Information Recall on Informed Consent to Intravenous Thrombolysis in Patients With Acute Ischaemic Stroke.
- Conditions
- Stroke
- Interventions
- Other: Group 1
- Registration Number
- NCT03246256
- Lead Sponsor
- Charite University, Berlin, 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 260
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 3 Group 1 Stroke patients with acute or subacute ischaemic stroke with a contraindication for intravenous thrombolysis Group 4 Group 1 Patients without an ischaemic stroke but similiar risk factors (admitted to the Departement of Cardiology and Pneumology, Charité, Campus Benjamin Franklin, Berlin, Germany) Group 5 Group 1 Patients with acute ischaemic stroke who were administered intavenous thrombolysis - recall 24 hours after the informed consent procedure Group 1 Group 1 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 Group 2 Group 1 1st of 2nd degree relatives of patients with acute ischaemic stroke, who witnessed the informed consent procedure
- Primary Outcome Measures
Name Time Method Recall of the designated facts given during informed consent procedure on intravenous thrombolysis after acute ischaemic stroke Within 24 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Universitätsklinikum Frankfurt
🇩🇪Frankfurt am Main, Germany
Department of Neurology, University Hospital Leipzig
🇩🇪Leipzig, Saxonia, Germany
Department of Neurology, University Hospital Würzburg
🇩🇪Würzburg, Bavaria, Germany
Department of Neurology, University of Heidelberg
🇩🇪Heidelberg, Germany
Klinikum der Stadt Ludwigshafen a. Rh.
🇩🇪Ludwigshafen am Rhein, Germany