NCT00744029

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,388

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Feb 2004

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2008

Completed
Last Updated

September 1, 2008

Status Verified

August 1, 2008

Enrollment Period

1.8 years

First QC Date

August 28, 2008

Last Update Submit

August 29, 2008

Conditions

Stroke

Keywords

prehospital delaysinterventionpopulation-basedstroke

Outcome Measures

Primary Outcomes (1)

  • Time between symptom onset and hospital admission

    Admission to hospital

Secondary Outcomes (2)

  • Proportion of patients with thrombolysis

    hospital stay

  • Mortality

    hospital stay

Study Arms (2)

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

Control group

NO INTERVENTION

No intervention was performed

Interventions

educational materialBEHAVIORAL

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.

Intervention group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Social Medicine, Epidemiology and Health Economics

Berlin, State of Berlin, 10098, Germany

Location

Related Publications (5)

  • 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.

    PMID: 16514090RESULT

  • 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.

    PMID: 15520707RESULT

  • 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.

    PMID: 16618337RESULT

  • 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.

    PMID: 18259083RESULT

  • 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.

    PMID: 19752406DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Stefan N Willich, MD

    Institute for Social Medicine, Epidemiology and Health Economics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 28, 2008

First Posted

August 29, 2008

Study Start

February 1, 2004

Primary Completion

December 1, 2005

Study Completion

June 1, 2007

Last Updated

September 1, 2008

Record last verified: 2008-08

Locations

DE(1)