Predictors for Prehospital Delay in Stroke Treatment

NCT03759691 | Completed

• 1 other identifier: 030683
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 2

Brief Summary

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. 1.To explore the knowledge of stroke in stroke patients and bystanders.
2. 2.To explore the process from onset of symptoms until admission to hospital and the reasons for prehospital delay.
3. 3.To explore the association between stroke knowledge, help-seeking behaviour and receiving revascularization therapy.
4. 4.To evaluate the immediate effect of the national campaign six months after initiation.

Conditions

Stroke

Keywords

prehospital delay; help-seeking behaviour

Outcome Measures

Primary Outcomes (2)

• 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

• The proportion of stroke patients/bystanders making a direct EMS call.

  Study period: 01/28/18 - 12/31/20

Secondary Outcomes (5)

• 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

• The proportion of patients contacting a family member or friend in first line.

  Study period: 01/28/18 - 12/31/20

• The average number of stroke symptoms each patient/bystander can identify.

  Study period: 01/28/18 - 12/31/20

• 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

• 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

Study Arms (2)

Stroke patients

Structured interviews of patients with stroke, admitted at the Department of Neurology, Aarhus University hospital and Regional Hospital West Jutland (Holstebro)

Behavioral: Structured interview

Bystander

Structured interviews of bystanders of patients with stroke, admitted at the Department of Neurology, Aarhus University hospital and Regional Hospital West Jutland (Holstebro)

Behavioral: Structured interview

Interventions

Structured interview BEHAVIORAL

Interview contains questions about stroke knowledge and help-seeking behaviour on the day the stroke occured.

Bystander; Stroke patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive patients (and bystanders) with AIS, transient ischemic attack (TIA) and intracerebral haemorrhage (ICH) admitted to the Department of Neurology and the vascular out-patient clinic at Aarhus University Hospital and Regional Hospital West Jutland (Holstebro) in the two study periodes.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Research Unit for General Practice, Aarhus University: collaborator
• Regional Hospital West Jutland: collaborator
• TrygFonden, Denmark: collaborator

Study Sites (2)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Research Unit for General Practice

Aarhus, 8000, Denmark

Location

Related Publications (27)

• Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available. Erratum In: Circulation. 2017 Mar 7;135(10):e646. doi: 10.1161/CIR.0000000000000491. Circulation. 2017 Sep 5;136(10):e196. doi: 10.1161/CIR.0000000000000530.

  PMID: 28122885 BACKGROUND

• GBD 2015 Neurological Disorders Collaborator Group. Global, regional, and national burden of neurological disorders during 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Neurol. 2017 Nov;16(11):877-897. doi: 10.1016/S1474-4422(17)30299-5. Epub 2017 Sep 17.

  PMID: 28931491 BACKGROUND

• Olesen J, Gustavsson A, Svensson M, Wittchen HU, Jonsson B; CDBE2010 study group; European Brain Council. The economic cost of brain disorders in Europe. Eur J Neurol. 2012 Jan;19(1):155-62. doi: 10.1111/j.1468-1331.2011.03590.x.

  PMID: 22175760 BACKGROUND

• Truelsen T, Piechowski-Jozwiak B, Bonita R, Mathers C, Bogousslavsky J, Boysen G. Stroke incidence and prevalence in Europe: a review of available data. Eur J Neurol. 2006 Jun;13(6):581-98. doi: 10.1111/j.1468-1331.2006.01138.x.

  PMID: 16796582 BACKGROUND

• Hacke W, Kaste M, Bluhmki E, Brozman M, Davalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, Schneider D, von Kummer R, Wahlgren N, Toni D; ECASS Investigators. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008 Sep 25;359(13):1317-29. doi: 10.1056/NEJMoa0804656.

  PMID: 18815396 BACKGROUND

• Berkhemer OA, Fransen PS, Beumer D, van den Berg LA, Lingsma HF, Yoo AJ, Schonewille WJ, Vos JA, Nederkoorn PJ, Wermer MJ, van Walderveen MA, Staals J, Hofmeijer J, van Oostayen JA, Lycklama a Nijeholt GJ, Boiten J, Brouwer PA, Emmer BJ, de Bruijn SF, van Dijk LC, Kappelle LJ, Lo RH, van Dijk EJ, de Vries J, de Kort PL, van Rooij WJ, van den Berg JS, van Hasselt BA, Aerden LA, Dallinga RJ, Visser MC, Bot JC, Vroomen PC, Eshghi O, Schreuder TH, Heijboer RJ, Keizer K, Tielbeek AV, den Hertog HM, Gerrits DG, van den Berg-Vos RM, Karas GB, Steyerberg EW, Flach HZ, Marquering HA, Sprengers ME, Jenniskens SF, Beenen LF, van den Berg R, Koudstaal PJ, van Zwam WH, Roos YB, van der Lugt A, van Oostenbrugge RJ, Majoie CB, Dippel DW; MR CLEAN Investigators. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015 Jan 1;372(1):11-20. doi: 10.1056/NEJMoa1411587. Epub 2014 Dec 17.

  PMID: 25517348 BACKGROUND

• Teuschl Y, Brainin M. Stroke education: discrepancies among factors influencing prehospital delay and stroke knowledge. Int J Stroke. 2010 Jun;5(3):187-208. doi: 10.1111/j.1747-4949.2010.00428.x.

  PMID: 20536616 BACKGROUND

• Fonarow GC, Zhao X, Smith EE, Saver JL, Reeves MJ, Bhatt DL, Xian Y, Hernandez AF, Peterson ED, Schwamm LH. Door-to-needle times for tissue plasminogen activator administration and clinical outcomes in acute ischemic stroke before and after a quality improvement initiative. JAMA. 2014 Apr 23-30;311(16):1632-40. doi: 10.1001/jama.2014.3203.

  PMID: 24756513 BACKGROUND

• Bouckaert M, Lemmens R, Thijs V. Reducing prehospital delay in acute stroke. Nat Rev Neurol. 2009 Sep;5(9):477-83. doi: 10.1038/nrneurol.2009.116. Epub 2009 Aug 11.

  PMID: 19668246 BACKGROUND

• Soomann M, Vibo R, Korv J. Acute stroke: why do some patients arrive in time and others do not? Eur J Emerg Med. 2015 Aug;22(4):285-7. doi: 10.1097/MEJ.0000000000000206.

  PMID: 25222429 BACKGROUND

• Barr J, McKinley S, O'Brien E, Herkes G. Patient recognition of and response to symptoms of TIA or stroke. Neuroepidemiology. 2006;26(3):168-75. doi: 10.1159/000091659. Epub 2006 Feb 21.

  PMID: 16493205 BACKGROUND

• Roebers S, Wagner M, Ritter MA, Dornbach F, Wahle K, Heuschmann PU. Attitudes and current practice of primary care physicians in acute stroke management. Stroke. 2007 Apr;38(4):1298-303. doi: 10.1161/01.STR.0000259889.72520.07. Epub 2007 Mar 1.

  PMID: 17332456 BACKGROUND

• Rasmussen BH, Germer U, Kammersgaard LP, Olsen TS. [Factors of importance for early and late admission of patients with stroke and transient cerebral ischemia]. Ugeskr Laeger. 2003 Jan 13;165(3):225-8. Danish.

  PMID: 12555704 BACKGROUND

• Middleton S, Sharpe D, Harris J, Corbett A, Lusby R, Ward J. Case scenarios to assess Australian general practitioners' understanding of stroke diagnosis, management, and prevention. Stroke. 2003 Nov;34(11):2681-6. doi: 10.1161/01.STR.0000096209.04460.BB. Epub 2003 Oct 16.

  PMID: 14563965 BACKGROUND

• Bray JE, Johnson R, Trobbiani K, Mosley I, Lalor E, Cadilhac D; National Stroke Foundation. Australian public's awareness of stroke warning signs improves after national multimedia campaigns. Stroke. 2013 Dec;44(12):3540-3. doi: 10.1161/STROKEAHA.113.002987. Epub 2013 Oct 17.

  PMID: 24135926 BACKGROUND

• Hickey A, Holly D, McGee H, Conroy R, Shelley E. Knowledge of stroke risk factors and warning signs in Ireland: development and application of the Stroke Awareness Questionnaire (SAQ). Int J Stroke. 2012 Jun;7(4):298-306. doi: 10.1111/j.1747-4949.2011.00698.x. Epub 2011 Dec 8.

  PMID: 22151425 BACKGROUND

• Trobbiani K, Freeman K, Arango M, Lalor E, Jenkinson D, Thrift AG. Comparison of stroke warning sign campaigns in Australia, England, and Canada. Int J Stroke. 2013 Oct;8 Suppl A100:28-31. doi: 10.1111/j.1747-4949.2012.00917.x. Epub 2012 Sep 27.

  PMID: 23013373 BACKGROUND

• Nordanstig A, Asplund K, Norrving B, Wahlgren N, Wester P, Rosengren L. Impact of the Swedish National Stroke Campaign on stroke awareness. Acta Neurol Scand. 2017 Oct;136(4):345-351. doi: 10.1111/ane.12777. Epub 2017 May 31.

  PMID: 28560735 BACKGROUND

• Marx JJ, Gube C, Faldum A, Kuntze H, Nedelmann M, Haertle B, Dieterich M, Eicke BM. An educational multimedia campaign improves stroke knowledge and risk perception in different stroke risk groups. Eur J Neurol. 2009 May;16(5):612-8. doi: 10.1111/j.1468-1331.2009.02555.x. Epub 2009 Feb 10.

  PMID: 19220447 BACKGROUND

• Zock E, Kerkhoff H, Kleyweg RP, van Bavel-Ta TB, Scott S, Kruyt ND, Nederkoorn PJ, van de Beek D. Help seeking behavior and onset-to-alarm time in patients with acute stroke: sub-study of the preventive antibiotics in stroke study. BMC Neurol. 2016 Nov 25;16(1):241. doi: 10.1186/s12883-016-0749-2.

  PMID: 27884126 BACKGROUND

• Lecouturier J, Rodgers H, Murtagh MJ, White M, Ford GA, Thomson RG. Systematic review of mass media interventions designed to improve public recognition of stroke symptoms, emergency response and early treatment. BMC Public Health. 2010 Dec 23;10:784. doi: 10.1186/1471-2458-10-784.

  PMID: 21182777 BACKGROUND

• Lundelin K, Graciani A, Garcia-Puig J, Guallar-Castillon P, Taboada JM, Rodriguez-Artalejo F, Banegas JR. Knowledge of stroke warning symptoms and intended action in response to stroke in Spain: a nationwide population-based study. Cerebrovasc Dis. 2012;34(2):161-8. doi: 10.1159/000341408. Epub 2012 Aug 17.

  PMID: 22907330 BACKGROUND

• Nishikawa T, Okamura T, Nakayama H, Miyamatsu N, Morimoto A, Toyoda K, Suzuki K, Toyota A, Hata T, Yamaguchi T. Effects of a Public Education Campaign on the Association Between Knowledge of Early Stroke Symptoms and Intention to Call an Ambulance at Stroke Onset: The Acquisition of Stroke Knowledge (ASK) Study. J Epidemiol. 2016;26(3):115-22. doi: 10.2188/jea.JE20150040. Epub 2015 Oct 3.

  PMID: 26441211 BACKGROUND

• Mosley I, Nicol M, Donnan G, Thrift AG, Dewey HM. What is stroke symptom knowledge? Int J Stroke. 2014 Jan;9(1):48-52. doi: 10.1111/ijs.12024. Epub 2013 Mar 19.

  PMID: 23506517 BACKGROUND

• Fassbender K, Balucani C, Walter S, Levine SR, Haass A, Grotta J. Streamlining of prehospital stroke management: the golden hour. Lancet Neurol. 2013 Jun;12(6):585-96. doi: 10.1016/S1474-4422(13)70100-5.

  PMID: 23684084 BACKGROUND

• Advani R, Naess H, Kurz M. Mass Media Intervention in Western Norway Aimed at Improving Public Recognition of Stroke, Emergency Response, and Acute Treatment. J Stroke Cerebrovasc Dis. 2016 Jun;25(6):1467-72. doi: 10.1016/j.jstrokecerebrovasdis.2016.02.026. Epub 2016 Mar 24.

  PMID: 27019989 BACKGROUND

• National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995 Dec 14;333(24):1581-7. doi: 10.1056/NEJM199512143332401.

  PMID: 7477192 BACKGROUND

Related Links

• World Health Organization: The top 10 causes of death

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Grethe Andersen, DMSc

  Professor, DMSc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2018
• First Posted: November 30, 2018
• Study Start: January 28, 2018
• Primary Completion: May 10, 2018
• Study Completion: December 29, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)