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Post-stroke Delirium Screening

Evaluation of Delirium Screening Tools for the Detection of Post-stroke Delirium

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03930719
Acronym
PSD Screen
Enrollment
141
Registered
2019-04-29
Start date
2019-04-22
Completion date
2019-08-31
Last updated
2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium, Ischemic Stroke, Transient Ischemic Attack

Keywords

stroke, delirium, screening tool

Brief summary

For a long time, delirium was considered a merely temporary dysfunction of the brain. Today, it is established that it is a brain disease associated with network dysfunction, neuroinflammation and impaired transmitter homeostasis in a multicausal model. Following an episode of delirium, many patients do not return to their prior level of cognitive and functional performance. In particular, failed or delayed diagnosis with consecutive inadequate therapy contribute to the development of long-term cognitive decline that may ultimately lead to long-term care. Stroke patients are a particularly common delirium-affected population (10-46% depending on severity). Despite the frequency and clinical relevance of delirium in stroke patients, diagnostic characteristics of common screening methods are unknown. Similarly, the clinical phenotype and risk factors of patients who develop delirium have not been adequately described. This study primarily aims to evaluate the diagnostic properties of established screening tools for delirium in a prospective cohort of well-characterised patients following ischemic cerebral events (either transient or manifest stroke). Secondary outcome criteria include predictors of post-stroke delirium (PSD) such as stroke location and size, pre-stroke cognitive functioning, ability to participate in daily routine activities and medical conditions.

Interventions

DIAGNOSTIC_TESTStroke screening tools

Patients are evaluated for the presence of PSD using DSM-5 criteria (gold standard). Established delirium detection tools are evaluated for their diagnostic accuracy compared to the gold standard.

Sponsors

University Medicine Greifswald
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* stroke unit admission for a high-risk transient ischemic attack (ABCD2 score \>= 6) or stroke within the last 24 hours

Exclusion criteria

* hemorrhagic stroke

Design outcomes

Primary

MeasureTime frameDescription
diagnostic accuracy of established delirium detection tools as compared to Diagnostic and Statistical Manual - 5th Version (DSM-5) criteriatwo times daily for 7 daysBinary outcomes of delirium screening tests will be compared, i.e. if they characterize an individual patient as delirious at any of two time points during the 7 day observation period. Instruments include: Nursing Delirium Screening Scale (Nu-DESC), Confusion Assessment Method (CAM), rapid assessment test for delirium (4-AT). Binary outcomes (yes or no according to each of the scales) are then aggregated in one test that compares the observed frequency of delirious patients (according the above mentioned tests) with the actual number of delirious patients as assessed by the DSM-5 standard.

Secondary

MeasureTime frameDescription
pre-stroke Barthel Indexonce on admissionability to take care of personal daily routine before stroke
PSD prevalencethree times daily for 7 daysDSM-5 criteria and chart review are used to assess the occurence of PSD among included patients over the complete study period
pre-stroke modified Rankin Scaleonce on admissionfunctional status before stroke
pre-stroke Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)once on admissioncognitive impairment before stroke
pre-stroke Groningen Frailty Index (GFI)once on admissionpresence of a frailty syndrome before stroke
Stroke location - clinical (classification of the OxfordshireCommunity Stroke Project (OCSP))once on admissionclinical characterisation based on phenotype as either total anterior, partial anterior, partial posterior or lacunar stroke
Stroke location - imaging (based on an atlas of anatomical regions of the human brain (aal MNI V4))once on admissionin patients with imaging of the definite stroke location, differences of mean locations between groups will be calculated
National Institutes of Health Stroke Scale (NIHSS)three times daily for three days starting on the day of admissionestimate of clinical stroke severity
Critical Care Pain Observation Tool (CPOT)once daily for three days starting on the day of admissionpain during stroke unit treatment

Other

MeasureTime frameDescription
demographic dataonce on admissionexploratory outcome required to adjust for confounding variates such as age, socioeconomic status and education
complications during stroke unit treatmentcontinuously during the study period and up to 7 daysany complication that arises during the study period (e.g. pneumonia, dysphagia)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026