A Model for Continuous Care of Fragile Patients (AFTER)

Azienda Sanitaria Locale CN2 Alba-Bra

Status: Not yet enrolling

Conditions: Fragile and More Vulnerable; Neurological Disorders; Orthopedic Disorders; Functional Decline

Treatments: Other: Telemedicine-Based Functional Monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT07299344

AFTER

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Medically Fragile Patients with Neurological or Orthopedic Conditions

Description:

This cohort includes medically fragile adult patients with mild-to-moderate neurological or orthopedic conditions who are able to ambulate independently with or without assistive devices. Eligible neurological conditions include mild-to-moderate stroke (mRS ≤ 3), Multiple Sclerosis (EDSS ≤ 6.5), Parkinson's disease or parkinsonisms, and neuromuscular diseases. Eligible orthopedic conditions include femur, pelvis, or humerus fractures. Participants must have adequate cognitive function (MMSE ≥ 24) and the presence of a cognitively capable caregiver.

Treatment:

Other: Telemedicine-Based Functional Monitoring