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Trial registered on ANZCTR


Registration number
ACTRN12623001139662
Ethics application status
Approved
Date submitted
28/09/2023
Date registered
3/11/2023
Date last updated
3/11/2023
Date data sharing statement initially provided
3/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Educational intervention related to nursing care of haemophilia patients
Scientific title
How an educational intervention affects the Confidence and Competence of nursing staff when caring for Patients with Haemophilia.
Secondary ID [1] 310429 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haemophilia 331202 0
Condition category
Condition code
Blood 327973 327973 0 0
Clotting disorders
Public Health 328481 328481 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The educational intervention group will be provided with a recorded 30–60 minute PowerPoint presentation via Microsoft Teams. A link to the Microsoft Teams recording will be emailed to participants. Participant access of the educational intervention will be monitored as participants will be prompted to request access to the educational intervention when clicking on the link. The investigator will receive an email upon each access request. Participants will have 2 weeks to review the presentation before completing the follow-up assessments. These follow-up assessments are to be completed 2 weeks after access is granted to the educational intervention and will include a confidence scale and competency questionnaire. The educational presentation will include information, graphics and visual aids relevant to best practice nursing care of haemophilia patients/clients. Presentation will cover elements such as: introduction to Haemophilia, bleed types & management, and role of the nurse in caring for patients with Haemophilia. Participants will be followed up to complete the educational intervention if necessary. Additionally, participants will be sent two automated reminder emails to review the presentation, at the end of the 1st and 2nd weeks of access.
Intervention code [1] 326831 0
Treatment: Other
Comparator / control treatment
The control group will not receive any educational intervention for the duration of the study. Follow-up assessments will be completed 2 weeks post intervention. At the end of the study (approximately 2 months post-study commencement), the educational intervention will be shared with the control group.
Control group
Active

Outcomes
Primary outcome [1] 335827 0
To assess nursing competence in caring for patients with Haemophilia. Confidence scores to be obtained via multiple choice competency questionnaire comprising of 18 questions. This multiple choice competency questionnaire was created specifically for this study.
Timepoint [1] 335827 0
Initial baseline competency questionnaire will be completed on enrolment. Follow-up competency questionnaire to be completed after 2 weeks of access to the educational intervention.
Secondary outcome [1] 425816 0
To measure nursing confidence in caring for patients/clients with Haemophilia. Confidence scores to be collected via Likert scale from 1 to 10.
Timepoint [1] 425816 0
Initial baseline confidence scale will be completed on enrolment. Follow-up confidence scale to be completed after 2 weeks of access to the educational intervention.

Eligibility
Key inclusion criteria
Nursing staff who are willing to engage and comply with the study procedures and have the capacity to give consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The study will exclude nursing students and staff who rate themselves as highly confident in caring for patients with haemophilia.

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)
Participants will be randomised to the educational intervention or control group (1:1). Simple randomisation and concealed allocation will be achieved using a computer-generated random number system. Participants will be notified of their study group via email.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation and concealed allocation will be achieved using a computer-generated random number system.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Based on the results of a previous survey of 8 nurses, a 2-point improvement on a 10-point scale was used in the calculation (smallest worthwhile effect of 2). Standard deviation calculated as 2, alpha nominated as 0.05, and beta nominated as 0.80. Sample size calculated as 34 participants (17 per group).

Any differences noted in baseline characteristics that the investigator considers significant enough to influence the outcome of the results will be commented on. If the baseline characteristic is known to be prognostic of outcome, it will be adjusted for in the analysis. If at the end of the study period missing data is identified, two reminders email will be sent, a week apart.

Change in competency questionnaire scores and Likert confidence scores at each of the two timepoints will be analysed as between-group differences with 95% confidence intervals. An intention to treat analysis will be applied, i.e., all subjects for whom outcome measures are available will be analysed in the groups to which they were originally randomised.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/11/2023
Actual
Date of last participant enrolment
Anticipated
4/12/2023
Actual
Date of last data collection
Anticipated
7/01/2024
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25427 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 41169 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 314637 0
Hospital
Name [1] 314637 0
Royal Prince Alfred Hospital
Country [1] 314637 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
RPAH, 50 Missenden Road, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 316600 0
None
Name [1] 316600 0
Address [1] 316600 0
Country [1] 316600 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313658 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 313658 0
RPAH Medical Centre Suite 210A, 100 Carillon Avenue Newtown NSW 2042
Ethics committee country [1] 313658 0
Australia
Date submitted for ethics approval [1] 313658 0
04/09/2023
Approval date [1] 313658 0
21/09/2023
Ethics approval number [1] 313658 0
Ethics committee name [2] 313905 0
Research Ethics & Governance Office, Royal Prince Alfred Hospital
Ethics committee address [2] 313905 0
Missenden Road CAMPERDOWN NSW 2050
Ethics committee country [2] 313905 0
Australia
Date submitted for ethics approval [2] 313905 0
11/09/2023
Approval date [2] 313905 0
28/09/2023
Ethics approval number [2] 313905 0

Summary
Brief summary
The research project is an investigator-initiated, open-label, randomised controlled trial which will explore the effect of an educational intervention in enhancing the confidence and competence of nursing staff when caring for patients with Haemophilia. The intervention group will receive an educational intervention which will be a PowerPoint presentation. The control group will receive no intervention.

The educational intervention is a 30-60 minute PowerPoint presentation. A link to the recording of the Microsoft Teams presentation will be emailed to participants. The presentation will contain information, graphics, and visual aids relevant to Haemophilia and best-practice nursing care for patients/clients with this condition. Participants will be required to review the educational presentation within 2 weeks. A reminder email will be sent at the end of the 1st and 2nd weeks of access, to remind participants to review the educational presentation.

The control group will receive access to the educational intervention once follow up assessments have been completed by both groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128910 0
Mr Miles Kenny
Address 128910 0
RPAH, Cell & Molecular Therapies, Room EDB.13A, Level 2, Building 89, RPAH, 50 Missenden Road, Camperdown, NSW, 2050, AUSTRALIA
Country 128910 0
Australia
Phone 128910 0
+61 02 9515 8453
Fax 128910 0
02 9515 4868
Email 128910 0
[email protected]
Contact person for public queries
Name 128911 0
Miles Kenny
Address 128911 0
RPAH, Cell & Molecular Therapies, Room EDB.13A, Level 2, Building 89, RPAH, 50 Missenden Road, Camperdown, NSW, 2050, AUSTRALIA
Country 128911 0
Australia
Phone 128911 0
+61 02 9515 8453
Fax 128911 0
02 9515 4868
Email 128911 0
[email protected]
Contact person for scientific queries
Name 128912 0
Miles Kenny
Address 128912 0
RPAH, Cell & Molecular Therapies, Room EDB.13A, Level 2, Building 89, RPAH, 50 Missenden Road, Camperdown, NSW, 2050, AUSTRALIA
Country 128912 0
Australia
Phone 128912 0
+61 02 9515 8453
Fax 128912 0
02 9515 4868
Email 128912 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Only de-identified data will be shared.
When will data be available (start and end dates)?
Individual participant data to be made publicly available immediately following publication with no end date.
Available to whom?
IPD will be made publicly available on a case-by-case basis, at the discretion of the investigator.
Available for what types of analyses?
Data will be available only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20075Study protocol    386463-(Uploaded-31-08-2023-14-08-02)-Study-related document.docx
20076Informed consent form    386463-(Uploaded-28-09-2023-09-28-10)-Study-related document.pdf
20077Data dictionary    386463-(Uploaded-01-09-2023-09-30-07)-Study-related document.pdf
20079Other    Appendix 1 Competency Questionnaire Appendix 2 ... [More Details] 386463-(Uploaded-31-08-2023-14-09-39)-Study-related document.docx
20080Other    Appendix 1 Competency Questionnaire Appendix 2 ... [More Details] 386463-(Uploaded-31-08-2023-14-09-58)-Study-related document.docx
20081Other    Appendix 1 Competency Questionnaire Appendix 2 ... [More Details] 386463-(Uploaded-31-08-2023-14-10-15)-Study-related document.docx
20082Other    Appendix 1 Competency Questionnaire Appendix 2 ... [More Details] 386463-(Uploaded-31-08-2023-14-10-34)-Study-related document.pdf
20083Other    Appendix 1 Competency Questionnaire Appendix 2 ... [More Details] 386463-(Uploaded-31-08-2023-14-10-52)-Study-related document.docx
20084Other    Appendix 1 Competency Questionnaire Appendix 2 ... [More Details] 386463-(Uploaded-28-09-2023-09-26-32)-Study-related document.docx
20085Other    Appendix 1 Competency Questionnaire Appendix 2 ... [More Details] 386463-(Uploaded-31-08-2023-14-11-15)-Study-related document.pdf
20086Other    Appendix 1 Competency Questionnaire Appendix 2 ... [More Details] 386463-(Uploaded-31-08-2023-14-11-27)-Study-related document.pdf
20087Other    Appendix 1 Competency Questionnaire Appendix 2 ... [More Details] 386463-(Uploaded-31-08-2023-14-11-42)-Study-related document.docx
20088Other    Appendix 1 Competency Questionnaire Appendix 2 ... [More Details] 386463-(Uploaded-31-08-2023-14-11-57)-Study-related document.pdf
20089Other    Appendix 1 Competency Questionnaire Appendix 2 ... [More Details] 386463-(Uploaded-31-08-2023-14-12-21)-Study-related document.docx
20518Ethical approval    386463-(Uploaded-28-09-2023-09-24-58)-Study-related document.pdf
20519Other    Appendix 1 Competency Questionnaire Appendix 2 ... [More Details] 386463-(Uploaded-28-09-2023-10-30-35)-Study-related document.pdf



Results publications and other study-related documents

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