Reduction of Prehospital Delays in Stroke and Transient Ischaemic Attack (TIA) (BASS)

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00744029
First received: August 28, 2008
Last updated: August 29, 2008
Last verified: August 2008
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Population-Based Intervention to Reduce Prehospital Delays in Patients With Stroke and Transient Ischaemic Attack

Resource links provided by NLM:


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
Active Comparator: Intervention group
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.
No Intervention: Control group
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
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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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Stefan N. Willich, Institute for Social Medicine, Epidemiology and Health Economics
ClinicalTrials.gov Identifier: NCT00744029     History of Changes
Other Study ID Numbers: Project Z1b
Study First Received: August 28, 2008
Last Updated: August 29, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
prehospital delays
intervention
population-based
stroke

Additional relevant MeSH terms:
Cerebral Infarction
Ischemic Attack, Transient
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014