Multimodal Assessment of Frailty in Acute Stroke Patients

Recruiting

• Conditions: Stroke; Frailty
• Interventions: Diagnostic Test: Multimodal frailty assessment

• Registration Number: NCT06031909
• Lead Sponsor: University of Giessen

Brief 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.

Study Timeline

• Study Start: 2023-08-01
• Study First Submitted: 2023-08-30
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-07
• Last Update Submitted: 2023-09-07
• Study First Posted: 2023-09-11
• Last Update Posted: 2023-09-11
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• treated at the certified stroke-unit of the Dpt. of Neurology, University Hospital Giessen
• diagnosis of ischemic (including transient ischemic attack) or hemorrhagic stroke

Exclusion Criteria

• withdrawal of care within 24 hours after admission

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stroke patients	Multimodal frailty assessment	Stroke patients admitted to the certified stroke-unit of the Department of Neurology, University Hospital Giessen, Germany.

Primary Outcome Measures

Name	Time	Method
Rate of good functional outcome	12 months	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
Prevalence of frailty in stroke patients	30 days	Percentage of patients with frailty treated for stroke compared to all patients admitted for stroke

Secondary Outcome Measures

Name	Time	Method
Patient reported outcome measures (PROM)	12 months	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.
Rate of rehospitalization	12 months	Percentage of patients needed to be hospitalized due to unplanned events during the follow-up
Major adverse cardiovascular events (MACE)	From date of admission until MACE or last follow-up, whichever comes first, assessed up to 12 months.	Rate of patients suffering from newly detected myocardial infarction, non-fatal stroke or cardiovascular death
Mortality rate	From date of admission until death or last follow-up, whichever comes first, assessed up to 12 months.	Rate of death observed during the follow-up period
Functional impairment in activities of daily living	12 months	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).
Cognitive outcome	12 months	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)

Trial Locations

Locations (1)

Department of Neurology, University Hospital Giessen; 🇩🇪 Gießen, Hesse, Germany