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Clinical Trials/NCT03930719
NCT03930719
Completed
Not Applicable

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

University Medicine Greifswald1 site in 1 country141 target enrollmentApril 22, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delirium
Sponsor
University Medicine Greifswald
Enrollment
141
Locations
1
Primary Endpoint
diagnostic accuracy of established delirium detection tools as compared to Diagnostic and Statistical Manual - 5th Version (DSM-5) criteria
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 22, 2019
End Date
August 31, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Medicine Greifswald
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

diagnostic accuracy of established delirium detection tools as compared to Diagnostic and Statistical Manual - 5th Version (DSM-5) criteria

Time Frame: 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 Outcomes

  • PSD prevalence(three times daily for 7 days)
  • pre-stroke modified Rankin Scale(once on admission)
  • pre-stroke Barthel Index(once on admission)
  • Critical Care Pain Observation Tool (CPOT)(once daily for three days starting on the day of admission)
  • pre-stroke Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)(once on admission)
  • Stroke location - clinical (classification of the OxfordshireCommunity Stroke Project (OCSP))(once on admission)
  • Stroke location - imaging (based on an atlas of anatomical regions of the human brain (aal MNI V4))(once on admission)
  • pre-stroke Groningen Frailty Index (GFI)(once on admission)
  • National Institutes of Health Stroke Scale (NIHSS)(three times daily for three days starting on the day of admission)

Study Sites (1)

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