Delirium, Ischemic Stroke, Transient Ischemic Attack
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| diagnostic accuracy of established delirium detection tools as compared to Diagnostic and Statistical Manual - 5th Version (DSM-5) criteria | two times daily for 7 days | Binary 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
| Measure | Time frame | Description |
|---|---|---|
| pre-stroke Barthel Index | once on admission | ability to take care of personal daily routine before stroke |
| PSD prevalence | three times daily for 7 days | DSM-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 Scale | once on admission | functional status before stroke |
| pre-stroke Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) | once on admission | cognitive impairment before stroke |
| pre-stroke Groningen Frailty Index (GFI) | once on admission | presence of a frailty syndrome before stroke |
| Stroke location - clinical (classification of the OxfordshireCommunity Stroke Project (OCSP)) | once on admission | clinical 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 admission | in 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 admission | estimate of clinical stroke severity |
| Critical Care Pain Observation Tool (CPOT) | once daily for three days starting on the day of admission | pain during stroke unit treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| demographic data | once on admission | exploratory outcome required to adjust for confounding variates such as age, socioeconomic status and education |
| complications during stroke unit treatment | continuously during the study period and up to 7 days | any complication that arises during the study period (e.g. pneumonia, dysphagia) |
Countries
Germany