Bowel PreparationARCHESNCT05041283
Impact of Artificial Intelligence-based Patient Reinforcement on Quality of Colonoscopy
A study testing Chatbot and Phone call in people with Bowel Preparation, run by University of Ulm at 3 sites in Germany.
Trial summary
In order to improve bowel preparation for colonoscopy and consequently enhance detection rate of malignant and premalignant findings, a prospective, randomized and controlled three-arm study was developed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- Chatbot and Phone call
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 3 sitesGermany
- Study dates
- 21 May 2021to 1 Feb 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- informed consent
- smartphone with access to WhatsApp
- indication for ambulatory colonoscopy
- ASA I or II
Who cannot join
- no informed consent given or possible
- no access to a smartphone with WhatsApp
- <18 years old
- Pregnancy/Lactation
- Allergy to Moviprep©
- ASA (American Society of Anesthesiologists) state >II
- extended abdominal surgery in past history
- no indication for ambulatory colonoscopy
Trial locations and contacts
3 sites in 1 country.
Germany3 sites, 3 recruiting
- Recruiting
Specialist Practice
Berlin, 13581
Jens Aschenbeck, MD, +4930 - 331 44 44, info@aschenbeck-berlin.de
- Recruiting
Specialist Practice Profes. Dikopoulos/Ludwig
Ulm, Baden-Würrtemberg, 89081
Nektarios Dikopoulos, Prof., +497348 9671747, info@praxis-endoskopie.de
Leopold Ludwig, Prof., +497348 9671747, info@praxis-endoskopie.de
- Recruiting
University of Ulm, Interdisciplinary Endoscopy
Ulm, Baden-Würrtemberg, 89081
benjamin Walter, MD, +497315000, benjamin.walter@uniklinik-ulm.de
About this study
In order to improve bowel preparation for colonoscopy and consequently enhance detection rate of malignant and premalignant findings, a prospective, randomized and controlled three-arm study was developed. Patients who undergo ambulatory colonoscopy are randomly assigned into a control group with standard preparation, a phone call supported preparation group or a group supported by an artificial intelligence based chatbot. Primary endpoint is defined as quality of bowel preparation (Boston Bowel Preparation Score), secondary endpoints are patients satisfaction, comprehensiveness of bowel preparation, sedation dose, rate of coecal intubation and the rate of adenoma and polyp detection, anxiety referred to colonoscopy and patients satisfaction with preparation support.
Read the detailed description
Adequate bowel preparation is crucial for detection of adenoma and polyps of the colon, which can transform into malignant and premalignant lesions. In particular ambulatory performed colonoscopy is often insufficient due to inadequate preparation by patients at home. To focus this issue, a artificial intelligence based chatbot was developed to help patients who undergo bowel preparation by answering questions concerning bowel preparation. To compare the effect of this program, a three-arm randomized, controled multicentric clinical trial was developed. All patients who undergo ambulatory colonoscopy and meet the inclusion criteria (18 y.o., informed consent, WhatsApp access) were randomized in a standard preparation group (medical briefing and preparation brochure), a group receiving phone calls with instructions for bowel preparation and a third group with access to the chat bot answering questions concerning bowel preparation and examination conduct. As the primary end point, the quality of bowel preparation measured as Boston Bowel Preparation Scale was defined. As secondary endpoints patients satisfaction, comprehensiveness of bowel preparation, sedation dose, rate of coecal intubation, the rate of adenoma and polyp detection, anxiety referred to colonoscopy and patients satisfaction with preparation support were measured.
- Conditions
- Bowel Preparation
- Being tested
- Chatbot, Phone call
- Keywords
- Bowel Preparation, Artificial Intelligence, Polyp Detection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChatbotOther
A artificial-intelligence based chatbot is provided 3 days before colonoscopy to answer questions concerning bowel preparation and colonoscopy conduct.
Phone callOther
A phone call is performed every day starting at 3 days before colonoscopy to support bowel preparation.
| Study group | Role | What they receive |
|---|---|---|
| Standard Preparation | No intervention | Control arm; patients receive a standard support for bowel preparation consisting of a explanatory dialogue with a gastroenterologist and a brochure with a structurated description of bowel preparation and colonoscopy conduct |
| Phone-call Supported Preparation | Active comparator | In addition to standard preparation, patients receive a phone call every day starting at 3 days before colonoscopy in which a investigator explains key points of bowel preparation and patients can ask questions concerning bowel preparation and colonoscopy conduct. Receives: Other: Phone call |
| Chatbot Supported Preparation | Experimental | In addition to standard preparation, patients receive an access to a chatbot which can be contacted via Whats App starting at 3 days before colonoscopy. The chatbot is programed to answer questions concerning bowel preparation and colonoscopy conduct. Receives: Other: Chatbot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of bowel preparation
evaluated with the Boston Bowel Preparation Scale (0-9, 1=worst preparation, 9= best preparation)
Measured: During colonoscopy
Secondary outcomes (7)
Patients satisfaction with bowel preparation
Via questionnaire; 8 items, ordinal scale with 4 grades (completely satisfied/mainly satisfied/mainly dissatisfied/completely dissatisfied)
Measured: Immediately after the intervention
Comprehensiveness of bowel preparation
Rate of successfully completed colonoscopy without premature termination due to remaining feces(from anus to terminal ileum)
Measured: During colonoscopy
Sedation dose
Total amount of administered sedation per examination
Measured: During colonoscopy
Coecal intubation
Successful coecal intubation during colonoscopy
Measured: During colonoscopy
Polyp and adenoma detection rate
Rate of detected polyps and adenomas
Measured: During colonoscopy
Patients satisfaction with preparation support
Via questionnaire; 8 items, ordinal scale with 4 grades (completely satisfied/mainly satisfied/mainly dissatisfied/completely dissatisfied)
Measured: Within 3 days after the intervention
Anxiety referred to colonoscopy
German ABI-MS questionnaire (questionnaire on overcoming fear considering medical therapy;
Measured: Within 3 days before the intervention and 3 days after the intervention; 8 items with binary answer yes/no)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start21 May 2021
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Seufferlein, University of Ulm
- Investigators
- Thomas Seufferlein, Prof., Principal investigator, University Hospital Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041283
- Sponsor's protocol ID
- ARCHES
- Acronym
- ARCHES
- Status last verified
- Sep 2021
- First submitted
- 6 Sep 2021
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Artificial Intelligence-based Patient Reinforcement on Quality of Colonoscopy
- ClinicalTrials.gov ID
- NCT05041283
- Acronym / sponsor ID
- ARCHES / ARCHES
- Conditions
- Bowel Preparation
- Keywords
- Bowel Preparation, Artificial Intelligence, Polyp Detection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 13 Sep 2021 (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.
In order to improve bowel preparation for colonoscopy and consequently enhance detection rate of malignant and premalignant findings, a prospective, randomized and controlled three-arm study was developed. Patients who undergo ambulatory colonoscopy are randomly assigned into a control group with standard preparation, a phone call supported preparation group or a group supported by an artificial intelligence based chatbot. Primary endpoint is defined as quality of bowel preparation (Boston Bowel Preparation Score), secondary endpoints are patients satisfaction, comprehensiveness of bowel preparation, sedation dose, rate of coecal intubation and the rate of adenoma and polyp detection, anxiety referred to colonoscopy and patients satisfaction with preparation support.
Detailed description
Adequate bowel preparation is crucial for detection of adenoma and polyps of the colon, which can transform into malignant and premalignant lesions. In particular ambulatory performed colonoscopy is often insufficient due to inadequate preparation by patients at home. To focus this issue, a artificial intelligence based chatbot was developed to help patients who undergo bowel preparation by answering questions concerning bowel preparation. To compare the effect of this program, a three-arm randomized, controled multicentric clinical trial was developed. All patients who undergo ambulatory colonoscopy and meet the inclusion criteria (18 y.o., informed consent, WhatsApp access) were randomized in a standard preparation group (medical briefing and preparation brochure), a group receiving phone calls with instructions for bowel preparation and a third group with access to the chat bot answering questions concerning bowel preparation and examination conduct. As the primary end point, the quality of bowel preparation measured as Boston Bowel Preparation Scale was defined. As secondary endpoints patients satisfaction, comprehensiveness of bowel preparation, sedation dose, rate of coecal intubation, the rate of adenoma and polyp detection, anxiety referred to colonoscopy and patients satisfaction with preparation support were measured.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Preparation | No intervention | –Control arm; patients receive a standard support for bowel preparation consisting of a explanatory dialogue with a gastroenterologist and a brochure with a structurated description of bowel preparation and colonoscopy conduct |
| Phone-call Supported Preparation | Active comparator | Other: Phone callIn addition to standard preparation, patients receive a phone call every day starting at 3 days before colonoscopy in which a investigator explains key points of bowel preparation and patients can ask questions concerning bowel preparation and colonoscopy conduct. |
| Chatbot Supported Preparation | Experimental | Other: ChatbotIn addition to standard preparation, patients receive an access to a chatbot which can be contacted via Whats App starting at 3 days before colonoscopy. The chatbot is programed to answer questions concerning bowel preparation and colonoscopy conduct. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- informed consent
- smartphone with access to WhatsApp
- indication for ambulatory colonoscopy
- ASA I or II
Key exclusion criteria (8 listed)
- no informed consent given or possible
- no access to a smartphone with WhatsApp
- <18 years old
- Pregnancy/Lactation
- Allergy to Moviprep©
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 |
|---|---|---|
| ChatbotA artificial-intelligence based chatbot is provided 3 days before colonoscopy to answer questions concerning bowel preparation and colonoscopy conduct. | Other | Chatbot Supported Preparation |
| Phone callA phone call is performed every day starting at 3 days before colonoscopy to support bowel preparation. | Other | Phone-call Supported Preparation |
Primary outcome
Quality of bowel preparation
Time frame: During colonoscopy
evaluated with the Boston Bowel Preparation Scale (0-9, 1=worst preparation, 9= best preparation)
7 secondary outcomes
Patients satisfaction with bowel preparation
Time frame: Immediately after the intervention
Comprehensiveness of bowel preparation
Time frame: During colonoscopy
Sedation dose
Time frame: During colonoscopy
Coecal intubation
Time frame: During colonoscopy
Polyp and adenoma detection rate
Time frame: During colonoscopy
Patients satisfaction with preparation support
Time frame: Within 3 days after the intervention
Anxiety referred to colonoscopy
Time frame: Within 3 days before the intervention and 3 days after the intervention; 8 items with binary answer yes/no)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
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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.
Thomas Seufferlein, Prof. principal investigator
University Hospital Ulm
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chatbot and Phone call in people with Bowel Preparation, run by University of Ulm at 3 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 8 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 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Walter, MD (+49731/5000, 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2021.