Improvement of Colonoscopy Preparation by Using a SPA
ColoprAPP
Evaluation of Improvement of Colonoscopy Preparation by Using a SPA
1 other identifier
interventional
500
1 country
4
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2017
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2017
CompletedFirst Posted
Study publicly available on registry
September 21, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2019
CompletedFebruary 5, 2019
February 1, 2019
1.5 years
September 15, 2017
February 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Adenoma detection rate
histological analysis after colonoscopy up to 10 days (d10)
Acceptance of patients towards bowel preparation procedure
at colonoscopy appointment (day 0)
Study Arms (2)
Control group
NO INTERVENTIONRegular colonoscopy preparation paper based information provided
ColoprAPP group
OTHERRegular colonoscopy preparation paper based information provided plus usage of a downloaded SPA (ColoprAPP) as a reminder system for colonoscopy preparation
Interventions
Additional downloaded SPA for reminding the crucial steps of colonoscopy preparation
Eligibility Criteria
You may qualify if:
- smartphone
- outpatient appointment for colonoscopy
- CRC Screening, surveillance
- \<ASA 3
You may not qualify if:
- no smartphone
- \>ASA 3 (no possibility for outpatient colonoscopy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Gastroenterologische Praxis Dornstadt
Dornstadt, Germany
Krankenhaus Landshut-Achdorf
Landshut, Germany
Krankenhaus Ludwigsburg
Ludwigsburg, Germany
Universitätsklinikum Ulm
Ulm, Germany
Related Publications (1)
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.
PMID: 32240835DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin M Walter, MD
Universitätsklinikum Ulm
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Endoscopy department
Study Record Dates
First Submitted
September 15, 2017
First Posted
September 21, 2017
Study Start
October 1, 2017
Primary Completion
March 30, 2019
Study Completion
May 28, 2019
Last Updated
February 5, 2019
Record last verified: 2019-02