Gastro-Intestinal DisordersNCT05214625

Questionnaire Study Concerning Artificial Intelligence

An observational study of Gastro-Intestinal Disorders, run by Maastricht University Medical Center at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastro-Intestinal Disorders
What is being tested?: Questionnaire
How many people: 457 participants
Where: 2 sitesNetherlands
Study dates: 8 Apr 2020to 12 Aug 2021
Phase: Observational
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

Study population: Gastroenterology patients who will have an outpatient appointment for an endoscopic procedure in the context of the national bowel cancer screening program, because of gastrointestinal symptoms, or because of follow-up of previously diagnosed bowel diseases, in one of two Dutch hospitals between April 2020 and September 2020. Gastroenterologists and gastroenterology fellows working in Dutch hospitals.

Who may be able to join

Gastrointestinal (GI) patients with an outpatient appointment in the gastroenterology department for an endoscopic procedure in the context of the Dutch national screening program, because of gastrointestinal symptoms, or because of follow-up of previously diagnosed bowel diseases (in one of the two participating hospitals);
Gastroenterologists working in Dutch hospitals;
Gastroenterology fellows working in Dutch hospitals;
Minimal age of 18 years old.

Who cannot join

No appropriate understanding of the Dutch language;
Not willing to sign informed consent;
Objection to participate in medical scientific research, reported in the medical file.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

Catharina Ziekenhuis Eindhoven
Eindhoven, North Brabant, 5623 EJ
Maastricht University Medical Center
Maastricht, Limburg, 6202AZ

Other trials in Netherlands

About this study

Official title: Questionnaire Study Concerning Artificial Intelligence and Its Application in (Gastrointestinal) Healthcare - Patients' and Physicians' Perspectives

This study aims to investigate the knowledge, experience, and opinion on AI among gastroenterology (GI) patients, gastroenterologists, and GI-fellows, particularly concerning implementation and application of AI (in assisting clinicians) in healthcare. The secondary aims are to investigate (dis)advantages of AI use in healthcare and the availability of technical facilities and infrastructures within endoscopy to implement and apply AI in Dutch hospitals.

Read the detailed description

In recent years, important developments have been made in the field of artificial intelligence (AI). These developments have led to the large-scale application of AI in our everyday lives and AI-research within healthcare. A potentially promising application of AI lies in imaging analysis. For example, within gastroenterology this means the detection and classification of colorectal polyps and Barrett's neoplasia, disease severity scoring of inflammatory bowel diseases, and differentiating pancreatic cancer from chronic pancreatitis.

Despite the investments in AI-research, there is a lack in knowledge concerning patients' and physicians' perspectives on AI in healthcare. This prospective questionnaire study investigates these perspectives, obtaining data from both gastroenterology (GI) patients and GI-physicians within the Netherlands. The questionnaires focus on the knowledge, experience, and opinion of AI, particularly concerning the implementation of AI in (gastroenterology) healthcare. Furthermore, the current (endoscopic) infrastructure within Dutch hospitals will be investigated for its readnessy for AI.

Conditions: Gastro-Intestinal Disorders
Being tested: Questionnaire
Keywords: Artificial intelligence, Patients' perspective, Physicians' perspective, Questionnaire

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QuestionnaireOther
Questionnaire concerning artificial intelligence and its implementation in healthcare. GI patients and GI physicians will be provided with slightly different questionnaires.

Study groups in NCT05214625
Study group	Role	What they receive
Gastroenterology patients		Patient receiving an endoscopic procedure because of regular care will be considered eligible for inclusion. Patients receive an endoscopic procedure in the context of the Dutch national screening program, because of gastrointestinal symptoms, or because of follow-up of previously diagnosed bowel diseases. Patients will be asked to complete a questionnaire concerning AI. No intervention will be administered. Receives: Other: Questionnaire
Gastroenterology physicians		GI physicians (both gastroenterologists and gastroenterology fellows), participating in a yearly gastroenterology and hepatology training day, will be asked for their participation in this study. Physician will be asked to complete a questionnaire concerning AI. No intervention will be administered. Receives: Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

The knowledge on AI investigated by means of a questionnaire
The knowledge on AI in healthcare among gastroenterology patients and physicians, investigated by means of a questionnaire.
Measured: 6 months
The experience with AI investigated by means of a questionnaire
The experience with AI (in healthcare) among gastroenterology patients and physicians, investigated by means of a questionnaire.
Measured: 6 months
The opinion on AI investigated by means of a questionnaire
The oninion on AI in healthcare among gastroenterology patients and physicians, investigated by means of a questionnaire.
Measured: 6 months

Secondary outcomes (5)

Willingness of physicians to use AI in (gastroenterology) healthcare
The willingness to apply AI in (gastroenterology) healthcare among gastroenterology physicians.
Measured: 6 months
Willingness to apply AI in (gastroenterology) healthcare
The willingness of gastroenterology patients for their physicians to apply AI in (gastroenterology) healthcare.
Measured: 6 months
Advantages and disadvantages of AI use in (gastroenterology) healthcare
Important advantages and disadvantages of AI use in (gastroenterology) healthcare among gastroenterology patients and physicians.
Measured: 6 months
Potential domains within gastroenterology and hepatology for AI use
Potential domains within gastroenterology and hepatology for AI use indicated by GI physicians.
Measured: 6 months
Mandatory infrastructure for AI use in healthcare
The availability of technical facilities and infrastructures within endoscopy to implement and apply AI in Dutch hospitals.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Apr 202012 Aug 2021

First posted31 Jan 2022
Study start8 Apr 2020
Primary completion12 Aug 2021
Study completion12 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Gastro-Intestinal DisordersStudies of the same condition, open and under way.
More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 457 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05214625
Sponsor's protocol ID: METC 2020-2281
Status last verified: Feb 2022
First submitted: 13 Jan 2022
Last updated: 18 Feb 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data collected for the study, including individual participant data, will be made available upon request. This data includes deidentified participant data. Additional documents that will be made available are the study protocol, the statistical analysis plan, the questionnaires, and the informed consent forms. Data will be available following publication with no end date. Requests should be methodologically sound proposals with the purpose to achieve aims in the approved proposal. Researchers who request the data should direct the proposal to q.vanderzander@maastrichtuniversity.nl to gain access. Data requestors will need to sign a data access agreement after approval of a proposal.

Publications

Le Berre C, Sandborn WJ, Aridhi S, Devignes MD, Fournier L, Smail-Tabbone M, Danese S, Peyrin-Biroulet L. Application of Artificial Intelligence to Gastroenterology and Hepatology. Gastroenterology. 2020 Jan;158(1):76-94.e2. doi: 10.1053/j.gastro.2019.08.058. Epub 2019 Oct 5.
PubMed 31593701
Shaban-Nejad A, Michalowski M, Buckeridge DL. Health intelligence: how artificial intelligence transforms population and personalized health. NPJ Digit Med. 2018 Oct 2;1:53. doi: 10.1038/s41746-018-0058-9. eCollection 2018.
PubMed 31304332
Labovitz DL, Shafner L, Reyes Gil M, Virmani D, Hanina A. Using Artificial Intelligence to Reduce the Risk of Nonadherence in Patients on Anticoagulation Therapy. Stroke. 2017 May;48(5):1416-1419. doi: 10.1161/STROKEAHA.116.016281. Epub 2017 Apr 6.
PubMed 28386037
Waymel Q, Badr S, Demondion X, Cotten A, Jacques T. Impact of the rise of artificial intelligence in radiology: What do radiologists think? Diagn Interv Imaging. 2019 Jun;100(6):327-336. doi: 10.1016/j.diii.2019.03.015. Epub 2019 May 6.
PubMed 31072803

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
Ulcerative Colitis
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Recruiting
TEAS Timing for Gastrectomy Recovery (TEAS-TIME Trial)
Gastric Cancer (GC), Stomach Neoplasms
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Effects of a Mindful Self-Compassion Intervention on Psychological Adjustment in Breast Cancer Survivors
Breast Cancer

All Gastro-Intestinal Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Questionnaire Study Concerning Artificial Intelligence and Its Application in (Gastrointestinal) Healthcare - Patients' and Physicians' Perspectives
ClinicalTrials.gov ID: NCT05214625
Acronym / sponsor ID: METC 2020-2281
Conditions: Gastro-Intestinal Disorders
Keywords: Artificial intelligence, Patients' perspective, Physicians' perspective, Questionnaire
Study type: Observational
Recruitment status: Completed
Enrolment: 457 participants (actual)
Lead sponsor: Maastricht University Medical CenterUniversity, hospital or other
Collaborators: Catharina Ziekenhuis Eindhoven
Study start: 8 Apr 2020 (actual)
Primary completion: 12 Aug 2021 (actual)
Study completion: 12 Aug 2021 (actual)
First posted: 31 Jan 2022 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Gastroenterology patients	–	Other: QuestionnairePatient receiving an endoscopic procedure because of regular care will be considered eligible for inclusion. Patients receive an endoscopic procedure in the context of the Dutch national screening program, because of gastrointestinal symptoms, or because of follow-up of previously diagnosed bowel diseases. Patients will be asked to complete a questionnaire concerning AI. No intervention will be administered.
Gastroenterology physicians	–	Other: QuestionnaireGI physicians (both gastroenterologists and gastroenterology fellows), participating in a yearly gastroenterology and hepatology training day, will be asked for their participation in this study. Physician will be asked to complete a questionnaire concerning AI. No intervention will be administered.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Gastroenterology patients who will have an outpatient appointment for an endoscopic procedure in the context of the national bowel cancer screening program, because of gastrointestinal symptoms, or because of follow-up of previously diagnosed bowel diseases, in one of two Dutch hospitals between April 2020 and September 2020. Gastroenterologists and gastroenterology fellows working in Dutch hospitals.

Key inclusion criteria (4 listed)

Gastrointestinal (GI) patients with an outpatient appointment in the gastroenterology department for an endoscopic procedure in the context of the Dutch national screening program, because of gastrointestinal symptoms, or because of follow-up of previously diagnosed bowel diseases (in one of the two participating hospitals);
Gastroenterologists working in Dutch hospitals;
Gastroenterology fellows working in Dutch hospitals;
Minimal age of 18 years old.

Key exclusion criteria (3 listed)

No appropriate understanding of the Dutch language;
Not willing to sign informed consent;
Objection to participate in medical scientific research, reported in the medical file.

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
QuestionnaireQuestionnaire concerning artificial intelligence and its implementation in healthcare. GI patients and GI physicians will be provided with slightly different questionnaires.	Other	Gastroenterology patients, Gastroenterology physicians

Primary outcome

The knowledge on AI investigated by means of a questionnaire
Time frame: 6 months
The knowledge on AI in healthcare among gastroenterology patients and physicians, investigated by means of a questionnaire.
The experience with AI investigated by means of a questionnaire
Time frame: 6 months
The experience with AI (in healthcare) among gastroenterology patients and physicians, investigated by means of a questionnaire.
The opinion on AI investigated by means of a questionnaire
Time frame: 6 months
The oninion on AI in healthcare among gastroenterology patients and physicians, investigated by means of a questionnaire.

5 secondary outcomes

Willingness of physicians to use AI in (gastroenterology) healthcare
Time frame: 6 months
Willingness to apply AI in (gastroenterology) healthcare
Time frame: 6 months
Advantages and disadvantages of AI use in (gastroenterology) healthcare
Time frame: 6 months
Potential domains within gastroenterology and hepatology for AI use
Time frame: 6 months
Mandatory infrastructure for AI use in healthcare
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
Background: PubMed 31593701Le Berre C, Sandborn WJ, Aridhi S, Devignes MD, Fournier L, Smail-Tabbone M, Danese S, Peyrin-Biroulet L. Application of Artificial Intelligence to Gastroenterology and Hepatology. Gastroenterology. 2020 Jan;158(1):76-94.e2. doi: 10.1053/j.gastro.2019.08.058. Epub 2019 Oct 5.
Background: PubMed 31304332Shaban-Nejad A, Michalowski M, Buckeridge DL. Health intelligence: how artificial intelligence transforms population and personalized health. NPJ Digit Med. 2018 Oct 2;1:53. doi: 10.1038/s41746-018-0058-9. eCollection 2018.
Background: PubMed 28386037Labovitz DL, Shafner L, Reyes Gil M, Virmani D, Hanina A. Using Artificial Intelligence to Reduce the Risk of Nonadherence in Patients on Anticoagulation Therapy. Stroke. 2017 May;48(5):1416-1419. doi: 10.1161/STROKEAHA.116.016281. Epub 2017 Apr 6.
Background: PubMed 31072803Waymel Q, Badr S, Demondion X, Cotten A, Jacques T. Impact of the rise of artificial intelligence in radiology: What do radiologists think? Diagn Interv Imaging. 2019 Jun;100(6):327-336. doi: 10.1016/j.diii.2019.03.015. Epub 2019 May 6.
Individual participant dataSharing planned: Yes. Data collected for the study, including individual participant data, will be made available upon request. This data includes deidentified participant data. Additional documents that will be made available are the study protocol, the statistical analysis plan, the questionnaires, and the informed consent forms. Data will be available following publication with no end date. Requests should be methodologically sound proposals with the purpose to achieve aims in the approved proposal. Researchers who request the data should direct the proposal to q.vanderzander@maastrichtuniversity.nl to gain access. Data requestors will need to sign a data access agreement after approval of a proposal.

Related trials for Gastro-Intestinal Disorders

Active, not recruitingObservational study
An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
Ulcerative Colitis
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Recruiting
TEAS Timing for Gastrectomy Recovery (TEAS-TIME Trial)
Gastric Cancer (GC), Stomach Neoplasms
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Effects of a Mindful Self-Compassion Intervention on Psychological Adjustment in Breast Cancer Survivors
Breast Cancer

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.

Ad Masclee, Prof Dr MD principal investigator

Maastricht Universitair Medisch Centrum

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Gastro-Intestinal Disorders, run by Maastricht University Medical Center at 2 sites in Netherlands.

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 3 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: finished, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The knowledge on AI investigated by means of a questionnaire (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT05214625, which also lists 4 linked publications.

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 18 Feb 2022.