Acute StrokeNCT01881152
Effectiveness of a Public Campaign to Increase Stroke Awareness in Reducing Prehospital Delay
A study testing Educational campaign in people with Acute Stroke, run by Azienda Ospedaliero-Universitaria di Parma at 5 sites in Italy.
Trial summary
The starting hypothesis is that a multilevel educational campaign, specifically developed for the local community, can increase public stroke awareness and reduce pre-hospital delay. The effectiveness of such intervention will be evaluated according to a cluster randomized, stepped wedged design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Educational campaign
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,772 participants
- Where
- 5 sitesItaly
- Study dates
- Jun 2013to Dec 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients consecutively admitted to the six participating hospitals for suspected stroke or transitory ischemic attack (TIA), defined as abrupt onset of focal or generalized neurologic deficit of vascular origin.
Who cannot join
- No information available on the time of stroke onset.
- No informed consent from patient or caregiver
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
AUSL Parma
Fidenza, 43016
Ospedale Civile S. Agostino Estense-Baggiovara-AUSL Modena
Modena
University Hospital of Parma
Parma, 43100
Ospedale Guglielmo di Siliceto-AUSL Piacenza
Piacenza
Arcispedale Santa Maria Nuova of Reggio Emilia
Reggio Emilia
About this study
Official title: Cluster Randomized Controlled Trial to Assess the Effectiveness of a Population-based Educational Campaign on Stroke Symptom Recognition in Reducing Pre-hospital Delay
The starting hypothesis is that a multilevel educational campaign, specifically developed for the local community, can increase public stroke awareness and reduce pre-hospital delay.
The effectiveness of such intervention will be evaluated according to a cluster randomized, stepped wedged design. The clusters are the four communities of the Area Vasta Emilia Nord, AVEN (Parma, Piacenza, Modena e Reggio Emilia). As analysis Units, we will consider the patients consecutively admitted to the six participating hospitals throughout the study period, for suspected stroke or transitory ischemic attack (TIA).
Read the detailed description
After a baseline 3 month period, the educational campaign will be sequentially launched in the four communities over four 3 month periods, according to a computer-generated list. The comparison will be the"usual care".
Primary outcome measures: The proportion of patients arriving at the Emergency Department (ED) with suspected stroke or TIA within two hours.
Secondary outcome measures: the proportion of patients with confirmed stroke or TIA diagnosis; the proportion of ischemic stroke patients evaluated for recominanat Tissue Plasminogen Activator (rTPA) therapy; the proportion of patients treated with rTPA; time interval between arrival at the ED and CT scan; for patients treated with rTPA, time interval between arrival at the ED and therapy initiation (door to needle time); death and disability (assessed as modified Rankin Score 3-5) at 1 and 3 month from stroke onset.
- Conditions
- Acute Stroke
- Being tested
- Educational campaign, Usual care
- Keywords
- Stroke, Community education, Awareness, Prehospital delay
- Medical subject headings
- Stroke, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational campaignOther
Also called Community campaign, Public campaign
Multilevel educational campaign on stroke sympton recognition and the need for calling the Emergency Services
Usual careOther
Information on stroke usually delivered at the community level.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Educational campaign Receives: Other: Educational campaign |
| Control | Other | Usual care Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of early admission
Proportion of patients arriving to the Emergency Department with suspected stroke or TIA within two hours
Measured: Time interval from stroke onset to arrival at the Emergency Department
Secondary outcomes (6)
Poor outcome at 1 month
Death or disability (modified Rankin Scale 3-6)at 1 month
Measured: 1 month from stroke onset
Poor outcome at 3 months
Death or disability (modified Rankin Scale 3-6) at 3 months
Measured: 3 months from stroke onset
Rate of thrombolysis
Proportion of patients given thrombolysis
Measured: Up to 4 hours and 30 minutes from stroke onset
Rate of thrombolysis activation
Proportion of patients evaluated for thrombolysis
Measured: Up to 3 hours from stroke onset
Delay in CT scan
Time interval between arrival at the Emergency Department and CT scan
Measured: Up to 12 hours from admission at the ED
Door to needle time
Time interval between arrival at the ED and thrombolysis initiation
Measured: Up to 4 hours and 30 minutes from stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,772 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Licia Denti, Azienda Ospedaliero-Universitaria di Parma
- Investigators
- Licia Denti, MD, Principal investigator, Parma University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881152
- Sponsor's protocol ID
- PRUa2-2010-013
- Status last verified
- Jan 2015
- First submitted
- 7 Jun 2013
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Denti L, Caminiti C, Scoditti U, Zini A, Malferrari G, Zedde ML, Guidetti D, Baratti M, Vaghi L, Montanari E, Marcomini B, Riva S, Iezzi E, Castellini P, Olivato S, Barbi F, Perticaroli E, Monaco D, Iafelice I, Bigliardi G, Vandelli L, Guareschi A, Artoni A, Zanferrari C, Schulz PJ. Impact on Prehospital Delay of a Stroke Preparedness Campaign: A SW-RCT (Stepped-Wedge Cluster Randomized Controlled Trial). Stroke. 2017 Dec;48(12):3316-3322. doi: 10.1161/STROKEAHA.117.018135. Epub 2017 Nov 3.
PubMed 29101258Caminiti C, Schulz P, Marcomini B, Iezzi E, Riva S, Scoditti U, Zini A, Malferrari G, Zedde ML, Guidetti D, Montanari E, Baratti M, Denti L; Educazione e Ritardo di Ospedalizzazione (E.R.O.I) study group. Development of an education campaign to reduce delays in pre-hospital response to stroke. BMC Emerg Med. 2017 Jun 24;17(1):20. doi: 10.1186/s12873-017-0130-9.
PubMed 28646851
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomized Controlled Trial to Assess the Effectiveness of a Population-based Educational Campaign on Stroke Symptom Recognition in Reducing Pre-hospital Delay
- ClinicalTrials.gov ID
- NCT01881152
- Acronym / sponsor ID
- PRUa2-2010-013
- Conditions
- Acute Stroke
- Keywords
- Stroke, Community education, Awareness, Prehospital delay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,772 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ParmaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Jun 2013 (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.
The starting hypothesis is that a multilevel educational campaign, specifically developed for the local community, can increase public stroke awareness and reduce pre-hospital delay.
The effectiveness of such intervention will be evaluated according to a cluster randomized, stepped wedged design. The clusters are the four communities of the Area Vasta Emilia Nord, AVEN (Parma, Piacenza, Modena e Reggio Emilia). As analysis Units, we will consider the patients consecutively admitted to the six participating hospitals throughout the study period, for suspected stroke or transitory ischemic attack (TIA).
Detailed description
After a baseline 3 month period, the educational campaign will be sequentially launched in the four communities over four 3 month periods, according to a computer-generated list. The comparison will be the"usual care".
Primary outcome measures: The proportion of patients arriving at the Emergency Department (ED) with suspected stroke or TIA within two hours.
Secondary outcome measures: the proportion of patients with confirmed stroke or TIA diagnosis; the proportion of ischemic stroke patients evaluated for recominanat Tissue Plasminogen Activator (rTPA) therapy; the proportion of patients treated with rTPA; time interval between arrival at the ED and CT scan; for patients treated with rTPA, time interval between arrival at the ED and therapy initiation (door to needle time); death and disability (assessed as modified Rankin Score 3-5) at 1 and 3 month from stroke onset.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Educational campaignEducational campaign |
| Control | Other | Other: Usual careUsual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients consecutively admitted to the six participating hospitals for suspected stroke or transitory ischemic attack (TIA), defined as abrupt onset of focal or generalized neurologic deficit of vascular origin.
Key exclusion criteria (2 listed)
- No information available on the time of stroke onset.
- No informed consent from patient or caregiver
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 campaignAlso: Community campaign, Public campaignMultilevel educational campaign on stroke sympton recognition and the need for calling the Emergency Services | Other | Intervention |
| Usual careInformation on stroke usually delivered at the community level. | Other | Control |
Primary outcome
Percentage of early admission
Time frame: Time interval from stroke onset to arrival at the Emergency Department
Proportion of patients arriving to the Emergency Department with suspected stroke or TIA within two hours
6 secondary outcomes
Poor outcome at 1 month
Time frame: 1 month from stroke onset
Poor outcome at 3 months
Time frame: 3 months from stroke onset
Rate of thrombolysis
Time frame: Up to 4 hours and 30 minutes from stroke onset
Rate of thrombolysis activation
Time frame: Up to 3 hours from stroke onset
Delay in CT scan
Time frame: Up to 12 hours from admission at the ED
Door to needle time
Time frame: Up to 4 hours and 30 minutes from stroke onset
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 14 Jan 2015.
- Derived from this study: PubMed 29101258Denti L, Caminiti C, Scoditti U, Zini A, Malferrari G, Zedde ML, Guidetti D, Baratti M, Vaghi L, Montanari E, Marcomini B, Riva S, Iezzi E, Castellini P, Olivato S, Barbi F, Perticaroli E, Monaco D, Iafelice I, Bigliardi G, Vandelli L, Guareschi A, Artoni A, Zanferrari C, Schulz PJ. Impact on Prehospital Delay of a Stroke Preparedness Campaign: A SW-RCT (Stepped-Wedge Cluster Randomized Controlled Trial). Stroke. 2017 Dec;48(12):3316-3322. doi: 10.1161/STROKEAHA.117.018135. Epub 2017 Nov 3.
- Derived from this study: PubMed 28646851Caminiti C, Schulz P, Marcomini B, Iezzi E, Riva S, Scoditti U, Zini A, Malferrari G, Zedde ML, Guidetti D, Montanari E, Baratti M, Denti L; Educazione e Ritardo di Ospedalizzazione (E.R.O.I) study group. Development of an education campaign to reduce delays in pre-hospital response to stroke. BMC Emerg Med. 2017 Jun 24;17(1):20. doi: 10.1186/s12873-017-0130-9.
Related trials for Acute Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
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.
Licia Denti, MD principal investigator
Parma University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational campaign in people with Acute Stroke, run by Azienda Ospedaliero-Universitaria di Parma at 5 sites in Italy.
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 2 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 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. 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?
Percentage of early admission (time frame: Time interval from stroke onset to arrival at the Emergency Department). 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 NCT01881152, which also lists 2 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 14 Jan 2015.