Multimodal Assessment of Frailty in Acute Stroke Patients

Stroke Clinical Trial

— MAFASP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06031909
• Other study ID #: AZ 220/21
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: September 2023
• Source: University of Giessen
• Contact: Stefan Gerner, MD
• Phone: +49-641/985-45301
• Email: stefan.gerner[@]neuro.med.uni-giessen.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Germany	Department of Neurology, University Hospital Giessen	Gießen	Hesse

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of frailty in stroke patients	Percentage of patients with frailty treated for stroke compared to all patients admitted for stroke	30 days
Primary	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
Secondary	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
Secondary	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).	12 months
Secondary	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.
Secondary	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
Secondary	Rate of rehospitalization	Percentage of patients needed to be hospitalized due to unplanned events during the follow-up	12 months
Secondary	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.

External Links

•   website of the recruiting site: Dpt. of Neurology, University Hospital Giessen