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The goal of this study is to investigate the influence of frailty on clinical and stroke characteristics, treatment and outcomes in patients with acute stroke.
The main questions it aims to answer are:
Stroke is one of the most common causes of disability and mortality worldwide. A recognized complication in stroke patients is frailty, which is associated with increased costs, poorer prognosis, and higher mortality rates. However, there is currently no uniform definition or diagnostic criteria for frailty in stroke patients, and there is a need for standardized frailty assessments in this patient population.
The aim of this study is to determine the prevalence of frailty in stroke patients at the Stroke Unit of the University Hospital Giessen and to analyze the associated characteristics and impacts on clinical outcomes. A multimodal frailty assessment will be conducted to capture a wide range of frailty features and investigate their significance. The study includes all stroke patients admitted to the certified stroke- unit of the University Hospital Giessen within a 3-month period. There are no inclusion criteria related to age, gender, or type of stroke.
The multimodal frailty assessment encompasses determining appropriate blood values (e.g., CRP, albumin), assessing muscle strength/mass through handheld dynamometry and sonographic muscle diameter, utilizing scores like the Clinical Frailty Scale (CFS) and the Groningen Frailty Indicator (GFI), evaluating nutritional status (BMI), collecting image-based frailty data (e.g., sarcopenia, cerebral white matter lesions, lacunar strokes, brain atrophy), and conducting suitable one-year follow-ups. Additionally, demographic and clinical data such as age, gender, type of stroke, and treatment details will be recorded.
The primary outcome is the prevalence of frailty among stroke patients. Secondary outcomes include the characteristics and impacts of frailty in stroke patients, including correlations between various frailty features and clinical outcomes such as length of hospital stay, mortality, and functional outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stroke patients | Stroke patients admitted to the certified stroke-unit of the Department of Neurology, University Hospital Giessen, Germany. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal frailty assessment | Diagnostic Test | Different domains are assessed during hospital stay, these include:
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of frailty in stroke patients | Percentage of patients with frailty treated for stroke compared to all patients admitted for stroke | 30 days |
| Rate of good functional outcome | Percentage of patients achieving a score of 0 to 2 on the modified Rankin scale (higher values indicating worse outcome, ranging from 0, no deficit, to 6, death) at 12 months follow-up | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported outcome measures (PROM) | Health-related quality measured using the visual analogue scale (VAS) of the Euroquol EQ-5D-3L tool. Score ranging from 0 to 100, with higher values indicating better quality of life. | 12 months |
| Functional impairment in activities of daily living |
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Inclusion Criteria:
Exclusion Criteria:
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All patients admitted with the diagnosis of acute stroke treated at the certified stroke-unit will be included. All patients who consent for participation are further eligible for the outcome assessment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan Gerner, MD | Contact | +49-641/985-45301 | stefan.gerner@neuro.med.uni-giessen.de | |
| Thorsten Doeppner, MD | Contact | +49-641/985-45301 | thorsten.doeppner@neuro.med.uni-giessen.de |
| Name | Affiliation | Role |
|---|---|---|
| Stefan Gerner, MD | Department of Neurology, University Hospital Giessen/Germany | Principal Investigator |
| Thorsten Doeppner, MD | Department of Neurology, University Hospital Giessen/Germany | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, University Hospital Giessen | Recruiting | Giessen | Hesse | 35392 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28419988 | Background | Giede-Jeppe A, Bobinger T, Gerner ST, Sembill JA, Sprugel MI, Beuscher VD, Lucking H, Hoelter P, Kuramatsu JB, Huttner HB. Neutrophil-to-Lymphocyte Ratio Is an Independent Predictor for In-Hospital Mortality in Spontaneous Intracerebral Hemorrhage. Cerebrovasc Dis. 2017;44(1-2):26-34. doi: 10.1159/000468996. Epub 2017 Apr 19. | |
| 30717052 |
| Label | URL |
|---|---|
| website of the recruiting site: Dpt. of Neurology, University Hospital Giessen | View source |
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Reasonable requests can be sent by mail.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
Impairment in activities of daily living measuring the score on the Barthel-Index (BI; ranging from 0 to 100, with higher values indicating less impairment in activities of daily living). |
| 12 months |
| Mortality rate | Rate of death observed during the follow-up period | From date of admission until death or last follow-up, whichever comes first, assessed up to 12 months. |
| Cognitive outcome | Assessment of cognition using the telephone Montreal Cognitive Assessment test (tMOCA; ranging from 0 to 22, with a score of 18 or below indicating mild cognitive dysfunction) | 12 months |
| Rate of rehospitalization | Percentage of patients needed to be hospitalized due to unplanned events during the follow-up | 12 months |
| Major adverse cardiovascular events (MACE) | Rate of patients suffering from newly detected myocardial infarction, non-fatal stroke or cardiovascular death | From date of admission until MACE or last follow-up, whichever comes first, assessed up to 12 months. |
| Hagen Huttner, MD, PhD | Department of Neurology, University Hospital Giessen/Germany | Study Chair |
| Giede-Jeppe A, Reichl J, Sprugel MI, Lucking H, Hoelter P, Eyupoglu IY, Kuramatsu JB, Huttner HB, Gerner ST. Neutrophil-to-lymphocyte ratio as an independent predictor for unfavorable functional outcome in aneurysmal subarachnoid hemorrhage. J Neurosurg. 2019 Feb 1;132(2):400-407. doi: 10.3171/2018.9.JNS181975. Print 2020 Feb 1. |
| 32623428 | Background | Gerner ST, Reichl J, Custal C, Brandner S, Eyupoglu IY, Lucking H, Holter P, Kallmunzer B, Huttner HB. Long-Term Complications and Influence on Outcome in Patients Surviving Spontaneous Subarachnoid Hemorrhage. Cerebrovasc Dis. 2020;49(3):307-315. doi: 10.1159/000508577. Epub 2020 Jul 3. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |