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 | Intervention/treatment |
|---|---|
| Delirium Ischemic Stroke Transient Ischemic Attack | Diagnostic Test: Stroke screening tools |
| 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 22, 2019 |
| Actual Primary Completion Date : | July 21, 2019 |
| Actual Study Completion Date : | August 31, 2019 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
PSD
Patients fulfilling DSM-5 criteria of PSD within 7 days of admission.
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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.
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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.
|
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
| Germany | |
| Department of Neurology | |
| Greifswald, Mecklenburg-Vorpommern, Germany, 17475 | |
| Principal Investigator: | Robert Fleischmann, MD | Department of Neurology |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 23, 2019 | ||||
| First Posted Date | April 29, 2019 | ||||
| Last Update Posted Date | June 4, 2020 | ||||
| Actual Study Start Date | April 22, 2019 | ||||
| Actual Primary Completion Date | July 21, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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.
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures |
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| Original Other Pre-specified Outcome Measures | Same as current | ||||
| Descriptive Information | |||||
| Brief Title | Post-stroke Delirium Screening | ||||
| Official Title | Evaluation of Delirium Screening Tools for the Detection of Post-stroke Delirium | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. | ||||
| Condition |
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| Intervention | 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.
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| Study Groups/Cohorts |
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| 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
141 | ||||
| Original Estimated Enrollment |
150 | ||||
| Actual Study Completion Date | August 31, 2019 | ||||
| Actual Primary Completion Date | July 21, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Germany | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03930719 | ||||
| Other Study ID Numbers | BB 031-19 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | University Medicine Greifswald | ||||
| Study Sponsor | University Medicine Greifswald | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | University Medicine Greifswald | ||||
| Verification Date | June 2020 | ||||