Clinical trial NCT06742385: Evaluation of a Remote Monitoring Application in the Follow-up of Patients With Active Inflammatory Bowel Diseases
Official title: Evaluation of a Remote Monitoring Application in the Follow-up of Patients With Active Inflammatory Bowel Diseases: The SECURITY Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Crohn Disease
Ulcerative Colitis
Lead sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter randomized controlled trial comparing two strategies to following-up patients with active IBD; Active arm: alerts activated, Control arm: alerts disabled
Primary purpose: OTHER

Brief summary: Telemonitoring is of definite theoretical interest for patients suffering from chronic diseases and could help to improve monitoring of treatment efficacy and tolerance, and hence remission and quality of life. Reimbursement is now planned in France for devices that have demonstrated a positive effect on patient intake. However, available studies testing different tools in IBD have shown no significant improvement in disease control or quality of life. Nevertheless, major secondary endpoints such as reduced hospitalization, complications and healthcare costs have been demonstrated. Several biases have been identified to explain these disappointing results, such as the heterogeneity of the tools/applications tested, methodological limitations concerning the main objective and technological limitations of the tools evaluated.

We propose here to evaluate a new remote monitoring tool, MedicWise, in the follow-up of patients with active IBD. The technology Rationale / background Telemonitoring is of definite theoretical interest for patients suffering from chronic diseases and could help to improve monitoring of treatment efficacy and tolerance, and hence remission and quality of life. Reimbursement is now planned in France for devices that have demonstrated a positive effect on patient intake. However, available studies testing different tools in IBD have shown no significant improvement in disease control or quality of life. Nevertheless, major secondary endpoints such as reduced hospitalization, complications and healthcare costs have been demonstrated. Several biases have been identified to explain these disappointing results, such as the heterogeneity of the tools/applications tested, methodological limitations concerning the main objective and technological limitations of the tools evaluated.

We propose here to evaluate a new remote monitoring tool, MedicWise, in the follow-up of patients with active IBD. The technology of this solution enables the automatic collection of a wide range of biological and healthcare consumption data, thus limiting the need for patient input. The SECURITY trial proposes to evaluate the impact of this remote monitoring tool on time spent in remission. Improvement of IBD related disability is also a major secondary objective of the study. It also has the following secondary objectives to analyze the impact of this tool on the organization of care teams caring for patients with IBD.

Main objective: To evaluate whether a remote monitoring device (MedicWise) improves disease activity (ie symptomatic remission) in patients with active Inflammatory Bowel Disease (IBD).


Eligibility criteria: Inclusion Criteria:

* CD/UC patients with a validated diagnosis
* Patients age \> 18 years
* IBD with clinical signs of PRO2 activity leading to modification of medical treatment: introduction of a new treatment, or change of dose or addition of a treatment (corticoids, ASA, IS, biotherapy)
* Patients equipped with a smartphone and agreeing to use it for the purpose of the study.
* Patients agreeing to participate for 52 weeks

Exclusion Criteria:

* Patients with an inability to use a smartphone and email
* Patients \< 18 years old
* Digestive surgery expected within 3 months
* Pregnancy at baseline
* Patients with an history of sub-total colectomy, coloproctectomy, digestive ostomy, extensive or multiple intestinal resections with sequelae of diarrhoea, short bowel syndrome.
* Patients who have had recent digestive surgery (ileal resection \< 6 months)

Primary outcomes:
measure: Proportion of time spent in clinical remission without symptoms within 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Absolute change in IBD Disk mean value between inclusion and M12
timeFrame: 12 months
measure: Average value of IBD disk change from baseline over 12 months
timeFrame: 12 months
measure: PR02 at M6 and M12
timeFrame: 6 and 12 months
measure: S-IBDQ delta mean value between inclusion and M12
timeFrame: 12 months
measure: Average value of S-IBDQ change from baseline over 12 months
timeFrame: 12 months
measure: Number of contacts / consultations / hospitalizations during 12 months
timeFrame: 12 months
measure: Medication and care compliance/consumption over 12 months
timeFrame: 12 months
measure: number of complications (AE/SAE, hospitalizations, surgeries) over 12 months
timeFrame: 12 months
measure: Satisfaction questionnaires (patients/care team) at M12
timeFrame: 12 months
Other outcomes:
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