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NCT Number: NCT07299344

A Model for Continuous Care of Fragile Patients

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.

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Key information

Conditions

Neurological Disorders Fragile and More Vulnerable Functional Decline Musculoskeletal Diseases Nervous System Diseases Orthopedic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Sanitaria Locale CN2 Alba-Bra, Ospedale Michele e Pietro Ferrero

Verduno, CN, 12060, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telemedicine-Based Functional Monitoring

Other

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.

Other names: Remote Functional Assessment Protocol, Telemedicine Follow-Up Monitoring

Primary outcomes

  1. Concordance Between In-Person and Telemedicine Assessments of Functional and Cognitive Performance

    Time frame: 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 outcomes

  1. Timed Up and Go (TUG) Test Performance

    Time frame: 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)

  2. General Practitioner Assessment of Cognition (GPCog) Score

    Time frame: 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)

  3. Modified Rankin Scale (mRS)

    Time frame: 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)

  4. Barthel Index for Activities of Daily Living

    Time frame: 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)

  5. SF-36 Composite Scores (Physical and Mental Component Summaries)

    Time frame: 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)

  6. Patient Satisfaction With Remote Monitoring

    Time frame: 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)

  7. Caregiver Satisfaction With Remote Monitoring

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Michele Dotta, Dr.

CONTACT

[email protected]

+39.0172.1408670

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria Locale CN2 Alba-Bra

Other

Collaborators

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

Registry information

Official study title

Un Modello di Presa in Carico Continua Del Paziente Fragile

Acronym: AFTER

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 23, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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