NCT07299344

A Model for Continuous Care of Fragile Patients

Un Modello di Presa in Carico Continua Del Paziente Fragile

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Azienda Sanitaria Locale CN2 Alba-Bra · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, observational, non-profit study. Primary Objective: To compare functional and cognitive test results at discharge from "La Residenza" rehabilitation center (Rodello - CN- Italy) with remote assessments at patients' homes, demonstrating that Timed Up and Go (TUG) and GPCog tests, validated in-person, can be reliably administered via telemedicine. Secondary Objectives: To monitor motor and cognitive function remotely at 3, 6, and 12 months after discharge, assessing clinical course and disease progression, and evaluating patient condition as stable, improved, or deteriorated. Study Timeline and Sample Size: Recruitment is expected from September 2025 to March 2026, with last follow-up in March 2027 and an additional 6 months for data analysis and publication. A total of 100 patients (50 orthopedic, 50 neurological) will be enrolled, accounting for a 25% expected loss, based on power calculations for paired t-tests comparing in-person and remote assessments.

Conditions

• Neurological Disorders
• Orthopedic Disorders
• Functional Decline
• Fragile and More Vulnerable

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2025-12-01
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2025-12-23
• Last updated: 2025-12-23

Locations

1 site across 1 country: Italy