Actively Recruiting
Effectiveness of Implementing Best Care Practices in the Management of Patients With Acute Stroke in Conventional Hospitalization: A Cluster-Randomized, Open, Stepped-Wedge Controlled Trial.
Led by University of Malaga · Updated on 2026-06-04
700
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Malaga
Lead Sponsor
I
Instituto de Salud Carlos III
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether a comprehensive nurse-led program called BEST CARE ICTUS_HC can reduce complications and improve recovery for adults aged 18 and older hospitalized with acute ischemic or hemorrhagic stroke in hospitals lacking specialized Stroke Units. The study aims to see if this program improves early detection of swallowing difficulties to prevent pneumonia and reduces attention problems like hemineglect, enhancing quality of life up to six months after discharge. This trial compares patients receiving the BEST CARE ICTUS_HC program with those receiving usual hospital care in a stepped-wedge design across multiple hospitals. The BEST CARE ICTUS_HC intervention includes specialized training for nursing staff, systematic use of the Modified Swallowing Assessment to detect dysphagia, and the FLECHA Project, which adapts the patient's environment with visual signs, spatial reorganization, and QR code-guided care plans tailored to stroke type and side. It also involves strict monitoring protocols for temperature, blood sugar, and blood pressure, plus early removal of invasive devices. During the control phase, usual care is provided without standardized dysphagia screening. The intervention phase adds educational outreach, compensatory care strategies, and ongoing support to ensure program implementation. Participants will be monitored from admission through hospitalization, discharge, and follow-up at 30 days and six months post-discharge. Assessments include swallowing tests, evaluation of hemineglect using the Catherine Bergego Scale, and health-related quality of life measurements. Vital signs and device use are tracked daily during hospital stay. Follow-up calls collect health and quality of life data. The study uses statistical methods to account for hospital differences and time effects, aiming to understand both clinical outcomes and how the program integrates into routine care.
CONDITIONS
Brief Title
Effectiveness of Best Care Practices in Acute Stroke in Conventional Hospitalization (BEST CARE ICTUS_HC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older.
- Clinical diagnosis of acute ischemic or hemorrhagic stroke.
- Admission to conventional hospitalization units (Internal Medicine) in regional hospitals without specialized Stroke Units.
You will not qualify if you...
- Patients admitted for a cause other than stroke who develop a stroke during their hospital stay (in-hospital stroke).
- Patients subjected to invasive neurological procedures.
- Patients undergoing invasive procedures, such as thrombectomy, who require transfer to a referral hospital and remain there for more than 48 hours.
- Patients with deterioration of the level of consciousness that prevents the performance of dysphagia testing.
- Patients that have been taken care of by Nurses and Nursing Assistants with >4 weeks of work experience in Stroke Units in the last 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Average of 9 days
Participants receive either usual care or the BEST CARE ICTUS_HC bundle during their hospital stay. This includes nursing staff training and implementation of structured care protocols to improve stroke management and prevent complications such as dysphagia and pneumonia.
Daily monitoring visits during hospitalization
Duration - 1 day
Participants undergo assessments at hospital discharge to evaluate stroke-related outcomes, including dysphagia detection and quality of life measures.
1 visit (in-person) at discharge
Duration - 6 months
Participants are contacted by phone to assess health-related quality of life and mortality outcomes at 30 days and 6 months post-discharge.
2 phone calls (at 30 days and 6 months post-discharge)
Trial Site Locations
Total: 4 locations
1
Hospital de Antequera
Antequera, Málaga, Spain, 29200
Not Yet Recruiting
2
Hospital Universitario Costa del Sol
Marbella, Málaga, Spain, 29603
Not Yet Recruiting
3
Hospital de la Serranía de Ronda
Ronda, Málaga, Spain, 29400
Not Yet Recruiting
4
Hospital Comarcal de la Axarquia
Málaga, Velez-Maálaga, Spain, 29700
Actively Recruiting
Research Team
J
JOSE MIGUEL MORALES-ASENCIO, PhD
L
Laura Gutierrez Rodriguez, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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