NCT03233490

Brief Summary

The overall aim of this thesis is to identify the factors that may affect 13 year old students' acquisition of CPR skills and their willingness to act. The primary hypothesis is that the training method (intervention) influences the participants' acquisition of practical CPR skills and willingness to intervene. The study used a cluster randomized design, based on a randomization list generated by an independent statistician. The school classes were randomly assigned to different CPR training interventions. A strategic sample, where invitation to participate in the study was sent to the headmasters of all council schools, with seventh grade students, in two Swedish municipalities (140,000). Thus, the sample consists of participants with different cultural as well as socio-economic background. Eighteen of 24 schools agreed to participate. Four schools did not respond and two schools had a routine to offer CPR education only for grade nine (all six schools from the same municipality). The eighteen schools who agreed to participate consisted of sixty-eight classes with 1547 students. Prior to study participation, students and their guardians obtained a letter with study information. Study participation of the individual students was voluntary and all participants gave an oral informed consent. Inclusion criteria: seventh grade student in one of the participating schools. Exclusion criteria: student does not want to participate, student with a physical handicap that limited the physical performance, classes of students with development disabilities (these classes are age-integrated and have fewer students per class).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,547

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Shorter than P25 for not_applicable

Status
completed

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

December 16, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2014

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

Enrollment Period

10 months

First QC Date

July 26, 2017

Last Update Submit

August 15, 2017

Conditions

Keywords

CPR trainingstudentswillingness

Outcome Measures

Primary Outcomes (1)

  • The total score of the modified Cardiff test at six months

    The total score was calculated by adding the individual scores of the 12 different categories (check responsiveness by talking, check responsiveness by shaking, open the airway, checks respiration, dials 112, compression/ventilation ratio, hand-position during compression, average compression depth, total compression counted, average ventilation volume, total ventilation counted, total hands-off time) assessed by the practical test.

    At six months follow-up test

Secondary Outcomes (3)

  • The total score of the modified Cardiff test directly after training

    Directly after training (on the day of intervention)

  • Self-reported willingness to make a lifesaving intervention

    Both directly after training (on the day of intervention) and at six months

  • Knowledge about stroke, acute myocardial infarction and living habits

    Both directly after training (on the day of intervention) and at six months

Study Arms (2)

CPR training and web corse intervention

EXPERIMENTAL

The students performed a web course (Help Brain Heart) prior training

Other: CPR training

CPR training intervention

EXPERIMENTAL

CPR training without web course

Other: web course

Interventions

Web course Help Brain Heart was conducted Before CPR training.

CPR training intervention

No web course was conducted

CPR training and web corse intervention

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • seventh grade student in one of the participating schools

You may not qualify if:

  • student does not want to participate
  • student with a physical handicap that significantly limited the physical performance
  • classes of students with development disabilities (these classes are age integrated and have fewer students per class).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hollenberg J, Claesson A, Ringh M, Nordberg P, Hasselqvist-Ax I, Nord A. Effects of native language on CPR skills and willingness to intervene in out-of-hospital cardiac arrest after film-based basic life support training: a subgroup analysis of a randomised trial. BMJ Open. 2019 May 5;9(5):e025531. doi: 10.1136/bmjopen-2018-025531.

Study Officials

  • L Svensson

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 26, 2017

First Posted

July 28, 2017

Study Start

December 16, 2013

Primary Completion

October 22, 2014

Study Completion

October 22, 2014

Last Updated

August 16, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

No data shall be analyzed at the individual level.