold Ludwig, MD
  • Landshut, Germany
    • Recruiting
    • Krankenhaus Landshut-Achdorf
    • Contact: Bruno Neu, MD
  • Ludwigsburg, Germany
    • Recruiting
    • Krankenhaus Ludwigsburg
    • Contact: Benjamin Meier, MD
  • Ulm, Germany
    • Recruiting
    • Universitätsklinikum Ulm
    • Contact: Benjamin M Walter, MD; Phone Number: 0049-731-500-44818; Email: Benjamin.walter@uniklinik-ulm.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• smartphone
• outpatient appointment for colonoscopy
• CRC Screening, surveillance
• <ASA 3

Exclusion Criteria:

• no smartphone
• >ASA 3 (no possibility for outpatient colonoscopy)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control group; Regular colonoscopy preparation paper based information provided
OTHER: ColoprAPP group; Regular colonoscopy preparation paper based information provided plus usage of a downloaded SPA (ColoprAPP) as a reminder system for colonoscopy preparation	Device: ColoprAPP; Additional downloaded SPA for reminding the crucial steps of colonoscopy preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Bowel preparation	Measurement of bowel cleanliness by Boston Bowel preparation Scale (BBPS) with special regard on percentage of insufficient results of bowel preparation	During colonoscopy procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate	Rate of adenoma detected and resected during colonoscopy	histological analysis after colonoscopy up to 10 days (d10)
Acceptance of patients towards bowel preparation procedure	Measurement of patient satisfaction and acceptance with colonoscopy preparation procedure rated by numeric Rating scale	at colonoscopy appointment (day 0)

Collaborators and Investigators

• Sponsor: University of Ulm
• Investigators: Principal Investigator: Benjamin M Walter, MD, Universitätsklinikum Ulm

Publications and helpful links

General Publications

• Walter B, Frank R, Ludwig L, Dikopoulos N, Mayr M, Neu B, Mayer B, Hann A, Meier B, Caca K, Seufferlein T, Meining A. Smartphone Application to Reinforce Education Increases High-Quality Preparation for Colorectal Cancer Screening Colonoscopies in a Randomized Trial. Clin Gastroenterol Hepatol. 2021 Feb;19(2):331-338.e5. doi: 10.1016/j.cgh.2020.03.051. Epub 2020 Mar 30. Erratum In: Clin Gastroenterol Hepatol. 2022 Jan;20(1):250.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2017
• Primary Completion (ANTICIPATED): March 30, 2019
• Study Completion (ANTICIPATED): May 28, 2019

Study Registration Dates

• First Submitted: September 15, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (ACTUAL): September 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 4, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Colonoscopy; preparation; APP; new media; SPA
• Other Study ID Numbers: ColoprAPP Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No