A Model for Continuous Care of Fragile Patients

Official title

Un Modello di Presa in Carico Continua Del Paziente Fragile

Overview

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

• 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 fu

Primary outcome measures

• Concordance Between In-Person and Telemedicine Assessments of Functional and Cognitive Performance [Time frame: 5-10 days after discharge]

Secondary outcome measures (7)

• Timed Up and Go (TUG) Test Performance [Time frame: 3, 6, and 12 months after discharge]
• General Practitioner Assessment of Cognition (GPCog) Score [Time frame: 3, 6, and 12 months after discharge]
• Modified Rankin Scale (mRS) [Time frame: Baseline and 12 months after discharge]
• Barthel Index for Activities of Daily Living [Time frame: Baseline and 12 months after discharge]
• SF-36 Composite Scores (Physical and Mental Component Summaries) [Time frame: At discharge and 12 months after discharge]
• Patient Satisfaction With Remote Monitoring [Time frame: 3, 6, and 12 months after discharge]
• Caregiver Satisfaction With Remote Monitoring [Time frame: 3, 6, and 12 months after discharge]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 1 center

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

Publications

• 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. PMID 27258421
• Giavarina D. Understanding Bland Altman analysis. Biochem Med (Zagreb). 2015 Jun 5;25(2):141-51. doi: 10.11613/BM.2015.015. eCollection 2015. PMID 26110027
• 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. PMID 36129554
• 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. PMID 11943052
• 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. PMID 36449413
• 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. PMID 30976999

Identifiers

NCT: NCT07299344 · AFTER

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗