Information Recall on Informed Consent to Intravenous Thrombolysis in Patients With Acute Ischaemic Stroke.

Charite University, Berlin, Germany260 enrolled

Overview

The aim of the study is to investigate the ability to recall information given during informed consent on intravenous thrombolysis in patients with acute ischaemic stroke.

The purpose of this prospective multi-center study is to investigate whether patients with acute ischaemic stroke are able to recall information given before providing informed consent to intravenous thrombolysis after the end of treatment. Patients with acute ischaemic stroke will be compared to a group of relatives who witnessed the informed consent procedure of a relative with acute ischaemic stroke, stroke patients who were not treated with intravenous thrombolysis and patients without an ischaemic stroke but similiar risk factors (admitted to the Departement of Cardiology and Pneumology, Charité, Campus Benjamin Franklin, Berlin, Germany).

Study Type

OBSERVATIONAL

Enrollment

260

Conditions

Stroke

Interventions

Group 1OTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria (all): * age ≥18 years * able to give informed consent * ability to understand and read German * no prior i.v.-thrombolysis Additional inclusion criteria - patients with acute ischaemic stroke: * suspected ischaemic stroke (according to brain CT) or MRI-proven acute ischaemic stroke * indication for intravenous thrombolysis Additional inclusion criteria - relatives: · relative (1st or 2nd dregree) of a patient with acute ischaemic stroke and present during the informed consent procedure Additional inclusion criteria - stroke patients with a contraindication for thrombolysis: * ischaemic stroke (according to brain MRI or CT) * contraindication for intravenous thrombolysis Additional inclusion criteria - non-stroke patients: · present admission at the Department of Cardiology and Pneumology, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany Exclusion criteria (all groups): * not able to give imformed consent or under legal supervision/guardianship * participation in an interventional study

Locations (5)

Department of Neurology, University Hospital Würzburg

Würzburg, Bavaria, Germany

Department of Neurology, University Hospital Leipzig

Leipzig, Saxony, Germany

Universitätsklinikum Frankfurt

Frankfurt am Main, Germany

Department of Neurology, University of Heidelberg

Heidelberg, Germany

Outcomes

Primary Outcomes

Recall of the designated facts given during informed consent procedure on intravenous thrombolysis after acute ischaemic stroke

Time frame: Within 24 hours

Data from ClinicalTrials.gov

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