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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03246256

Collaborator

Department of Neurology, Charité - Universitätsmedizin Berlin, Germany (Other), Department of Cardiology and Pneumology, Charité, Campus Benjamin Franklin (Other)

260

Enrollment

Locations

53.3

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Other: Group 1

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).

Study Design

Study Type:

Observational

Anticipated Enrollment :

260 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Recall of Information on Intravenous Thrombolysis in Acute Ischaemic Stroke Patients Given During Informed Consent: a Prospective Observational Study.

Actual Study Start Date :

Dec 21, 2016

Actual Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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	Other: Group 1 Other Names: Group 2 Group 3 Group 4 Group 5
Group 2 1st of 2nd degree relatives of patients with acute ischaemic stroke, who witnessed the informed consent procedure	Other: Group 1 Other Names: Group 2 Group 3 Group 4 Group 5
Group 3 Stroke patients with acute or subacute ischaemic stroke with a contraindication for intravenous thrombolysis	Other: Group 1 Other Names: Group 2 Group 3 Group 4 Group 5
Group 4 Patients without an ischaemic stroke but similiar risk factors (admitted to the Departement of Cardiology and Pneumology, Charité, Campus Benjamin Franklin, Berlin, Germany)	Other: Group 1 Other Names: Group 2 Group 3 Group 4 Group 5
Group 5 Patients with acute ischaemic stroke who were administered intavenous thrombolysis - recall 24 hours after the informed consent procedure	Other: Group 1 Other Names: Group 2 Group 3 Group 4 Group 5

Outcome Measures

Primary Outcome Measures

Recall of the designated facts given during informed consent procedure on intravenous thrombolysis after acute ischaemic stroke [Within 24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Department of Neurology, University Hospital Würzburg	Würzburg	Bavaria	Germany
2	Department of Neurology, University Hospital Leipzig	Leipzig	Saxonia	Germany
3	Universitätsklinikum Frankfurt	Frankfurt am Main		Germany
4	Department of Neurology, University of Heidelberg	Heidelberg		Germany
5	Klinikum der Stadt Ludwigshafen a. Rh.	Ludwigshafen am Rhein		Germany

Sponsors and Collaborators

Charite University, Berlin, Germany
Department of Neurology, Charité - Universitätsmedizin Berlin, Germany
Department of Cardiology and Pneumology, Charité, Campus Benjamin Franklin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Karl Georg Haeusler, Consultant Neurologist, Wuerzburg University Hospital

ClinicalTrials.gov Identifier:

NCT03246256

Other Study ID Numbers:

EA4/140/16

First Posted:

Aug 11, 2017

Last Update Posted:

Nov 13, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Karl Georg Haeusler, Consultant Neurologist, Wuerzburg University Hospital

acute

informed consent

thrombolysis

Additional relevant MeSH terms:

Stroke

Ischemic Stroke

Study Results

No Results Posted as of Nov 13, 2020