NCT04251325

Brief Summary

Aim The aim of the study is to characterize the typical basic life support (BLS) course participant. The characterization include age, sex, education, ethnicity, income, health care data and cohabitation. All data will be compared with that of the general population. Hereby the study wish identify potential focus areas for recruitment of willing and able bystanders to increase survival. Furthermore, this study will provide a foundation for evaluation of current initiatives. Significance In Denmark, several population-based campaigns have been initiated to increase the amount of able and willing laypersons to assist at out-of-hospital cardiac arrest (OHCA). The main focus has been on increasing the quantity of laypersons attending BLS courses. Even measures of changing legislation mandating course participation have been passed and implemented. Estimates state that approximately 3-4.5% of the entire Danish population participates in BLS courses annually. Consequently, a substantial amount of resources has been spent on educating and certifying laypersons in BLS on a population level. In this study, the characteristics of these BLS course participants will be described. This will provide the basis for evaluation of already implemented interventions. Additionally, this study will be able to support course distributors, foundations and national councils in making strategies for further recruitment based on evidence. The present study will assist in pinpointing society groups with a theoretical bystander potential, but low level of BLS education. This can guide future efforts in trying to improve bystander initiated cardiopulmonary resuscitation (CPR) and survival from OHCA. Methods The study population includes all Danish citizens who attended a BLS training course certificate from 2016-2018 above the age of 15. This cut off is based on the earliest mandatory BLS training in primary school. Using Personal Identifications Numbers (PIN) of BLS course participant from January 1st, 2016 to December 31st, 2018, data will be extracted and delivered anonymously, including information on age, sex, income, education, ethnicity and cohabitation, from the Statistics Denmark. The relative risk of BLS course attendance stratified by education and income level, cohabitation status, age of youngest child, urbanization level, sex and ethnicity of the Danish BLS course participants compared to the general population will be presented. Prevalence of BLS courses participants by age and sex will be analyzed and graphically display and prevalence of BLS course participants by income and age will be calculated by regression models. A layperson focus group interview consisting of BLS course participants will be conducted to explore the attending courses participants views of the project and to revise accordingly. Anonymity is secured through a data processing agreement between the Danish First Aid Council and Statistics Denmark, facilitated by the Copenhagen Emergency Medical Services. An application will be formulated to the Danish Data protection agency regarding storage of data. Expected outcome A characterization of the typical BLS course participants in Denmark with median age, sex, cohabitation, income and education. The association between sociodemographic characteristics of BLS course participants and relevant prevalence's by the entire population will be presented.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

June 25, 2020

Status Verified

June 1, 2020

Enrollment Period

2.1 years

First QC Date

January 30, 2020

Last Update Submit

June 24, 2020

Conditions

Outcome Measures

Primary Outcomes (9)

  • Sex

    Male, female

    2016-2018

  • Age

    In either month or days (to enable smooth curves)

    2016-2018

  • Ethnicity

    born in Denmark by at least one ethnically Danish parent, born in Denmark by non-Danish parents, born in a Western country other than Denmark, or born in a non-Western country)

    2016-2018

  • Parental birth place

    Danish region

    2016-2018

  • Cohabitation status

    Living with parents, living alone, living with a person of opposite gender, living with a person of same gender, living in a multi-household which is a household with three or more unrelated adults

    2016-2018

  • Age of youngest child in the household

    0, 1-2, 3-5, 6-8, 9-11 or 12+ years old, or no children

    2016-2018

  • Level of urbanization

    \<25, 25-350, \>350-1000, \>1000-2000, \>2000 persons per square kilometer

    2016-2018

  • Education

    Primary and lower secondary education, high school, technical and vocational education and training, higher short/middle length education, higher long term education

    2016-2018

  • Income

    Deciles relative to gender and birth year

    2016-2018

Other Outcomes (1)

  • Health care data

    2016-2018

Study Arms (2)

Basic Life Support Course Participants

The study population includes all Danish citizens who attended a BLS training course certificate from 2016-2018 above the age of 15.

Other: Basic Life Support Courses

Background population

The entire danish population above 15 years whom have not attended a BLS training course certificate from 2016-2018.

Interventions

4 hours basic life support courses for laypersons

Basic Life Support Course Participants

Eligibility Criteria

Age15 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All danish citizens whom participated in a certified basic life support course between 2016 and 2019.

You may qualify if:

  • All danish citizens, with a verified personal identification number, whom participated in a certified basic life support course between 2016 and 2019.

You may not qualify if:

  • Basic life support course participants with in-complete/faulty registered personal identification number.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen Emergency Medical Services

Copenhagen, 2750, Denmark

Location

Related Publications (17)

  • Eisenberg M, et al. Acting on the Call. 2019 [ONLINE] Available at: http://www.globalresuscitationalliance.org/wp-content/pdf/acting_on_the_call.pdf

    BACKGROUND
  • Eisenberg M, et al. A call to establish a global resuscitation alliance. 2018 [ONLINE] Available at: https://foundation915.files.wordpress.com/2016/07/a-call-to-establish-a-global-resuscitation-alliance-2016.pdf [Accessed November 18 2019].

    BACKGROUND
  • Dansk Hjertestopsregister [Internet/in Danish]. [cited 2019 Nov 06]; Available from: http://hjertestopregister.dk/wp-content/uploads/2019/11/Dansk-Hjertestopregister-2018.pdf

    BACKGROUND
  • Wissenberg M, Lippert FK, Folke F, Weeke P, Hansen CM, Christensen EF, Jans H, Hansen PA, Lang-Jensen T, Olesen JB, Lindhardsen J, Fosbol EL, Nielsen SL, Gislason GH, Kober L, Torp-Pedersen C. Association of national initiatives to improve cardiac arrest management with rates of bystander intervention and patient survival after out-of-hospital cardiac arrest. JAMA. 2013 Oct 2;310(13):1377-84. doi: 10.1001/jama.2013.278483.

    PMID: 24084923BACKGROUND
  • Hansen SM, Hansen CM, Folke F, Rajan S, Kragholm K, Ejlskov L, Gislason G, Kober L, Gerds TA, Hjortshoj S, Lippert F, Torp-Pedersen C, Wissenberg M. Bystander Defibrillation for Out-of-Hospital Cardiac Arrest in Public vs Residential Locations. JAMA Cardiol. 2017 May 1;2(5):507-514. doi: 10.1001/jamacardio.2017.0008.

    PMID: 28297003BACKGROUND
  • Kragholm K, Wissenberg M, Mortensen RN, Hansen SM, Malta Hansen C, Thorsteinsson K, Rajan S, Lippert F, Folke F, Gislason G, Kober L, Fonager K, Jensen SE, Gerds TA, Torp-Pedersen C, Rasmussen BS. Bystander Efforts and 1-Year Outcomes in Out-of-Hospital Cardiac Arrest. N Engl J Med. 2017 May 4;376(18):1737-1747. doi: 10.1056/NEJMoa1601891.

    PMID: 28467879BACKGROUND
  • Hansen CM, Lippert FK, Wissenberg M, Weeke P, Zinckernagel L, Ruwald MH, Karlsson L, Gislason GH, Nielsen SL, Kober L, Torp-Pedersen C, Folke F. Temporal trends in coverage of historical cardiac arrests using a volunteer-based network of automated external defibrillators accessible to laypersons and emergency dispatch centers. Circulation. 2014 Nov 18;130(21):1859-67. doi: 10.1161/CIRCULATIONAHA.114.008850. Epub 2014 Oct 1.

    PMID: 25274002BACKGROUND
  • Malta Hansen C, Zinckernagel L, Ersboll AK, Tjornhoj-Thomsen T, Wissenberg M, Lippert FK, Weeke P, Gislason GH, Kober L, Torp-Pedersen C, Folke F. Cardiopulmonary Resuscitation Training in Schools Following 8 Years of Mandating Legislation in Denmark: A Nationwide Survey. J Am Heart Assoc. 2017 Mar 14;6(3):e004128. doi: 10.1161/JAHA.116.004128.

    PMID: 28292745BACKGROUND
  • Copenhagen Emergency Medical Services, research presentation [Internet/in Danish]. [cited 2019 Nov 30]; Available from: https://docplayer.dk/159358374-Trygfondens-hjerteloeber-projekt-region-syd-vejle-12-august-2019.html

    BACKGROUND
  • TrygFonden [Internet/in Danish]. [cited 2019 Nov 06]; Available from: https://genoplivning.dk/nyt-studie-4-5-danskere-har-vaeret-paa-foerstehjaelpskursus/

    BACKGROUND
  • Perkins GD, Handley AJ, Koster RW, Castren M, Smyth MA, Olasveengen T, Monsieurs KG, Raffay V, Grasner JT, Wenzel V, Ristagno G, Soar J; Adult basic life support and automated external defibrillation section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 2. Adult basic life support and automated external defibrillation. Resuscitation. 2015 Oct;95:81-99. doi: 10.1016/j.resuscitation.2015.07.015. Epub 2015 Oct 15. No abstract available.

    PMID: 26477420BACKGROUND
  • Burgdorf KS, Simonsen J, Sundby A, Rostgaard K, Pedersen OB, Sorensen E, Nielsen KR, Bruun MT, Frisch M, Edgren G, Erikstrup C, Hjalgrim H, Ullum H. Socio-demographic characteristics of Danish blood donors. PLoS One. 2017 Feb 9;12(2):e0169112. doi: 10.1371/journal.pone.0169112. eCollection 2017.

    PMID: 28182624BACKGROUND
  • Ou Y, Yau KK, Poon CM, Hui YV, Lee SS, Lee CK. Donation frequency and its association with demographic characteristics--a 1-year observational study. Transfus Med. 2015 Dec;25(6):366-73. doi: 10.1111/tme.12267. Epub 2016 Jan 5.

    PMID: 26729059BACKGROUND
  • Ritter S, Willand L, Reinhard B, Offergeld R, Hamouda O. [Demography and donation frequencies of blood and plasma donor populations in Germany]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2008 Aug;51(8):915-25. doi: 10.1007/s00103-008-0613-7. German.

    PMID: 18787870BACKGROUND
  • Lattimore S, Wickenden C, Brailsford SR. Blood donors in England and North Wales: demography and patterns of donation. Transfusion. 2015 Jan;55(1):91-9. doi: 10.1111/trf.12835. Epub 2014 Sep 1.

    PMID: 25178387BACKGROUND
  • Schmidt M, Schmidt SAJ, Adelborg K, Sundboll J, Laugesen K, Ehrenstein V, Sorensen HT. The Danish health care system and epidemiological research: from health care contacts to database records. Clin Epidemiol. 2019 Jul 12;11:563-591. doi: 10.2147/CLEP.S179083. eCollection 2019.

    PMID: 31372058BACKGROUND
  • Cleveland WS. Devlin SJ, and Grosse E. (1988).

    BACKGROUND

Study Officials

  • Freddy K Lippert, MD,Ass.Prof

    Copenhagen Emergency Medical Services

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2020

First Posted

January 31, 2020

Study Start

January 1, 2020

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

June 25, 2020

Record last verified: 2020-06

Locations