NCT05575869

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2022

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

October 6, 2022

Last Update Submit

November 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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%.

    3 weeks

Secondary Outcomes (2)

  • Confidence levels (survey scores)

    3 weeks

  • Difference between the "Knowledge application" (test score) between the groups

    3 weeks

Study Arms (2)

Experimental group: Access to online PRONEtect educational material

EXPERIMENTAL

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

Other: (online) PRONEtect educational material

Control group: Classic one-hour lecture

ACTIVE COMPARATOR

Didactive presentation by the usual nursing school lecturer.

Other: Classic (normal) one hour lesson/lecture

Interventions

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.

Experimental group: Access to online PRONEtect educational material

As per normal, a classroom lecture given by the nursing school by one of the nursing school lecturers.

Control group: Classic one-hour lecture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2022

First Posted

October 12, 2022

Study Start

September 27, 2022

Primary Completion

December 23, 2022

Study Completion

December 23, 2022

Last Updated

November 14, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations