Virtual Stroke Units Versus Conventional Stroke Unit Care in Non-Thrombectomy-Candidate Patients. (VSU)
Virtual Stroke Units Versus Conventional Stroke Unit Care in Non-Thrombectomy-Candidate Patients: A Non-Inferiority Prospective Cohort Study
Stroke is the leading cause of acquired disability in adults and a major cause of mortality worldwide; in Spain, Andalusia shows the highest stroke-related mortality rate. Comprehensive Stroke Units (SU) are the gold-standard organizational model for acute stroke care; however, only a fraction of patients have direct access to an SU, particularly those not eligible for mechanical thrombectomy who are admitted to regional or district hospitals without on-site SU capacity.
The Virtual Stroke Unit (VSU) concept extends specialized stroke care to non-SU hospitals by combining standardized in-hospital monitoring boxes with synchronous remote multidisciplinary assessment by a stroke neurologist and stroke nurse from a reference center, via the regional telemedicine platform (CATI).
This prospective, multicenter, non-inferiority cohort study compares effectiveness, safety, and feasibility of VSU care versus conventional SU care in patients with acute ischemic or hemorrhagic stroke who are not candidates for mechanical thrombectomy. Recruitment targets 363 patients per arm (726 total). The primary outcome is death or dependency at 3 months (modified Rankin Scale 3-6) - the canonical measure of stroke-unit effectiveness - with functional independence (mRS 0-2), adherence to the stroke-unit care quality bundle, safety, mortality, recurrence, length of stay, satisfaction (TUQ/TSQ/TMPQ) and cost-effectiveness as secondary outcomes.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Background. Stroke Units reduce mortality and dependence in acute stroke patients regardless of stroke subtype, severity, age or sex. However, in Andalusia, only a small proportion of acute stroke patients are admitted to an SU; many patients who are not candidates for mechanical thrombectomy remain hospitalized in non-SU wards of regional hospitals, with limited access to structured stroke-specific multidisciplinary care.
Rationale. Telemedicine-supported organizational models have shown promise to bridge the access gap for time-sensitive stroke care. The Virtual Stroke Unit (VSU) is a novel organizational model that combines (i) standardized monitoring boxes in non-SU hospitals with predefined nursing protocols, (ii) a daily synchronous joint visit between the local team and the reference SU team via the CATI telemedicine platform, and (iii) structured remote follow-up and discharge planning. The VSU model has not been formally evaluated in a comparative prospective study.
Objectives. Primary: to test whether VSU care is non-inferior to conventional SU care for 3-month functional outcome (mRS) in patients with acute stroke not eligible for mechanical thrombectomy. Secondary: to evaluate safety (in-hospital complications, mortality), efficiency (length of stay, inter-hospital transfers), patient and provider satisfaction (TUQ/TSQ/TMPQ), 1-year functional outcome and recurrence, and cost-effectiveness.
Design. Prospective multicenter cohort study with two parallel groups:
- VSU group: consecutive eligible patients admitted to Hospital de Riotinto (Huelva) or Hospital San Juan de Dios del Aljarafe (Bormujos), receiving structured remote care from the CATI/Virgen Macarena stroke team.
- Conventional SU group (control): consecutive eligible patients admitted to the Stroke Unit of Hospital Universitario Virgen Macarena (Sevilla), without telemedicine support.
Sample size. 363 patients per group (726 total) to detect non-inferiority of VSU vs SU on the primary outcome, with a non-inferiority margin of 10%, 80% power, two-sided α = 5%, and an estimated 15% loss to follow-up.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Seville, 스페인
- 모병
- Hospital San Juan de Dios, Bormujos
-
연락하다:
- Barragán, PhD, MD
- 전화번호: +34628551316
- 이메일: ana.barragan.prieto.sspa@juntadeandalucia.es
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria
- Age ≥ 18 years.
- Diagnosis of acute stroke (ischemic or hemorrhagic) confirmed by clinical assessment and neuroimaging (CT and/or MRI) within 24 hours of symptom onset or last-seen-well.
- Not a candidate for mechanical thrombectomy according to current clinical guidelines.
- Admission to a participating hospital (Hospital de Riotinto, Hospital San Juan de Dios del Aljarafe, or Hospital Universitario Virgen Macarena).
- Signed informed consent by the participant or legal representative. Exclusion Criteria
- Pre-stroke modified Rankin Scale (mRS) ≥ 4.
- Life expectancy < 6 months due to non-stroke comorbid conditions.
- Inability to complete protocolized follow-up (geographical, social, or clinical reasons).
- Concurrent participation in another interventional clinical trial that may affect study endpoints.
- Refusal to provide informed consent.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
|
Group 1 - Virtual Stroke Unit (VSU)
Patients with acute stroke (ischemic or hemorrhagic) not eligible for mechanical thrombectomy, admitted consecutively to Hospital de Riotinto (Huelva) or Hospital San Juan de Dios del Aljarafe (Bormujos, Sevilla).
Care is delivered in standardized monitoring boxes following an SU-equivalent nursing protocol, with daily synchronous joint assessment by the reference stroke team (Hospital Universitario Virgen Macarena) via the CATI telemedicine platform.
|
Structured multidisciplinary stroke care delivered remotely from the reference Stroke Unit (Hospital Universitario Virgen Macarena) to non-SU hospitals (Hospital de Riotinto, Hospital San Juan de Dios del Aljarafe).
Components: (i) standardized stroke monitoring boxes with predefined nursing protocols; (ii) synchronous joint assessment between local team and reference stroke neurologist/nurse via CATI videoconferencing on day 1 of admission; (iii) structured remote follow-up during hospitalization; (iv) standardized teleconsultation discharge report; (v) protocolized scheduled remote re-assessment at 1 week, 1 month, 3 months and 12 months.
|
|
Group 2 - Conventional Stroke Unit (Control)
Patients with acute stroke (ischemic or hemorrhagic) not eligible for mechanical thrombectomy, admitted consecutively to the Stroke Unit of Hospital Universitario Virgen Macarena (Sevilla).
Care is delivered in person by the local SU multidisciplinary team without telemedicine support.
|
Bundle of conventional stroke unit care
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Death or dependency at 90 days (modified Rankin Scale 3-6)
기간: 90 days from index admission
|
Proportion of participants who are dead or functionally dependent (mRS 3-6) at 90 ± 15 days post-admission.
The mRS is a 7-level clinician-rated scale (0 = no symptoms; 6 = death); the 3-6 range is the canonical measure of stroke-unit effectiveness (avoidance of death or dependency).
Non-inferiority of VSU versus conventional SU care is declared if the upper limit of the one-sided 95% confidence interval for the between-group difference does not exceed the pre-specified +10 percentage-point margin.
|
90 days from index admission
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Adherence to the stroke-unit care quality bundle
기간: Index admission
|
Proportion of participants receiving a predefined stroke-unit care bundle during the index admission, equivalent to conventional SU standards: dysphagia screening before oral intake, early mobilization, neurological/vital-sign monitoring protocol, antithrombotic therapy within 48 h when indicated, and structured multidisciplinary assessment.
Measures whether VSU care reproduces the quality of conventional stroke-unit care.
|
Index admission
|
|
In-hospital complications (composite safety endpoint)
기간: Index admission (median 7-10 days)
|
Composite of in-hospital medical complications: symptomatic intracranial hemorrhage, early neurological worsening (NIHSS ≥ 4 points), aspiration pneumonia, deep vein thrombosis, urinary tract infection, in-hospital death.
|
Index admission (median 7-10 days)
|
|
Etiological classification (TOAST)
기간: 3 months
|
Distribution of TOAST etiological categories in ischemic strokes (large-artery atherosclerosis, cardioembolic, small-vessel, other determined, undetermined).
|
3 months
|
|
Adherence to secondary prevention
기간: 3 and 12 months
|
Proportion of participants on guideline-concordant secondary prevention (antithrombotic therapy, antihypertensives, statins, anticoagulation if indicated) at 3 and 12 months.
|
3 and 12 months
|
|
Length of hospital stay
기간: Index admission
|
Length of index admission in days, from admission to discharge
|
Index admission
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Behrens JR, Kaffes M, Aigner A, Herm J, Erdur H, Siepmann T, Barlinn J, Hubert G, Wiestler H, Gumbinger C, Ranta A, von Weitzel-Mudersbach P, Rocco A, Hofmann-Shen C, Muhn F, Liman T, Rozanski M, Litmeier S, Riegler C, Hellwig S, Geran R, Koschutzke L, Ditsche H, Kotlarz-Bottcher M, Kinze S, Audebert H. Teleneurology vs On-Site Neurology Consultation for Postadmission Hospital Care of Stroke. JAMA Neurol. 2026 Apr 6:e260615. doi: 10.1001/jamaneurol.2026.0615. Online ahead of print.
- Martins SO, Feigin V, Carbonera LA, de Souza AC, Secchi TL, Nair B, Sposato LA, Liu L, Molina CA, Nogueira RG. Integrating Digital Health Into Stroke Policies. Stroke. 2026 Jun;57(6):1796-1809. doi: 10.1161/STROKEAHA.125.050451. Epub 2026 Mar 30.
- Barragan-Prieto A, Perez-Sanchez S, Moniche F, Moyano RV, Delgado F, Martinez-Sanchez P, Moya M, Oropesa JM, Minguez-Castellanos A, Villegas I, Alvarez Soria MJ, Tamayo Toledo JA, de la Cruz Cosme C, Canto Neguillo R, Herrerias Esteban JM, Montero Cobos DJ, Moreno Munoz JA, Gonzalez A, Montaner J. Express improvement of acute stroke care accessibility in large regions using a centralized telestroke network. Eur Stroke J. 2022 Sep;7(3):259-266. doi: 10.1177/23969873221101282. Epub 2022 May 25.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- PI24/01807
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .