Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
| Semeia | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Main objective: To evaluate whether tight control through remote monitoring device improves disease activity compare to standard of care in patients with active Inflammatory Bowel Disease (IBD).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active arm | Experimental | 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. |
|
| Control arm | No Intervention | Both arms are equipped with the application, data are collected via the application and telemonitoring with alerts to the care team are inactivated in the active control arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MedicWise | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 months |
| Average value of IBD disk change from baseline over 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xavier TRETON, Pr | Contact | + 33 (0) 9 72 57 61 60 | projet@getaid.org | |
| GETAID GETAID | Contact | + 33 (0) 9 72 57 61 60 | projet@getaid.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut des MICI | Recruiting | Neuilly-sur-Seine | France | 92200 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Multicenter randomized controlled trial comparing two strategies to following-up patients with active IBD; Active arm: alerts activated, Control arm: alerts disabled
Not provided
Not provided
Not provided
Not provided
|
Average value of IBD disk change from baseline over 12 months
| 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 | 6 and 12 months |
| 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 | 12 months |
| Average value of 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.) change from baseline over 12 months | Average value of 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.) change from baseline over 12 months | 12 months |
| Number of contacts / consultations / hospitalizations during 12 months | Number of contacts / consultations / hospitalizations during 12 months | 12 months |
| Medication and care compliance/consumption over 12 months | Medication and care compliance/consumption over 12 months | 12 months |
| number of complications (AE/SAE, hospitalizations, surgeries) over 12 months | number of complications (AE/SAE, hospitalizations, surgeries) over 12 months | 12 months |
| Satisfaction questionnaires (patients/care team) at M12 | Satisfaction questionnaires (patients/care team) at M12 | 12 months |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |