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| Name | Class |
|---|---|
| Agentschap Innoveren & Ondernemen (VLAIO) | UNKNOWN |
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To develop digital biomarkers associated with disease activity of inflammatory bowel disease
The trial aims to develop digital biomarkers based on a large dataset of imput data. These data come from diffent sources including wearable data, grocery shopping data, patient reported outcome data, laboratory data and technical exam data. A model will be build that predict disease activity in IBD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with IBD |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| monitoring of wearable data, shopping data, biomarkers and patient reported outcomes | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients in which a flare can be detected based on passive monitoring data. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients in which a biomarker flare can be detected based on passive monitoring data | 1 year | |
| Proportion of patients in which an objective disease flare (combination of flare and biomarker flare) can be detected based on passive monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| - Interval between onset of a flare and detection based on passive monitoring data | exploratory outcome | 1 year |
| - Subgroup analysis based on the food frequency questionnaire | Exploratory outcome |
Inclusion Criteria:
Exclusion Criteria:
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This is an open label observational trial with partially blinded data collection (wearable and shopping data blinded for the patient and treating HCP). Patients in the study will not be randomized. Patients will be recruited via planned outpatient visits and day clinic admissions. Patients will be allocated to one of the three target patient groups at the investigator's discretion.
From the moment 60 patients are included, no additional patients can be recruited in group 1 or 3 prior to completion of group 2.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Bossuyt, MD PhD | Contact | +32 15 50 56 91 | peter.bossuyt@imelda.be | |
| Lieven Pouillon, MD | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imelda General Hospital | Bonheiden | 2820 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39826619 | Background | Hirten RP, Danieletto M, Sanchez-Mayor M, Whang JK, Lee KW, Landell K, Zweig M, Helmus D, Fuchs TJ, Fayad ZA, Nadkarni GN, Keefer L, Suarez-Farinas M, Sands BE. Physiological Data Collected From Wearable Devices Identify and Predict Inflammatory Bowel Disease Flares. Gastroenterology. 2025 May;168(5):939-951.e5. doi: 10.1053/j.gastro.2024.12.024. Epub 2025 Jan 16. | |
| 28146002 |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000071066 | Patient Reported Outcome Measures |
| ID | Term |
|---|---|
| D019538 | Health Care Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
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|
| 1 year |
| Proportion of patients in which a flare can be detected based on food purchase data | 1 year |
| Proportion of patients in which a biomarker flare can be detected based on food purchase data | 1 year |
| Proportion of patients in which an objective disease flare (combination of flare and biomarker flare) can be detected based on food purchase data | 1 year |
| 1 year |
| - Patient satisfaction based on patient experience questionnaire | Exploratory outcome | 1 year |
| - Proportion of patients in which (different levels of) disability can be detected based on passive monitoring data | .exploratory outcome | 1 year |
| - Proportion of patients in which a change of IBD medication can be detected based on passive monitoring data | Exploratory outcome | 1 year |
| Ghosh S, Louis E, Beaugerie L, Bossuyt P, Bouguen G, Bourreille A, Ferrante M, Franchimont D, Frost K, Hebuterne X, Marshall JK, O'Shea C, Rosenfeld G, Williams C, Peyrin-Biroulet L. Development of the IBD Disk: A Visual Self-administered Tool for Assessing Disability in Inflammatory Bowel Diseases. Inflamm Bowel Dis. 2017 Mar;23(3):333-340. doi: 10.1097/MIB.0000000000001033. |
| 35762696 | Background | Rowan C, Hirten R. The future of telemedicine and wearable technology in IBD. Curr Opin Gastroenterol. 2022 Jul 1;38(4):373-381. doi: 10.1097/MOG.0000000000000845. |
| 39213525 | Background | Singh B, Chastin S, Miatke A, Curtis R, Dumuid D, Brinsley J, Ferguson T, Szeto K, Simpson C, Eglitis E, Willems I, Maher C. Real-World Accuracy of Wearable Activity Trackers for Detecting Medical Conditions: Systematic Review and Meta-Analysis. JMIR Mhealth Uhealth. 2024 Aug 30;12:e56972. doi: 10.2196/56972. |
| 39632541 | Background | Louis S, Lembrechts N, Pouillon L. Towards a Greener IBD-Care: Let's INTERACT! United European Gastroenterol J. 2025 Mar;13(2):276-277. doi: 10.1002/ueg2.12728. Epub 2024 Dec 4. No abstract available. |
| 31793628 | Background | Pouillon L, Hoefkens E, Verheyen V, Bronswijk M, Van Olmen A, Van Dessel S, Siborgs N, Bossuyt P. Letter to the Editor: Feasibility and Efficiency of an E-Health Preadmission Assessment System for Intravenous Therapy in Inflammatory Bowel Disease. Inflamm Bowel Dis. 2020 Jan 6;26(2):e11-e12. doi: 10.1093/ibd/izz304. No abstract available. |
| 30343866 | Background | Bossuyt P, Hoefkens E, Pouillon L. Prime Time Was Yesterday for Patient-reported Outcomes in Daily Care of Patients With Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2018 Nov;16(11):1839. doi: 10.1016/j.cgh.2018.05.029. No abstract available. |
| 34169226 | Background | Schoenfeld R, Nguyen GC, Bernstein CN. Integrated Care Models: Optimizing Adult Ambulatory Care in Inflammatory Bowel Disease. J Can Assoc Gastroenterol. 2018 Oct 15;3(1):44-53. doi: 10.1093/jcag/gwy060. eCollection 2020 Feb. |
| 33359090 | Background | Turner D, Ricciuto A, Lewis A, D'Amico F, Dhaliwal J, Griffiths AM, Bettenworth D, Sandborn WJ, Sands BE, Reinisch W, Scholmerich J, Bemelman W, Danese S, Mary JY, Rubin D, Colombel JF, Peyrin-Biroulet L, Dotan I, Abreu MT, Dignass A; International Organization for the Study of IBD. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021 Apr;160(5):1570-1583. doi: 10.1053/j.gastro.2020.12.031. Epub 2021 Feb 19. |
| 28158501 | Background | Magro F, Gionchetti P, Eliakim R, Ardizzone S, Armuzzi A, Barreiro-de Acosta M, Burisch J, Gecse KB, Hart AL, Hindryckx P, Langner C, Limdi JK, Pellino G, Zagorowicz E, Raine T, Harbord M, Rieder F; European Crohn's and Colitis Organisation [ECCO]. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 1: Definitions, Diagnosis, Extra-intestinal Manifestations, Pregnancy, Cancer Surveillance, Surgery, and Ileo-anal Pouch Disorders. J Crohns Colitis. 2017 Jun 1;11(6):649-670. doi: 10.1093/ecco-jcc/jjx008. No abstract available. |
| Background | Gordon H, Minozzi S, Kopylov U, et al. ECCO Guidelines on Therapeutics in Crohn's Disease: Medical Treatment. J Crohns Colitis. Oct 15 2024;18(10):1531-1555. doi:10.1093/ecco-jcc/jjae091 7. Harbord M, Eliakim R, Bettenworth D, et al. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 2: Current Management. J Crohns Colitis. Jul 1 2017;11(7):769-784. doi:10.1093/ecco-jcc/jjx009 |
| 38878002 | Background | Adamina M, Minozzi S, Warusavitarne J, Buskens CJ, Chaparro M, Verstockt B, Kopylov U, Yanai H, Vavricka SR, Sigall-Boneh R, Sica GS, Reenaers C, Peros G, Papamichael K, Noor N, Moran GW, Maaser C, Luglio G, Kotze PG, Kobayashi T, Karmiris K, Kapizioni C, Iqbal N, Iacucci M, Holubar S, Hanzel J, Sabino JG, Gisbert JP, Fiorino G, Fidalgo C, Ellu P, El-Hussuna A, de Groof J, Czuber-Dochan W, Casanova MJ, Burisch J, Brown SR, Bislenghi G, Bettenworth D, Battat R, Atreya R, Allocca M, Agrawal M, Raine T, Gordon H, Myrelid P. ECCO Guidelines on Therapeutics in Crohn's Disease: Surgical Treatment. J Crohns Colitis. 2024 Oct 15;18(10):1556-1582. doi: 10.1093/ecco-jcc/jjae089. |
| 36871566 | Background | Burisch J, Zhao M, Odes S, De Cruz P, Vermeire S, Bernstein CN, Kaplan GG, Duricova D, Greenberg D, Melberg HO, Watanabe M, Ahn HS, Targownik L, Pittet VEH, Annese V, Park KT, Katsanos KH, Hoivik ML, Krznaric Z, Chaparro M, Loftus EV Jr, Lakatos PL, Gisbert JP, Bemelman W, Moum B, Gearry RB, Kappelman MD, Hart A, Pierik MJ, Andrews JM, Ng SC, D'Inca R, Munkholm P. The cost of inflammatory bowel disease in high-income settings: a Lancet Gastroenterology & Hepatology Commission. Lancet Gastroenterol Hepatol. 2023 May;8(5):458-492. doi: 10.1016/S2468-1253(23)00003-1. Epub 2023 Mar 2. |
| 29050646 | Background | Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, Panaccione R, Ghosh S, Wu JCY, Chan FKL, Sung JJY, Kaplan GG. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2017 Dec 23;390(10114):2769-2778. doi: 10.1016/S0140-6736(17)32448-0. Epub 2017 Oct 16. |
| 27914657 | Background | Ungaro R, Mehandru S, Allen PB, Peyrin-Biroulet L, Colombel JF. Ulcerative colitis. Lancet. 2017 Apr 29;389(10080):1756-1770. doi: 10.1016/S0140-6736(16)32126-2. Epub 2016 Dec 1. |
| 27914655 | Background | Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Crohn's disease. Lancet. 2017 Apr 29;389(10080):1741-1755. doi: 10.1016/S0140-6736(16)31711-1. Epub 2016 Dec 1. |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D008919 |
| Investigative Techniques |
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D063868 | Patient Outcome Assessment |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |