Clinical trial NCT06670716: BRIEF COGNITIVE and DELIRIUM ASSESSMENTS in STROKE PATIENTS
Official title: VERY BRIEF SPEECH and MEMORY ASSESSMENTS USING ALBA a PICNIR TESTS and DELIRIUM ASSESSMENTS USING CAM-ICU and ICDSC TESTS in PATIENTS SHORTLY AFTER the STROKE
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stroke Acute
Keywords: stroke
kognitive function
delirium
Lead sponsor: Faculty Hospital Kralovske Vinohrady
Sponsor class: OTHER_GOV
First posted: 2024-11-01
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the monitored bed of the neurological ICU for ischemic or hemorrhagic CVA with the possibility of initial examination within 24 hours of admission (not the onset of CVA), with an anticipated length of hospitalization longer than five days, will be included in the study.

Brief summary: The aim of the project is to validate the ALBA and PICNIR tests for the easy detection of memory and speech disorders in patients after a stroke. Patients, after their first stroke, with the possibility of initial clinical evaluation within 24 hours of admission to the Neurology Clinic ICU, will undergo a neurological examination, cognitive tests using the ALBA and PICNIR tests, delirium tests using the CAM-ICU and ICDSC tools, and a speech therapy test using the MASTcz tool. If possible, these will be conducted simultaneously in one half-day. A similar structured examination will take place within five days, with a tolerance of one day. Upon demonstrating utility, doctors will be able to utilize the very brief ALBA and POBAV methods for detecting memory and speech disorders in post-stroke patients in clinical practice.

Detailed description: Speech and motor production disorders are easily recognizable or examinable symptoms of stroke (Cerebrovascular Accident - CVA). In contrast, memory disorders are rarely examined, primarily within research studies rather than routine clinical practice, for several reasons. Fatigue-related disorders cause difficulties in memory and other cognitive function examinations. Aphasia is accompanied by cognitive deficits, which are not always easy to detect due to speech and motor impairments. Another reason is the scarcity of suitable tests that are brief yet informative. Since stroke patients are typically older, it can be assumed that memory disorders are frequent in this population. There is a bidirectional relationship between cognitive disorders and stroke. Cognitive impairment increases the risk of stroke and death, while post-stroke cognitive impairment may have existed before the stroke or may be partly caused by it. It can occur early or later after the event. Cognitive impairment persists in patients after a CVA, even after successful clinical recovery, and is closely related to poor functional outcomes.

Assessing cognitive impairment after a stroke is significant in both acute and chronic care. It helps to determine whether the patient remembers important information regarding their health status and recommendations for lifestyle changes (e.g., not smoking, adhering to a diabetic diet, regular blood pressure checks), as well as the use of essential treatments like antihypertensives or secondary preventive treatments-antiplatelet and anticoagulant therapy. Speech and memory disorders affect acute and chronic patient care-nursing, caregiving, rehabilitation, and speech therapy, as well as care in the home environment. Expressive aphasia is easily noticed, but often not quantified. Sensory aphasia is generally less recognizable from ordinary contact. The quality of the examination determines the extent of the disorder found. It is crucial for healthcare personnel to understand what to expect regarding collaboration. It is also essential to estimate whether the patient will understand the significance of the communicated information and how well they will cooperate during rehabilitation.

A physician can quickly and easily quantify speech and memory disorders after a stroke using the original Czech and innovative tests, Amnesia Light and Brief Assessment (ALBA) and Picture Naming and Immediate Recall (PICNIR). Although initially developed for patients with cognitive disorders or dementia, they are also well-suited for post-stroke patients. The validated ALBA test involves learning and repeating a six-word sentence, demonstrating six gestures according to instructions and naming them, and concluding by recalling as many words of the sentence as possible after a distraction. The validated PICNIR test consists of two parts. First, the patient names 20 black-and-white pictures. Then, the task is to recall and rewrite as many of the picture names as possible within one minute. Both tests allow for a quick and simultaneous assessment of speech and memory.

Delirium may develop in 10-30% of patients after a stroke. Post-stroke delirium may be associated with the development of cognitive impairment or dementia within three months to two years. These findings emphasize the importance of rapid detection and treatment of delirium post-stroke, as well as the monitoring of cognitive functions in subsequent years. Detecting delirium is crucial for the proper management of post-stroke care. Various tests have been developed for delirium detection. The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) or the Intensive Care Delirium Screening Checklist (ICDSC) are commonly used. The CAM-ICU test was designed for use by both doctors and nurses in intensive care settings and has already been validated in Czech for stroke patients. While the Czech version of the ICDSC has not been validated, foreign studies suggest it is a suitable tool for delirium detection. A survey among Czech neurological departments has highlighted the need for such tests.

The investigators aim to assess the usefulness of all four methods in clinical practice for patients after a stroke. Therefore, they have prepared a project to evaluate the benefits and utilization of cognitive tests ALBA and PICNIR, and delirium tests CAM-ICU and ICDSC, in the acute phase of stroke. Additionally, they aim to validate the very short ALBA and PICNIR tests, which take less than five minutes, to improve post-stroke care in the future.

Eligibility criteria: Inclusion Criteria:

* Native speaker of the Czech Republic. Czech must be the patient\&amp;#39;s native language.
* Admission to the monitored bed of the neurological ICU with the possibility of initial examination within 24 hours of admission (not the onset of CVA).
* Anticipated length of hospitalization longer than five days.
* First clinical CVA in life. Subclinical signs of CVA on brain CT are acceptable.
* Absence of previous neurological deficit of any etiology affecting the brain, e.g., trauma, or spinal cord.
* Vigilant, i.e., without quantitative impairment of consciousness. Delirium may be present.

Exclusion Criteria:

* Native speaker of the Czech Republic. Czech must be the patient\&amp;#39;s mother tongue.
* Admission to the monitored bed of the neurological ICU with the possibility of initial examination within 24 hours of admission (not the onset of CVA).
* Anticipated length of hospitalization longer than five days.
* First clinical CVA in life. Subclinical signs of CVA on brain CT are acceptable.
* Absence of previous neurological deficit of any etiology affecting the brain, e.g., trauma, or spinal cord.
* Vigilant, i.e., without quantitative impairment of consciousness. Delirium may be present.
* Presence of a previous neurological deficit.
* Unfavorable prognosis upon admission.
* Discharge or anticipation of early discharge from the ICU before the follow-up examination after 5 days.
* Transient ischemic attack and conditions mimicking stroke.
* Resolution of deficit before the initial examination.
* Absence of the principal investigator.
* Intubation upon admission.
* Refusal to participate in the study by the patient or relatives.
* Complications during hospitalization affecting brain function, e.g., aspiration with hypoxia.
* Sudden progression of the condition to unconsciousness.
* Unique situations, e.g., acute endarterectomy.

Primary outcomes:
measure: POBAV test
timeFrame: 1st day after a stroke, 5th day after a stroke
measure: ALBA test
timeFrame: 1st day after a stroke, 5th day after a stroke
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Fakultní Nemocnice Královské Vinohrady
state: Hlavní město Praha
Study officials:
References:
citation: Bartos A, Weinerova J, Diondet S. Effects of human probiotics on memory and psychological and physical measures in community-dwelling older adults with normal and mildly impaired cognition: results of a bi-center, double-blind, randomized, and placebo-controlled clinical trial (CleverAge biota). Front Aging Neurosci. 2023 Jul 7;15:1163727. doi: 10.3389/fnagi.2023.1163727. eCollection 2023.
citation: Bartoš, A., Test ALBA byl uznán jako certifikovaná metodika Ministerstvem zdravotnictví ČR (2024) Ceska a Slovenska Neurologie a Neurochirurgie, 87 (3), p. 153.