Improvement of Colonoscopy Preparation by Using a SPA

NCT ID: NCT03290157

Last Updated: 2019-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-05-28

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Colonoscopy Preparation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Control group

Regular colonoscopy preparation paper based information provided

Group Type NO_INTERVENTION

No interventions assigned to this group

ColoprAPP group

Regular colonoscopy preparation paper based information provided plus usage of a downloaded SPA (ColoprAPP) as a reminder system for colonoscopy preparation

Group Type OTHER

ColoprAPP

Intervention Type DEVICE

Additional downloaded SPA for reminding the crucial steps of colonoscopy preparation

Interventions

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ColoprAPP

Additional downloaded SPA for reminding the crucial steps of colonoscopy preparation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* no smartphone
* \>ASA 3 (no possibility for outpatient colonoscopy)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ulm

OTHER

Sponsor Role lead

Responsible Party

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Alexander Meining

Head of Endoscopy department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benjamin M Walter, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Ulm

Locations

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Gastroenterologische Praxis Dornstadt

Dornstadt, , Germany

Site Status RECRUITING

Krankenhaus Landshut-Achdorf

Landshut, , Germany

Site Status RECRUITING

Krankenhaus Ludwigsburg

Ludwigsburg, , Germany

Site Status RECRUITING

Universitätsklinikum Ulm

Ulm, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Benjamin M Walter, MD

Role: CONTACT

0049-731-500-44818

Facility Contacts

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Leopold Ludwig, MD

Role: primary

Bruno Neu, MD

Role: primary

Benjamin Meier, MD

Role: primary

Benjamin M Walter, MD

Role: primary

0049-731-500-44818

References

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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.

Reference Type DERIVED
PMID: 32240835 (View on PubMed)

Other Identifiers

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ColoprAPP Study

Identifier Type: -

Identifier Source: org_study_id

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