Colonoscopy PreparationColoprAPPNCT03290157
Improvement of Colonoscopy Preparation by Using a SPA
A study testing ColoprAPP in people with Colonoscopy Preparation, run by University of Ulm at 4 sites in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy Preparation
- What is being tested?
- ColoprAPP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 4 sitesGermany
- Study dates
- 1 Oct 2017to 28 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- smartphone
- outpatient appointment for colonoscopy
- CRC Screening, surveillance
- <ASA 3
Who cannot join
- no smartphone
- >ASA 3 (no possibility for outpatient colonoscopy)
Trial locations and contacts
4 sites in 1 country.
Germany4 sites, 4 recruiting
- Recruiting
Gastroenterologische Praxis Dornstadt
Dornstadt
Leopold Ludwig, MD
- Recruiting
Krankenhaus Landshut-Achdorf
Landshut
Bruno Neu, MD
- Recruiting
Krankenhaus Ludwigsburg
Ludwigsburg
Benjamin Meier, MD
- Recruiting
Universitätsklinikum Ulm
Ulm
Benjamin M Walter, MD, 0049-731-500-44818, Benjamin.walter@uniklinik-ulm.de
About this study
Official title: 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).
Read the 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.
- Conditions
- Colonoscopy Preparation
- Being tested
- ColoprAPP
- Keywords
- Colonoscopy, preparation, new media, SPA, APP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColoprAPPDevice
Additional downloaded SPA for reminding the crucial steps of colonoscopy preparation
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Regular colonoscopy preparation paper based information provided |
| ColoprAPP group | Other | Regular colonoscopy preparation paper based information provided plus usage of a downloaded SPA (ColoprAPP) as a reminder system for colonoscopy preparation Receives: Device: ColoprAPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During colonoscopy procedure
Secondary outcomes (2)
Adenoma detection rate
Rate of adenoma detected and resected during colonoscopy
Measured: 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
Measured: at colonoscopy appointment (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start1 Oct 2017
- Primary completion30 Mar 2019 (estimated)
- Study completion28 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonoscopy PreparationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Meining, University of Ulm
- Investigators
- Benjamin M Walter, MD, Principal investigator, Universitätsklinikum Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290157
- Sponsor's protocol ID
- ColoprAPP Study
- Acronym
- ColoprAPP
- Status last verified
- Feb 2019
- First submitted
- 15 Sep 2017
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 32240835
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Improvement of Colonoscopy Preparation by Using a SPA
- ClinicalTrials.gov ID
- NCT03290157
- Acronym / sponsor ID
- ColoprAPP / ColoprAPP Study
- Conditions
- Colonoscopy Preparation
- Keywords
- Colonoscopy, preparation, new media, SPA, APP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Mar 2019 (estimated)
- Study completion
- 28 May 2019 (estimated)
- First posted
- 21 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Regular colonoscopy preparation paper based information provided |
| ColoprAPP group | Other | Device: ColoprAPPRegular colonoscopy preparation paper based information provided plus usage of a downloaded SPA (ColoprAPP) as a reminder system for colonoscopy preparation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- smartphone
- outpatient appointment for colonoscopy
- CRC Screening, surveillance
- <ASA 3
Key exclusion criteria (2 listed)
- no smartphone
- >ASA 3 (no possibility for outpatient colonoscopy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColoprAPPAdditional downloaded SPA for reminding the crucial steps of colonoscopy preparation | Device | ColoprAPP group |
Primary outcome
Quality of Bowel preparation
Time frame: During colonoscopy procedure
Measurement of bowel cleanliness by Boston Bowel preparation Scale (BBPS) with special regard on percentage of insufficient results of bowel preparation
2 secondary outcomes
Adenoma detection rate
Time frame: histological analysis after colonoscopy up to 10 days (d10)
Acceptance of patients towards bowel preparation procedure
Time frame: at colonoscopy appointment (day 0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Derived from this study: PubMed 32240835Walter 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin M Walter, MD principal investigator
Universitätsklinikum Ulm
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ColoprAPP in people with Colonoscopy Preparation, run by University of Ulm at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin M Walter, MD (0049-731-500-44818, Benjamin.walter@uniklinik-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Bowel preparation (time frame: During colonoscopy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03290157, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019; AzTrials last refreshed its copy on 5 Nov 2026.