A Model for Continuous Care of Fragile Patients

NCT07299344 | Not Yet Recruiting

• 1 other identifier: AFTER
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Functional Monitoring; Functional Decline; Medically Fragile Patients; Neurological Disorders; Orthopedic Conditions; Rehabilitation; Proactive Care Model; Continuous Patient Management; Rehabilitation Setting; Early Detection of Functional Changes; telemedicine

Outcome Measures

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.

  5-10 days after discharge

Secondary Outcomes (7)

• Timed Up and Go (TUG) Test Performance

  3, 6, and 12 months after discharge

• General Practitioner Assessment of Cognition (GPCog) Score

  3, 6, and 12 months after discharge

• Modified Rankin Scale (mRS)

  Baseline and 12 months after discharge

• Barthel Index for Activities of Daily Living

  Baseline and 12 months after discharge

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

  At discharge and 12 months after discharge

Study Arms (1)

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

Interventions

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.

Also known as: Remote Functional Assessment Protocol, Telemedicine Follow-Up Monitoring

Medically Fragile Patients with Neurological or Orthopedic Conditions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 .

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Verduno, CN, 12060, Italy

Location

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Nervous System Diseases; Musculoskeletal Diseases

Central Study Contacts

Michele Dotta, Dr.

CONTACT

+39.0172.1408670; mdotta@aslcn2.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 23, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

IT (1)