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Evaluation of the Impact of the PRONEtect Education Hub vs. Classic Lecture, on the Competencies of Nursing Students

Primary Purpose

Prone Position, Pressure Ulcer

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
(online) PRONEtect educational material
Classic (normal) one hour lesson/lecture
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prone Position

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

Nursing students who are not yet in their final year of studies.

Sites / Locations

  • Ghent University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group: Access to online PRONEtect educational material

Control group: Classic one-hour lecture

Arm Description

A website with educational material (simulation video, protocol, checklist).

Didactive presentation by the usual nursing school lecturer.

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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%.
Difference between the "Knowledge application" (test score) between the groups
Difference between the "Knowledge application" (test score) of 1-2 points between the groups

Full Information

First Posted
October 6, 2022
Last Updated
January 27, 2023
Sponsor
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT05575869
Brief Title
Evaluation of the Impact of the PRONEtect Education Hub vs. Classic Lecture, on the Competencies of Nursing Students
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 27, 2022 (Actual)
Primary Completion Date
December 23, 2022 (Actual)
Study Completion Date
December 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prone Position, Pressure Ulcer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The lecturers at the nursing schools (x2) will have no access to the results of the surveys. A study number is assigned to the students and with the study number they enter their answers to the questionnaires
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group: Access to online PRONEtect educational material
Arm Type
Experimental
Arm Description
A website with educational material (simulation video, protocol, checklist).
Arm Title
Control group: Classic one-hour lecture
Arm Type
Active Comparator
Arm Description
Didactive presentation by the usual nursing school lecturer.
Intervention Type
Other
Intervention Name(s)
(online) PRONEtect educational material
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Classic (normal) one hour lesson/lecture
Intervention Description
As per normal, a classroom lecture given by the nursing school by one of the nursing school lecturers.
Primary Outcome Measure Information:
Title
Knowledge assessment (test score)
Description
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%.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Confidence levels (survey scores)
Description
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%.
Time Frame
3 weeks
Title
Difference between the "Knowledge application" (test score) between the groups
Description
Difference between the "Knowledge application" (test score) of 1-2 points between the groups
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Nursing students who are not yet in their final year of studies.
Facility Information:
Facility Name
Ghent University
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the Impact of the PRONEtect Education Hub vs. Classic Lecture, on the Competencies of Nursing Students

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