- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
개입 / 치료
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Klaus Fassbender, Professor
- 전화번호: +49 681 302 75027
- 이메일: klaus.fassbender@uks.eu
연구 연락처 백업
- 이름: Silke Walter
- 이메일: silke.walter@uni-saarland.de
연구 장소
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Saarland
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Homburg, Saarland, 독일, 66421
- Nursing Homes in Saarland
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Residents of participating nursing homes
- Informed consent from participant or legal representative
Exclusion Criteria:
- Acute life-threatening conditions requiring immediate hospitalisation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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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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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hospital admissions per person-year
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mortality
기간: Day 180
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Mortality
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Day 180
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Functional status; mobility: modified Rankin Scale (mRS)
기간: 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
기간: 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
기간: 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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Healthcare costs
기간: 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
기간: Day 30
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Hospitalisation-free survival at day 30
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Day 30
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Quality of life (EQ-5D-5L)
기간: Day 180
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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
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Klaus Fassbender, Professor, Universität des Saarlandes
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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기타 연구 ID 번호
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