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 the impact of a tight remote monitoring through digital tool on disease control, in patients with active IBD, thanks to the MedicWise platform. The technology of the MedicWise solution enables the automatic collection of a wide range of biological and healthcare consumption data, thus limiting the need for patient input. MedicWise has obtained the CE label and is already used and reimbursed in France in other chronic diseases. The SECURITY trial proposes to evaluate the impact of a tight remote monitoring through digital 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.
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 (a 4 week induction phase is authorized
Patients willing and able to participate in the collection of data via SEMEIA App on their smartphone
Patients with an inability to use a smartphone and email
Patients < 18 years old
Digestive surgery expected within 3 months
Pregnancy at baseline
Parallel
MedicWise
Device* Both arms are equipped with the application, data are collected via the application and telemonitoring with alerts to the care team are activated in the active telemonitoring arm. * Data are collected in both arms at baseline, M3, M6, M9 and M12 * Each center defines who handles alerts internally (physicians, IBD nurses, others, etc.) according to its internal organization. The application does not impose an internal operation. * the alert thresholds are identical and fixed for all centers during the study. Within the framework of the study, alerts are defined according to the study's modalities but cannot be modified by the centers. * Participating sites will have no obligation to respond to alerts. * Randomization will be stratified by centers and by diseases (Crohn and UC) with unbalanced blocks of randomization
Percentage of cumulative time spent in symptomatic remission within 12 months
Percentage of cumulative time spent in symptomatic remission within 12 months Time spent in symptomatic remission defined by (PRO2): MC: abdominal pain ≤ 1 and stool frequency ≤ 3 defined clinical remission in CD, both not worsening compared from inclusion UC: absence of rectal bleeding (score 0) and stool frequency score ≤ 1, both not worsening compared with inclusion
Average value of IBD disk change from baseline over 12 months (M3, M6, M9 and M12)
Average value of IBD disk change from baseline over 12 months (M3, M6, M9 and M12)
Average value of IBD disk change from baseline over 12 months
Average value of IBD disk change from baseline over 12 months
Patient report outcomes (PR02), questionnaire to assess this outcome measure at M6 and M12
Patient report outcomes (PR02), questionnaire to assess this outcome measure at M6 and M12
Short Inflammatory Bowel Disease (S-IBDQ) delta mean value between inclusion and M12 (The total score ranges from 10 to 70, with the higher the score, the better the quality of life.)
Short Inflammatory Bowel Disease (S-IBDQ) delta mean value between inclusion and M12
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Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Lead sponsor
AbbVie
Collaborator
Semeia
Collaborator
