Cardiopulmonary ResuscitationNCT03586752
CPR Education: Traditional Program Versus On-line Program
A study testing On-line program and Standard program in people with Cardiopulmonary Resuscitation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Out-of-hospital cardiac arrest (OHCA) is an important public health issue. Chang Gung Memorial Hospital, a university affiliated medical center in Taoyuan city, northern Taiwan, actively cooperated with the government policy to donate a total of 250 automated external defibrillators (AED) and to deploy them in public… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Resuscitation
- What is being tested?
- On-line program and Standard program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 832 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2016to 31 Dec 2018
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 20 and over
- Adults who have not attended CPR training for at least one year prior to enrollment
Who cannot join
- unable to kneel to practice CPR
- pregnant
- unwilling to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "iGOGO-Automated External Defibrillator Donation "Continuing Education Project
Out-of-hospital cardiac arrest (OHCA) is an important public health issue. Chang Gung Memorial Hospital, a university affiliated medical center in Taoyuan city, northern Taiwan, actively cooperated with the government policy to donate a total of 250 automated external defibrillators (AED) and to deploy them in public areas during the period of 2012 to 2014. In addition, nearly 200 courses of cardiopulmonary resuscitation (CPR) education for healthcare providers and citizens were provided.
In order to keep the skills and the abilities of emergency medical responses in these 200 and more AED recipient areas, repeated CPR education and training should be implemented. Quality assurance and regular follow-up by medical directors with professional advice and feedback can therefore be provided at the same time. Therefore, this project aims to assess the quality of emergency responses in the recipient units in the next four years via regular follow-up by medical directors with advice and feedback. Continuing medical education of both e-learning and classes, online registration system, as well as first aid supplies will be provided at the regular follow-up visits. The results of this project will provide a feasible model of quality assurance of first aid and AED implementation program in the community.
Read the detailed description
The core value of the investigation is to provide high quality, convenient, time-saving, and cost-effective CPR training model. The training proctors will either instruct laypersons or healthcare providers to watch on-line video for 18 minutes at home then practice the skills for 30 minutes in the training scene or provide standard CPR program (90 minutes in the scene) and empower them with the life-saving skills of CPR. The American Heart Association's CPR with a DVD and laerdal QCPR manikin will be used to record. Participants will be randomly allocate into either the on-line or standard method of the training program. To assess the effects of training, the participants will receive written examinations before and after the course. The investigators will also follow up with the study participants and conduct CPR skills tests at 6 and 12 months from the time of training to assess whether the subjects retain their skills or if they have an opportunity to use the skills that they learned. Information about the willing of performing CPR and satisfaction to the training will also be collected.
- Conditions
- Cardiopulmonary Resuscitation
- Being tested
- On-line program, Standard program
- Keywords
- HQCPR between standard and on-line program, Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-line programOther
18 minutes on-line video at home and 30 minutes CPR skill practice at scene in 3 days after watching on-line video
Standard programOther
60-minute CPR teaching video with practice, 20 minutes of automated electrical defibrillator operation, and a 10-minute discussion with regard to the legal issues associated with bystander CPR in Taiwan
| Study group | Role | What they receive |
|---|---|---|
| On-line group | Experimental | On-line program course Receives: Other: On-line program |
| Standard group | Active comparator | Standard program course Receives: Other: Standard program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Written test for knowledge about CPR
Knowledge about CPR will be assessed via a written test before and after the CPR training. The test includes 25 questions with a total score of 100 (4 points for each).
Measured: 4 days
CPR flow checklist
An evaluator who is blinded to the training allocation will assess the performance of CPR via a flow checklist. A total of 20 items will be checked with a maximum sum score of 40 points.
Measured: 4 days
Secondary outcomes (5)
The percentage of correct depth of all compressions
The percentage of correct depth (5-6 centimeters) of all compressions will be assessed by High Quality CPR (HQCPR).
HQCPR is a machine with interactive response system which can provide information while performing CPR on manikin (Laerdal, Resusci Anne QCPR).
Measured: 90 minutes
The percentage of correct speed of compressions of all compressions
The percentage of correct speed of compressions (100 to 200 per minute) of all compressions will be assessed by HQCPR.
HQCPR is a machine with interactive response system which can provide information while performing CPR on manikin (Laerdal, Resusci Anne QCPR).
Measured: 90 minutes
The percentage of correct recoil of all compressions
The percentage of correct recoil (full chest recoil) of all compressions will be assessed by HQCPR.
HQCPR is a machine with interactive response system which can provide information while performing CPR on manikin (Laerdal, Resusci Anne QCPR).
Measured: 90 minutes
The average compression depth
The average compression depth (unit in centimeter) is calculated by summing up the depth of each compression then to be divided by the number of total compressions. The compression depth is recorded by HQCPR.
HQCPR is an interactive response machine to provide the information on depth, speed and recoil while performing CPR on manikin (Laerdal, Resusci Anne QCPR).
Measured: 90 minutes
The average compression speed
The average compression speed is presented as the number of compressions per minute by HQCPR.
HQCPR is an interactive response machine to provide the information on depth, speed and recoil while performing CPR on manikin (Laerdal, Resusci Anne QCPR).
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start1 Jun 2016
- Primary completion30 Nov 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary ResuscitationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 832 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheng-Yu Chien, Dr., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586752
- Sponsor's protocol ID
- GMRPG3F1273
- Status last verified
- Mar 2020
- First submitted
- 28 Jun 2018
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chien CY, Fang SY, Tsai LH, Tsai SL, Chen CB, Seak CJ, Weng YM, Lin CC, Chien WC, Huang CH, Lin CY, Chaou CH, Liu PH, Tseng HJ, Chen JC, Peng SY, Cheng TH, Hsu KH, Ng CJ. Traditional versus blended CPR training program: A randomized controlled non-inferiority study. Sci Rep. 2020 Jun 22;10(1):10032. doi: 10.1038/s41598-020-67193-1.
PubMed 32572100
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "iGOGO-Automated External Defibrillator Donation "Continuing Education Project
- ClinicalTrials.gov ID
- NCT03586752
- Acronym / sponsor ID
- GMRPG3F1273
- Conditions
- Cardiopulmonary Resuscitation
- Keywords
- HQCPR between standard and on-line program, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 832 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 16 Jul 2018 (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.
Out-of-hospital cardiac arrest (OHCA) is an important public health issue. Chang Gung Memorial Hospital, a university affiliated medical center in Taoyuan city, northern Taiwan, actively cooperated with the government policy to donate a total of 250 automated external defibrillators (AED) and to deploy them in public areas during the period of 2012 to 2014. In addition, nearly 200 courses of cardiopulmonary resuscitation (CPR) education for healthcare providers and citizens were provided.
In order to keep the skills and the abilities of emergency medical responses in these 200 and more AED recipient areas, repeated CPR education and training should be implemented. Quality assurance and regular follow-up by medical directors with professional advice and feedback can therefore be provided at the same time. Therefore, this project aims to assess the quality of emergency responses in the recipient units in the next four years via regular follow-up by medical directors with advice and feedback. Continuing medical education of both e-learning and classes, online registration system, as well as first aid supplies will be provided at the regular follow-up visits. The results of this project will provide a feasible model of quality assurance of first aid and AED implementation program in the community.
Detailed description
The core value of the investigation is to provide high quality, convenient, time-saving, and cost-effective CPR training model. The training proctors will either instruct laypersons or healthcare providers to watch on-line video for 18 minutes at home then practice the skills for 30 minutes in the training scene or provide standard CPR program (90 minutes in the scene) and empower them with the life-saving skills of CPR. The American Heart Association's CPR with a DVD and laerdal QCPR manikin will be used to record. Participants will be randomly allocate into either the on-line or standard method of the training program. To assess the effects of training, the participants will receive written examinations before and after the course. The investigators will also follow up with the study participants and conduct CPR skills tests at 6 and 12 months from the time of training to assess whether the subjects retain their skills or if they have an opportunity to use the skills that they learned. Information about the willing of performing CPR and satisfaction to the training will also be collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On-line group | Experimental | Other: On-line programOn-line program course |
| Standard group | Active comparator | Other: Standard programStandard program course |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 20 and over
- Adults who have not attended CPR training for at least one year prior to enrollment
Key exclusion criteria (3 listed)
- unable to kneel to practice CPR
- pregnant
- unwilling to sign informed consent
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 |
|---|---|---|
| On-line program18 minutes on-line video at home and 30 minutes CPR skill practice at scene in 3 days after watching on-line video | Other | On-line group |
| Standard program60-minute CPR teaching video with practice, 20 minutes of automated electrical defibrillator operation, and a 10-minute discussion with regard to the legal issues associated with bystander CPR in Taiwan | Other | Standard group |
Primary outcome
Written test for knowledge about CPR
Time frame: 4 days
Knowledge about CPR will be assessed via a written test before and after the CPR training. The test includes 25 questions with a total score of 100 (4 points for each).
CPR flow checklist
Time frame: 4 days
An evaluator who is blinded to the training allocation will assess the performance of CPR via a flow checklist. A total of 20 items will be checked with a maximum sum score of 40 points.
5 secondary outcomes
The percentage of correct depth of all compressions
Time frame: 90 minutes
The percentage of correct speed of compressions of all compressions
Time frame: 90 minutes
The percentage of correct recoil of all compressions
Time frame: 90 minutes
The average compression depth
Time frame: 90 minutes
The average compression speed
Time frame: 90 minutes
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 12 Mar 2020.
- Derived from this study: PubMed 32572100Chien CY, Fang SY, Tsai LH, Tsai SL, Chen CB, Seak CJ, Weng YM, Lin CC, Chien WC, Huang CH, Lin CY, Chaou CH, Liu PH, Tseng HJ, Chen JC, Peng SY, Cheng TH, Hsu KH, Ng CJ. Traditional versus blended CPR training program: A randomized controlled non-inferiority study. Sci Rep. 2020 Jun 22;10(1):10032. doi: 10.1038/s41598-020-67193-1.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiopulmonary Resuscitation
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Generative AI and Gamified Simulation-Based Train-the-Trainer Basic Life Support Training for High School Teachers in Vietnam
Cardiac Arrest, Cardiopulmonary Resuscitation
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Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
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The OXY-VENT Study
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Sustained Inflation and Chest Compression vs 3:1 C:V Ratio in Asphyxiated Newborns
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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.
Cheng-Yu Chien, Dr. principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-line program and Standard program in people with Cardiopulmonary Resuscitation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 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 12 Mar 2020. 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 Taiwan. 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?
Written test for knowledge about CPR (time frame: 4 days). The study lists 2 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 NCT03586752, which also lists 1 linked publication.
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 12 Mar 2020.