Prone PositionNCT05575869
Evaluation of the Impact of the PRONEtect Education Hub vs. Classic Lecture, on the Competencies of Nursing Students
A study testing (online) PRONEtect educational material and Classic (normal) one hour lesson/lecture in people with Prone Position and Pressure Ulcer, run by University Ghent at 1 site in Belgium.
Trial summary
The goal of this randomised controlled trial is to compare the impact of online educational material versus a classic lecture on the confidence levels, knowledge and knowledge application of final-year nursing students. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prone Position, Pressure Ulcer
- What is being tested?
- (online) PRONEtect educational material and Classic (normal) one hour lesson/lecture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Sep 2022to 23 Dec 2022
- 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
- Final year nursing students studying towards their Bachelor in Nursing degree
- Chosen topics of critical care nursing as supplementary subject or critical care subjects as part of their course or complex wound management as part of their course.
Who cannot join
- Nursing students who are not yet in their final year of studies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate the Impact of Online Educational Material (PRONEtect Educational Hub) on Nursing Students' Knowledge, Confidence Levels, and Application of Knowledge Regarding Skin Protection of the Prone Ventilated Patient - a Randomised Controlled Study
The goal of this randomised controlled trial is to compare the impact of online educational material versus a classic lecture on the confidence levels, knowledge and knowledge application of final-year nursing students.
Participants will be asked to complete a baseline self-efficacy evaluation and a baseline knowledge test which were validated by the 11-member international expert panel previously established.
Read more
After randomization, the control group will be asked to attend a classic 1-hour lecture at the nursing school about the topic of prone positioning and skin/tissue damage prevention.
The experimental group will get access to the PRONEtect educational website containing short simulation videos and other learning materials.
Three weeks later the participants will be asked to complete the self-efficacy evaluation and knowledge assessment again, additionally a knowledge application assessment.
All the questionnaires will be administered via Qualtrics.
- Conditions
- Prone Position, Pressure Ulcer
- Being tested
- (online) PRONEtect educational material, Classic (normal) one hour lesson/lecture
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(online) PRONEtect educational materialOther
This is a website containing educational material like short simulation videos on how to turn a patient from supine-to-prone and prone-to-supine positioning, how to protect the skin from incontinence, or before securing endotracheal-/nasogastric tubes, how to reposition the patient to prevent pressure injuries, a full protocol regarding prone positioning etc.
Classic (normal) one hour lesson/lectureOther
As per normal, a classroom lecture given by the nursing school by one of the nursing school lecturers.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: Access to online PRONEtect educational material | Experimental | A website with educational material (simulation video, protocol, checklist). Receives: Other: (online) PRONEtect educational material |
| Control group: Classic one-hour lecture | Active comparator | Didactive presentation by the usual nursing school lecturer. Receives: Other: Classic (normal) one hour lesson/lecture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge assessment (test score)
A total sample size of 78 participants (39 in each group, 1:1 allocation ratio) to have at least 80% power to demonstrate non-inferiority of the online package (experimental group) compared to the classical lecture (control group) with respect to the mean change from baseline in knowledge at week 3 at the one-sided 1.25% significance level, when the non-inferiority margin is set at 1 point and when we assume a common standard deviation in both groups of 2.5 points, a true difference between the groups of 1 point in favor of the online package, and a drop-out rate of 20%.
Measured: 3 weeks
Secondary outcomes (2)
Confidence levels (survey scores)
A total sample size of 78 participants (39 in each group, 1:1 allocation ratio) to have at least 80% power to demonstrate non-inferiority of the online package (experimental group) compared to the classical lecture (control group) with respect to the mean change from baseline in knowledge at week 3 at the one-sided 1.25% significance level, when the non-inferiority margin is set at 1 point and when we assume a common standard deviation in both groups of 2.5 points, a true difference between the groups of 1 point in favor of the online package, and a drop-out rate of 20%.
Measured: 3 weeks
Difference between the "Knowledge application" (test score) between the groups
Difference between the "Knowledge application" (test score) of 1-2 points between the groups
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start27 Sep 2022
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
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 Prone PositionStudies of the same condition, open and under way.
- More trials run by University GhentThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575869
- Sponsor's protocol ID
- PRONEtection #2
- Status last verified
- Nov 2023
- First submitted
- 6 Oct 2022
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fourie A, Ahtiala M, Black J, Campos HH, Coyer F, Gefen A, LeBlanc K, Smet S, Vollman K, Walsh Y, Karlberg-Traav M, Beeckman D. Enhancing prone positioning and skin damage prevention education: A randomized controlled non-inferiority trial comparing a digital education hub (PRONEtect) and a traditional lecture on final-year nursing participants' confidence and knowledge. J Tissue Viability. 2024 May;33(2):298-304. doi: 10.1016/j.jtv.2024.02.008. Epub 2024 Feb 19.
PubMed 38402096
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Impact of Online Educational Material (PRONEtect Educational Hub) on Nursing Students' Knowledge, Confidence Levels, and Application of Knowledge Regarding Skin Protection of the Prone Ventilated Patient - a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT05575869
- Acronym / sponsor ID
- PRONEtection #2
- Conditions
- Prone Position, Pressure Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 12 Oct 2022 (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 goal of this randomised controlled trial is to compare the impact of online educational material versus a classic lecture on the confidence levels, knowledge and knowledge application of final-year nursing students.
Participants will be asked to complete a baseline self-efficacy evaluation and a baseline knowledge test which were validated by the 11-member international expert panel previously established.
After randomization, the control group will be asked to attend a classic 1-hour lecture at the nursing school about the topic of prone positioning and skin/tissue damage prevention.
The experimental group will get access to the PRONEtect educational website containing short simulation videos and other learning materials.
Three weeks later the participants will be asked to complete the self-efficacy evaluation and knowledge assessment again, additionally a knowledge application assessment.
All the questionnaires will be administered via Qualtrics.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group: Access to online PRONEtect educational material | Experimental | Other: (online) PRONEtect educational materialA website with educational material (simulation video, protocol, checklist). |
| Control group: Classic one-hour lecture | Active comparator | Other: Classic (normal) one hour lesson/lectureDidactive presentation by the usual nursing school lecturer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Final year nursing students studying towards their Bachelor in Nursing degree
- Chosen topics of critical care nursing as supplementary subject or critical care subjects as part of their course or complex wound management as part of their course.
Key exclusion criteria (1 listed)
- Nursing students who are not yet in their final year of studies.
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 |
|---|---|---|
| (online) PRONEtect educational materialThis is a website containing educational material like short simulation videos on how to turn a patient from supine-to-prone and prone-to-supine positioning, how to protect the skin from incontinence, or before securing endotracheal-/nasogastric tubes, how to reposition the patient to prevent pressure injuries, a full protocol regarding prone positioning etc. | Other | Experimental group: Access to online PRONEtect educational material |
| Classic (normal) one hour lesson/lectureAs per normal, a classroom lecture given by the nursing school by one of the nursing school lecturers. | Other | Control group: Classic one-hour lecture |
Primary outcome
Knowledge assessment (test score)
Time frame: 3 weeks
A total sample size of 78 participants (39 in each group, 1:1 allocation ratio) to have at least 80% power to demonstrate non-inferiority of the online package (experimental group) compared to the classical lecture (control group) with respect to the mean change from baseline in knowledge at week 3 at the one-sided 1.25% significance level, when the non-inferiority margin is set at 1 point and when we assume a common standard deviation in both groups of 2.5 points, a true difference between the groups of 1 point in favor of the online package, and a drop-out rate of 20%.
2 secondary outcomes
Confidence levels (survey scores)
Time frame: 3 weeks
Difference between the "Knowledge application" (test score) between the groups
Time frame: 3 weeks
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 14 Nov 2023.
- Derived from this study: PubMed 38402096Fourie A, Ahtiala M, Black J, Campos HH, Coyer F, Gefen A, LeBlanc K, Smet S, Vollman K, Walsh Y, Karlberg-Traav M, Beeckman D. Enhancing prone positioning and skin damage prevention education: A randomized controlled non-inferiority trial comparing a digital education hub (PRONEtect) and a traditional lecture on final-year nursing participants' confidence and knowledge. J Tissue Viability. 2024 May;33(2):298-304. doi: 10.1016/j.jtv.2024.02.008. Epub 2024 Feb 19.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (online) PRONEtect educational material and Classic (normal) one hour lesson/lecture in people with Prone Position and Pressure Ulcer, run by University Ghent at 1 site in Belgium.
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 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: finished, as of the sponsor's last update on 14 Nov 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 Belgium. 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?
Knowledge assessment (test score) (time frame: 3 weeks). 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 NCT05575869, 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 14 Nov 2023.