Multiple Digital Biomarkers for Optimization of IBD Care

ConditionsCrohn Disease (CD)Ulcerative Colitis (UC)Inflammatory Bowel Disease (IBD)

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorImelda GI Clinical Research Center

About this trial

To develop digital biomarkers associated with disease activity of inflammatory bowel disease

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

This is an open label observational trial with partially blinded data collection (wearable and shopping data blinded for the patient and treating HCP). Patients in the study will not be randomized. Patients will be recruited via planned outpatient visits and day clinic admissions. Patients will be allocated to one of the three target patient groups at the investigator's discretion. 1. Patients with IBD in longstanding remission (\>2 years) (maximum of 20 patients) 2. Patients with IBD recent event (diagnosis or flare of IBD) (\<1year) (minimum 20 patients) 3. Additional patients with IBD in standard follow up. From the moment 60 patients are included, no additional patients can be recruited in group 1 or 3 prior to completion of group 2.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

monitoring of wearable data, shopping data, biomarkers and patient reported outcomes
Device
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

Treatment groups

80 Participants

are divided into 1 treatment group

Group A: Patients with IBD1 intervention

Trial outcomes

Primary outcomes

Proportion of patients in which a flare can be detected based on passive monitoring data.

Time frame

1 year

Secondary outcomes

Proportion of patients in which a biomarker flare can be detected based on passive monitoring data

Time frame

1 year

Proportion of patients in which an objective disease flare (combination of flare and biomarker flare) can be detected based on passive monitoring

Time frame

1 year

Proportion of patients in which a flare can be detected based on food purchase data

Time frame

1 year

Proportion of patients in which a biomarker flare can be detected based on food purchase data

Time frame

1 year

Other outcomes

- Interval between onset of a flare and detection based on passive monitoring data

exploratory outcome

Time frame

1 year

- Subgroup analysis based on the food frequency questionnaire

Exploratory outcome

Time frame

1 year

- Patient satisfaction based on patient experience questionnaire

Exploratory outcome

Time frame

1 year

- Proportion of patients in which (different levels of) disability can be detected based on passive monitoring data

.exploratory outcome

Time frame

1 year

Sponsors and contacts

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

Imelda GI Clinical Research Center

Lead sponsor

Agentschap Innoveren & Ondernemen (VLAIO)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: