Acute Myocardial InfarctionNCT00954161
Bystander Helping Behaviour for Myocardial Infarction Following First Aid Training
A study testing Helping behaviour curriculum and First aid only curriculum in people with Acute Myocardial Infarction, run by KU Leuven at 1 site in Belgium.
Trial summary
The objective of this study is to measure the effect of an innovative training programme on the help seeking behaviour and helping rates of bystanders in medical emergencies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Helping behaviour curriculum and First aid only curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2009to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Course participants that are 18 years or older
Who cannot join
- Course participants that are younger than 18 years
- Health care students
- Health care professionals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bystander Helping Behaviour for Acute Myocardial Infarction Following a First Aid Training Programme That Draws Attention to the Barriers to Providing Help - Protocol for a Randomized Controlled Trial
The objective of this study is to measure the effect of an innovative training programme on the help seeking behaviour and helping rates of bystanders in medical emergencies.
Read the detailed description
A systematic review on the effects of first aid training concluded that training must also include ways to overcome obstacles to bystander intervention. This could lead to better help and higher helping rates in medical emergencies.
The objective of this paper is to measure the effect of an innovative training programme on the help seeking behaviour and helping rates of bystanders in medical emergencies. We chose to test the helping behaviour for acute myocardial infarction because it is an important cause of mortality and invalidity. While the victim is urgently in need of help, delay in seeking professional help is an important problem.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Helping behaviour curriculum, First aid only curriculum
- Keywords
- First aid, Helping behaviour, Health education, Myocardial infarction, Emergencies
- Medical subject headings
- Health Education, Myocardial Infarction, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helping behaviour curriculumOther
The objective of the helping behaviour curriculum is to sensitise participants to develop a helping reaction, and to teach participants how to deal with barriers to helping. The helping behaviour curriculum is being taught in 2hours.
First aid only curriculumOther
Two hours training on first aid for alcohol and drug incidents
| Study group | Role | What they receive |
|---|---|---|
| first aid and helping behaviour | Experimental | The helping behaviour training is given after 24 hours first aid training and aims to sensitise participants towards a helping reaction and teach participants how to deal with barriers to helping Receives: Other: Helping behaviour curriculum |
| first aid only | Active comparator | This group receives training in first aid only without training in helping behaviour. Receives: Other: First aid only curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay time for seeking help during deception experiment
Time to seeking help was measured between the simulated patient grabbing the heart and the study participant opening the door to get help.
Measured: within 4 weeks after the control or intervention training
Secondary outcomes (5)
Rate of helping during deception experiment
This refers to the number of participants that assessed the victim, or asked for help, or provided direct help to the victim during the test.
Measured: within 4 weeks after control or intervention training
First aid self efficacy belief
scores on 6 questions related to helping behaviour barriers with the following structure: " I will do x (action) even if y (barrier)"
Measured: within 15 minutes after experimental or control intervention
Impact of event
This indicates how shocking the study participants found the simulated emergency situation
Measured: Within 15 minutes after deception experiment
State of mood
Indication of how study participants feel after being told about the deception.
Measured: Within 15 minutes after deception experiment
Credibility of deception
Indication of how credible study participants found the simulated emergency situation
Measured: Within 15 minutes after deception
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Belgian Red Cross, University Ghent, Laerdal Medical
- Investigators
- Bert Aertgeerts, Principal investigator, Academic Centre for General Practice, Catholic University Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954161
- Sponsor's protocol ID
- S51742
- Other IDs
- S51742, ML5859, B32220096701
- Status last verified
- May 2011
- First submitted
- 6 Aug 2009
- Last updated
- 3 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Van de Velde S, Heselmans A, Roex A, Vandekerckhove P, Ramaekers D, Aertgeerts B. Effectiveness of nonresuscitative first aid training in laypersons: a systematic review. Ann Emerg Med. 2009 Sep;54(3):447-57, 457.e1-5. doi: 10.1016/j.annemergmed.2008.11.005. Epub 2009 Jan 21.
PubMed 19157654Van de Velde S, Roex A, Vangronsveld K, Niezink L, Van Praet K, Heselmans A, Donceel P, Vandekerckhove P, Ramaekers D, Aertgeerts B. Can training improve laypersons helping behaviour in first aid? A randomised controlled deception trial. Emerg Med J. 2013 Apr;30(4):292-7. doi: 10.1136/emermed-2012-201128. Epub 2012 May 5.
PubMed 22562070
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bystander Helping Behaviour for Acute Myocardial Infarction Following a First Aid Training Programme That Draws Attention to the Barriers to Providing Help - Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00954161
- Acronym / sponsor ID
- S51742
- Conditions
- Acute Myocardial Infarction
- Keywords
- First aid, Helping behaviour, Health education, Myocardial infarction, Emergencies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Belgian Red Cross, University Ghent, Laerdal Medical
- Study start
- Sep 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 7 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to measure the effect of an innovative training programme on the help seeking behaviour and helping rates of bystanders in medical emergencies.
Detailed description
A systematic review on the effects of first aid training concluded that training must also include ways to overcome obstacles to bystander intervention. This could lead to better help and higher helping rates in medical emergencies.
The objective of this paper is to measure the effect of an innovative training programme on the help seeking behaviour and helping rates of bystanders in medical emergencies. We chose to test the helping behaviour for acute myocardial infarction because it is an important cause of mortality and invalidity. While the victim is urgently in need of help, delay in seeking professional help is an important problem.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first aid and helping behaviour | Experimental | Other: Helping behaviour curriculumThe helping behaviour training is given after 24 hours first aid training and aims to sensitise participants towards a helping reaction and teach participants how to deal with barriers to helping |
| first aid only | Active comparator | Other: First aid only curriculumThis group receives training in first aid only without training in helping behaviour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Course participants that are 18 years or older
Key exclusion criteria (3 listed)
- Course participants that are younger than 18 years
- Health care students
- Health care professionals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Helping behaviour curriculumThe objective of the helping behaviour curriculum is to sensitise participants to develop a helping reaction, and to teach participants how to deal with barriers to helping. The helping behaviour curriculum is being taught in 2hours. | Other | first aid and helping behaviour |
| First aid only curriculumTwo hours training on first aid for alcohol and drug incidents | Other | first aid only |
Primary outcome
Delay time for seeking help during deception experiment
Time frame: within 4 weeks after the control or intervention training
Time to seeking help was measured between the simulated patient grabbing the heart and the study participant opening the door to get help.
5 secondary outcomes
Rate of helping during deception experiment
Time frame: within 4 weeks after control or intervention training
First aid self efficacy belief
Time frame: within 15 minutes after experimental or control intervention
Impact of event
Time frame: Within 15 minutes after deception experiment
State of mood
Time frame: Within 15 minutes after deception experiment
Credibility of deception
Time frame: Within 15 minutes after deception
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2011.
- Background: PubMed 19157654Van de Velde S, Heselmans A, Roex A, Vandekerckhove P, Ramaekers D, Aertgeerts B. Effectiveness of nonresuscitative first aid training in laypersons: a systematic review. Ann Emerg Med. 2009 Sep;54(3):447-57, 457.e1-5. doi: 10.1016/j.annemergmed.2008.11.005. Epub 2009 Jan 21.
- Derived from this study: PubMed 22562070Van de Velde S, Roex A, Vangronsveld K, Niezink L, Van Praet K, Heselmans A, Donceel P, Vandekerckhove P, Ramaekers D, Aertgeerts B. Can training improve laypersons helping behaviour in first aid? A randomised controlled deception trial. Emerg Med J. 2013 Apr;30(4):292-7. doi: 10.1136/emermed-2012-201128. Epub 2012 May 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bert Aertgeerts principal investigator
Academic Centre for General Practice, Catholic University Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helping behaviour curriculum and First aid only curriculum in people with Acute Myocardial Infarction, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delay time for seeking help during deception experiment (time frame: within 4 weeks after the control or intervention training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00954161, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2011.