Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000759796
Ethics application status
Approved
Date submitted
3/05/2022
Date registered
27/05/2022
Date last updated
10/05/2023
Date data sharing statement initially provided
27/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Online Mood Assessment Post Stroke Training Program
Scientific title
Online Mood Assessment Post Stroke Training – For Health professionals (in partnership with the Stroke Foundation of Australia).
Secondary ID [1] 307055 0
na
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-stroke Anxiety
326200 0
Post stroke Depression 326201 0
Post Stroke suicidal tendencies 326393 0
Post-Stroke Specific phobias 326394 0
Condition category
Condition code
Mental Health 323501 323501 0 0
Anxiety
Mental Health 323502 323502 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study, a research partnership with the Stroke Foundation was formed to develop and evaluate the online “Mood Assessment Post-Stroke (MAPS)” training program via the Stroke Foundation’s “Inform me” website (a free professional development site for stroke clinicians.The one and a half hour (self-paced) training works through offering participants didactic online lectures explaining the rationale behind screening, instructions on how to screen and respond to various screening results, and how to provide short term care strategies to patients. Within these modules participants will also be shown role play videos modelling how to conduct screening, and will have the opportunity to consolidate their learnings by answering case scenario questions around the process of screening. Participants can then use this training to implement their own routine screening practices within their workplace if they choose.
Objectives of this study include:
To evaluate the online “Mood Assessment Post-Stroke (MAPS)” training program through:
a) Assessing mood screening knowledge and skills via a pre and post training quiz and a consolidation exercise.
b) Validating the Mood Screening Self-Efficacy Questionnaire (MSEQ)
c) Assessing changes in with a screening self-efficacy questionnaire pre and post training.
d) Evaluating the acceptability and feasibility of the training through qualitative feedback.
e) Obtaining self-report feedback on whether routine mood screening has been implemented by participants post-training.
Adherence will be monitored through the engagement multiple choice questions asked throughout the training.
Intervention code [1] 323504 0
Prevention
Comparator / control treatment
Randomised wait list control will be utilised whereby half of the participants will have to wait one week prior to starting the online training.
Control group
Active

Outcomes
Primary outcome [1] 331254 0
Assessing mood screening knowledge via a pre and post training quiz and a consolidation exercise as a composite outcome. The quiz and consolidation exercise were both designed specifically for this study.
Timepoint [1] 331254 0
Immediately before starting the training and immediately after finishing the training intervention. ie. same day the person starts the training they complete the pre-training quiz and the same day the person finishes the training, they complete the post-training quiz and consolidation exercise.
Primary outcome [2] 331255 0
Assessing changes in screening self-efficacy pre and post training using the Mood Screening Post Stroke Self-efficacy Questionnaire - which was designed specifically for this study.
Timepoint [2] 331255 0
Immediately before starting the training and immediately after finishing the training intervention. ie. same day the person starts the training they complete the self-efficacy quiz and the same day the person finishes the training, they complete the self-efficacy quiz again.
Primary outcome [3] 331256 0
Evaluating the acceptability and feasibility of the training through qualitative feedback. An online study-specific questionnaire will be used.
Timepoint [3] 331256 0
One month post intervention completion.
Secondary outcome [1] 409325 0
Obtaining self-report feedback via an online free response feedback field to determine whether routine mood screening has been implemented by participants post-training.
Timepoint [1] 409325 0
One month post-training completion.

Eligibility
Key inclusion criteria
We have adjusted this to all health clinicians who are working in stroke or may be interested in working with stroke patients in the future.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Must have at least provisional license as a health professional to be eligible for the 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)
Allocation will be concealed. Central randomisation by computer will be used. We will be using redcap software for allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). We are using REDCAP software for the randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Waitlist controls must wait one week before starting the online training.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data Analysis:

Validation of the MSEQ:
The association of total scores on the MSEQ completed at time 1 will be considered with respect to whether participants were ‘psychologists or not’, ‘had mental health training or not’, and ‘whether they were experienced in mood screening or not’, using Pearson’s point-biserial correlation coefficient (this is to assess the predictive validity of the measure). The MSEQ will also be correlated with the GSE with a Pearson’s test (this is to assess the convergent validity of the measure).

Reliability of the MSEQ:
The MSEQ’s internal validity will be statistically analysed via Cronbach's alpha. Test-re-test stability / reliability will be investigated using Kendall’s tau-b correlation coefficient.

Efficacy of the training:
Major analysis: Mixed Model Repeated Measure ANOVAs will be used to assess differences in participant’s self-efficacy Pre to Post training across the two groups.
Subsidiary analysis: T-tests will be used to compare mean scores on screening knowledge pre to post intervention. Achievement on consolidation exercises will be recorded.

Acceptability/feasibility of the training:
A reflexive thematic analysis outlined by Braun and Clarke, 2009 will be utilised to analyse qualitative survey feedback.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/05/2023
Actual
Date of last participant enrolment
Anticipated
31/08/2023
Actual
Date of last data collection
Anticipated
1/10/2023
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24747 0
New Zealand
State/province [1] 24747 0
All states
Country [2] 24748 0
United Kingdom
State/province [2] 24748 0
All states

Funding & Sponsors
Funding source category [1] 311360 0
University
Name [1] 311360 0
University of Technology Sydney
Country [1] 311360 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Stroke Foundation
Address
Level 7, 461 Bourke Street Melbourne Victoria 3000
Country
Australia
Secondary sponsor category [1] 312749 0
None
Name [1] 312749 0
Address [1] 312749 0
Country [1] 312749 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310853 0
UTS Human Research Ethics Comittee
Ethics committee address [1] 310853 0
100 Broadway Chippendale NSW 2008
Ethics committee country [1] 310853 0
Australia
Date submitted for ethics approval [1] 310853 0
Approval date [1] 310853 0
09/03/2022
Ethics approval number [1] 310853 0
ETH21-6745

Summary
Brief summary
This study is being conducted in partnership with the Stroke Foundation by Professor Ian Kneebone, Dr Brooke Ryan, and PhD student Rebecca El-Helou. Additionally, Dr Jeffrey Rogers, Dr Di Marsden, and Professor Andrew Baillie also are members of this research project and informed it’s development.The purpose of this research is to evaluate the online Mood Assessment Post Stroke Training program. The aim is to determine whether the training improves self-efficacy, knowledge, and skills in screening for mood problems in stroke survivors, including those with cognitive or communication deficits.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119098 0
A/Prof Ian Kneebone
Address 119098 0
University of Technology Sydney, Graduate School of Health, 100 Broadway, Chippendale NSW 2008
Country 119098 0
Australia
Phone 119098 0
+61295141448
Fax 119098 0
na.
Email 119098 0
ian.kneebone@uts.edu.au
Contact person for public queries
Name 119099 0
Miss Rebecca El-Helou
Address 119099 0
University of Technology Sydney, Graduate School of Health, 100 Broadway, Chippendale NSW 2008
Country 119099 0
Australia
Phone 119099 0
+61 424687505
Fax 119099 0
na
Email 119099 0
rebecca.el-helou@student.uts.edu.au
Contact person for scientific queries
Name 119100 0
Miss Rebecca El-Helou
Address 119100 0
University of Technology Sydney, Graduate School of Health, 100 Broadway, Chippendale NSW 2008
Country 119100 0
Australia
Phone 119100 0
+61424687505
Fax 119100 0
na
Email 119100 0
rebecca.el-helou@student.uts.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.