Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.



Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619001696189
Ethics application status
Approved
Date submitted
14/11/2019
Date registered
2/12/2019
Date last updated
2/12/2019
Date data sharing statement initially provided
2/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of simulation education for improving critical care nurses' knowledge and clinical skills for recognition and management of delirium
Scientific title
The impact of scenario-based education initiative and objective structured clinical examination (OSCE) on knowledge and clinical skills for recognition and management of delirium for critical care nurses
Secondary ID [1] 299824 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
delirium 315209 0
Condition category
Condition code
Public Health 313527 313527 0 0
Health promotion/education
Neurological 313719 313719 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention session consists of a three part delirium education program (total of 2 hours). Each participant will undertake one session.
(1) face-to-face delirium care educational lecture by an ICU clinical nurse (30 minutes in duration);
(2) online delirium care learning videos, including 5 videos for delirium care which designed specifically for this study (30 minutes in duration);
(3) Simulation education: role-play scenario-based education initiative and objective structured clinical examination (OSCE) conducted by an ICU clinical nurse (60 minutes in duration).

The control group will received the same (1) face-to-face delirium care educational lecture; and (2) online delirium care learning videos.
Intervention code [1] 316084 0
Behaviour
Comparator / control treatment
1. face-to-face delirium care educational lecture (30 minutes in duration);
2. online delirium care learning videos (20 minutes in duration)
Control group
Active

Outcomes
Primary outcome [1] 321976 0
Delirium Knowledge will be assessed by a 10 items questionnaire designed by research and has been examined by five experts to confirm the content validity and face validity. This questionnaire will be distributed to participants at all timepoints measurement.
Timepoint [1] 321976 0
Measures will be assessed at three timepoints: T0 (Baseline), T1 (Immediately after the intervention), T2 (Six weeks after the intervention).
Primary outcome [2] 322139 0
Delirium skills will be assessed by a 10 items questionnaire designed by research and has been examined by five experts to confirm the content validity and face validity. This questionnaire will be distributed to participants at all timepoints measurement.
Timepoint [2] 322139 0
Measures will be assessed at three timepoints: T0 (Baseline), T1 (Immediately after the intervention), T2 (Six weeks after the intervention).
Secondary outcome [1] 376899 0
A specific self-efficacy scale which modified from General Self-Efficacy Scale (GSE) for assessing delirium care self-efficacy will be used and it has been examined by five experts to confirm the content validity and face validity will be adopted.
Timepoint [1] 376899 0
Measures will be assessed at three timepoints: T0 (Baseline), T1 (Immediately after the intervention), T2 (Six weeks after the intervention).

Eligibility
Key inclusion criteria
Registered nurse worked in acute care unit and care with critical patients.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unwilling to involve in this study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/03/2020
Actual
Date of last participant enrolment
Anticipated
30/04/2020
Actual
Date of last data collection
Anticipated
30/06/2020
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 22116 0
Taiwan, Province Of China
State/province [1] 22116 0

Funding & Sponsors
Funding source category [1] 304286 0
Hospital
Name [1] 304286 0
Taipei Medical University Hospital
Country [1] 304286 0
Taiwan, Province Of China
Funding source category [2] 304288 0
University
Name [2] 304288 0
University of Wollongong
Country [2] 304288 0
Australia
Primary sponsor type
Individual
Name
Professor Shu-Tai Shen Hsiao
Country
Taiwan, Province Of China
Secondary sponsor category [1] 304529 0
Individual
Name [1] 304529 0
Professor Victoria Traynor
Country [1] 304529 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304743 0
Taipei Medical University (TMU) TMU-Joint Institutional Review Board
Ethics committee address [1] 304743 0
Ethics committee country [1] 304743 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 304743 0
Approval date [1] 304743 0
25/04/2019
Ethics approval number [1] 304743 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 98054 0
Mr Mu-Hsing Ho
Address 98054 0
B41 Sciences Building, R 116 School of Nursing Faculty of Science, Medicine and Health Northfields Avenue University of Wollongong NSW 2522
Country 98054 0
Australia
Phone 98054 0
+61431309108
Fax 98054 0
Email 98054 0
mhh838@uowmail.edu.au
Contact person for public queries
Name 98055 0
Mu-Hsing Ho
Address 98055 0
B41 Sciences Building, R 116 School of Nursing Faculty of Science, Medicine and Health Northfields Avenue University of Wollongong NSW 2522
Country 98055 0
Australia
Phone 98055 0
+61431309108
Fax 98055 0
Email 98055 0
mhh838@uowmail.edu.au
Contact person for scientific queries
Name 98056 0
Mu-Hsing Ho
Address 98056 0
B41 Sciences Building, R 116 School of Nursing Faculty of Science, Medicine and Health Northfields Avenue University of Wollongong NSW 2522
Country 98056 0
Australia
Phone 98056 0
+61431309108
Fax 98056 0
Email 98056 0
mhh838@uowmail.edu.au

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Case-by-case basis at the discretion of the Primary Sponsor.

Conditions for requesting access:
• -

What individual participant data might be shared?
• All of the individual participant data collected during the trail, after de-identification.

What types of analyses could be done with individual participant data?
• For IPD meta-analyses.

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication; no end date determined.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator.
Mu-Hsing Ho
Email: mhh838@uowmail.edu.au
School of Nursing
Faculty of Science Medicine and Health
University of Wollongong NSW 2522 Australia

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.