Cardiac Arrest CirculatoryNCT03266263
A Study of Improving Education of Community Chain of Survival
A study testing automatic computer-led feedback and instructor-led feedback in people with Cardiac Arrest Circulatory, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
"High-quality cardiopulmonary resuscitation (CPR)" and "early defibrillation" are the most important parts of "the chain of survival", and they are highly associated with the survival rate and life quality of patients with cardiac arrest. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest Circulatory
- What is being tested?
- automatic computer-led feedback and instructor-led feedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2016to 31 Jul 2019
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy laypersons without CPR training within two years
Who cannot join
- non
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
NTUH
Taipei
Chih-Wei Yang, 886-23123456 ext. 61426, cwyang0413@gmail.com
About this study
Official title: Improving Education of Community Chain of Survival Through Innovative Teaching, Implementing Teamwork Skills, and Survey on Attitude and Willingness: A Pilot Study
"High-quality cardiopulmonary resuscitation (CPR)" and "early defibrillation" are the most important parts of "the chain of survival", and they are highly associated with the survival rate and life quality of patients with cardiac arrest. It needs the witness to perform bystander CPR and use the automated external defibrillator (AED) if CPR and defibrillation are expected to be performed earlier. Nevertheless, few patients with cardiac arrest received bystander CPR in Taiwan. It might be caused by some reasons. First, traditional training programs were inefficient and ineffective in the retention of skills and thus students were not confident in their CPR skills after receiving training programs. Second, the current training module focused on personal skill training only and lacked teamwork skills training. It led to poor performance of the students in actual resuscitation scene, where on-scene resuscitators were usually more than one. Third, the current training contents did not improve the attitudes and willingness of performing bystander CPR and it caused people who had received training program did not resuscitate the patients finally. To improve the above-mentioned problem, a three-year research project will be implemented. The aims of the project are the following:
- to explore the effect of different teaching contents and hand-on practice feedback methods on the students' performance of chest compressing, ventilating and using AED in the CPR and AED training courses.
- to analyze the current situation of teamwork when CPR and AED were performed, to build up the collaborating module accordingly and evaluate the effect of the new module on the students' performance of chest compressing, ventilating and using AED after the module is introduced into the training course.
- to understand the factors affecting the motivations and willingness of people to learn and practice CPR and AED by utilizing questionnaires, and then to evaluate the effect of the creative program, which was modified according to the results of the questionnaires, on the motivations and willingness of people to learn and practice CPR and AED.
The investigators expect to design a more efficient resuscitation skill training course by implementing the research project and further to improve the motivations and willingness of people to learn and practice CPR and AED in the future.
- Conditions
- Cardiac Arrest Circulatory
- Being tested
- automatic computer-led feedback, instructor-led feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
automatic computer-led feedbackDevice
automated feedback software for CPR quality, including compression depth, rate, recoil, hands-off time, and ventilation volume
instructor-led feedbackOther
feedback for CPR quality by instructors
| Study group | Role | What they receive |
|---|---|---|
| automatic computer-led feedback | Experimental | automated feedback for CPR quality provided by computers Receives: Device: automatic computer-led feedback |
| instructor-led feedback | Active comparator | feedback for CPR quality provided by instructors Receives: Other: instructor-led feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
chest compression rate
differences of chest compression rates
Measured: immediately after the training course
chest compression depth
differences of chest compression depth
Measured: immediately after the training course
hands-off time of chest compression
differences of hands-off time of chest compression
Measured: immediately after the training course
score of checklist
differences of scores of checklists
Measured: immediately after the training course
Secondary outcomes (1)
score of satisfaction questionnaire
differences of scores of satisfaction questionnaire
Measured: immediately after the training course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start1 Aug 2016
- Primary completion31 Jul 2019 (estimated)
- Study completion31 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest CirculatoryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266263
- Sponsor's protocol ID
- 201606085RIND
- Status last verified
- Aug 2016
- First submitted
- 17 Aug 2017
- Last updated
- 30 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Education of Community Chain of Survival Through Innovative Teaching, Implementing Teamwork Skills, and Survey on Attitude and Willingness: A Pilot Study
- ClinicalTrials.gov ID
- NCT03266263
- Acronym / sponsor ID
- 201606085RIND
- Conditions
- Cardiac Arrest Circulatory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 30 Aug 2017 (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.
"High-quality cardiopulmonary resuscitation (CPR)" and "early defibrillation" are the most important parts of "the chain of survival", and they are highly associated with the survival rate and life quality of patients with cardiac arrest. It needs the witness to perform bystander CPR and use the automated external defibrillator (AED) if CPR and defibrillation are expected to be performed earlier. Nevertheless, few patients with cardiac arrest received bystander CPR in Taiwan. It might be caused by some reasons. First, traditional training programs were inefficient and ineffective in the retention of skills and thus students were not confident in their CPR skills after receiving training programs. Second, the current training module focused on personal skill training only and lacked teamwork skills training. It led to poor performance of the students in actual resuscitation scene, where on-scene resuscitators were usually more than one. Third, the current training contents did not improve the attitudes and willingness of performing bystander CPR and it caused people who had received training program did not resuscitate the patients finally. To improve the above-mentioned problem, a three-year research project will be implemented. The aims of the project are the following:
- to explore the effect of different teaching contents and hand-on practice feedback methods on the students' performance of chest compressing, ventilating and using AED in the CPR and AED training courses.
- to analyze the current situation of teamwork when CPR and AED were performed, to build up the collaborating module accordingly and evaluate the effect of the new module on the students' performance of chest compressing, ventilating and using AED after the module is introduced into the training course.
- to understand the factors affecting the motivations and willingness of people to learn and practice CPR and AED by utilizing questionnaires, and then to evaluate the effect of the creative program, which was modified according to the results of the questionnaires, on the motivations and willingness of people to learn and practice CPR and AED.
The investigators expect to design a more efficient resuscitation skill training course by implementing the research project and further to improve the motivations and willingness of people to learn and practice CPR and AED in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| automatic computer-led feedback | Experimental | Device: automatic computer-led feedbackautomated feedback for CPR quality provided by computers |
| instructor-led feedback | Active comparator | Other: instructor-led feedbackfeedback for CPR quality provided by instructors |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- healthy laypersons without CPR training within two years
Key exclusion criteria (1 listed)
- non
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 |
|---|---|---|
| automatic computer-led feedbackautomated feedback software for CPR quality, including compression depth, rate, recoil, hands-off time, and ventilation volume | Device | automatic computer-led feedback |
| instructor-led feedbackfeedback for CPR quality by instructors | Other | instructor-led feedback |
Primary outcome
chest compression rate
Time frame: immediately after the training course
differences of chest compression rates
chest compression depth
Time frame: immediately after the training course
differences of chest compression depth
hands-off time of chest compression
Time frame: immediately after the training course
differences of hands-off time of chest compression
score of checklist
Time frame: immediately after the training course
differences of scores of checklists
1 secondary outcome
score of satisfaction questionnaire
Time frame: immediately after the training course
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing automatic computer-led feedback and instructor-led feedback in people with Cardiac Arrest Circulatory, run by National Taiwan University 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 1 inclusion and 1 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 30 Aug 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chih-Wei Yang (886-23123456 ext. 61426, cwyang0413@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chest compression rate (time frame: immediately after the training course). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2017.