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SECURITYNCT06742385

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

StatusActive, Not Recruiting
PhaseNot applicable
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 12 words
    • Enrollment closed, study ongoing
    • Secondary endpoints: details revised at 5 of 9 entries
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 9 more changesShow less
    • Primary completion date: Jan 15, 2027 to Sep 18, 2027
    • Start date changed from estimate of Jan 15, 2025 to Sep 18, 2025
    • Eligibility criteria expanded, about 26 words
    • Primary endpoint revised
    • Study sites: 0 to 1
    • Study completion date: Jan 15, 2028 to Sep 18, 2028
    • Secondary endpoints revised (9)
    • Study description expanded, about 273 words
    • Collaborators expanded, about 2 words
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Percentage of cumulative time spent in symptomatic remission within 12 months
Timeframe: 12 months

Secondary (9)

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
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.)
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
Show 4 moreShow less
Number of contacts / consultations / hospitalizations during 12 months
Medication and care compliance/consumption over 12 months
number of complications (AE/SAE, hospitalizations, surgeries) over 12 months
Satisfaction questionnaires (patients/care team) at M12

Arms and interventions

Active armExperimental

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 armNo 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.

Devices: MedicWise

Sites

1 site in 1 country

  • Institut des MICINeuilly-sur-Seine, France, France