Trial Outcomes & Findings for Self-learning vs Instructor-led Learning in BLS (NCT NCT03141528)
NCT ID: NCT03141528
Last Updated: 2020-01-13
Results Overview
The percentage of correct compressions obtained from the printed report from the Laerdal Skill Reporter.
COMPLETED
NA
240 participants
after first BLS course and 3 months later
2020-01-13
Participant Flow
Participant milestones
| Measure |
Instructor-led Learning
This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
|
Self-learning
This group will Train alone without supervision and without communicating with the other participants.
Self-learning: Training without supervision
|
|---|---|---|
|
Overall Study
STARTED
|
122
|
118
|
|
Overall Study
COMPLETED
|
75
|
77
|
|
Overall Study
NOT COMPLETED
|
47
|
41
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Self-learning vs Instructor-led Learning in BLS
Baseline characteristics by cohort
| Measure |
Instructor-led Learning
n=122 Participants
This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
|
Self-learning
n=118 Participants
This group will Train alone without supervision and without communicating with the other participants.
Self-learning: Training without supervision
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
122 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
21 years
n=5 Participants
|
21 years
n=7 Participants
|
21 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
122 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
122 participants
n=5 Participants
|
118 participants
n=7 Participants
|
240 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after first BLS course and 3 months laterThe percentage of correct compressions obtained from the printed report from the Laerdal Skill Reporter.
Outcome measures
| Measure |
Instructor-led Learning
n=105 Participants
This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
|
Self-learning
n=105 Participants
This group will Train alone without supervision and without communicating with the other participants.
Self-learning: Training without supervision
|
|---|---|---|
|
Percentage of Correct Compressions
Teaching
|
48 percentage of correct compressions
Interval 10.0 to 83.0
|
42 percentage of correct compressions
Interval 14.0 to 81.0
|
|
Percentage of Correct Compressions
Follow - up
|
28 percentage of correct compressions
Interval 6.0 to 59.0
|
47 percentage of correct compressions
Interval 12.0 to 78.0
|
SECONDARY outcome
Timeframe: after first BLS course and 3 months laterAssessment of the participant's BLS competence by the study team after test. Rated on a Visual Analogue Scale from 0-100mm, where 0mm = completely incompetent, no idea what to do, and 100mm = totally competent, cannot be done better.
Outcome measures
| Measure |
Instructor-led Learning
n=122 Participants
This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
|
Self-learning
n=118 Participants
This group will Train alone without supervision and without communicating with the other participants.
Self-learning: Training without supervision
|
|---|---|---|
|
Assessment of the Participants BLS Competences After Test
Teaching
|
73 units on a scale
Interval 61.0 to 81.0
|
68 units on a scale
Interval 56.0 to 77.0
|
|
Assessment of the Participants BLS Competences After Test
Follow-up
|
68 units on a scale
Interval 56.0 to 81.0
|
65 units on a scale
Interval 54.0 to 77.0
|
SECONDARY outcome
Timeframe: before first BLS course and 3 months laterThe participants assessment of their own BLS competences. Rated on a Visual Analogue Scale from 0-100mm, where 0mm = completely incompetent, no idea what to do, and 100mm = totally competent, cannot be done better.
Outcome measures
| Measure |
Instructor-led Learning
n=122 Participants
This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
|
Self-learning
n=118 Participants
This group will Train alone without supervision and without communicating with the other participants.
Self-learning: Training without supervision
|
|---|---|---|
|
Self-assessment of the Participants BLS Competences Before Test
Follow-up
|
60 score on a scale
Interval 49.0 to 70.0
|
59 score on a scale
Interval 49.0 to 68.0
|
|
Self-assessment of the Participants BLS Competences Before Test
Teaching
|
71 score on a scale
Interval 63.0 to 77.0
|
70 score on a scale
Interval 63.0 to 80.0
|
SECONDARY outcome
Timeframe: after first BLS courseThe participants assessment of the teaching method. Rated on a Visual Analogue Scale from 0-100mm, where 0mm = completely inefficient, and 100mm = totally efficient, nothing can be done better."
Outcome measures
| Measure |
Instructor-led Learning
n=122 Participants
This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
|
Self-learning
n=118 Participants
This group will Train alone without supervision and without communicating with the other participants.
Self-learning: Training without supervision
|
|---|---|---|
|
Assessment of the Teaching Method
|
80 score on a scale
Interval 70.0 to 90.0
|
75 score on a scale
Interval 62.0 to 84.0
|
SECONDARY outcome
Timeframe: after first BLS course and 3 months laterVentilation volume from the printed report from the Laerdal Skill Reporter (LSR)
Outcome measures
| Measure |
Instructor-led Learning
n=105 Participants
This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
|
Self-learning
n=105 Participants
This group will Train alone without supervision and without communicating with the other participants.
Self-learning: Training without supervision
|
|---|---|---|
|
Average Ventilation Volume
Teaching
|
790 ml
Interval 640.0 to 1010.0
|
810 ml
Interval 620.0 to 1150.0
|
|
Average Ventilation Volume
Follow-up
|
615 ml
Interval 530.0 to 770.0
|
660 ml
Interval 570.0 to 800.0
|
SECONDARY outcome
Timeframe: after first BLS course and 3 months laterNumber of ventilations per minute from the printed report from the Laerdal Skill Reporter (LSR)
Outcome measures
| Measure |
Instructor-led Learning
n=105 Participants
This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
|
Self-learning
n=105 Participants
This group will Train alone without supervision and without communicating with the other participants.
Self-learning: Training without supervision
|
|---|---|---|
|
Number of Ventilations Per Minute
Teaching
|
2 (ventilations/min)
Interval 2.0 to 3.0
|
2 (ventilations/min)
Interval 2.0 to 3.0
|
|
Number of Ventilations Per Minute
Follow-up
|
2 (ventilations/min)
Interval 2.0 to 3.0
|
3 (ventilations/min)
Interval 2.0 to 3.0
|
SECONDARY outcome
Timeframe: after first BLS course and 3 months laterPercentage of correct ventilations from the printed report from the Laerdal Skill Reporter (LSR)
Outcome measures
| Measure |
Instructor-led Learning
n=105 Participants
This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
|
Self-learning
n=105 Participants
This group will Train alone without supervision and without communicating with the other participants.
Self-learning: Training without supervision
|
|---|---|---|
|
Percentage of Correct Ventilations
Teaching
|
25 percentage of corrent ventilations
Interval 5.0 to 50.0
|
22 percentage of corrent ventilations
Interval 3.0 to 50.0
|
|
Percentage of Correct Ventilations
Follow-up
|
50 percentage of corrent ventilations
Interval 15.0 to 71.0
|
41 percentage of corrent ventilations
Interval 17.0 to 70.0
|
SECONDARY outcome
Timeframe: after first BLS course and 3 months laterthe relationship between ventilations and compressions from the printed report from the Laerdal Skill Reporter (LSR). Ventilations - relationship 30 compressions and 2 ventilations.
Outcome measures
| Measure |
Instructor-led Learning
n=105 Participants
This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
|
Self-learning
n=105 Participants
This group will Train alone without supervision and without communicating with the other participants.
Self-learning: Training without supervision
|
|---|---|---|
|
Number of Participants Using Correct Ratio of Compressions:Ventilations
Teaching
|
18 Participants
|
16 Participants
|
|
Number of Participants Using Correct Ratio of Compressions:Ventilations
Follow-up
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: after first BLS course and 3 months laterCompression depth from the printed report from the Laerdal Skill Reporter (LSR)
Outcome measures
| Measure |
Instructor-led Learning
n=105 Participants
This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
|
Self-learning
n=105 Participants
This group will Train alone without supervision and without communicating with the other participants.
Self-learning: Training without supervision
|
|---|---|---|
|
Compression Depth
Teaching
|
52 mm
Interval 44.0 to 57.0
|
52 mm
Interval 45.0 to 57.0
|
|
Compression Depth
Follow-up
|
50 mm
Interval 42.0 to 56.0
|
53 mm
Interval 46.0 to 58.0
|
SECONDARY outcome
Timeframe: after first BLS course and 3 months laterNumber of compressions per minute from the Laerdal Skill Reporter (LSR)
Outcome measures
| Measure |
Instructor-led Learning
n=105 Participants
This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
|
Self-learning
n=105 Participants
This group will Train alone without supervision and without communicating with the other participants.
Self-learning: Training without supervision
|
|---|---|---|
|
Number of Compressions Per Minute
Teaching
|
54 compressions per minute
Interval 46.0 to 58.0
|
51 compressions per minute
Interval 44.0 to 57.0
|
|
Number of Compressions Per Minute
Follow-up
|
57 compressions per minute
Interval 53.0 to 64.0
|
59 compressions per minute
Interval 51.0 to 63.0
|
SECONDARY outcome
Timeframe: after first BLS course and 3 months laterCompression frequency from the Laerdal Skill Reporter (LSR). Compressions per minute ventilation break included.
Outcome measures
| Measure |
Instructor-led Learning
n=105 Participants
This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
|
Self-learning
n=105 Participants
This group will Train alone without supervision and without communicating with the other participants.
Self-learning: Training without supervision
|
|---|---|---|
|
Compression Frequency
Teaching
|
112 compressions per minute
Interval 105.0 to 118.0
|
111 compressions per minute
Interval 103.0 to 116.0
|
|
Compression Frequency
Follow - up
|
113 compressions per minute
Interval 104.0 to 121.0
|
114 compressions per minute
Interval 103.0 to 122.0
|
SECONDARY outcome
Timeframe: after first BLS course and 3 months laterTotal percentage of Compressions too shallow from the Laerdal Skill Reporter (LSR)
Outcome measures
| Measure |
Instructor-led Learning
n=105 Participants
This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
|
Self-learning
n=105 Participants
This group will Train alone without supervision and without communicating with the other participants.
Self-learning: Training without supervision
|
|---|---|---|
|
Compressions Too Shallow
Teaching
|
25 percentage of Compressions too shallow
Interval 4.0 to 82.0
|
24 percentage of Compressions too shallow
Interval 2.0 to 76.0
|
|
Compressions Too Shallow
Follow-up
|
44 percentage of Compressions too shallow
Interval 3.0 to 87.0
|
18 percentage of Compressions too shallow
Interval 4.0 to 66.0
|
SECONDARY outcome
Timeframe: after first BLS course and 3 months laterFalse hand placement during compressions.
Outcome measures
| Measure |
Instructor-led Learning
n=105 Participants
This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
|
Self-learning
n=105 Participants
This group will Train alone without supervision and without communicating with the other participants.
Self-learning: Training without supervision
|
|---|---|---|
|
False Hand Placement During Compressions
Teaching
|
6 percentage of False hand placement durin
Interval 0.3 to 20.0
|
6 percentage of False hand placement durin
Interval 0.0 to 34.0
|
|
False Hand Placement During Compressions
Follow-up
|
13 percentage of False hand placement durin
Interval to 41.0
|
15 percentage of False hand placement durin
Interval 0.0 to 96.0
|
SECONDARY outcome
Timeframe: after first BLS course and 3 months laterIncomplete decompression from the Laerdal Skill Reporter (LSR)
Outcome measures
| Measure |
Instructor-led Learning
n=105 Participants
This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
|
Self-learning
n=105 Participants
This group will Train alone without supervision and without communicating with the other participants.
Self-learning: Training without supervision
|
|---|---|---|
|
Incomplete Decompression
Teaching
|
0 percentage of Incomplete decompression
Interval 0.0 to 0.3
|
0 percentage of Incomplete decompression
Interval 0.0 to 0.3
|
|
Incomplete Decompression
Follow - up
|
0 percentage of Incomplete decompression
Interval 0.0 to 0.0
|
0 percentage of Incomplete decompression
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: after first BLS course and 3 months laterTime measured from the beginning of the test until the participant calls for help.
Outcome measures
| Measure |
Instructor-led Learning
n=122 Participants
This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
|
Self-learning
n=118 Participants
This group will Train alone without supervision and without communicating with the other participants.
Self-learning: Training without supervision
|
|---|---|---|
|
Time From Start of Test Till Call for Help
Teaching
|
10 seconds
Interval 7.0 to 16.0
|
12 seconds
Interval 8.0 to 18.0
|
|
Time From Start of Test Till Call for Help
Follow-up
|
9 seconds
Interval 5.0 to 16.0
|
8 seconds
Interval 5.0 to 15.0
|
SECONDARY outcome
Timeframe: after first BLS course and 3 months laterTime measured from the beginning of the test until the participant makes the first compression.
Outcome measures
| Measure |
Instructor-led Learning
n=122 Participants
This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
|
Self-learning
n=118 Participants
This group will Train alone without supervision and without communicating with the other participants.
Self-learning: Training without supervision
|
|---|---|---|
|
Time From Start of Test Till First Compression
Teaching
|
35 seconds
Interval 27.0 to 46.0
|
35 seconds
Interval 26.0 to 46.0
|
|
Time From Start of Test Till First Compression
Follow-up
|
28 seconds
Interval 23.0 to 35.0
|
25 seconds
Interval 21.0 to 32.0
|
SECONDARY outcome
Timeframe: after first BLS course and 3 months laterTime measured from the beginning of the test until the participant makes the first ventilation.
Outcome measures
| Measure |
Instructor-led Learning
n=122 Participants
This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
|
Self-learning
n=118 Participants
This group will Train alone without supervision and without communicating with the other participants.
Self-learning: Training without supervision
|
|---|---|---|
|
Time From Start of Test Till First Ventilation
Teaching
|
70 seconds
Interval 56.0 to 112.0
|
64 seconds
Interval 55.0 to 92.0
|
|
Time From Start of Test Till First Ventilation
Follow-up
|
93 seconds
Interval 56.0 to 106.0
|
63 seconds
Interval 45.0 to 97.0
|
SECONDARY outcome
Timeframe: after first BLS course and 3 months laterTime measured from the beginning of the test until the participant gives the first shock.
Outcome measures
| Measure |
Instructor-led Learning
n=122 Participants
This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
Instructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
|
Self-learning
n=118 Participants
This group will Train alone without supervision and without communicating with the other participants.
Self-learning: Training without supervision
|
|---|---|---|
|
Time From Start of Test Till First Shock
Teaching
|
100 seconds
Interval 82.0 to 120.0
|
118 seconds
Interval 95.0 to 145.0
|
|
Time From Start of Test Till First Shock
Follow-up
|
83 seconds
Interval 73.0 to 102.0
|
88 seconds
Interval 75.0 to 107.0
|
Adverse Events
Instructor-led Learning
Self-learning
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place