Reduction of Prehospital Delays in Stroke and Transient Ischaemic Attack (TIA) - Full Text View

Sponsors and Collaborators:	Charite University, Berlin, Germany German Federal Ministry of Education and Research
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00744029

Purpose

In patients with acute stroke, systemic thrombolysis needs to be administered within three hours of symptom onset. The aim of the present study was to reduce prehospital delays in a population-based intervention.The intervention consisted of an educational letter indicating stroke symptoms and emphasizing the importance of calling the emergency medical services (EMS). The investigators additionally included a bookmark and sticker with the EMS telephone number. A total of 75,720 inhabitants received the intervention. Between 2004 and 2005, 741 patients with cerebrovascular events were admitted from the control areas (n=24) and 647 from the intervention areas (n=24).

Condition	Intervention
Stroke	Behavioral: educational material

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment
Official Title:	Population-Based Intervention to Reduce Prehospital Delays in Patients With Stroke and Transient Ischaemic Attack

Resource links provided by NLM:

MedlinePlus related topics: Transient Ischemic Attack

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:

Time between symptom onset and hospital admission [ Time Frame: Admission to hospital ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients with thrombolysis [ Time Frame: hospital stay ] [ Designated as safety issue: No ]
Mortality [ Time Frame: hospital stay ] [ Designated as safety issue: No ]

Enrollment:	1388
Study Start Date:	February 2004
Study Completion Date:	June 2007
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Intervention group: Active Comparator Educational letter indicating stroke symptoms and emphasizing the importance of calling the emergency medical services (EMS) as well as a bookmark and sticker with the EMS telephone number.	Behavioral: educational material Educational letter indicating stroke symptoms and emphasizing the importance of calling the emergency medical services (EMS) as well as a bookmark and sticker with the EMS telephone number.
Control group: No Intervention No intervention was performed

Detailed Description:

Background and Purpose:

In patients with acute stroke, systemic thrombolysis needs to be administered within three hours of symptom onset. The aim of the present study was to reduce prehospital delays in a population-based intervention.

Methods:

We performed a cluster-randomized trial with 48 zip code areas as cluster units in the catchment area of three inner-city hospitals in Berlin. The primary endpoint was time between symptom onset and hospital admission. The intervention consisted of an educational letter indicating stroke symptoms and emphasizing the importance of calling the emergency medical services (EMS). We additionally included a bookmark and sticker with the EMS telephone number. We fitted a lognormal survival regression model (time-to-admission) with frailty terms shared by inhabitants of the same zip code area.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients with stroke or transient ischaemic attacks from the postal code areas of the study being admitted to one of the participating hospitals

Exclusion Criteria:

Patients with stroke or transient ischaemic attacks from outside the postal code areas of the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744029

Locations

Germany
Institute of Social Medicine, Epidemiology and Health Economics
Berlin, Germany, 10098

Sponsors and Collaborators

Charite University, Berlin, Germany

German Federal Ministry of Education and Research

Investigators

Principal Investigator:

Stefan N Willich, MD

Institute for Social Medicine, Epidemiology and Health Economics

More Information

Publications:

Müller-Nordhorn J, Nolte CH, Rossnagel K, Jungehülsing GJ, Reich A, Roll S, Villringer A, Willich SN. Knowledge about risk factors for stroke: a population-based survey with 28,090 participants. Stroke. 2006 Apr;37(4):946-50. Epub 2006 Mar 2.

Rossnagel K, Jungehülsing GJ, Nolte CH, Müller-Nordhorn J, Roll S, Wegscheider K, Villringer A, Willich SN. Out-of-hospital delays in patients with acute stroke. Ann Emerg Med. 2004 Nov;44(5):476-83.

Jungehulsing GJ, Rossnagel K, Nolte CH, Muller-Nordhorn J, Roll S, Klein M, Wegscheider K, Einhaupl KM, Willich SN, Villringer A. Emergency department delays in acute stroke - analysis of time between ED arrival and imaging. Eur J Neurol. 2006 Mar;13(3):225-32.

Jungehülsing GJ, Müller-Nordhorn J, Nolte CH, Roll S, Rossnagel K, Reich A, Wagner A, Einhäupl KM, Willich SN, Villringer A. Prevalence of stroke and stroke symptoms: a population-based survey of 28,090 participants. Neuroepidemiology. 2008;30(1):51-7. Epub 2008 Feb 7.

Responsible Party:	Institute for Social Medicine, Epidemiology and Health Economics ( Prof. Stefan N. Willich )
Study ID Numbers:	Project Z1b
Study First Received:	August 28, 2008
Last Updated:	August 29, 2008
ClinicalTrials.gov Identifier:	NCT00744029 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:

prehospital delays
intervention
population-based
stroke

Study placed in the following topic categories:

Ischemic Attack, Transient
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Brain Ischemia

Brain Infarction
Ischemia
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:

Ischemic Attack, Transient
Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases

Brain Ischemia
Cardiovascular Diseases
Brain Infarction
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on September 10, 2009