Post-stroke Delirium Screening

NCT03930719 | Completed

• 1 other identifier: BB 031-19
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Ischemic Stroke; Transient Ischemic Attack

Keywords

stroke; delirium; screening tool

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• PSD prevalence

  three times daily for 7 days

• pre-stroke modified Rankin Scale

  once on admission

• pre-stroke Barthel Index

  once on admission

• pre-stroke Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)

  once on admission

• pre-stroke Groningen Frailty Index (GFI)

  once on admission

Other Outcomes (2)

• demographic data

  once on admission

• complications during stroke unit treatment

  continuously during the study period and up to 7 days

Study Arms (2)

PSD

Patients fulfilling DSM-5 criteria of PSD within 7 days of admission.

Diagnostic Test: Stroke screening tools

No PSD

Patients NOT fulfilling DSM-5 criteria of PSD within 7 days of admission.

Diagnostic Test: Stroke screening tools

Interventions

Stroke screening tools DIAGNOSTIC_TEST

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.

No PSD; PSD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any patient admitted to the emergency department for a suspected ischemic cerebrovascular event is eligible to participate. A neurologist must then confirm the diagnosis and necessity for stroke unit monitoring.

You may qualify if:

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

You may not qualify if:

• hemorrhagic stroke

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

Department of Neurology

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

Related Publications (1)

• Fleischmann R, Warwas S, Andrasch T, Kunz R, Witt C, Mengel A, von Sarnowski B. Course and Recognition of Poststroke Delirium: A Prospective Noninferiority Trial of Delirium Screening Tools. Stroke. 2021 Jan;52(2):471-478. doi: 10.1161/STROKEAHA.120.031019. Epub 2020 Dec 31.

  PMID: 33380165 DERIVED

MeSH Terms

Conditions

Delirium; Ischemic Stroke; Ischemic Attack, Transient; Stroke

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Study Officials

• Robert Fleischmann, MD

  Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 29, 2019
• Study Start: April 22, 2019
• Primary Completion: July 21, 2019
• Study Completion: August 31, 2019
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)