DeliriumPSD ScreenNCT03930719
Post-stroke Delirium Screening
An observational study of Delirium and Ischemic Stroke, run by University Medicine Greifswald at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Delirium, Ischemic Stroke, Transient Ischemic Attack
- What is being tested?
- Stroke screening tools
- How many people
- 141 participants
- Where
- 1 siteGermany
- Study dates
- 22 Apr 2019to 31 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- stroke unit admission for a high-risk transient ischemic attack (ABCD2 score >= 6) or stroke within the last 24 hours
Who cannot join
- hemorrhagic stroke
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology
Greifswald, Mecklenburg-Vorpommern, 17475
About this study
Official title: Evaluation of Delirium Screening Tools for the Detection of Post-stroke Delirium
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
- Being tested
- Stroke screening tools
- Keywords
- stroke, delirium, screening tool
- Medical subject headings
- Delirium, Ischemic Stroke, Ischemic Attack, Transient, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stroke screening toolsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| PSD | Patients fulfilling DSM-5 criteria of PSD within 7 days of admission. Receives: Diagnostic Test: Stroke screening tools | |
| No PSD | Patients NOT fulfilling DSM-5 criteria of PSD within 7 days of admission. Receives: Diagnostic Test: Stroke screening tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two times daily for 7 days
Secondary outcomes (9)
PSD prevalence
DSM-5 criteria and chart review are used to assess the occurence of PSD among included patients over the complete study period
Measured: three times daily for 7 days
pre-stroke modified Rankin Scale
functional status before stroke
Measured: once on admission
pre-stroke Barthel Index
ability to take care of personal daily routine before stroke
Measured: once on admission
pre-stroke Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
cognitive impairment before stroke
Measured: once on admission
pre-stroke Groningen Frailty Index (GFI)
presence of a frailty syndrome before stroke
Measured: once on admission
National Institutes of Health Stroke Scale (NIHSS)
estimate of clinical stroke severity
Measured: three times daily for three days starting on the day of admission
Critical Care Pain Observation Tool (CPOT)
pain during stroke unit treatment
Measured: once daily for three days starting on the day of admission
Stroke location - clinical (classification of the OxfordshireCommunity Stroke Project (OCSP))
clinical characterisation based on phenotype as either total anterior, partial anterior, partial posterior or lacunar stroke
Measured: once on admission
Stroke location - imaging (based on an atlas of anatomical regions of the human brain (aal MNI V4))
in patients with imaging of the definite stroke location, differences of mean locations between groups will be calculated
Measured: once on admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start22 Apr 2019
- Primary completion21 Jul 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Fleischmann, MD, Principal investigator, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930719
- Sponsor's protocol ID
- BB 031-19
- Acronym
- PSD Screen
- Status last verified
- Jun 2020
- First submitted
- 23 Apr 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33380165
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Delirium Screening Tools for the Detection of Post-stroke Delirium
- ClinicalTrials.gov ID
- NCT03930719
- Acronym / sponsor ID
- PSD Screen / BB 031-19
- Conditions
- Delirium, Ischemic Stroke, Transient Ischemic Attack
- Keywords
- stroke, delirium, screening tool
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 21 Jul 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSD | – | Diagnostic Test: Stroke screening toolsPatients fulfilling DSM-5 criteria of PSD within 7 days of admission. |
| No PSD | – | Diagnostic Test: Stroke screening toolsPatients NOT fulfilling DSM-5 criteria of PSD within 7 days of admission. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- stroke unit admission for a high-risk transient ischemic attack (ABCD2 score >= 6) or stroke within the last 24 hours
Key exclusion criteria (1 listed)
- hemorrhagic stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stroke screening toolsPatients 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. | Diagnostic test | No PSD, PSD |
Primary outcome
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.
9 secondary outcomes
PSD prevalence
Time frame: three times daily for 7 days
pre-stroke modified Rankin Scale
Time frame: once on admission
pre-stroke Barthel Index
Time frame: once on admission
pre-stroke Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
Time frame: once on admission
pre-stroke Groningen Frailty Index (GFI)
Time frame: once on admission
National Institutes of Health Stroke Scale (NIHSS)
Time frame: three times daily for three days starting on the day of admission
Critical Care Pain Observation Tool (CPOT)
Time frame: once daily for three days starting on the day of admission
Stroke location - clinical (classification of the OxfordshireCommunity Stroke Project (OCSP))
Time frame: once on admission
Stroke location - imaging (based on an atlas of anatomical regions of the human brain (aal MNI V4))
Time frame: once on admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Derived from this study: PubMed 33380165Fleischmann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Fleischmann, MD principal investigator
Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Ischemic Stroke, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03930719, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.