Effectiveness of Best Care Practices in Acute Stroke in Conventional Hospitalization (BEST CARE ICTUS_HC) (BESTCAREICTUS)
29 de mayo de 2026 actualizado por: JOSE MIGUEL MORALES ASENCIO, University of Malaga
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.
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:
- Does the implementation of the program increase the early and correct detection of swallowing difficulties (dysphagia) to prevent pneumonia?
- 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
#Background and Context# Significant disparities exist in acute stroke outcomes depending on the type of hospital where a patient is admitted. In the Province of Malaga, peripheral hospitals lack specialized Stroke Units, meaning patients are managed in general internal medicine or standard hospitalization wards. Evidence suggests that nurse-led protocols (such as the FeSS protocols) can reduce mortality and complications like Stroke-Associated Pneumonia (SAP), yet these are rarely standardized in non-specialized settings.
The BEST CARE ICTUS_HC model aims to bridge this gap by implementing a structured bundle of care designed to minimize preventable complications and standardize nursing excellence in these peripheral centers.
The study follows the RE-AIM framework to assess reach, effectiveness, adoption, implementation, and maintenance. In accordance with the RE-AIM framework, the study will go beyond mere clinical efficacy to analyze how the intervention's integration into routine practice modifies professional behaviors and healthcare delivery processes.
#Description of the intervention#
The intervention employs a five-pillar strategy to enhance patient safety and clinical outcomes:
- Educational Outreach: Intensive training for nursing staff in peripheral wards on stroke pathophysiology and the "compensatory care" model.
- Dysphagia and Complication Prevention: Systematic use of the Modified Swallowing Assessment (MSA) to prevent aspiration and pneumonia, replacing informal clinical judgment.
The "FLECHA" Project (Environmental Adaptation and Compensatory Care):
- Visual Signaling System: Use of standardized, color-coded pictograms and directional arrows placed at the patient's bedside. This system provides an immediate visual cue to healthcare staff and family members regarding the stroke-affected side, ensuring all interactions account for the patient's specific deficits.
- Therapeutic Spatial Reorganization: Strategic modification of the patient's immediate environment (arrangement of furniture, bedside tables, and personal items). This is designed to either encourage active visual scanning toward the neglected side (stimulation) or to safely compensate for the deficit, depending on the patient's clinical status and safety needs.
- Digital Integration of Personalized Care: Implementation of bedside QR codes that provide instant access to evidence-based nursing protocols. These digital care plans are tailored to the specific type of stroke and its lateralization, offering precise guidance on therapeutic positioning, safe mobilization techniques, and the management of invasive devices (e.g., catheters or IV lines) to prevent secondary complications.
- Physiological Control Protocols: Algorithms for the strict monitoring of temperature, blood glucose, and blood pressure to prevent secondary brain injury.
- Invasive Device Stewardship: Protocols for the early removal of catheters to reduce hospital-acquired infections and promote early mobilization.
The comparator will be the usual care provided by each unit. During the control period, hospitals will provide standard care according to their existing institutional protocols.
#Data Collection and Analysis# Data will be collected at baseline (admission), during hospitalization (daily monitoring), at discharge, and via follow-up (phone) at 30 days and 6 months. An "Intention-to-Treat" analysis will be performed using Generalized Linear Mixed Models (GLMM) to account for the clustering effect of hospitals and the time effect inherent in the stepped-wedge design.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
700
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: JOSE MIGUEL MORALES-ASENCIO, PhD
- Número de teléfono: +34951952833
- Correo electrónico: jmmasen@uma.es
Copia de seguridad de contactos de estudio
- Nombre: Laura Gutierrez Rodriguez, PhD
- Número de teléfono: +34951952880
- Correo electrónico: laura_gr@uma.es
Ubicaciones de estudio
-
-
Málaga
-
Antequera, Málaga, España, 29200
- Aún no reclutando
- Hospital de Antequera
-
Contacto:
- María Socorro Zurita, Nurse
- Número de teléfono: 951 06 16 00
- Correo electrónico: socorro.zurita.sspa@juntadeandalucia.es
-
Marbella, Málaga, España, 29603
- Aún no reclutando
- Hospital Universitario Costa del Sol
-
Contacto:
- Leticia García, Nurse
- Número de teléfono: 951 97 66 69
- Correo electrónico: marialeticia.garcia.d.sspa@juntadeandalucia.es
-
Ronda, Málaga, España, 29400
- Aún no reclutando
- Hospital de la Serranía de Ronda
-
Contacto:
- Ángeles Gordillo, Nurse
- Número de teléfono: 951 06 50 00
- Correo electrónico: angeles.gordillo.sspa@juntadeandalucia.es
-
-
Velez-Maálaga
-
Málaga, Velez-Maálaga, España, 29700
- Reclutamiento
- Hospital Comarcal de la Axarquía
-
Contacto:
- Carmen Lupiañez Bueno, Nurse
- Número de teléfono: +34 951 06 70 00
- Correo electrónico: mc.lupianez.sspa@juntadeandalucia.es
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: No Intervention: usual care (control phase)
Patients receive standard clinical care according to the existing protocols of each Internal Medicine Unit before the hospital crosses over to the intervention phase.
In this phase, dysphagia screening is not standardized and relies on routine clinical assessment and medical history records.
|
|
|
Experimental: Experimental: BEST CARE ICTUS_HC (intervention phase)
1) 3-hour training for staff on stroke care, dysphagia, and the "FLECHA" project.
2) Mandatory use of Modified Swallowing Assessment (MSA).
3) Compensatory care strategies (pictograms, spatial reorganization for hemineglect).
4) QR code-guided specific care plans.
During the implementation, in addition to the educational intervention for nurses, several complementary strategies will be employed: local leadership, analysis of barriers and facilitators, audit and feedback, provision of resources and materials, evaluation of intervention fidelity, and outreach facilitation.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of participants with detected post-stroke dysphagia
Periodo de tiempo: Measured at hospital admission (baseline) and at hospital discharge (average of 9 days).
|
Identification of swallowing difficulties. Control Group: Dyspaghia detection based on usual care (standard clinical observation and records). Intervention Group: Dysphagia detection using the Modified Swallowing Assessment (MSA) tool. |
Measured at hospital admission (baseline) and at hospital discharge (average of 9 days).
|
|
Catherine Bergego Scale (CBS) score for Hemineglect
Periodo de tiempo: At hospital admission (baseline) and at hospital discharge (average of 9 days).
|
The CBS is a functional assessment of unilateral neglect.
It consists of 10 items related to daily living activities.
Scores range from 0 to 30, where 0 indicates no neglect and 30 indicates severe neglect.
|
At hospital admission (baseline) and at hospital discharge (average of 9 days).
|
|
Health-Related Quality of Life (HRQoL).
Periodo de tiempo: At hospital discharge, 30 days post-discharge, and 6 months post-discharge.
|
Measured using the SF-36 Health Survey in both groups.
The survey covers eight health domains, with scores ranging from 0 to 100 (higher scores indicate better health status).
|
At hospital discharge, 30 days post-discharge, and 6 months post-discharge.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mortality
Periodo de tiempo: At hospital discharge, 30 days post-discharge, and 6 months post-discharge.
|
Incidence of death from any cause in both groups.
|
At hospital discharge, 30 days post-discharge, and 6 months post-discharge.
|
|
Mean Systolic Blood Pressure during hospitalization.
Periodo de tiempo: From hospital admission (baseline) up to hospital discharge (average of 9 days).
|
Average of systolic blood pressure readings recorded to assess physiological stability.
Unit of measurement: millimeters of mercury (mmHg).
|
From hospital admission (baseline) up to hospital discharge (average of 9 days).
|
|
Mean Body Temperature during hospitalization.
Periodo de tiempo: From hospital admission (baseline) up to hospital discharge (average of 9 days).
|
Average of body temperature readings measured daily.
Unit of measurement: degrees Celsius (°C).
|
From hospital admission (baseline) up to hospital discharge (average of 9 days).
|
|
Mean Capillary Glycemia during hospitalization.
Periodo de tiempo: From hospital admission (baseline) up to hospital discharge (average of 9 days). Unit of measurement: milligrams per deciliter (mg/dL)
|
Average of blood glucose levels.
|
From hospital admission (baseline) up to hospital discharge (average of 9 days). Unit of measurement: milligrams per deciliter (mg/dL)
|
|
Incidence of Stroke-Associated Pneumonia (SAP)
Periodo de tiempo: Through hospital discharge (average of 9 days)
|
Number of participants who develop pneumonia according to the PISCES criteria (Pneumonia in Stroke Consensus).
|
Through hospital discharge (average of 9 days)
|
|
Environmental Adaptation Compliance (Intervention Group).
Periodo de tiempo: Daily from hospital admission up to hospital discharge (average of 9 days).
|
Measured using an Intervention Checklist.
It evaluates the daily implementation of: spatial reorganization, placement of visual cues (pictograms), and accessibility of QR-coded care plans.
|
Daily from hospital admission up to hospital discharge (average of 9 days).
|
|
Duration of invasive device use
Periodo de tiempo: During hospitalization (from admission to discharge).
|
Time in days from insertion until removal of invasive devices to evaluate the impact of early removal protocols.
Specific measures include the duration of: venous access (peripheral catheters), nasogastric tubes, urinary catheters, and other catheterizations.
|
During hospitalization (from admission to discharge).
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sociodemographic Variables
Periodo de tiempo: At hospital admission.
|
Registration of sex, age, educational level, main caregiver availability and main caregiver's sex.
|
At hospital admission.
|
|
Clinical Characterization
Periodo de tiempo: At hospital admission.
|
Assessment of comorbidities (Charlson Comorbidity Index), type of stroke (ischemic/hemorrhagic), affected side, and prescribed treatments.
|
At hospital admission.
|
|
Length of Hospital Stay.
Periodo de tiempo: Through hospital discharge (average of 9 days).
|
Total number of days from hospital admission to discharge.
|
Through hospital discharge (average of 9 days).
|
|
All-cause hospital readmission rate at 30 days.
Periodo de tiempo: 30 days after hospital discharge.
|
Proportion of participants readmitted to the hospital for any cause within 30 days after discharge.
|
30 days after hospital discharge.
|
|
Number of rehabilitation sessions received.
Periodo de tiempo: Up to 6 months post-discharge.
|
Total count of rehabilitation sessions received by the participant.
|
Up to 6 months post-discharge.
|
|
Functional Independence measured by the Barthel Index.
Periodo de tiempo: At hospital admission (baseline) and at hospital discharge (average of 9 days)
|
Assessed using the Barthel Index (activities of daily living) and the Modified Rankin Scale (mRS) (global disability) in both groups.
|
At hospital admission (baseline) and at hospital discharge (average of 9 days)
|
|
Global disability measured by the Modified Rankin Scale (mRS).
Periodo de tiempo: At hospital admission (baseline) and at hospital discharge (average of 9 days).
|
The mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke.
Scores range from 0 (no symptoms) to 6 (death).
Higher scores indicate greater disability.
|
At hospital admission (baseline) and at hospital discharge (average of 9 days).
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: JOSE MIGUEL MORALES-ASENCIO, PhD, Universidad de Málaga
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Pollock A, Hazelton C, Rowe FJ, Jonuscheit S, Kernohan A, Angilley J, Henderson CA, Langhorne P, Campbell P. Interventions for visual field defects in people with stroke. Cochrane Database Syst Rev. 2019 May 23;5(5):CD008388. doi: 10.1002/14651858.CD008388.pub3.
- Middleton S, Lydtin A, Comerford D, Cadilhac DA, McElduff P, Dale S, Hill K, Longworth M, Ward J, Cheung NW, D'Este C; QASCIP Working Group and Steering Committee. From QASC to QASCIP: successful Australian translational scale-up and spread of a proven intervention in acute stroke using a prospective pre-test/post-test study design. BMJ Open. 2016 May 6;6(5):e011568. doi: 10.1136/bmjopen-2016-011568.
- Langhorne P, Ramachandra S; Stroke Unit Trialists' Collaboration. Organised inpatient (stroke unit) care for stroke: network meta-analysis. Cochrane Database Syst Rev. 2020 Apr 23;4(4):CD000197. doi: 10.1002/14651858.CD000197.pub4.
- Eltringham SA, Kilner K, Gee M, Sage K, Bray BD, Pownall S, Smith CJ. Impact of Dysphagia Assessment and Management on Risk of Stroke-Associated Pneumonia: A Systematic Review. Cerebrovasc Dis. 2018;46(3-4):99-107. doi: 10.1159/000492730. Epub 2018 Sep 10.
- Burgos R, Breton I, Cereda E, Desport JC, Dziewas R, Genton L, Gomes F, Jesus P, Leischker A, Muscaritoli M, Poulia KA, Preiser JC, Van der Marck M, Wirth R, Singer P, Bischoff SC. ESPEN guideline clinical nutrition in neurology. Clin Nutr. 2018 Feb;37(1):354-396. doi: 10.1016/j.clnu.2017.09.003. Epub 2017 Sep 22.
- Norrving B, Barrick J, Davalos A, Dichgans M, Cordonnier C, Guekht A, Kutluk K, Mikulik R, Wardlaw J, Richard E, Nabavi D, Molina C, Bath PM, Stibrant Sunnerhagen K, Rudd A, Drummond A, Planas A, Caso V. Action Plan for Stroke in Europe 2018-2030. Eur Stroke J. 2018 Dec;3(4):309-336. doi: 10.1177/2396987318808719. Epub 2018 Oct 29.
- Azouvi P, Bartolomeo P, Beis JM, Perennou D, Pradat-Diehl P, Rousseaux M. A battery of tests for the quantitative assessment of unilateral neglect. Restor Neurol Neurosci. 2006;24(4-6):273-85.
- Perry L. Screening swallowing function of patients with acute stroke. Part two: Detailed evaluation of the tool used by nurses. J Clin Nurs. 2001 Jul;10(4):474-81. doi: 10.1046/j.1365-2702.2001.00502.x.
- Wolfson M, Champion H, McCoy TP, Rhodes SD, Ip EH, Blocker JN, Martin BA, Wagoner KG, O'Brien MC, Sutfin EL, Mitra A, Durant RH. Impact of a randomized campus/community trial to prevent high-risk drinking among college students. Alcohol Clin Exp Res. 2012 Oct;36(10):1767-78. doi: 10.1111/j.1530-0277.2012.01786.x. Epub 2012 Jul 23.
- Middleton S, Levi C, Ward J, Grimshaw J, Griffiths R, D'Este C, Dale S, Cheung NW, Quinn C, Evans M, Cadilhac D. Fever, hyperglycaemia and swallowing dysfunction management in acute stroke: a cluster randomised controlled trial of knowledge transfer. Implement Sci. 2009 Mar 16;4:16. doi: 10.1186/1748-5908-4-16.
- Bravata DM, Daggett VS, Woodward-Hagg H, Damush T, Plue L, Russell S, Allen G, Williams LS, Harezlak J, Chumbler NR. Comparison of two approaches to screen for dysphagia among acute ischemic stroke patients: nursing admission screening tool versus National Institutes of Health stroke scale. J Rehabil Res Dev. 2009;46(9):1127-34. doi: 10.1682/jrrd.2008.12.0169.
- Urimubenshi G, Langhorne P, Cadilhac DA, Kagwiza JN, Wu O. Association between patient outcomes and key performance indicators of stroke care quality: A systematic review and meta-analysis. Eur Stroke J. 2017 Dec;2(4):287-307. doi: 10.1177/2396987317735426. Epub 2017 Oct 5.
- Paley L, Williamson E, Bray BD, Hoffman A, James MA, Rudd AG; SSNAP Collaboration. Associations Between 30-Day Mortality, Specialist Nursing, and Daily Physician Ward Rounds in a National Stroke Registry. Stroke. 2018 Sep;49(9):2155-2162. doi: 10.1161/STROKEAHA.118.021518.
- Purvis T, Middleton S, Craig LE, Kilkenny MF, Dale S, Hill K, D'Este C, Cadilhac DA. Inclusion of a care bundle for fever, hyperglycaemia and swallow management in a National Audit for acute stroke: evidence of upscale and spread. Implement Sci. 2019 Sep 2;14(1):87. doi: 10.1186/s13012-019-0934-y.
- Middleton S, Pfeilschifter W. International translation of Fever, Sugar, Swallow Protocols: The Quality in Acute Stroke Care Europe Project. Int J Stroke. 2020 Aug;15(6):591-594. doi: 10.1177/1747493020915130. Epub 2020 Apr 16.
- Middleton S, Coughlan K, Mnatzaganian G, Low Choy N, Dale S, Jammali-Blasi A, Levi C, Grimshaw JM, Ward J, Cadilhac DA, McElduff P, Hiller JE, D'Este C. Mortality Reduction for Fever, Hyperglycemia, and Swallowing Nurse-Initiated Stroke Intervention: QASC Trial (Quality in Acute Stroke Care) Follow-Up. Stroke. 2017 May;48(5):1331-1336. doi: 10.1161/STROKEAHA.116.016038. Epub 2017 Apr 7.
- Pinero Saez S, Sanz Aznarez AC, Ruiz Garcia MV, Gonzalez Garcia MJ, Mena Sucunza L, Corcoles Jimenez MP; en nombre del Grupo de Trabajo del Programa de implantacion de buenas practicas en centros comprometidos con la excelencia en cuidados(R). Implementation of the Best practice guideline: Stroke assessment across the continuum of care in hospitalised patients. Enferm Clin (Engl Ed). 2020 May-Jun;30(3):160-167. doi: 10.1016/j.enfcli.2019.10.026. Epub 2020 Apr 14. English, Spanish.
- Hammond L, Conroy T, Murray J. Exploring oral care practices, barriers, and facilitators in an inpatient stroke unit: a thematic analysis. Disabil Rehabil. 2023 Mar;45(5):796-804. doi: 10.1080/09638288.2022.2040616. Epub 2022 Feb 21.
- Baatiema L, Otim ME, Mnatzaganian G, de-Graft Aikins A, Coombes J, Somerset S. Health professionals' views on the barriers and enablers to evidence-based practice for acute stroke care: a systematic review. Implement Sci. 2017 Jun 5;12(1):74. doi: 10.1186/s13012-017-0599-3.
- Clare CS. Role of the nurse in acute stroke care. Nurs Stand. 2020 Apr 1;35(4):75-82. doi: 10.7748/ns.2020.e11482. Epub 2020 Mar 30.
- Green TL, McNair ND, Hinkle JL, Middleton S, Miller ET, Perrin S, Power M, Southerland AM, Summers DV; American Heart Association Stroke Nursing Committee of the Council on Cardiovascular and Stroke Nursing and the Stroke Council. Care of the Patient With Acute Ischemic Stroke (Posthyperacute and Prehospital Discharge): Update to 2009 Comprehensive Nursing Care Scientific Statement: A Scientific Statement From the American Heart Association. Stroke. 2021 May;52(5):e179-e197. doi: 10.1161/STR.0000000000000357. Epub 2021 Mar 11.
- Gillen RW, Fusco-Gessick B, Harmon EY. How We Assess Spatial Neglect Matters: Prevalence of Spatial Neglect as Measured by the Catherine Bergego Scale and Impact on Rehabilitation Outcomes. Am J Phys Med Rehabil. 2021 May 1;100(5):443-449. doi: 10.1097/PHM.0000000000001710.
- Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.
- Tucker N, Stoffel JM, Hayes L, Jones GM. Blood Pressure Management Following Acute Ischemic Stroke: A Review of Primary Literature. Crit Care Nurs Q. 2020 Apr/Jun;43(2):109-121. doi: 10.1097/CNQ.0000000000000297.
- Savopoulos C, Kaiafa G, Kanellos I, Fountouki A, Theofanidis D, Hatzitolios AI. Is management of hyperglycaemia in acute phase stroke still a dilemma? J Endocrinol Invest. 2017 May;40(5):457-462. doi: 10.1007/s40618-016-0584-8. Epub 2016 Nov 21.
- Zapata-Arriaza E, Serrano-Gotarredona P, Navarro-Herrero S, Moniche F, Pardo-Galiana B, Pallisa E, Vega-Salvatierra A, Mancha F, Escudero-Martinez I, Bustamante A, Montaner J. Chest Computed Tomography Findings and Validation of Clinical Criteria of Stroke Associated Pneumonia. J Stroke. 2019 May;21(2):217-219. doi: 10.5853/jos.2018.03251. Epub 2019 Apr 17. No abstract available.
- Smith CJ, Kishore AK, Vail A, Chamorro A, Garau J, Hopkins SJ, Di Napoli M, Kalra L, Langhorne P, Montaner J, Roffe C, Rudd AG, Tyrrell PJ, van de Beek D, Woodhead M, Meisel A. Diagnosis of Stroke-Associated Pneumonia: Recommendations From the Pneumonia in Stroke Consensus Group. Stroke. 2015 Aug;46(8):2335-40. doi: 10.1161/STROKEAHA.115.009617. Epub 2015 Jun 25.
- Eltringham SA, Kilner K, Gee M, Sage K, Bray BD, Smith CJ, Pownall S. Factors Associated with Risk of Stroke-Associated Pneumonia in Patients with Dysphagia: A Systematic Review. Dysphagia. 2020 Oct;35(5):735-744. doi: 10.1007/s00455-019-10061-6. Epub 2019 Sep 6.
- Middleton S, McElduff P, Ward J, Grimshaw JM, Dale S, D'Este C, Drury P, Griffiths R, Cheung NW, Quinn C, Evans M, Cadilhac D, Levi C; QASC Trialists Group. Implementation of evidence-based treatment protocols to manage fever, hyperglycaemia, and swallowing dysfunction in acute stroke (QASC): a cluster randomised controlled trial. Lancet. 2011 Nov 12;378(9804):1699-706. doi: 10.1016/S0140-6736(11)61485-2. Epub 2011 Oct 11.
- Pudar J, Strong B, Howard VJ, Reeves MJ. Reporting of Results by Sex in Randomized Controlled Trials of Acute Stroke Therapies (2010-2020). Stroke. 2021 Nov;52(11):e702-e705. doi: 10.1161/STROKEAHA.120.034099. Epub 2021 Sep 16.
- Strong B, Pudar J, Thrift AG, Howard VJ, Hussain M, Carcel C, de Los Campos G, Reeves MJ. Sex Disparities in Enrollment in Recent Randomized Clinical Trials of Acute Stroke: A Meta-analysis. JAMA Neurol. 2021 Jun 1;78(6):666-677. doi: 10.1001/jamaneurol.2021.0873.
- Rexrode KM, Madsen TE, Yu AYX, Carcel C, Lichtman JH, Miller EC. The Impact of Sex and Gender on Stroke. Circ Res. 2022 Feb 18;130(4):512-528. doi: 10.1161/CIRCRESAHA.121.319915. Epub 2022 Feb 17.
- Alvarez-Sabin J, Quintana M, Masjuan J, Oliva-Moreno J, Mar J, Gonzalez-Rojas N, Becerra V, Torres C, Yebenes M; CONOCES Investigators Group. Economic impact of patients admitted to stroke units in Spain. Eur J Health Econ. 2017 May;18(4):449-458. doi: 10.1007/s10198-016-0799-9. Epub 2016 Apr 15.
- Ruiz Alvarez M, Aginagalde Llorente AH, Del Llano Senaris JE. [Los determinantes sociales de la salud en Espana (2010-2021): una revision exploratoria de la literatura.]. Rev Esp Salud Publica. 2022 May 12;96:e202205041. Spanish.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
12 de mayo de 2026
Finalización primaria (Estimado)
1 de diciembre de 2028
Finalización del estudio (Estimado)
1 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
8 de febrero de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de mayo de 2026
Publicado por primera vez (Actual)
4 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Enfermedades metabólicas
- Infecciones del Tracto Respiratorio
- Infecciones
- Enfermedades de las vías respiratorias
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Manifestaciones neuroconductuales
- Enfermedades pulmonares
- Trastornos del metabolismo de la glucosa
- Enfermedades esofágicas
- Neumonía
- Enfermedades Otorrinolaringológicas
- Enfermedades faríngeas
- Cambios de temperatura corporal
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Accidente cerebrovascular isquémico
- Ataque hemorragico
- Carrera
- Trastornos de la deglución
- Hiperglucemia
- Trastornos cerebrovasculares
- Fiebre
- Neumonía, Aspiración
- Trastornos de la percepción
Otros números de identificación del estudio
- PI25/00516
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
The decision to share individual participant data has not yet been determined.
The study involves sensitive, coded clinical data, with access restricted to the research team.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .