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Prospective Evaluation of Flare Detection in IBD With Digital Biomarkers: Bring Your Own Device Study

ConditionsInflammatory Bowel Disease (IBD)Ulcerative Colitis (UC)Crohn Disease (CD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMaastricht University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

No specific exclusion criteria will be used. Subgroup analysis will be performed for patients with e.g. heart problems or arrhythmia, medication impacting HR (such as beta blockers), pregnancy, thyroid problems, shift work...

Trial population

Patients from MyIBDCoach, IBDream cohort and IBDthuis (Luscii cohort) with ulcerative colitis or Crohn's Disease.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Wearing their own wearable device.

    Device

    Wearing their own wearable device.

Treatment groups

600 Participants
are divided into 1 treatment group
Group A: Patients with IBD1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year

Secondary outcomes

1

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.

Time frame
1 year
2

Identification of a discrepancy between inflammatory flares and symptomatic flares (MIAH-CD>3.6 and MIAH-UC>3.5) regarding HRV.

Time frame
1 year
3

To study the inter-device variability in mean HRV metrics (including MESOR, acrophase, amplitude, SDNN, RMSSD), PA and sleep parameters, compared to resting state.

Time frame
1 year
4

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.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maastricht University Medical Center

Lead sponsor

Maastricht University

Collaborator

TNO

Collaborator

Franciscus Gasthuis & Vlietland (Hospital)

Collaborator

Jeroen Bosch Ziekenhuis, s'-Hertogenbosch

Collaborator

Source ClinicalTrials.gov
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