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Starting soon Observational

A Model for Continuous Care of Fragile Patients

NCT07299344 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-12
Last updated
2025-12-23

Condition(s) studied

Neurological DisordersOrthopedic DisordersFunctional DeclineFragile and More Vulnerable

Investigational drug(s) / intervention(s)

Telemedicine-Based Functional Monitoring

Telemedicine-Based Functional Monitoring: This intervention provides structured functional monitoring of medically fragile patients with neurological and/or orthopedic conditions using telemedicine. Patients undergo MMSE, Rankin Scale, Barthel Index, TUG, GPCog, and SF-36 assessments at discharge and during follow-up at 3, 6, and 12 months. Patient and caregiver satisfaction with remote monitoring is also evaluated. All remote assessments are performed via the TESI eViSus BioCare® system on mobile devices, allowing early detection of functional decline and supporting proactive patient management.

Study summary

This observational study aims to monitor functional status and identify potential declines in the functioning of medically fragile patients with neurological and/or orthopedic conditions, representing an added value for ensuring appropriate patient management. This approach improves system efficiency and supports a proactive strategy that promotes the appropriate use of resources.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria: * Adult medically fragile patients with one of the following neurological conditions: mild-to-moderate stroke (Rankin ≤ 3), Multiple Sclerosis (EDSS ≤ 6.5), Parkinson's disease or parkinsonisms, neuromuscular diseases; or orthopedic conditions: femur, pelvis, or humerus fracture. * Able to walk independently, with or without assistive devices. * Adequate cognitive function (MMSE ≥ 24). * Patient or caregiver owns and can use a mobile device with internet/data connection. * Presence of a cognitively capable, cooperative caregiver willing to participate in the study. Exclusion criteria: * Patients with severe neurological or orthopedic conditions who cannot walk independently, even with assistive devices. * Patients with moderate or severe cognitive impairment (MMSE \< 24). * Patients with Barthel Index \> 60. * Patients or caregivers unable to use a mobile device or without internet/data connection. * Patients without a cooperative, cognitively capable caregiver.

Primary outcome measure(s)

  • Concordance Between In-Person and Telemedicine Assessments of Functional and Cognitive Performance — 5-10 days after discharge
    Percentage of patients for whom the Timed Up and Go (TUG) test differs by less than 3.5 seconds and the GPCog test differs by less than 3 points between in-person and telemedicine assessments.

Trial sites (1)

FacilityCityRegionStatus
Azienda Sanitaria Locale CN2 Alba-Bra, Ospedale Michele e Pietro Ferrero Verduno CN
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07299344 on ClinicalTrials.gov ↗ ← All trials in Italy