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Completed

NCT Number: NCT03930719

Post-stroke Delirium Screening

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.

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Key information

Conditions

Delirium Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Confusion Ischemic Attack, Transient Ischemic Stroke Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Transient Ischemic Attack Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. PSD prevalence

    Time frame: 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

  2. pre-stroke modified Rankin Scale

    Time frame: once on admission

    functional status before stroke

  3. pre-stroke Barthel Index

    Time frame: once on admission

    ability to take care of personal daily routine before stroke

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

    Time frame: once on admission

    cognitive impairment before stroke

  5. pre-stroke Groningen Frailty Index (GFI)

    Time frame: once on admission

    presence of a frailty syndrome before stroke

  6. National Institutes of Health Stroke Scale (NIHSS)

    Time frame: three times daily for three days starting on the day of admission

    estimate of clinical stroke severity

  7. Critical Care Pain Observation Tool (CPOT)

    Time frame: once daily for three days starting on the day of admission

    pain during stroke unit treatment

  8. Stroke location - clinical (classification of the OxfordshireCommunity Stroke Project (OCSP))

    Time frame: once on admission

    clinical characterisation based on phenotype as either total anterior, partial anterior, partial posterior or lacunar stroke

  9. Stroke location - imaging (based on an atlas of anatomical regions of the human brain (aal MNI V4))

    Time frame: once on admission

    in patients with imaging of the definite stroke location, differences of mean locations between groups will be calculated

Other outcomes

  1. demographic data

    Time frame: once on admission

    exploratory outcome required to adjust for confounding variates such as age, socioeconomic status and education

  2. complications during stroke unit treatment

    Time frame: continuously during the study period and up to 7 days

    any complication that arises during the study period (e.g. pneumonia, dysphagia)

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Registry information

Official study title

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

Acronym: PSD Screen

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 29, 2019
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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