Crohn Disease (CD), Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC)
Conditions
Keywords
biomarkers, artificial intelligence, wearable, shopping data, life style
Brief summary
To develop digital biomarkers associated with disease activity of inflammatory bowel disease
Detailed description
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.
Interventions
DEVICEmonitoring 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
Sponsors
Agentschap Innoveren & Ondernemen (VLAIO)
Imelda GI Clinical Research Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients in which a flare can be detected based on passive monitoring data. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients in which a biomarker flare can be detected based on passive monitoring data | 1 year |
| Proportion of patients in which an objective disease flare (combination of flare and biomarker flare) can be detected based on passive monitoring | 1 year |
| Proportion of patients in which a flare can be detected based on food purchase data | 1 year |
| Proportion of patients in which a biomarker flare can be detected based on food purchase data | 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 | 1 year |
Other
| Measure | Time frame | Description |
|---|---|---|
| - Subgroup analysis based on the food frequency questionnaire | 1 year | Exploratory outcome |
| - Patient satisfaction based on patient experience questionnaire | 1 year | Exploratory outcome |
| - Proportion of patients in which (different levels of) disability can be detected based on passive monitoring data | 1 year | .exploratory outcome |
| - Proportion of patients in which a change of IBD medication can be detected based on passive monitoring data | 1 year | Exploratory outcome |
| - Interval between onset of a flare and detection based on passive monitoring data | 1 year | exploratory outcome |
Countries
Belgium
Contacts
Primary ContactPeter Bossuyt, MD PhD
Backup ContactLieven Pouillon, MD
Outcome results
None listed