A Model for Continuous Care of Fragile Patients (AFTER)

Un Modello di Presa in Carico Continua Del Paziente Fragile

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neurological Disorders; Orthopedic Disorders; Functional Decline; Fragile and More Vulnerable
• Intervention / Treatment: Other: Telemedicine-Based Functional Monitoring

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Michele Dotta, Dr.; Phone Number: +39.0172.1408670; Email: mdotta@aslcn2.it

Study Locations

• Italy
  • CN
    • Verduno, CN, Italy, 12060
      • Azienda Sanitaria Locale CN2 Alba-Bra, Ospedale Michele e Pietro Ferrero

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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 .

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Medically Fragile Patients with Neurological or Orthopedic Conditions; 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.

Other: Telemedicine-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.; Other Names: Remote Functional Assessment Protocol; Telemedicine Follow-Up Monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5-10 days after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	Baseline and 12 months after discharge
SF-36 Composite Scores (Physical and Mental Component Summaries)	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)	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)	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)	3, 6, and 12 months after discharge

Collaborators and Investigators

• Sponsor: Azienda Sanitaria Locale CN2 Alba-Bra
• Collaborators: Casa di Cura La Residenza di Rodello (CN, Italy)

Publications and helpful links

General Publications

• van Dyck CH, Swanson CJ, Aisen P, Bateman RJ, Chen C, Gee M, Kanekiyo M, Li D, Reyderman L, Cohen S, Froelich L, Katayama S, Sabbagh M, Vellas B, Watson D, Dhadda S, Irizarry M, Kramer LD, Iwatsubo T. Lecanemab in Early Alzheimer's Disease. N Engl J Med. 2023 Jan 5;388(1):9-21. doi: 10.1056/NEJMoa2212948. Epub 2022 Nov 29.
• Feeney J, Savva GM, O'Regan C, King-Kallimanis B, Cronin H, Kenny RA. Measurement Error, Reliability, and Minimum Detectable Change in the Mini-Mental State Examination, Montreal Cognitive Assessment, and Color Trails Test among Community Living Middle-Aged and Older Adults. J Alzheimers Dis. 2016 May 31;53(3):1107-14. doi: 10.3233/JAD-160248.
• Giavarina D. Understanding Bland Altman analysis. Biochem Med (Zagreb). 2015 Jun 5;25(2):141-51. doi: 10.11613/BM.2015.015. eCollection 2015.
• Viglino G, Neri L, Barbieri S, Tortone C. Peritoneal dialysis training performed remotely: results and comparison with Home Training. Clin Exp Nephrol. 2023 Jan;27(1):72-78. doi: 10.1007/s10157-022-02276-z. Epub 2022 Sep 21.
• Brodaty H, Pond D, Kemp NM, Luscombe G, Harding L, Berman K, Huppert FA. The GPCOG: a new screening test for dementia designed for general practice. J Am Geriatr Soc. 2002 Mar;50(3):530-4. doi: 10.1046/j.1532-5415.2002.50122.x.
• de Joode SGCJ, Kalmet PHS, Fiddelers AAA, Poeze M, Blokhuis TJ. Long-term functional outcome after a low-energy hip fracture in elderly patients. J Orthop Traumatol. 2019 Apr 11;20(1):20. doi: 10.1186/s10195-019-0529-z.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Rehabilitation; telemedicine; Neurological Disorders; Functional Decline; Functional Monitoring; Medically Fragile Patients; Orthopedic Conditions; Proactive Care Model; Continuous Patient Management; Rehabilitation Setting; Early Detection of Functional Changes
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases
• Other Study ID Numbers: AFTER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No