Out-Of-Hospital Cardiac ArrestMOBI-CPRNCT05784675
Impact of Mobile Phone Application Use on Adult BLS
A study testing MOBI-CPR game in people with Out-Of-Hospital Cardiac Arrest and Mobile Phone Use, run by Nino Fijačko at 1 site in Slovenia.
Trial summary
The aim of the study is to investigate whether a serious smartphone game (called MOBI-CPR game) used in the home environment has an impact on the retention of adult basic life support knowledge and skills. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest, Mobile Phone Use, Stress
- What is being tested?
- MOBI-CPR game
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSlovenia
- Study dates
- 16 Mar 2023to 31 Aug 2023
- 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
- Nursing students over eighteen years old
- Without training in adult basic life support or within the past six mounts
- Physically able to perform CPR
- Willingness to perform rescue breathing on a manikin
- A completed and signed consent form
Who cannot join
- Nursing student younger than 18 years old
- Undergone training on adult basic life support within the past six mounts
- Physically not able to perform CPR
- Do not want to perform rescue breathing on a manikin
- Do not want to participate
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
University of Maribor Faculty of health sciences
Maribor, 2000
Nino Fijacko, +38623004764, nino.fijacko@um.si
Gregor
About this study
Official title: Impact of Serious Smartphone-based Game Use on Adult Performance of Basic Life Support Skills
The aim of the study is to investigate whether a serious smartphone game (called MOBI-CPR game) used in the home environment has an impact on the retention of adult basic life support knowledge and skills.
Read the detailed description
The trial design will be randomized, controlled, cross-over study. Data will be collected between March and May 2023 at the Faculty of health science, University of Maribor. The consentience of nursing students will be collected. The Faculty of health science, University of Maribor already give permission for conducting this study. The goal will be to have around 100 nursing students in the study.
In the study a serious smartphone game called MOBI-CPR will be used. The MOBI-CPR game will be available at https://mobicpr.si/. The MOBI-CPR game will be install on the smartphone and will be used at home by nursing students with a goal to obtain adult basic life support knowledge and skills.
Before each nursing student will get MOBI-CPR game for home usage we will 1) measure acute stress, and 2) assess adult basic life support knowledge and skills.
For measuring acute stress the Empatica E4 watch will be used. Measuring will be perform in a quiet room without disruptions. When measuring acute stress each nursing student will be coloring the mandalas circles. Level of acute stress measure by Empatica E4 watch (1-5 is non stress area, and 6-10 is stress area).
For the knowledge part the online modified questionnaire (available in: https://www.1ka.si/d/en) the multiple choice questions will be used, and for the skills part the Resusci Anne QCPR QCPR manikin and Defibtech Trainer AED will be used. Each nursing student will be given the scenarios to read before the start of the assistance to the victim of a sudden cardiac arrest. The investigators will use a modified checklist to assess students' performance in adult basic life support.
- Being tested
- MOBI-CPR game
- Keywords
- basic life support, adult, mobile learning, stress, knowledge, skills, retention, home
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Cell Phone Use, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOBI-CPR gameDevice
Participants use MOBI-CPR game at home environment.
| Study group | Role | What they receive |
|---|---|---|
| MOBI-CPR | Experimental | Participants use MOBI-CPR game at home environment. Receives: Device: MOBI-CPR game |
| No MOBI-CPR | No intervention | Participants do not use MOBI-CPR game at home environment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of the use of the MOBI-CPR game on the total score of theoretical adult basic life support knowledge
Total score from the questionnaire (50 questions with multiple open answer, each right answer is 1 point) on the theoretical adult basic life support knowledge. If the assessment score is over 70%, it indicates that the nursing student is successful.
Measured: 2 weeks after baseline intervention
Impact of the use of the MOBI-CPR game on the total score of theoretical adult basic life support knowledge
Total score from the questionnaire (50 questions with multiple open answer, each right answer is 1 point) on the theoretical adult basic life support knowledge. If the assessment score is over 70%, it indicates that the nursing student is successful.
Measured: 4 weeks after baseline intervention
Impact of the use of the MOBI-CPR game on the total score of theoretical adult basic life support knowledge
Total score from the questionnaire (50 questions with multiple open answer, each right answer is 1 point) on the theoretical adult basic life support knowledge. If the assessment score is over 70%, it indicates that the nursing student is successful.
Measured: 6 mounts after baseline intervention
Impact of the use of the MOBI-CPR game on the total score of theoretical adult basic life support knowledge
Total score from the questionnaire (50 questions with multiple open answer, each right answer is 1 point) on the theoretical adult basic life support knowledge. If the assessment score is over 70%, it indicates that the nursing student is successful.
Measured: 1 year after baseline intervention
Impact of the use of the MOBI-CPR game on the total score of theoretical adult basic life support knowledge
Total score from the questionnaire (50 questions with multiple open answer, each right answer is 1 point) on the theoretical adult basic life support knowledge. If the assessment score is over 70%, it indicates that the nursing student is successful.
Measured: 3 years after baseline intervention
Impact of the use of the MOBI-CPR game on the total score of practical adult basic life support skills
Total score from the checklist (20 steps with correct or not correct assess of the adult basic life support, each right assess is 1 point) on the practical adult basic life support skills. If the assessment score is over 70%, it indicates that the nursing student is successful.
Measured: 2 weeks after baseline intervention
Impact of the use of the MOBI-CPR game on the total score of practical adult basic life support skills
Total score from the checklist (20 steps with correct or not correct assess of the adult basic life support, each right assess is 1 point) on the practical adult basic life support skills. If the assessment score is over 70%, it indicates that the nursing student is successful.
Measured: 4 weeks after baseline intervention
Impact of the use of the MOBI-CPR game on the total score of practical adult basic life support skills
Total score from the checklist (20 steps with correct or not correct assess of the adult basic life support, each right assess is 1 point) on the practical adult basic life support skills. If the assessment score is over 70%, it indicates that the nursing student is successful.
Measured: 6 mounts after baseline intervention
Impact of the use of the MOBI-CPR game on the total score of practical adult basic life support skills
Total score from the checklist (20 steps with correct or not correct assess of the adult basic life support, each right assess is 1 point) on the practical adult basic life support skills. If the assessment score is over 70%, it indicates that the nursing student is successful.
Measured: 1 year after baseline intervention
Impact of the use of the MOBI-CPR game on the total score of practical adult basic life support skills
Total score from the checklist (20 steps with correct or not correct assess of the adult basic life support, each right assess is 1 point) on the practical adult basic life support skills. If the assessment score is over 70%, it indicates that the nursing student is successful.
Measured: 3 years after baseline intervention
Impact of the use of the MOBI-CPR game on the level of acute stress
Level of acute stress measure by Empatica E4 watch (1-5 is non stress area, and 6-10 is stress area).
Measured: 2 weeks after baseline intervention
Impact of the use of the MOBI-CPR game on the level of acute stress
Level of acute stress measure by Empatica E4 watch (1-5 is non stress area, and 6-10 is stress area).
Measured: 4 weeks after baseline intervention
Impact of the use of the MOBI-CPR game on the level of acute stress
Level of acute stress measure by Empatica E4 watch (1-5 is non stress area, and 6-10 is stress area).
Measured: 6 mounts after baseline intervention
Impact of the use of the MOBI-CPR game on the level of acute stress
Level of acute stress measure by Empatica E4 watch (1-5 is non stress area, and 6-10 is stress area).
Measured: 1 year after baseline intervention
Impact of the use of the MOBI-CPR game on the level of acute stress
Level of acute stress measure by Empatica E4 watch (1-5 is non stress area, and 6-10 is stress area).
Measured: 3 years after baseline intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start16 Mar 2023
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Balanced and randomized controlled cross-over within-subjects design
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nino Fijačko
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nino Fijačko, University Maribor
- Investigators
- Nino Fijačko, Msc, Principal investigator, University of Maribor, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784675
- Sponsor's protocol ID
- MOBI-CPR game trial
- Acronym
- MOBI-CPR
- Status last verified
- May 2023
- First submitted
- 2 Mar 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hernandez-Padilla J, Suthers F, Fernandez-Sola C, Granero-Molina J. Development and psychometric assessment of the Basic Resuscitation Skills Self-Efficacy Scale. Eur J Cardiovasc Nurs. 2016 Apr;15(3):e10-8. doi: 10.1177/1474515114562130. Epub 2014 Nov 24.
PubMed 25422522Papalexopoulou K, Chalkias A, Dontas I, Pliatsika P, Giannakakos C, Papapanagiotou P, Aggelina A, Moumouris T, Papadopoulos G, Xanthos T. Education and age affect skill acquisition and retention in lay rescuers after a European Resuscitation Council CPR/AED course. Heart Lung. 2014 Jan-Feb;43(1):66-71. doi: 10.1016/j.hrtlng.2013.09.008. Epub 2013 Oct 11.
PubMed 24246726Fijacko N, Masterson Creber R, Metlicar S, Strnad M, Greif R, Stiglic G, Skok P. Effects of a Serious Smartphone Game on Nursing Students' Theoretical Knowledge and Practical Skills in Adult Basic Life Support: Randomized Wait List-Controlled Trial. JMIR Serious Games. 2024 Apr 5;12:e56037. doi: 10.2196/56037.
PubMed 38578690
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Serious Smartphone-based Game Use on Adult Performance of Basic Life Support Skills
- ClinicalTrials.gov ID
- NCT05784675
- Acronym / sponsor ID
- MOBI-CPR / MOBI-CPR game trial
- Keywords
- basic life support, adult, mobile learning, stress, knowledge, skills, retention, home
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nino FijačkoUniversity, hospital or other
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 27 Mar 2023 (actual)
- 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 aim of the study is to investigate whether a serious smartphone game (called MOBI-CPR game) used in the home environment has an impact on the retention of adult basic life support knowledge and skills.
Detailed description
The trial design will be randomized, controlled, cross-over study. Data will be collected between March and May 2023 at the Faculty of health science, University of Maribor. The consentience of nursing students will be collected. The Faculty of health science, University of Maribor already give permission for conducting this study. The goal will be to have around 100 nursing students in the study.
In the study a serious smartphone game called MOBI-CPR will be used. The MOBI-CPR game will be available at https://mobicpr.si/. The MOBI-CPR game will be install on the smartphone and will be used at home by nursing students with a goal to obtain adult basic life support knowledge and skills.
Before each nursing student will get MOBI-CPR game for home usage we will 1) measure acute stress, and 2) assess adult basic life support knowledge and skills.
For measuring acute stress the Empatica E4 watch will be used. Measuring will be perform in a quiet room without disruptions. When measuring acute stress each nursing student will be coloring the mandalas circles. Level of acute stress measure by Empatica E4 watch (1-5 is non stress area, and 6-10 is stress area).
For the knowledge part the online modified questionnaire (available in: https://www.1ka.si/d/en) the multiple choice questions will be used, and for the skills part the Resusci Anne QCPR QCPR manikin and Defibtech Trainer AED will be used. Each nursing student will be given the scenarios to read before the start of the assistance to the victim of a sudden cardiac arrest. The investigators will use a modified checklist to assess students' performance in adult basic life support.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Balanced and randomized controlled cross-over within-subjects design
| Arm | Type | Receives |
|---|---|---|
| MOBI-CPR | Experimental | Device: MOBI-CPR gameParticipants use MOBI-CPR game at home environment. |
| No MOBI-CPR | No intervention | –Participants do not use MOBI-CPR game at home environment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Nursing students over eighteen years old
- Without training in adult basic life support or within the past six mounts
- Physically able to perform CPR
- Willingness to perform rescue breathing on a manikin
- A completed and signed consent form
Key exclusion criteria (5 listed)
- Nursing student younger than 18 years old
- Undergone training on adult basic life support within the past six mounts
- Physically not able to perform CPR
- Do not want to perform rescue breathing on a manikin
- Do not want to participate
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 |
|---|---|---|
| MOBI-CPR gameParticipants use MOBI-CPR game at home environment. | Device | MOBI-CPR |
Primary outcome
Impact of the use of the MOBI-CPR game on the total score of theoretical adult basic life support knowledge
Time frame: 2 weeks after baseline intervention
Total score from the questionnaire (50 questions with multiple open answer, each right answer is 1 point) on the theoretical adult basic life support knowledge. If the assessment score is over 70%, it indicates that the nursing student is successful.
Impact of the use of the MOBI-CPR game on the total score of theoretical adult basic life support knowledge
Time frame: 4 weeks after baseline intervention
Total score from the questionnaire (50 questions with multiple open answer, each right answer is 1 point) on the theoretical adult basic life support knowledge. If the assessment score is over 70%, it indicates that the nursing student is successful.
Impact of the use of the MOBI-CPR game on the total score of theoretical adult basic life support knowledge
Time frame: 6 mounts after baseline intervention
Total score from the questionnaire (50 questions with multiple open answer, each right answer is 1 point) on the theoretical adult basic life support knowledge. If the assessment score is over 70%, it indicates that the nursing student is successful.
Impact of the use of the MOBI-CPR game on the total score of theoretical adult basic life support knowledge
Time frame: 1 year after baseline intervention
Total score from the questionnaire (50 questions with multiple open answer, each right answer is 1 point) on the theoretical adult basic life support knowledge. If the assessment score is over 70%, it indicates that the nursing student is successful.
Impact of the use of the MOBI-CPR game on the total score of theoretical adult basic life support knowledge
Time frame: 3 years after baseline intervention
Total score from the questionnaire (50 questions with multiple open answer, each right answer is 1 point) on the theoretical adult basic life support knowledge. If the assessment score is over 70%, it indicates that the nursing student is successful.
Impact of the use of the MOBI-CPR game on the total score of practical adult basic life support skills
Time frame: 2 weeks after baseline intervention
Total score from the checklist (20 steps with correct or not correct assess of the adult basic life support, each right assess is 1 point) on the practical adult basic life support skills. If the assessment score is over 70%, it indicates that the nursing student is successful.
Impact of the use of the MOBI-CPR game on the total score of practical adult basic life support skills
Time frame: 4 weeks after baseline intervention
Total score from the checklist (20 steps with correct or not correct assess of the adult basic life support, each right assess is 1 point) on the practical adult basic life support skills. If the assessment score is over 70%, it indicates that the nursing student is successful.
Impact of the use of the MOBI-CPR game on the total score of practical adult basic life support skills
Time frame: 6 mounts after baseline intervention
Total score from the checklist (20 steps with correct or not correct assess of the adult basic life support, each right assess is 1 point) on the practical adult basic life support skills. If the assessment score is over 70%, it indicates that the nursing student is successful.
Impact of the use of the MOBI-CPR game on the total score of practical adult basic life support skills
Time frame: 1 year after baseline intervention
Total score from the checklist (20 steps with correct or not correct assess of the adult basic life support, each right assess is 1 point) on the practical adult basic life support skills. If the assessment score is over 70%, it indicates that the nursing student is successful.
Impact of the use of the MOBI-CPR game on the total score of practical adult basic life support skills
Time frame: 3 years after baseline intervention
Total score from the checklist (20 steps with correct or not correct assess of the adult basic life support, each right assess is 1 point) on the practical adult basic life support skills. If the assessment score is over 70%, it indicates that the nursing student is successful.
Impact of the use of the MOBI-CPR game on the level of acute stress
Time frame: 2 weeks after baseline intervention
Level of acute stress measure by Empatica E4 watch (1-5 is non stress area, and 6-10 is stress area).
Impact of the use of the MOBI-CPR game on the level of acute stress
Time frame: 4 weeks after baseline intervention
Level of acute stress measure by Empatica E4 watch (1-5 is non stress area, and 6-10 is stress area).
Impact of the use of the MOBI-CPR game on the level of acute stress
Time frame: 6 mounts after baseline intervention
Level of acute stress measure by Empatica E4 watch (1-5 is non stress area, and 6-10 is stress area).
Impact of the use of the MOBI-CPR game on the level of acute stress
Time frame: 1 year after baseline intervention
Level of acute stress measure by Empatica E4 watch (1-5 is non stress area, and 6-10 is stress area).
Impact of the use of the MOBI-CPR game on the level of acute stress
Time frame: 3 years after baseline intervention
Level of acute stress measure by Empatica E4 watch (1-5 is non stress area, and 6-10 is stress area).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Background: PubMed 25422522Hernandez-Padilla J, Suthers F, Fernandez-Sola C, Granero-Molina J. Development and psychometric assessment of the Basic Resuscitation Skills Self-Efficacy Scale. Eur J Cardiovasc Nurs. 2016 Apr;15(3):e10-8. doi: 10.1177/1474515114562130. Epub 2014 Nov 24.
- Background: PubMed 24246726Papalexopoulou K, Chalkias A, Dontas I, Pliatsika P, Giannakakos C, Papapanagiotou P, Aggelina A, Moumouris T, Papadopoulos G, Xanthos T. Education and age affect skill acquisition and retention in lay rescuers after a European Resuscitation Council CPR/AED course. Heart Lung. 2014 Jan-Feb;43(1):66-71. doi: 10.1016/j.hrtlng.2013.09.008. Epub 2013 Oct 11.
- Derived from this study: PubMed 38578690Fijacko N, Masterson Creber R, Metlicar S, Strnad M, Greif R, Stiglic G, Skok P. Effects of a Serious Smartphone Game on Nursing Students' Theoretical Knowledge and Practical Skills in Adult Basic Life Support: Randomized Wait List-Controlled Trial. JMIR Serious Games. 2024 Apr 5;12:e56037. doi: 10.2196/56037.
- Empatica E4 watchLink provided by the sponsor.
- Software for questionnaireLink provided by the sponsor.
- Resusci Anne QCPR manikinLink provided by the sponsor.
- AED Defibtech Trainer AEDLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Nino Fijačko, Msc principal investigator
University of Maribor, Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOBI-CPR game in people with Out-Of-Hospital Cardiac Arrest and Mobile Phone Use, run by Nino Fijačko at 1 site in Slovenia.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 May 2023. 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 Slovenia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nino Fijačko, Msc (+38623004764, nino.fijacko@um.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of the use of the MOBI-CPR game on the total score of theoretical adult basic life support knowledge (time frame: 2 weeks after baseline intervention). The study lists 15 primary outcomes in all. 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 NCT05784675, which also lists 3 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 11 May 2023.