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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
educational material
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke focused on measuring prehospital delays, intervention, population-based, stroke

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Social Medicine, Epidemiology and Health Economics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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 was performed

Outcomes

Primary Outcome Measures

Time between symptom onset and hospital admission

Secondary Outcome Measures

Proportion of patients with thrombolysis
Mortality

Full Information

First Posted
August 28, 2008
Last Updated
August 29, 2008
Sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT00744029
Brief Title
Reduction of Prehospital Delays in Stroke and Transient Ischaemic Attack (TIA)
Acronym
BASS
Official Title
Population-Based Intervention to Reduce Prehospital Delays in Patients With Stroke and Transient Ischaemic Attack
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
prehospital delays, intervention, population-based, stroke

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1388 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention was performed
Intervention Type
Behavioral
Intervention Name(s)
educational material
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time between symptom onset and hospital admission
Time Frame
Admission to hospital
Secondary Outcome Measure Information:
Title
Proportion of patients with thrombolysis
Time Frame
hospital stay
Title
Mortality
Time Frame
hospital stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan N Willich, MD
Organizational Affiliation
Institute for Social Medicine, Epidemiology and Health Economics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Social Medicine, Epidemiology and Health Economics
City
Berlin
ZIP/Postal Code
10098
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
16514090
Citation
Muller-Nordhorn J, Nolte CH, Rossnagel K, Jungehulsing 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. doi: 10.1161/01.STR.0000209332.96513.82. Epub 2006 Mar 2.
Results Reference
result
PubMed Identifier
15520707
Citation
Rossnagel K, Jungehulsing GJ, Nolte CH, Muller-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. doi: 10.1016/j.annemergmed.2004.06.019.
Results Reference
result
PubMed Identifier
16618337
Citation
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. doi: 10.1111/j.1468-1331.2006.01170.x.
Results Reference
result
PubMed Identifier
18259083
Citation
Jungehulsing GJ, Muller-Nordhorn J, Nolte CH, Roll S, Rossnagel K, Reich A, Wagner A, Einhaupl 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. doi: 10.1159/000115750. Epub 2008 Feb 7.
Results Reference
result
PubMed Identifier
19752406
Citation
Muller-Nordhorn J, Wegscheider K, Nolte CH, Jungehulsing GJ, Rossnagel K, Reich A, Roll S, Villringer A, Willich SN. Population-based intervention to reduce prehospital delays in patients with cerebrovascular events. Arch Intern Med. 2009 Sep 14;169(16):1484-90. doi: 10.1001/archinternmed.2009.232.
Results Reference
derived

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

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