Crohn Disease (CD), Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC)
Conditions
Keywords
Inflammatory Bowel Disease, Digital biomarkers, Heart rate variability
Brief summary
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.
Detailed description
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.
Interventions
DEVICEWearing their own wearable device.
Wearing their own wearable device.
Sponsors
Maastricht University Medical Center
Maastricht University
TNO
Franciscus Gasthuis & Vlietland (Hospital)
Jeroen Bosch Ziekenhuis, s'-Hertogenbosch
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Crohn's Disease or ulcerative colitis * Having a smartwatch and/or a smartphone * Apple watch, Samsung Watch, Fitbit, Garmin, Polar (devices will not be made available)
Exclusion criteria
* No specific
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prediction of mucosal inflammation (calprotectin≥250 µg/g and/or CRP≥5mg/l with UCEIS≥1 or Mayo≥1 (UC) and SES CD≥3 (CD) on endoscopic/radiological evaluation) using HRV-changes relative to individual baseline. | 1 year |
Secondary
| Measure | 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. | 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 |
Countries
Netherlands
Contacts
CONTACTE Godecharle, MD
PRINCIPAL_INVESTIGATORMJ Pierik, Prof. Dr.
Maastricht UMC
Outcome results
None listed