- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05493189
Assessment of CPR Skills Acquisition and Retention: Impact of Technology and Self-training (TrainCPR)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The objectives of this study include:
- Study the impact of using technology, namely simulators with automatic feedback, in CPR training.
- Study the potential of autonomous training as a complementary and/or alternative methodology in CPR training.
- Assess the acquisition and retention/maintenance of CPR skills, through autonomous and regular training.
The findings of this project are expected to promote awareness and behavioral change in the rescuer, leading to better outcomes for patients.
Experimental case-control study, aligned in two phases. In a first phase, all participants will be exposed to a period of autonomous training, with measurements of performance and quality of CPR, before and after training. This phase will allow investigating the acquisition of skills through autonomous training and leveling the skills of the entire sample. In a second phase, the sample will be randomly distributed between two groups and the retention/maintenance of skills will be evaluated over 1 year, considering that one of the groups will be exposed to 2 additional autonomous training sessions (after 2 and 6 months). The collection of technical skills data will be performed in the pre-training period, post-training (time zero) and after 2, 6 and 12 months - corresponding to 5 data collection moments, in both groups.
Both autonomous training and technical skills data collection will take place using a feedback CPR training simulator (eg Laerdal Little Anne QCPR). Along with the collection of technical skills data, theoretical knowledge will be assessed through a questionnaire. The duration of the autonomous training will be 30 minutes.
The sample will be recruited by convenience (non-probabilistic sample), using students of the 4th year of the Integrated Master in Medicine of the Faculty of Medicine of the University of Porto.
Data collection will take place at the Clinical Simulation Center of the Faculty of Medicine of the University of Porto (Portugal);
An estimate of the sample size was calculated considering the use of an ANOVA test for repeated measures. Using the G-Power software and considering an effect size of 0.20, significance level of 0.05, power of 0.95, for two groups and five measures, 96 participants will be needed. In this calculation, a null correlation coefficient was used, opting for a conservative approach to sample size calculation. Anticipating eventual dropouts, 150 participants will be recruited.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Abel Nicolau, MSc, PhDc
- Phone Number: 26836 (+351) 220426836
- Email: anicolau@med.up.pt
Study Contact Backup
- Name: Janete Santos, PhD
- Phone Number: (+351) 225 513 600
- Email: investigaclinica@med.up.pt
Study Locations
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-
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Porto, Portugal, 4200-319
- Recruiting
- Faculty of Medicine (FMUP)
-
Contact:
- Abel Nicolau, MSc, PhDc
- Phone Number: 26836 (+351) 220426836
- Email: anicolau@med.up.pt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults (>= 18 years of age);
- Good state of health;
- Lack of formal training in CPR.
Exclusion Criteria:
- Pregnant women;
- Individuals with reduced mobility;
- Physical fatigue and/or reported muscle pain;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
Participants with no additional autonomous training sessions.
|
|
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Experimental: Intervention Group
Participants exposed to 2 additional autonomous training sessions (after 2 and 6 months).
|
The duration of the autonomous training will be 30 minutes, using a feedback CPR training simulator (eg Laerdal Little Anne QCPR).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in CPR skills (acquisition)
Time Frame: Measurements of performance and quality of CPR (2 minutes of continuous chest compressions), immediately before and immediately after training, during the first phase (before randomization and group allocation).
|
Technical skills data collection will take place using a feedback CPR training simulator (eg Laerdal Little Anne QCPR).
Along with the collection of technical skills data, theoretical knowledge will be assessed through a questionnaire.
Both technical skills and theoretical knowledge will be aggregated to one general skills score.
|
Measurements of performance and quality of CPR (2 minutes of continuous chest compressions), immediately before and immediately after training, during the first phase (before randomization and group allocation).
|
|
Difference in CPR skills retention
Time Frame: Measurements of performance and quality of CPR (2 minutes of continuous chest compressions), in second phase at 2, 6 and 12 months.
|
Technical skills data collection will take place using a feedback CPR training simulator (eg Laerdal Little Anne QCPR).
Along with the collection of technical skills data, theoretical knowledge will be assessed through a questionnaire.
Both technical skills and theoretical knowledge will be aggregated to one general skills score.
|
Measurements of performance and quality of CPR (2 minutes of continuous chest compressions), in second phase at 2, 6 and 12 months.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Carla Sa-Couto, PhD, Faculty of Medicine (FMUP)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TrainCPR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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