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Completed

NCT Number: NCT01881152

Effectiveness of a Public Campaign to Increase Stroke Awareness in Reducing Prehospital 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).

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Key information

Conditions

Acute Stroke Adherence Interventions Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Health Behavior Health Education Medication Adherence Nervous System Diseases Patient Acceptance of Health Care Patient Compliance Stroke Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AUSL Parma, Fidenza, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • No information available on the time of stroke onset.
  • No informed consent from patient or caregiver

Treatment and study plan

Educational campaign

Other

Multilevel educational campaign on stroke sympton recognition and the need for calling the Emergency Services

Other names: Community campaign, Public campaign

Usual Care

Other

Information on stroke usually delivered at the community level.

Primary outcomes

  1. 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

Secondary outcomes

  1. Poor outcome at 1 month

    Time frame: 1 month from stroke onset

    Death or disability (modified Rankin Scale 3-6)at 1 month

  2. Poor outcome at 3 months

    Time frame: 3 months from stroke onset

    Death or disability (modified Rankin Scale 3-6) at 3 months

  3. Rate of thrombolysis

    Time frame: Up to 4 hours and 30 minutes from stroke onset

    Proportion of patients given thrombolysis

  4. Rate of thrombolysis activation

    Time frame: Up to 3 hours from stroke onset

    Proportion of patients evaluated for thrombolysis

  5. Delay in CT scan

    Time frame: Up to 12 hours from admission at the ED

    Time interval between arrival at the Emergency Department and CT scan

  6. Door to needle time

    Time frame: Up to 4 hours and 30 minutes from stroke onset

    Time interval between arrival at the ED and thrombolysis initiation

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria di Parma

Other

Registry information

Official study title

Cluster Randomized Controlled Trial to Assess the Effectiveness of a Population-based Educational Campaign on Stroke Symptom Recognition in Reducing Pre-hospital Delay

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 19, 2013
Registry last updated
Jan 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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