Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001044617
Ethics application status
Approved
Date submitted
7/09/2023
Date registered
27/09/2023
Date last updated
27/09/2023
Date data sharing statement initially provided
27/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Strive to Thrive: Piloting a self-management tool for stroke survivors
Scientific title
Strive to Thrive: A pilot study evaluating satisfaction with a self-management tool for stroke survivors
Secondary ID [1] 310563 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
S2T
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 331405 0
Condition category
Condition code
Stroke 328146 328146 0 0
Haemorrhagic
Stroke 328147 328147 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Strive to Thrive is an intervention designed to help people who have had a stroke identify what helps and hinders them at their work and create a personalised action plan to manage the impact of the stroke on their day-to-day work life.
Strive to Thrive involves 3 x 1 hour sessions, held at least one week apart, completed individually with a facilitator (clinical psychologist; clinical psychology intern; stroke nurse) over teleconference. The first session will be brainstorming different thoughts and ideas around factors affecting work and management strategies; an action plan is developed in session 2 using the management strategies identified in session 1 (e.g. ensuring meetings are spaced apart with a break between each) and a review in the third session.
The completed Strive to Thrive forms will be reviewed by the research team to ensure all components have been completed during the sessions.
Intervention code [1] 326961 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336021 0
Satisfaction, assessed by:
- Client Satisfaction Questionnaire-8
- Qualitative interviews (approx. 15 minutes), using a semi-structured interview schedule created for the study; conducted by a member of the research team and audio recorded.
Timepoint [1] 336021 0
Post-intervention (approximately 1 month post-baseline)
Secondary outcome [1] 426498 0
Work ability measured by the Work Ability Index
Timepoint [1] 426498 0
Change from baseline to follow-up (approx. 1 month post-baseline).
Secondary outcome [2] 426499 0
Work productivity, measured by the Work Productivity and Impairment Questionnaire
Timepoint [2] 426499 0
Change from baseline to follow-up (approx. 1 month post-baseline).
Secondary outcome [3] 426500 0
Depression measured by the depression subscale of the Depression, Anxiety and Stress scale-21 (DASS-21)
Timepoint [3] 426500 0
Change from baseline to follow-up (approx. 1 month post-baseline).
Secondary outcome [4] 426501 0
Anxiety measured by the anxiety subscale of the Depression, Anxiety and Stress scale-21 (DASS-21)
Timepoint [4] 426501 0
Change from baseline to follow-up (approx. 1 month post-baseline).
Secondary outcome [5] 426502 0
Stress measured by the stress subscale of the Depression, Anxiety and Stress scale-21 (DASS-21)
Timepoint [5] 426502 0
Change from baseline to follow-up (approx. 1 month post-baseline).

Eligibility
Key inclusion criteria
Inclusion criteria:
* Had experienced a stroke at least one month prior.
* Currently participating in paid or unpaid work outside the home (employment, volunteer work, committee work and so on).
* Able to read and understand English.
* Able to provide informed consent and follow the study protocol.
* Residing in Australia.
* Able to access Zoom (or equivalent) for the sessions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
* Retired.

Study design
Purpose of the study
Educational / counselling / training
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/10/2023
Actual
Date of last participant enrolment
Anticipated
31/01/2024
Actual
Date of last data collection
Anticipated
29/02/2024
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314767 0
University
Name [1] 314767 0
IMPACT, Deakin University
Country [1] 314767 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
HERB, Level 3, PO Box 281, Geelong, VIC, 3220
Country
Australia
Secondary sponsor category [1] 316752 0
None
Name [1] 316752 0
Address [1] 316752 0
Country [1] 316752 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313777 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 313777 0
The Human Research Ethics Office, Deakin University, 221 Burwood Highway, Burwood Victoria 3125
Ethics committee country [1] 313777 0
Australia
Date submitted for ethics approval [1] 313777 0
23/06/2023
Approval date [1] 313777 0
06/09/2023
Ethics approval number [1] 313777 0
2023-217

Summary
Brief summary
Strive to Thrive was created by people with a lived experience of stroke, clinicians and researchers. It is designed to help people who have had a stroke identify what helps and hinders them at their work and create a personalised action plan to manage the impact of the stroke on their day-to-day work life. We want to see if Strive to Thrive is acceptable to a broader group of people who have had a stroke, and make further adjustments and improvements based on their feedback. If Strive to Thrive is acceptable and seen as useful, we can then do a larger study to find out if it has a positive effect on the person who has had a stroke.
Trial website
https://redcap.link/S2Tstudy
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129326 0
Dr Alyna Turner
Address 129326 0
IMPACT TRIALS, Deakin University, HERB B Level 3, PO Box 281, Geelong, VIC, 3220
Country 129326 0
Australia
Phone 129326 0
+61 3 42153313
Fax 129326 0
Email 129326 0
a.turner@deakin.edu.au
Contact person for public queries
Name 129327 0
Dr Alyna Turner
Address 129327 0
IMPACT TRIALS, Deakin University, HERB B Level 3, PO Box 281, Geelong, VIC, 3220
Country 129327 0
Australia
Phone 129327 0
+61 3 42153313
Fax 129327 0
Email 129327 0
a.turner@deakin.edu.au
Contact person for scientific queries
Name 129328 0
Dr Alyna Turner
Address 129328 0
IMPACT TRIALS, Deakin University, HERB B Level 3, PO Box 281, Geelong, VIC, 3220
Country 129328 0
Australia
Phone 129328 0
+61 3 42153313
Fax 129328 0
Email 129328 0
a.turner@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Line by line quantitative data (data underlining published results only)
Aggregated qualitative data
When will data be available (start and end dates)?
Immediately after publication, available for 15 years after publication.
Available to whom?
Researchers who provide a sound proposal
Available for what types of analyses?
IPD meta-analyses
How or where can data be obtained?
Request via email to PI Dr Alyna Turner, a.turner@deakin.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20272Informed consent form    386567-(Uploaded-07-09-2023-14-42-32)-Study-related document.pdf
20273Other    Flyer 386567-(Uploaded-07-09-2023-14-49-40)-Study-related document.pdf



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.