Effectiveness of Best Care Practices in Acute Stroke in Conventional Hospitalization (BEST CARE ICTUS_HC)

NCT07627399 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2026-06-04

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate whether a multicomponent nurse-led intervention (BEST CARE ICTUS\_HC) can reduce stroke-related complications and improve recovery in adults (18 years and older) hospitalized with an acute ischemic or hemorrhagic stroke in hospitals without specialized Stroke Units. The main questions it aims to answer are:

1. Does the implementation of the program increase the early and correct detection of swallowing difficulties (dysphagia) to prevent pneumonia?
2. Does the program reduce the severity of attention problems (hemineglect) and improve the patients' quality of life up to 6 months after discharge?

Researchers will compare patients receiving the BEST CARE ICTUS\_HC program to patients receiving usual hospital care to see if this new approach improves patient safety and long-term functional recovery.

Participants will:

* Receive either the usual hospital care for stroke or the BEST CARE ICTUS\_HC nursing program, depending on the study phase of the hospital.
* Be screened for swallowing problems using a standardized test before receiving any food or drink.
* Be cared for in an adapted environment (FLECHA Project) that uses visual signs and room organization to help with orientation and safety.
* Have their temperature, blood sugar, and blood pressure monitored under a strict specialized protocol.
* Be contacted by phone 30 days and 6 months after leaving the hospital to answer questions about their health and quality of life.

Conditions

  • Stroke
  • Acute Stroke
  • Ischemic Stroke
  • Hemorrhagic Stroke
  • Cerebrovascular Disorders
  • Deglutition Disorders
  • Perceptual Disorders
  • Unilateral Neglect
  • Pneumonia, Aspiration

Interventions

OTHER

BEST CARE ICTUS_HC BUNDLE

Multicomponent nursing intervention including: 1) Specialized staff training on acute stroke care. 2) Systematic dysphagia screening using the Modified Swallowing Assessment (MSA). 3) Implementation of the "FLECHA Project", a compensatory care model that harmonizes all care delivery based on stroke laterality aimed at developing early functional rehabilitation for unilateral neglect, hemiplegia, hemiparesis, and anosognosia (strategies include use of bedside pictograms, spatial reorganization, and QR-guided specific care plans). 4) Protocols for physiological stability monitoring and early device removal.

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV
  • Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

    collaborator OTHER
  • Andalusian Health Service

    collaborator OTHER_GOV
  • University of Malaga

    lead OTHER

Principal Investigators

  • JOSE MIGUEL MORALES-ASENCIO, PhD · Universidad de Málaga

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-12
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07627399 on ClinicalTrials.gov