- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05214625
Questionnaire Study Concerning Artificial Intelligence
Questionnaire Study Concerning Artificial Intelligence and Its Application in (Gastrointestinal) Healthcare - Patients' and Physicians' Perspectives
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6202AZ
- Maastricht University Medical Center
-
-
Noord-Brabant
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Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
- Catharina Ziekenhuis Eindhoven
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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. |
Questionnaire concerning artificial intelligence and its implementation in healthcare.
GI patients and GI physicians will be provided with slightly different questionnaires.
|
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. |
Questionnaire concerning artificial intelligence and its implementation in healthcare.
GI patients and GI physicians will be provided with slightly different questionnaires.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
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.
|
6 months
|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Willingness of physicians to use AI in (gastroenterology) healthcare
Time Frame: 6 months
|
The willingness to apply AI in (gastroenterology) healthcare among gastroenterology physicians.
|
6 months
|
Willingness to apply AI in (gastroenterology) healthcare
Time Frame: 6 months
|
The willingness of gastroenterology patients for their physicians to apply AI in (gastroenterology) healthcare.
|
6 months
|
Advantages and disadvantages of AI use in (gastroenterology) healthcare
Time Frame: 6 months
|
Important advantages and disadvantages of AI use in (gastroenterology) healthcare among gastroenterology patients and physicians.
|
6 months
|
Potential domains within gastroenterology and hepatology for AI use
Time Frame: 6 months
|
Potential domains within gastroenterology and hepatology for AI use indicated by GI physicians.
|
6 months
|
Mandatory infrastructure for AI use in healthcare
Time Frame: 6 months
|
The availability of technical facilities and infrastructures within endoscopy to implement and apply AI in Dutch hospitals.
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ad Masclee, Prof Dr MD, Maastricht Universitair Medisch Centrum
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- METC 2020-2281
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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