Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Maastricht University | OTHER |
| TNO | OTHER |
| Franciscus Gasthuis & Vlietland (Hospital) | OTHER |
| Jeroen Bosch Ziekenhuis, s'-Hertogenbosch |
Not provided
Not provided
Not provided
Not provided
The aim of this study is to identify HRV changes predictive of IBD flares using patient-own wearable devices in a large cohort supplemented by additional data layers including sleep parameters, step count and clinical data extracted from electronic patient files.
IBD, comprising Crohn's disease and ulcerative colitis, is a chronic inflammatory condition of the gastrointestinal tract, with a globally rising prevalence. Current medical care consists of outpatient visits combined with blood and stool tests, radiological examination and endoscopy. The disease is costly to manage, also leading to indirect costs such as reduced work productivity. Telemonitoring platforms, including MyIBDCoach, IBD@home(Luscii) and IBDream, can alleviate these factors by enabling remote cost-effective monitoring of patient's health. However, data collection largely relies on burdensome questionnaires which are susceptible to bias. Emerging technologies such as wearable devices and smartphones enable continuous remote monitoring through digital biomarkers. This Bring Your Own Device (BYOD) study is part of the IBDigital project, which aims to enrich existing monitoring platforms by integrating digital biomarkers.
In this prospective, observational, multicenter cohort study, patients with IBD will be recruited from the outpatient clinics of the participating centers. Data will be collected from participants' personal smartwatches (and smartphones). Following an inclusion period of approximately four months, participants will enter a one-year follow-up period. During follow-up, standard-of-care clinical data will be collected during outpatient visits. In addition, wearable-derived data, including heart rate metrics, sleep parameters, and physical activity measures, will be continuously collected.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with IBD | âĽ18 years or older with Crohn's disease or ulcerative colitis, and having a smartwatch (Apple watch, Samsung Watch, Fitbit, Garmin, Polar (devices will not be made available) ) and/or a smartphone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearing their own wearable device. | Device | Wearing their own wearable device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prediction of mucosal inflammation (calprotectinâĽ250 Âľg/g and/or CRPâĽ5mg/l with UCEISâĽ1 or MayoâĽ1 (UC) and SES CDâĽ3 (CD) on endoscopic/radiological evaluation) using HRV-changes relative to individual baseline. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Prediction of mucosal inflammation (assessed by laboratory tests and/or imaging in IBD) using changes in physical activity and sleep metrics relative to individual baseline. | 1 year | |
| Identification of a discrepancy between inflammatory flares and symptomatic flares (MIAH-CD>3.6 and MIAH-UC>3.5) regarding HRV. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients from MyIBDCoach, IBDream cohort and IBDthuis (Luscii cohort) with ulcerative colitis or Crohn's Disease.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| E Godecharle, MD | Contact | +31 43 388 50 65 | eline.godecharle@maastrichtuniversity.nl |
| Name | Affiliation | Role |
|---|---|---|
| MJ Pierik, Prof. Dr. | Maastricht UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeroen Bosch Hospital | 's-Hertogenbosch | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33750250 | Background | Leung W, Case L, Jung J, Yun J. Factors associated with validity of consumer-oriented wearable physical activity trackers: a meta-analysis. J Med Eng Technol. 2021 Apr;45(3):223-236. doi: 10.1080/03091902.2021.1893395. Epub 2021 Mar 22. | |
| 40681759 | Background | Kaplan GG. The global burden of inflammatory bowel disease: from 2025 to 2045. Nat Rev Gastroenterol Hepatol. 2025 Oct;22(10):708-720. doi: 10.1038/s41575-025-01097-1. Epub 2025 Jul 18. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| UNKNOWN |
Not provided
Not provided
Not provided
| 1 year |
| To study the inter-device variability in mean HRV metrics (including MESOR, acrophase, amplitude, SDNN, RMSSD), PA and sleep parameters, compared to resting state. | 1 year |
| Investigation of additional digital phenotypes that can be derived from the available (wearable/clinical) data and how these phenotypes differ across relevant subgroups within the study population. | 1 year |
| To study the difference in step count measured by smartwatches compared with smartphones. | 1 year |
| To investigate if changes in HRV, PA and sleep relative to baseline predict clinical/symptomatic remission in IBD. | 1 year |
| Maastricht UMC+ | Maastricht | Netherlands |
|
| Franciscus Hospital | Rotterdam | Netherlands |
|
| 40578576 | Background | Bossuyt P, De Nollin I, De Moor T, Trekels G, Maes I, Dewulf G, Pouillon L. Inflammation Is a Large Dataset of Heartbeats, Groceries, Night Rest, and More. Gastroenterology. 2025 Oct;169(5):1085-1086. doi: 10.1053/j.gastro.2025.05.029. Epub 2025 Jun 25. No abstract available. |
| 32335133 | Background | de Jong MJ, Boonen A, van der Meulen-de Jong AE, Romberg-Camps MJ, van Bodegraven AA, Mahmmod N, Markus T, Dijkstra G, Winkens B, van Tubergen A, Masclee A, Jonkers DM, Pierik MJ. Cost-effectiveness of Telemedicine-directed Specialized vs Standard Care for Patients With Inflammatory Bowel Diseases in a Randomized Trial. Clin Gastroenterol Hepatol. 2020 Jul;18(8):1744-1752. doi: 10.1016/j.cgh.2020.04.038. Epub 2020 Apr 23. |
| 28267047 | Background | de Jong M, van der Meulen-de Jong A, Romberg-Camps M, Degens J, Becx M, Markus T, Tomlow H, Cilissen M, Ipenburg N, Verwey M, Colautti-Duijsens L, Hameeteman W, Masclee A, Jonkers D, Pierik M. Development and Feasibility Study of a Telemedicine Tool for All Patients with IBD: MyIBDcoach. Inflamm Bowel Dis. 2017 Apr;23(4):485-493. doi: 10.1097/MIB.0000000000001034. |
| 33382065 | Background | Hirten RP, Danieletto M, Scheel R, Shervey M, Ji J, Hu L, Sauk J, Chang L, Arnrich B, BÓ§ttinger E, Dudley J, Keefer L, Sands BE. Longitudinal Autonomic Nervous System Measures Correlate With Stress and Ulcerative Colitis Disease Activity and Predict Flare. Inflamm Bowel Dis. 2021 Oct 18;27(10):1576-1584. doi: 10.1093/ibd/izaa323. |
| 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. |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
Not provided
Not provided