monitoring of wearable data, shopping data, biomarkers and patient reported outcomes
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 one of the Colruyt Group stores. He/she will always need to offer the loyalty card to the cashier prior to payment. The purchase receipt will then be automatically sent to the central food data repository at the sponsor set up for this study. Non-food or non-food related data will neither be captured nor stored during the trial.
3. biomarkers in blood and feaces will be monitored according to standard of care
4. patient reported outcomes will be monitored according to standard of care
Study summary
To develop digital biomarkers associated with disease activity of inflammatory bowel disease
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
Proportion of patients in which a flare can be detected based on passive monitoring data. — 1 year
Trial sites (1)
Facility
City
Region
Status
Imelda General Hospital
Bonheiden
Belgium
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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