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Trial registered on ANZCTR
Registration number
ACTRN12624001018505
Ethics application status
Approved
Date submitted
6/08/2024
Date registered
22/08/2024
Date last updated
22/08/2024
Date data sharing statement initially provided
22/08/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Determining whether access to a co-designed website and an online self-management facilitation session improves self-efficacy in survivors of stroke
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Scientific title
Determining whether access to EmpowerMe, a codesigned website and one online Take Charge session improves self-efficacy in survivors of stroke
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Secondary ID [1]
312696
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None
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Universal Trial Number (UTN)
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Trial acronym
ASSET-Stroke
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
stroke
334718
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Condition category
Condition code
Stroke
331277
331277
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0
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Haemorrhagic
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Stroke
331278
331278
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0
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Ischaemic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Prior to this trial, a website (EmpowerMe) has been co-designed with survivors of stroke and carers to enhance self-efficacy after stroke. The website includes a tailoring tool to support users find information relevant to their needs, nine content pages on topics prioritised as most important with regard to self-efficacy by survivors and carers (what is self-efficacy, being involved in decisions about your care and treatment, seeking information you need, advocating for yourself, managing fatigue, managing emotional problems, managing mobility changes, managing speaking difficulties) and a resources bank (fact sheets, internal and external website links, videos). All content pages include video-stories of survivors and carers, text and a downloadable 2-page PDF fact sheet. The website has undergone usability testing and subsequent refinement. Access to the website is password protected and only research participants will have access during the trial period.
Survivors of stroke will be stratified according to age (18-64, 65+) and time since stroke (within 12 months, 12 months or more).
All recruited participants will receive one individual 60-minute Take Charge session via Zoom, delivered by a research nurse or physiotherapist. All people delivering the intervention will receive training prior to delivering any sessions. The survivor can participate in the session on their own or with support people (family members, friends) present.
Delivery of Take Charge will be consistent with delivery described by original investigators (Harwood M, Weatherall M, Talemaitoga A, Barber PA, Gommans J, Taylor W, McPherson K, McNaughton H. Taking charge after stroke: promoting self-directed rehabilitation to improve quality of life - a randomized controlled trial. Clin Rehabil. 2012;26:493-501) although we will deliver sessions online rather than in-person.
The research team member will facilitate discussions on the following topics, which are outlined in a take Charge manual, supplied in hard copy to participants: Hopes for next 12 months, Main fears, My “best day”, Physical things, Communication, Emotional issues, Information needs, Financial issues, My support network, Preventing strokes and heart attacks in the future.
Participants are supported to identify person-centred goals for each of the discussion topics when relevant. Identified goals are written in the booklet. Participants are encouraged to see this process as ongoing, and something they can do on their own. For the identified goals, participants are supported to identify interim steps, and how these can be achieved. In this way, participants are encouraged to “take charge” of working through what matters most, and how to address the things that matter most to them.
On completion of the Take Charge session, participants are provided with the password to access the EmpowerMe website for the following 4 weeks. Frequency and duration of website use will be at the discretion of the participant. Google analytics will be used to monitor access to the website and content within the website. This will measure general, not individual, access to the content and site.
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Intervention code [1]
329225
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Rehabilitation
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Intervention code [2]
329290
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Behaviour
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Intervention code [3]
329291
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Treatment: Other
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
339036
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Self-efficacy
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Assessment method [1]
339036
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Stroke Self-Efficacy scale
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Timepoint [1]
339036
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baseline, 4 weeks post-commencement (primary endpoint), 12 weeks post-commencement
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Primary outcome [2]
339037
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Health-related quality of life
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Assessment method [2]
339037
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36-Item Short Form Survey Instrument (SF-36)
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Timepoint [2]
339037
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baseline, 4 weeks post-commencement (primary endpoint), 12 weeks post-commencement
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Primary outcome [3]
339038
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Participation
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Assessment method [3]
339038
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The Oxford Participation and Activities Questionnaire (OX-PAQ)
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Timepoint [3]
339038
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baseline, 4 weeks post-commencement (primary endpoint), 12 weeks post-commencement
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Secondary outcome [1]
438323
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Anxiety and depression
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Assessment method [1]
438323
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Hospital anxiety and depression scale
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Timepoint [1]
438323
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baseline, 4 weeks post-commencement, 12 weeks post-commencement
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Eligibility
Key inclusion criteria
Survivor of stroke
Living in community
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Living in residential aged care
Full recovery from stroke
Severe communication or cognitive deficit precluding personal written informed consent using aphasia-friendly consent processes
Premorbid condition making 12-month survival unlikely.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
For each individual stratum (4 strata in total, maximum 25 participants per stratum), the proportion of participants with promising response will be evaluated against the pre-specified decision logic thresholds. The decisions to stop recruiting a specific stratum for futility or to continue recruitment will be made. For each stratum, if 12 or more participants of 25 exhibit promising response, this stratum will be deemed as of sufficient promise to be taken into subsequent seamless Phase IIb/III clinical trial. Secondary outcomes will be presented with 95% confidence intervals to inform power analysis of subsequent trials.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
9/09/2024
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Actual
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Date of last participant enrolment
Anticipated
30/05/2025
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Actual
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Date of last data collection
Anticipated
30/11/2025
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
317128
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Government body
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Name [1]
317128
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Medical Research Futures Fund, Department of Health and Aged Care
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Address [1]
317128
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Country [1]
317128
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Australia
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Primary sponsor type
University
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Name
Flinders University
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Address
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Country
Australia
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Secondary sponsor category [1]
319389
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University
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Name [1]
319389
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University of Newcastle
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Address [1]
319389
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Country [1]
319389
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Australia
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Secondary sponsor category [2]
319390
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University
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Name [2]
319390
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Edith Cowan University
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Address [2]
319390
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Country [2]
319390
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Australia
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Secondary sponsor category [3]
319391
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University
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Name [3]
319391
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University of Melbourne
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Address [3]
319391
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Country [3]
319391
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Australia
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Secondary sponsor category [4]
319392
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Charities/Societies/Foundations
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Name [4]
319392
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Stroke Foundation
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Address [4]
319392
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Country [4]
319392
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315880
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Flinders University Human Research Ethics Committee
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Ethics committee address [1]
315880
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https://staff-projects.flinders.edu.au/research-support/integrity/human-ethics
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Ethics committee country [1]
315880
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Australia
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Date submitted for ethics approval [1]
315880
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06/08/2024
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Approval date [1]
315880
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20/08/2024
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Ethics approval number [1]
315880
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5886
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Summary
Brief summary
We have co-designed a website to help improve self-efficacy (feeling of confidence in your abilities) after stroke. Survivors of stroke will be invited to take part in one online "take Charge" session (60 minutes) to discuss what matters most to them, After this session, they will have access to the co-designed website for 4 weeks. We will measure self-efficacy, health-related quality of life and participation before and after the 4 weeks. We would like to test the Take Charge session and access to the website on different groups of survivors to see who the solution looks likely to help. This will guide future research.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
136078
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A/Prof Elizabeth Lynch
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Address
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Caring Futures Institute, College of Nursing and Health Sciences, Flinders University. GPO Box 2100, Adelaide 5001, South Australia
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Country
136078
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Australia
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Phone
136078
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+61 422963471
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Fax
136078
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Email
136078
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[email protected]
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Contact person for public queries
Name
136079
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Elizabeth Lynch
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Address
136079
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Caring Futures Institute, College of Nursing and Health Sciences, Flinders University. GPO Box 2100, Adelaide, 5001, South Australia
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Country
136079
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Australia
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Phone
136079
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+61 422963471
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Fax
136079
0
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Email
136079
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[email protected]
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Contact person for scientific queries
Name
136080
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Elizabeth Lynch
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Address
136080
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Caring Futures Institute, College of Nursing and Health Sciences, Flinders University. GPO Box 2100, Adelaide, 5001, South Australia
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Country
136080
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Australia
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Phone
136080
0
+61 422963471
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Fax
136080
0
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Email
136080
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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