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| Name | Class |
|---|---|
| Casa di Cura La Residenza di Rodello (CN, Italy) | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion criteria:
Exclusion criteria:
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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 .
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michele Dotta, Dr. | Contact | +39.0172.1408670 | mdotta@aslcn2.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Sanitaria Locale CN2 Alba-Bra, Ospedale Michele e Pietro Ferrero | Verduno | CN | 12060 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27258421 | Background | 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. | |
| 26110027 |
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| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009140 | Musculoskeletal Diseases |
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| 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 |
| Giavarina D. Understanding Bland Altman analysis. Biochem Med (Zagreb). 2015 Jun 5;25(2):141-51. doi: 10.11613/BM.2015.015. eCollection 2015. |
| 36129554 | 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. |
| 11943052 | 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. |
| 36449413 | 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. |
| 30976999 | 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. |