Fragile and More Vulnerable, Functional Decline, Neurological Disorders, Orthopedic Disorders
Conditions
Keywords
Functional Monitoring, Functional Decline, Medically Fragile Patients, Neurological Disorders, Orthopedic Conditions, Rehabilitation, Proactive Care Model, Continuous Patient Management, Rehabilitation Setting, Early Detection of Functional Changes, telemedicine
Brief 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.
Interventions
OTHERTelemedicine-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.
Sponsors
Casa di Cura La Residenza di Rodello (CN, Italy)
Azienda Sanitaria Locale CN2 Alba-Bra
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General Practitioner Assessment of Cognition (GPCog) Score | 3, 6, and 12 months after discharge | 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) |
| Modified Rankin Scale (mRS) | Baseline and 12 months after discharge | 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) |
| Barthel Index for Activities of Daily Living | Baseline and 12 months after discharge | 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) |
| Timed Up and Go (TUG) Test Performance | 3, 6, and 12 months after discharge | 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) |
| Patient Satisfaction With Remote Monitoring | 3, 6, and 12 months after discharge | 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) |
| Caregiver Satisfaction With Remote Monitoring | 3, 6, and 12 months after discharge | 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) |
| SF-36 Composite Scores (Physical and Mental Component Summaries) | At discharge and 12 months after discharge | 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) |
Countries
Italy
Contacts
Primary ContactMichele Dotta, Dr.
Outcome results
None listed