- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07634757
Mobile Geriatric Unit (MGU) to Reduce Hospitalisations in Nursing Home Residents (MGU)
Mobile Geriatric Unit (MGU) to Reduce Hospitalisations in Nursing Home Residents: A Prospective Observational Before-After Study
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This prospective observational before-after study evaluates the impact of a Mobile Geriatric Unit (MGU) on hospitalisation rates among nursing home residents in Saarland, Germany. The study includes a 12-month control phase with usual care followed by a 12-month intervention phase with MGU implementation in 46 nursing homes.
The MGU provides on-site advanced diagnostics (CT, X-ray, ultrasound, ECG, EEG, and laboratory testing) supported by telemedicine consultation with hospital specialists. A physician and radiology technician perform diagnostics in the nursing home, with results communicated to the general practitioner for treatment decisions within 48 hours.
Usual care involves hospital referral and in-hospital diagnostics. The intervention aims to reduce avoidable hospital admissions by providing diagnostics and specialist input directly in the nursing home.
The primary outcome is hospital admissions per person-year. Secondary outcomes include mortality, functional and cognitive status, quality of life (EQ-5D-5L), complications, healthcare costs, and 30-day hospitalisation-free survival.
Eligible participants are nursing home residents with consent or proxy consent; those requiring immediate hospitalisation are excluded.
Data are obtained from routine care and medical records, MGU documentation, structured assessments, and follow-up. Multilevel Poisson regression and interrupted time series analysis will be used.
The study was approved by the Ethics Committee of Saarland (AZ 159-21) and conducted in accordance with the Declaration of Helsinki.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Klaus Fassbender, Professor
- Numero di telefono: +49 681 302 75027
- Email: klaus.fassbender@uks.eu
Backup dei contatti dello studio
- Nome: Silke Walter
- Email: silke.walter@uni-saarland.de
Luoghi di studio
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Saarland
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Homburg, Saarland, Germania, 66421
- Nursing Homes in Saarland
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Residents of participating nursing homes
- Informed consent from participant or legal representative
Exclusion Criteria:
- Acute life-threatening conditions requiring immediate hospitalisation
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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Control Phase (Usual Care)
Usual care including general practitioner (GP) referral, hospital transport, and in-hospital diagnostics and treatment.
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|
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Intervention Phase (MGU)
On-site diagnostic evaluation using the Mobile Geriatric Unit with broad diagnostic capabilities followed by teleconsultation and further treatment by the general practitioner.
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The MGU is a mobile diagnostic unit providing on-site diagnostics in nursing homes.
It includes a 32-slice (64 slice reconstruction) whole body CT scanner, digital X-ray, portable ultrasound, ECG, EEG, and point-of-care laboratory diagnostics.
A physician and radiology technician perform diagnostics on-site.
Results are transmitted via telemedicine to hospital specialists and communicated to the general practitioner for treatment decisions within 48 hours.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Hospital admissions per person-year
Lasso di tempo: Up to 24 months
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Number of inpatient hospital admissions, excluding elective admissions.
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Up to 24 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Mortality
Lasso di tempo: Day 180
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Mortality
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Day 180
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Functional status; mobility: modified Rankin Scale (mRS)
Lasso di tempo: Day 180
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Modified Rankin Scale (mRS): 0: No symptoms
Minimum value: 0 (best outcome) Maximum value: 6 (worst outcome) |
Day 180
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Functional status; frailty: Clinical Frailty Scale
Lasso di tempo: Day 180
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Clinical Frailty Scale (as according to Moorhouse and Rockwood*):
Minimum value: 1 (best outcome) Maximum value: 9 (worst outcome) * Moorhouse P, Rockwood K. Frailty and its quantitative clinical evaluation. J R Coll Physicians Edinb 2012; 42: 333-40 |
Day 180
|
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Cognitive status
Lasso di tempo: Day 180
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The cognitive performance assessment is carried out through subjective evaluation by the nursing home's nursing staff at day 180.
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Day 180
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Quality of life (EQ-5D-5L)
Lasso di tempo: Day 180
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EQ-5D-5L
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Day 180
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Healthcare costs
Lasso di tempo: Day 360
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Hospitalisation, transport, and MGU costs
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Day 360
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30-day hospitalisation-free survival
Lasso di tempo: Day 30
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Hospitalisation-free survival at day 30
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Day 30
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Klaus Fassbender, Professor, Universität Des Saarlandes
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- MGU
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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