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

RecruitingNAAges 18 Years - 80 YearsAllGroupe d'Etude Therapeutique des Affections Infla…
NCT06742385 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 monito

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📋 Eligibility rules (as published)
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 (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 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) Patients with any other uncontrolled somatic or psychiatric pathology * Patients enrolled in a trial with an investigational treatment
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What it tests

  • MedicWise
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Where

1 site
Institut des MICI
Neuilly-sur-Seine, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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