NCT06031909

Multimodal Assessment of Frailty in Acute Stroke Patients

Multimodal Assessment of Frailty in Acute Stroke Patients Treated at a Certified Stroke-unit

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: University of Giessen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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: 1. How prevalent is frailty in patients with stroke? 2. Which impairments (e.g. undernutrion, impaired mobility, laboratory markers) contribute to frailty? 3. Is the outcome of frail patients worse than those without? 4. Are in-hospital complications more frequent in frail patients than those without?

Detailed description

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.

Conditions

• Stroke
• Frailty

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2023-09-11
• Last updated: 2023-09-11

Locations

1 site across 1 country: Germany