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A Model for Continuous Care of Fragile Patients

ConditionsNeurological DisordersOrthopedic DisordersFunctional DeclineFragile and More Vulnerable
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Sanitaria Locale CN2 Alba-Bra

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Medically fragile patients with various neurological or orthopedic conditions will be recruited from Casa di Cura "La Residenza" in Rodello (CN - Italy) for intensive rehabilitation. Patients will come from the Neurology and Orthopedics Units of Michele e Pietro Ferrero Hospital in Verduno (CN - Italy) - ASL CN2 .

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Telemedicine-Based Functional Monitoring

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Medically Fragile Patients with Neurological or Orthopedic Conditions1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda Sanitaria Locale CN2 Alba-Bra

Lead sponsor

Casa di Cura La Residenza di Rodello (CN, Italy)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: