Stroke Clinical Trial
Official title:
Stroke Awareness and Help-seeking Behaviour: Predictors for Prehospital Delay in Stroke Treatment
NCT number | NCT03759691 |
Other study ID # | 030683 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 28, 2018 |
Est. completion date | December 29, 2020 |
Verified date | April 2021 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Stroke is the second-leading cause of death worldwide and a leading cause of long-term disability. Annually 12,000 people in Denmark suffers a stroke; half of them will have long-term disabilities that may affect the activities of daily living. In addition to substantial individual suffering, stroke is also associated with considerable costs to society. Acute reperfusion therapies started within 4.5 to 6 hours (in some up to 24 hours) from symptom onset for acute ischaemic stroke (AIS) have revolutionized the acute stroke treatment and considerably improved the overall prognosis and mortality. However, only 15-25% of Danish patients are eligible to acute treatment. Numerous attempts to reduce both prehospital and in-hospital delay in stroke have been made, but much time is still lost in the prehospital phase. Many stroke patients do not recognize their own symptoms as signs of a stroke or do not understand the importance of calling Emergecy Medical Services (EMS) immediately. Others cannot call for help unless they have a bystander, because of cognitive impairment or aphasia. Some patients have a wait-and-see attitude, contact their GP or out-of-hours GP, which also can increase the delay. Educational stroke campaigns can increase knowledge, improve help-seeking behaviour and increase the number of patients eligible for reperfusion therapies. The foundation TrygFonden is planning a national stroke campaign in 2019. Aims: 1. To explore the knowledge of stroke in stroke patients and bystanders. 2. To explore the process from onset of symptoms until admission to hospital and the reasons for prehospital delay. 3. To explore the association between stroke knowledge, help-seeking behaviour and receiving revascularization therapy. 4. To evaluate the immediate effect of the national campaign six months after initiation. Material and methods: Study 1: Structured interviews of stroke patients (and bystanders) admitted to the Department of Neurology at Aarhus University Hospital and Regional Hospital West Jutland (Holstebro). The investigators will use the patient's medical record (EPJ) and the Danish Stroke Register (DSR) and map the patient's route from onset of symptoms to admission to stroke centre, including contact to general practitioner (GP), out-of-hours GP or Emergency Medical Services (EMS). For patients who have been in contact with their GP, the GP will receive an electronic questionnaire to explore the time- and event pathway from first contact until admitting the patient to hospital. The investigators will interview 500 patients and approximately 300 bystanders over a period of 3 months. Study 2: The investigators will evaluate the effect of the national stroke campaign by conducting a similar study in 2020 when the campaign has been running for six months. Perspectives: This study will provide new information about stroke patients and bystanders, their knowledge of stroke and their help-seeking behaviour. If more knowledge about the factors that cause prehospital delay in stroke treatment are obtained, the investigators will know which areas to focus on in the future to improve the outcome for stroke patients. Part of this project will examine the effect of TrygFondens national stroke campaign, which is expected to have impact on general knowledge and help-seeking behaviour. If more people know the core symptoms of stroke, hopefully more people will also know how to react to these symptoms by calling EMS. This will eventually increase reperfusion therapy rates, considerably improve stroke morbidity and mortality and reduce both individual suffering and the societal costs.
Status | Completed |
Enrollment | 650 |
Est. completion date | December 29, 2020 |
Est. primary completion date | May 10, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diagnosed with AIS, TIA or ICH - Admitted to the Department of Neurology at Aarhus University Hospital or Regional Hospital West Jutland (Holstebro) - Age = 18 years - Onset of symptoms = 7 days before time of interview Exclusion Criteria: - Modified Rankin Scale (mRS) = 3* (pre-stroke) - Transferred from other regions in Denmark or abroad - Not willing to participate in the study - Cannot be reached ("out of office") - Non-Danish speaking |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus | |
Denmark | Research Unit for General Practice | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Aarhus University Hospital, Regional Hospital West Jutland, Research Unit for General Practice, Aarhus University, TrygFonden, Denmark |
Denmark,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of stroke patients/bystanders knowing at least two core symptoms of stroke (defined as facial palsy, palsy of extremities and aphasia/dysarthria). | Study period: 01/28/18 - 12/31/20 | ||
Primary | The proportion of stroke patients/bystanders making a direct EMS call. | Study period: 01/28/18 - 12/31/20 | ||
Secondary | The proportion of stroke patients/bystanders contacting their GP or out-of-hours GP in first line. | Study period: 01/28/18 - 12/31/20 | ||
Secondary | The proportion of patients contacting a family member or friend in first line. | Study period: 01/28/18 - 12/31/20 | ||
Secondary | The average number of stroke symptoms each patient/bystander can identify. | Study period: 01/28/18 - 12/31/20 | ||
Secondary | The proportion of patients arriving at hospital within 3 hours of symptom onset overall and stratified by whether the patients made a direct EMS call or had knowledge of at least to core stroke symptoms. | Study period: 01/28/18 - 12/31/20 | ||
Secondary | The proportion of patients receiving revascularization therapy overall and stratified by whether the patients made a direct EMS call or had knowledge of at least to core stroke symptoms. | Study period: 01/28/18 - 12/31/20 |
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