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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03290157
Other study ID # ColoprAPP Study
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date May 28, 2019

Study information

Verified date February 2019
Source University of Ulm
Contact Benjamin M Walter, MD
Phone 0049-731-500-44818
Email Benjamin.walter@uniklinik-ulm.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date May 28, 2019
Est. primary completion date March 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- smartphone

- outpatient appointment for colonoscopy

- CRC Screening, surveillance

- <ASA 3

Exclusion Criteria:

- no smartphone

- >ASA 3 (no possibility for outpatient colonoscopy)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ColoprAPP
Additional downloaded SPA for reminding the crucial steps of colonoscopy preparation

Locations

Country Name City State
Germany Gastroenterologische Praxis Dornstadt Dornstadt
Germany Krankenhaus Landshut-Achdorf Landshut
Germany Krankenhaus Ludwigsburg Ludwigsburg
Germany Universitätsklinikum Ulm Ulm

Sponsors (1)

Lead Sponsor Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Adenoma detection rate Rate of adenoma detected and resected during colonoscopy histological analysis after colonoscopy up to 10 days (d10)
Secondary 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)
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