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

Charité University Medicine Berlin

Status: Unknown

Conditions: Stroke

Treatments: Other: Group 1

Study type: Observational

Funder types: Other

Identifiers

NCT03246256

EA4/140/16

Details and patient eligibility

About

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.

Full 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).

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

260 participants in 5 patient groups

Group 1

Description:

Patients with acute ischaemic stroke who were administered intavenous thrombolysis or patients with acute ischaemic stroke refusing intravenous thrombolysis; recall in both cases 60 to 90 minutes after the informed consent procedure

Treatment:

Other: Group 1

Group 2

Description:

1st of 2nd degree relatives of patients with acute ischaemic stroke, who witnessed the informed consent procedure

Treatment:

Other: Group 1

Group 3

Description:

Stroke patients with acute or subacute ischaemic stroke with a contraindication for intravenous thrombolysis

Treatment:

Other: Group 1

Group 4

Description:

Patients without an ischaemic stroke but similiar risk factors (admitted to the Departement of Cardiology and Pneumology, Charité, Campus Benjamin Franklin, Berlin, Germany)

Treatment:

Other: Group 1

Group 5

Description:

Patients with acute ischaemic stroke who were administered intavenous thrombolysis - recall 24 hours after the informed consent procedure

Treatment:

Other: Group 1