Post-stroke Delirium Screening

Ischemic Stroke Clinical Trial

— PSD Screen  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930719
• Other study ID #: BB 031-19
• Status: Completed
• Start date: April 22, 2019
• Est. completion date: August 31, 2019

Study information

• Verified date: June 2020
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: August 31, 2019
• Est. primary completion date: July 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

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

Related Conditions & MeSH terms

• Delirium
• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Stroke
• Transient Ischemic Attack

Intervention

Diagnostic Test:
• Stroke 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.

Locations

Country	Name	City	State
Germany	Department of Neurology	Greifswald	Mecklenburg-Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	demographic data	exploratory outcome required to adjust for confounding variates such as age, socioeconomic status and education	once on admission
Other	complications during stroke unit treatment	any complication that arises during the study period (e.g. pneumonia, dysphagia)	continuously during the study period and up to 7 days
Primary	diagnostic accuracy of established delirium detection tools as compared to Diagnostic and Statistical Manual - 5th Version (DSM-5) criteria	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.	two times daily for 7 days
Secondary	PSD prevalence	DSM-5 criteria and chart review are used to assess the occurence of PSD among included patients over the complete study period	three times daily for 7 days
Secondary	pre-stroke modified Rankin Scale	functional status before stroke	once on admission
Secondary	pre-stroke Barthel Index	ability to take care of personal daily routine before stroke	once on admission
Secondary	pre-stroke Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)	cognitive impairment before stroke	once on admission
Secondary	pre-stroke Groningen Frailty Index (GFI)	presence of a frailty syndrome before stroke	once on admission
Secondary	National Institutes of Health Stroke Scale (NIHSS)	estimate of clinical stroke severity	three times daily for three days starting on the day of admission
Secondary	Critical Care Pain Observation Tool (CPOT)	pain during stroke unit treatment	once daily for three days starting on the day of admission
Secondary	Stroke location - clinical (classification of the OxfordshireCommunity Stroke Project (OCSP))	clinical characterisation based on phenotype as either total anterior, partial anterior, partial posterior or lacunar stroke	once on admission
Secondary	Stroke location - imaging (based on an atlas of anatomical regions of the human brain (aal MNI V4))	in patients with imaging of the definite stroke location, differences of mean locations between groups will be calculated	once on admission