Multiple Digital Biomarkers for Optimization of IBD Care

Обзор

To develop digital biomarkers associated with disease activity of inflammatory bowel disease

Подробное описание

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.

Вмешательства

• Устройство monitoring of wearable data, shopping data, biomarkers and patient reported outcomes
  1. All participants will receive a wearable device type Corsano Health Cardio watch 287-2 which is provided by the sponsor via Inovigate. Participants will be encouraged to wear the device 24h per day and need to wear the wearable device at least 12 hours per day, preferential during daytime. 2. All participants will receive a loyalty card (Xtra card Colruyt group) which is provided by the sponsor via Inovigate for food data capturing. The patient is requested to execute all grocery shopping at

Первичные конечные точки

• Proportion of patients in which a flare can be detected based on passive monitoring data. [Срок оценки: 1 year]

Вторичные конечные точки (5)

• Proportion of patients in which a biomarker flare can be detected based on passive monitoring data [Срок оценки: 1 year]
• Proportion of patients in which an objective disease flare (combination of flare and biomarker flare) can be detected based on passive monitoring [Срок оценки: 1 year]
• Proportion of patients in which a flare can be detected based on food purchase data [Срок оценки: 1 year]
• Proportion of patients in which a biomarker flare can be detected based on food purchase data [Срок оценки: 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 [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Males or females aged > 18 years
• Diagnosis of CD, UC or IBD-unspecified for at least 1 month
• Treatment with conventional or advanced therapy for IBD at initiation of the study
• The patient must have access to an email address
• The patient must be willing to perform all the groceries shopping at any of the Colruyt Group stores during this study, using an Xtra card created by the study team.
• Capacity to independently answer regular digital questionnaires
• Capacity and willingness to use a smartphone and activity tracker

Критерии исключения

• Planned extended (> 1 month) overseas travel during the study period of 12 months, if internet access would be impossible, inconvenient or unaffordable during this time
• Previous colectomy
• Inability to communicate well with investigators or unable to comply with the study requirements
• Significant medical condition interfering with physiological measurements trough a wearable device (heart failure, pacemaker or defibrillator)
• Inclusion or planned inclusion in an interventional IBD-related clinical trial

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Бельгия · 1 центр

• Imelda General Hospital — Bonheiden

Публикации

• 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. PMID 39826619
• 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. PMID 28146002
• 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. PMID 35762696
• 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. PMID 39213525
• 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. PMID 39632541
• 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. PMID 31793628
• 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. PMID 30343866
• 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. PMID 34169226

Идентификаторы

NCT: NCT07159776 · imelda 202501

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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