Trial Review

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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
Scientific title
Determining whether access to EmpowerMe, a codesigned website and one online Take Charge session improves self-efficacy in survivors of stroke
Secondary ID [1] 312696 0
None
Universal Trial Number (UTN)
Trial acronym
ASSET-Stroke
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 334718 0
Condition category
Condition code
Stroke 331277 331277 0 0
Haemorrhagic
Stroke 331278 331278 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329225 0
Rehabilitation
Intervention code [2] 329290 0
Behaviour
Intervention code [3] 329291 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339036 0
Self-efficacy
Timepoint [1] 339036 0
baseline, 4 weeks post-commencement (primary endpoint), 12 weeks post-commencement
Primary outcome [2] 339037 0
Health-related quality of life
Timepoint [2] 339037 0
baseline, 4 weeks post-commencement (primary endpoint), 12 weeks post-commencement
Primary outcome [3] 339038 0
Participation
Timepoint [3] 339038 0
baseline, 4 weeks post-commencement (primary endpoint), 12 weeks post-commencement
Secondary outcome [1] 438323 0
Anxiety and depression
Timepoint [1] 438323 0
baseline, 4 weeks post-commencement, 12 weeks post-commencement

Eligibility
Key inclusion criteria
Survivor of stroke
Living in community
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/09/2024
Actual
Date of last participant enrolment
Anticipated
30/05/2025
Actual
Date of last data collection
Anticipated
30/11/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317128 0
Government body
Name [1] 317128 0
Medical Research Futures Fund, Department of Health and Aged Care
Country [1] 317128 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 319389 0
University
Name [1] 319389 0
University of Newcastle
Address [1] 319389 0
Country [1] 319389 0
Australia
Secondary sponsor category [2] 319390 0
University
Name [2] 319390 0
Edith Cowan University
Address [2] 319390 0
Country [2] 319390 0
Australia
Secondary sponsor category [3] 319391 0
University
Name [3] 319391 0
University of Melbourne
Address [3] 319391 0
Country [3] 319391 0
Australia
Secondary sponsor category [4] 319392 0
Charities/Societies/Foundations
Name [4] 319392 0
Stroke Foundation
Address [4] 319392 0
Country [4] 319392 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315880 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 315880 0
Ethics committee country [1] 315880 0
Australia
Date submitted for ethics approval [1] 315880 0
06/08/2024
Approval date [1] 315880 0
20/08/2024
Ethics approval number [1] 315880 0
5886

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136078 0
A/Prof Elizabeth Lynch
Address 136078 0
Caring Futures Institute, College of Nursing and Health Sciences, Flinders University. GPO Box 2100, Adelaide 5001, South Australia
Country 136078 0
Australia
Phone 136078 0
+61 422963471
Fax 136078 0
Email 136078 0
elizabeth.lynch@flinders.edu.au
Contact person for public queries
Name 136079 0
Elizabeth Lynch
Address 136079 0
Caring Futures Institute, College of Nursing and Health Sciences, Flinders University. GPO Box 2100, Adelaide, 5001, South Australia
Country 136079 0
Australia
Phone 136079 0
+61 422963471
Fax 136079 0
Email 136079 0
elizabeth.lynch@flinders.edu.au
Contact person for scientific queries
Name 136080 0
Elizabeth Lynch
Address 136080 0
Caring Futures Institute, College of Nursing and Health Sciences, Flinders University. GPO Box 2100, Adelaide, 5001, South Australia
Country 136080 0
Australia
Phone 136080 0
+61 422963471
Fax 136080 0
Email 136080 0
elizabeth.lynch@flinders.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.