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

Not Applicable

Not yet recruiting

• Conditions: Crohn Disease; Ulcerative Colitis

• Registration Number: NCT06742385
• Lead Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-18
• Last Update Submitted: 2024-12-18
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19
• Study Start: 2025-01-15
• Primary Completion: 2027-01-15
• Study Completion: 2028-01-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 290

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of time spent in clinical remission without symptoms within 12 months	12 months	Proportion of time spent in clinical remission without symptoms within 12 months; Time spent in clinical remission over 12 months 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

Secondary Outcome Measures

Name	Time	Method
Absolute change in IBD Disk mean value between inclusion and M12	12 months	Absolute change in IBD Disk mean value between inclusion and M12
Average value of IBD disk change from baseline over 12 months	12 months	Average value of IBD disk change from baseline over 12 months
PR02 at M6 and M12	6 and 12 months	PR02 at M6 and M12
S-IBDQ delta mean value between inclusion and M12	12 months	S-IBDQ delta mean value between inclusion and M12
Average value of S-IBDQ change from baseline over 12 months	12 months	Average value of S-IBDQ change from baseline over 12 months
Number of contacts / consultations / hospitalizations during 12 months	12 months	Number of contacts / consultations / hospitalizations during 12 months
Medication and care compliance/consumption over 12 months	12 months	Medication and care compliance/consumption over 12 months
number of complications (AE/SAE, hospitalizations, surgeries) over 12 months	12 months	number of complications (AE/SAE, hospitalizations, surgeries) over 12 months
Satisfaction questionnaires (patients/care team) at M12	12 months	Satisfaction questionnaires (patients/care team) at M12