Post-stroke Delirium Screening

Completed

• Conditions: Transient Ischemic Attack; Ischemic Stroke; Delirium
• Interventions: Diagnostic Test: Stroke screening tools

• Registration Number: NCT03930719
• Lead Sponsor: University Medicine Greifswald

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-22
• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-04-26
• Study First Posted: 2019-04-29
• Primary Completion: 2019-07-21
• Study Completion: 2019-08-31
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-02
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PSD	Stroke screening tools	Patients fulfilling DSM-5 criteria of PSD within 7 days of admission.
No PSD	Stroke screening tools	Patients NOT fulfilling DSM-5 criteria of PSD within 7 days of admission.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 Barthel Index	once on admission	ability to take care of personal daily routine before stroke
Critical Care Pain Observation Tool (CPOT)	once daily for three days starting on the day of admission	pain during stroke unit treatment
pre-stroke Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)	once on admission	cognitive impairment 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
pre-stroke Groningen Frailty Index (GFI)	once on admission	presence of a frailty syndrome before stroke
National Institutes of Health Stroke Scale (NIHSS)	three times daily for three days starting on the day of admission	estimate of clinical stroke severity

Trial Locations

Locations (1)

Department of Neurology; 🇩🇪 Greifswald, Mecklenburg-Vorpommern, Germany