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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 |
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 |
MedlinePlus related topics: | Transient Ischemic Attack |
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 |
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.
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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.
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Control group: No Intervention
No intervention was performed
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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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |||||
Institute of Social Medicine, Epidemiology and Health Economics | |||||
Berlin, Germany, 10098 |
Charite University, Berlin, Germany |
German Federal Ministry of Education and Research |
Principal Investigator: | Stefan N Willich, MD | Institute for Social Medicine, Epidemiology and Health Economics |
Responsible Party: | Institute for Social Medicine, Epidemiology and Health Economics ( Prof. Stefan N. Willich ) |
Study ID Numbers: | Project Z1b |
First Received: | August 28, 2008 |
Last Updated: | August 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00744029 |
Health Authority: | Germany: Ethics Commission |
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