- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Klaus Fassbender, Professor
- Telefonnummer: +49 681 302 75027
- E-mail: klaus.fassbender@uks.eu
Undersøgelse Kontakt Backup
- Navn: Silke Walter
- E-mail: silke.walter@uni-saarland.de
Studiesteder
-
-
Saarland
-
Homburg, Saarland, Tyskland, 66421
- Nursing Homes in Saarland
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Residents of participating nursing homes
- Informed consent from participant or legal representative
Exclusion Criteria:
- Acute life-threatening conditions requiring immediate hospitalisation
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Control Phase (Usual Care)
Usual care including general practitioner (GP) referral, hospital transport, and in-hospital diagnostics and treatment.
|
|
|
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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Hospital admissions per person-year
Tidsramme: Up to 24 months
|
Number of inpatient hospital admissions, excluding elective admissions.
|
Up to 24 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mortality
Tidsramme: Day 180
|
Mortality
|
Day 180
|
|
Functional status; mobility: modified Rankin Scale (mRS)
Tidsramme: Day 180
|
Modified Rankin Scale (mRS): 0: No symptoms
Minimum value: 0 (best outcome) Maximum value: 6 (worst outcome) |
Day 180
|
|
Functional status; frailty: Clinical Frailty Scale
Tidsramme: Day 180
|
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
|
|
Cognitive status
Tidsramme: Day 180
|
The cognitive performance assessment is carried out through subjective evaluation by the nursing home's nursing staff at day 180.
|
Day 180
|
|
Healthcare costs
Tidsramme: Day 360
|
Hospitalisation, transport, and MGU costs
|
Day 360
|
|
30-day hospitalisation-free survival
Tidsramme: Day 30
|
Hospitalisation-free survival at day 30
|
Day 30
|
|
Quality of life (EQ-5D-5L)
Tidsramme: Day 180
|
EQ-5D-5L is a standardised measure of health-related quality of life developed by the EuroQol Group and assesses health status in terms of five dimensions of health. The five levels in each dimension are worded as (1) 'not /no problems', (2) 'slight problems', (3) 'moderate problems', (4) 'severe problems' and (5) 'unable to' (mobility, self-care, usual activities), 'extreme' (pain/depression), or 'extremely' (anxiety/depression). Minimum value: 1 (best outcome) Maximum value: 5 (worst outcome) |
Day 180
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Klaus Fassbender, Professor, Universität des Saarlandes
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- MGU
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .