Neurological DisordersAFTERNCT07299344
A Model for Continuous Care of Fragile Patients
An observational study of Neurological Disorders and Orthopedic Disorders, run by Azienda Sanitaria Locale CN2 Alba-Bra at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurological Disorders, Orthopedic Disorders, Functional Decline
- What is being tested?
- Telemedicine-Based Functional Monitoring
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2025to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 .
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Azienda Sanitaria Locale CN2 Alba-Bra, Ospedale Michele e Pietro Ferrero
Verduno, CN, 12060
About this study
Official title: 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.
Read the 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.
- Conditions
- Neurological Disorders, Orthopedic Disorders, Functional Decline, Fragile and More Vulnerable
- Being tested
- Telemedicine-Based Functional Monitoring
- 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
- Medical subject headings
- Nervous System Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine-Based Functional MonitoringOther
Also called Remote Functional Assessment Protocol, Telemedicine Follow-Up 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Telemedicine-Based Functional Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5-10 days after discharge
Secondary outcomes (7)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 3, 6, and 12 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neurological DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale CN2 Alba-Bra
- Sponsor type
- University, hospital or other
- Collaborators
- Casa di Cura La Residenza di Rodello (CN, Italy)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299344
- Sponsor's protocol ID
- AFTER
- Acronym
- AFTER
- Status last verified
- Dec 2025
- First submitted
- 28 Nov 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 27258421Giavarina D. Understanding Bland Altman analysis. Biochem Med (Zagreb). 2015 Jun 5;25(2):141-51. doi: 10.11613/BM.2015.015. eCollection 2015.
PubMed 26110027Viglino 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.
PubMed 36129554Brodaty 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.
PubMed 11943052van 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.
PubMed 36449413de 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.
PubMed 30976999
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Un Modello di Presa in Carico Continua Del Paziente Fragile
- ClinicalTrials.gov ID
- NCT07299344
- Acronym / sponsor ID
- AFTER / AFTER
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Azienda Sanitaria Locale CN2 Alba-BraUniversity, hospital or other
- Collaborators
- Casa di Cura La Residenza di Rodello (CN, Italy)
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medically Fragile Patients with Neurological or Orthopedic Conditions | – | Other: Telemedicine-Based Functional MonitoringThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 .
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine-Based Functional MonitoringAlso: Remote Functional Assessment Protocol, Telemedicine Follow-Up MonitoringThis 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 | Medically Fragile Patients with Neurological or Orthopedic Conditions |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Background: PubMed 27258421Feeney 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.
- Background: PubMed 26110027Giavarina D. Understanding Bland Altman analysis. Biochem Med (Zagreb). 2015 Jun 5;25(2):141-51. doi: 10.11613/BM.2015.015. eCollection 2015.
- Background: PubMed 36129554Viglino 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.
- Background: PubMed 11943052Brodaty 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.
- Background: PubMed 36449413van 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.
- Background: PubMed 30976999de 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurological Disorders and Orthopedic Disorders, run by Azienda Sanitaria Locale CN2 Alba-Bra at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele Dotta, Dr. (+39.0172.1408670, mdotta@aslcn2.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance Between In-Person and Telemedicine Assessments of Functional and Cognitive Performance (time frame: 5-10 days after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07299344, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.