Evaluation of a Remote Monitoring Application in the Follow-up of Patients With Active Inflammatory Bowel Diseases

Официальное название

Evaluation of a Remote Monitoring Application in the Follow-up of Patients With Active Inflammatory Bowel Diseases: The SECURITY Trial

Обзор

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.

Подробное описание

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).

Вмешательства

• Устройство MedicWise
  * 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 dur

Первичные конечные точки

• Percentage of cumulative time spent in symptomatic remission within 12 months [Срок оценки: 12 months]

Вторичные конечные точки (9)

• Average value of IBD disk change from baseline over 12 months (M3, M6, M9 and M12) [Срок оценки: 12 months]
• Average value of IBD disk change from baseline over 12 months [Срок оценки: 12 months]
• Patient report outcomes (PR02), questionnaire to assess this outcome measure at M6 and M12 [Срок оценки: 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.) [Срок оценки: 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 [Срок оценки: 12 months]
• Number of contacts / consultations / hospitalizations during 12 months [Срок оценки: 12 months]
• Medication and care compliance/consumption over 12 months [Срок оценки: 12 months]
• number of complications (AE/SAE, hospitalizations, surgeries) over 12 months [Срок оценки: 12 months]
• Satisfaction questionnaires (patients/care team) at M12 [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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 agreeing to participate for 12 months

Критерии исключения

• 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) Patients with any other uncontrolled somatic or psychiatric pathology
• Patients enrolled in a trial with an investigational treatment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Institut des MICI — Neuilly-sur-Seine

Идентификаторы

NCT: NCT06742385 · GETAID-2023-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗