Multimodal Assessment of Frailty in Acute Stroke Patients

NCT06031909 | Unknown

• 1 other identifier: AZ 220/21
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke; Frailty

Keywords

frailty; outcome; elderly

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Patient reported outcome measures (PROM)

  12 months

• Functional impairment in activities of daily living

  12 months

• Mortality rate

  From date of admission until death or last follow-up, whichever comes first, assessed up to 12 months.

• Cognitive outcome

  12 months

• Rate of rehospitalization

  12 months

Study Arms (1)

Stroke patients

Stroke patients admitted to the certified stroke-unit of the Department of Neurology, University Hospital Giessen, Germany.

Diagnostic Test: Multimodal frailty assessment

Interventions

Multimodal frailty assessment DIAGNOSTIC_TEST

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.

Stroke patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• withdrawal of care within 24 hours after admission

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

Department of Neurology, University Hospital Giessen

Giessen, Hesse, 35392, Germany

RECRUITING

Related Publications (3)

• 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.

  PMID: 28419988 BACKGROUND

• 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.

  PMID: 30717052 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.

  PMID: 32623428 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Stroke; Frailty

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan Gerner, MD

  Department of Neurology, University Hospital Giessen/Germany

  PRINCIPAL INVESTIGATOR

• Thorsten Doeppner, MD

  Department of Neurology, University Hospital Giessen/Germany

  STUDY CHAIR

• Hagen Huttner, MD, PhD

  Department of Neurology, University Hospital Giessen/Germany

  STUDY CHAIR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate professor

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 11, 2023
• Study Start: August 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

DE (1)