Clinical trial NCT03246256: Information Recall on Informed Consent to Intravenous Thrombolysis in Patients With Acute Ischaemic Stroke.
Official title: Recall of Information on Intravenous Thrombolysis in Acute Ischaemic Stroke Patients Given During Informed Consent: a Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: acute
informed consent
thrombolysis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Department of Neurology, Charité - Universitätsmedizin Berlin, Germany
name: Department of Cardiology and Pneumology, Charité, Campus Benjamin Franklin
First posted: 2017-08-11
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute ischaemic stroke and intravenous thrombolysis or patients with acute ischaemic stroke refusing intravenous thrombolysis, relatives (1st or 2nd degree) of patients with acute ischaemic stroke, patient with acute or subacute ischaemic stroke with a contraindication for intravenous thrombolysis and patients without acute ischaemic stroke (admitted to the Department of Cardiology (Charité, Campus Benjamin Franklin, Germany).

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Recall of the designated facts given during informed consent procedure on intravenous thrombolysis after acute ischaemic stroke
timeFrame: Within 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Würzburg
country: Germany
facility: Department of Neurology, University Hospital Würzburg
state: Bavaria
city: Leipzig
country: Germany
facility: Department of Neurology, University Hospital Leipzig
state: Saxonia
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
city: Heidelberg
country: Germany
facility: Department of Neurology, University of Heidelberg
city: Ludwigshafen am Rhein
country: Germany
facility: Klinikum der Stadt Ludwigshafen a. Rh.
Study officials:
References: