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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Post-stroke Delirium Screening

Clinicaltrials.gov identifier NCT03930719

Recruitment Status Completed

First Posted April 29, 2019

Last update posted June 4, 2020

Study Description

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.

  • Condition or Disease:Delirium
    Ischemic Stroke
    Transient Ischemic Attack
  • Intervention/Treatment: Diagnostic Test: Stroke screening tools
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Actual Enrollment: 141 participants
  • Observational Model: Case-Control
  • Time Perspective: Prospective
  • Official Title: Evaluation of Delirium Screening Tools for the Detection of Post-stroke Delirium
  • Actual Study Start Date: April 2019
  • Actual Primary Completion Date: July 2019
  • Actual Study Completion Date: August 2019
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: No PSD
Patients NOT fulfilling DSM-5 criteria of PSD within 7 days of admission.
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.
: PSD
Patients fulfilling DSM-5 criteria of PSD within 7 days of admission.
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.
Outcome Measures
  • Primary Outcome Measures: 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 Outcome Measures: 1. Critical Care Pain Observation Tool (CPOT) [ Time Frame: once daily for three days starting on the day of admission ]
    pain during stroke unit treatment
  • 2. 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
  • 3. 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
  • 4. pre-stroke modified Rankin Scale [ Time Frame: once on admission ]
    functional status before stroke
  • 5. pre-stroke Barthel Index [ Time Frame: once on admission ]
    ability to take care of personal daily routine before stroke
  • 6. pre-stroke Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) [ Time Frame: once on admission ]
    cognitive impairment before stroke
  • 7. pre-stroke Groningen Frailty Index (GFI) [ Time Frame: once on admission ]
    presence of a frailty syndrome before stroke
  • 8. 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
  • 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 Outcome Measures: 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)
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • 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.
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

Contacts and Locations
Contacts
Locations

Germany, Mecklenburg-Vorpommern
Department of Neurology
Greifswald

Sponsors and Collaborators

University Medicine Greifswald

Investigators

Principal Investigator: Robert Fleischmann, MD Department of Neurology

More Information
  • Responsible Party: University Medicine Greifswald
  • ClinicalTrials.gov Identifier: NCT03930719 History of Changes
  • Other Study ID Numbers: BB 031-19
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: June 4, 2020
  • Last Verified: June 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University Medicine Greifswald: stroke
    delirium
    screening tool
  • Additional relevant MeSH terms: Ischemic Attack, Transient
    Stroke
    Delirium
    Ischemia