An observational study in Stroke and Frailty, sponsored by University of Giessen. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-11.
Sponsored by University of Giessen · Observational
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.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's planned enrollment of 200 is above the median of 160 across 1,729 observational studies indexed under Stroke.
Browse Stroke studies →University of Giessen is the lead sponsor of 95 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Stroke patients admitted to the certified stroke-unit of the Department of Neurology, University Hospital Giessen, Germany.
Diagnostic Test: Multimodal frailty assessment
Different domains are assessed during hospital stay, these include: * Clinical scores: Clinical Frailty scale (CFS), Groningen Frailty index (GFI) * Brain frailty: assessing white matter hyperintensieties, atrophy and lacunar strokes in initial brain imaging * Laboratory values: laboratory Frailty index (FI-Lab), inflammatory markers * Nutrition: Controlling nutritional status score (CONUT-score), body mass index, dysphagia assessment (FOIS) * Mobility/strengths: de Morton Mobility Index (DEMMI), grip strenghts of non-paralytic arm via dynamometer, muscle mass estimated by sonographic measurement of the biceps brachii muscle and the rectus femoris muscle.
Prevalence of frailty in stroke patients
Percentage of patients with frailty treated for stroke compared to all patients admitted for stroke
Time frame: 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
Time frame: 12 months
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.
Time frame: 12 months
Functional impairment in activities of daily living
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).
Time frame: 12 months
Mortality rate
Rate of death observed during the follow-up period
Time frame: 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)
Time frame: 12 months
Rate of rehospitalization
Percentage of patients needed to be hospitalized due to unplanned events during the follow-up
Time frame: 12 months
Major adverse cardiovascular events (MACE)
Rate of patients suffering from newly detected myocardial infarction, non-fatal stroke or cardiovascular death
Time frame: From date of admission until MACE or last follow-up, whichever comes first, assessed up to 12 months.
Plan to share: Undecided — Reasonable requests can be sent by mail.
Started Aug 2023 (actual). Primary completion is estimated for Oct 2024, 14 months after the start.
Of 787 non-industry observational studies under Stroke, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 101. This study's planned 14 months is below that.
Counting every sponsor, half of 833 studies reached it within 41 months; a quarter within 18 and three quarters within 92.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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University of Giessen