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.
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.
Study Type
OBSERVATIONAL
Enrollment
100
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.
Azienda Sanitaria Locale CN2 Alba-Bra, Ospedale Michele e Pietro Ferrero
Verduno, CN, Italy
Concordance Between In-Person and Telemedicine Assessments of Functional and Cognitive Performance
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.
Time frame: 5-10 days after discharge
Timed Up and Go (TUG) Test Performance
The Timed Up and Go (TUG) test assesses functional mobility by measuring the time it takes (in seconds) for a participant to stand up from a chair, walk 3 meters, turn, walk back, and sit down. Lower times indicate better functional mobility. Unit of Measure: Seconds (s)
Time frame: 3, 6, and 12 months after discharge
General Practitioner Assessment of Cognition (GPCog) Score
General Practitioner Assessment of Cognition (GPCog), total score range 0-9. Higher scores indicate better cognitive functioning. Unit of Measure: Score on a scale (0-9)
Time frame: 3, 6, and 12 months after discharge
Modified Rankin Scale (mRS)
Modified Rankin Scale score assessing global disability. Range 0-6, where 0 = no symptoms and 6 = death. Higher scores indicate worse disability. Unit of Measure: Score on a scale (0-6)
Time frame: Baseline and 12 months after discharge
Barthel Index for Activities of Daily Living
Barthel Index score assessing independence in activities of daily living. Range 0-100. Higher scores indicate greater independence. Unit of Measure: Score on a scale (0-100)
Time frame: Baseline and 12 months after discharge
SF-36 Composite Scores (Physical and Mental Component Summaries)
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Short Form-36 (SF-36) Health Survey assessing quality of life across multiple domains. Scores range 0-100 for each domain. Higher scores indicate better perceived health status. Unit of Measure: Score on a scale (0-100)
Time frame: At discharge and 12 months after discharge
Patient Satisfaction With Remote Monitoring
Patient satisfaction assessed using a validated satisfaction questionnaire (e.g., Likert scale 1-5). Higher scores indicate greater satisfaction. Unit of Measure: Score on a Likert scale (1-5)
Time frame: 3, 6, and 12 months after discharge
Caregiver Satisfaction With Remote Monitoring
Caregiver satisfaction assessed using a validated satisfaction questionnaire (e.g., Likert scale 1-5). Higher scores indicate greater satisfaction. Unit of Measure: Score on a Likert scale (1-5)
Time frame: 3, 6, and 12 months after discharge