StrokeBASSNCT00744029
Reduction of Prehospital Delays in Stroke and Transient Ischaemic Attack (TIA)
A study testing educational material in people with Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- educational material
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,388 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2004to Jun 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with stroke or transient ischaemic attacks from the postal code areas of the study being admitted to one of the participating hospitals
Who cannot join
- Patients with stroke or transient ischaemic attacks from outside the postal code areas of the study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Social Medicine, Epidemiology and Health Economics
Berlin, State of Berlin, 10098
About this study
Official title: Population-Based Intervention to Reduce Prehospital Delays in Patients With Stroke and Transient Ischaemic Attack
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).
Read the 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.
- Conditions
- Stroke
- Being tested
- educational material
- Keywords
- prehospital delays, intervention, population-based, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational materialBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: educational material |
| Control group | No intervention | No intervention was performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time between symptom onset and hospital admission
Measured: Admission to hospital
Secondary outcomes (2)
Proportion of patients with thrombolysis
Measured: hospital stay
Mortality
Measured: hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startFeb 2004
- Primary completionDec 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Investigators
- Stefan N Willich, MD, Principal investigator, Institute for Social Medicine, Epidemiology and Health Economics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744029
- Sponsor's protocol ID
- Project Z1b
- Acronym
- BASS
- Status last verified
- Aug 2008
- First submitted
- 28 Aug 2008
- Last updated
- 1 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16514090Rossnagel 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.
PubMed 15520707Jungehulsing 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.
PubMed 16618337Jungehulsing 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.
PubMed 18259083Muller-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.
PubMed 19752406
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population-Based Intervention to Reduce Prehospital Delays in Patients With Stroke and Transient Ischaemic Attack
- ClinicalTrials.gov ID
- NCT00744029
- Acronym / sponsor ID
- BASS / Project Z1b
- Conditions
- Stroke
- Keywords
- prehospital delays, intervention, population-based, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,388 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Feb 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 29 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: educational materialEducational 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with stroke or transient ischaemic attacks from the postal code areas of the study being admitted to one of the participating hospitals
Key exclusion criteria (1 listed)
- Patients with stroke or transient ischaemic attacks from outside the postal code areas of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational materialEducational 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. | Behavioural | Intervention group |
Primary outcome
Time between symptom onset and hospital admission
Time frame: Admission to hospital
2 secondary outcomes
Proportion of patients with thrombolysis
Time frame: hospital stay
Mortality
Time frame: hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2008.
- Results publication: PubMed 16514090Muller-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 publication: PubMed 15520707Rossnagel 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 publication: PubMed 16618337Jungehulsing 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 publication: PubMed 18259083Jungehulsing 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.
- Derived from this study: PubMed 19752406Muller-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan N Willich, MD principal investigator
Institute for Social Medicine, Epidemiology and Health Economics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational material in people with Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time between symptom onset and hospital admission (time frame: Admission to hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00744029, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2008.