Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000723482
Ethics application status
Approved
Date submitted
21/05/2025
Date registered
7/07/2025
Date last updated
7/07/2025
Date data sharing statement initially provided
7/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the feasibility and acceptability of a tailored support package for informal stroke carers
Scientific title
An evaluation of the feasibility and acceptability of a tailored support package for informal carers of stroke survivors
Secondary ID [1] 314322 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Caregiver burden 337275 0
Depression 337793 0
Anxiety 337276 0
Condition category
Condition code
Mental Health 334137 334137 0 0
Depression
Stroke 333679 333679 0 0
Haemorrhagic
Mental Health 333680 333680 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The tailored support package is a 12-week program designed for informal carers of people who have had a stroke. The program has been co-designed with carers and allied healthcare professionals to ensure the program is addressing carer needs and priorities.

Once enrolled, Participants will be asked to complete a sociodemographic questionnaire to collect information such as age, sex, relationship to stroke patient etc. Participants will also be asked to indicate and provide their preferred method of contact (phone call, zoom, text, email) for regular ‘check-in sessions’ to be conducted by a member of the research team every 3 weeks for the duration of the study. Participants will be advised that they can opt in for additional ‘check in sessions’ and provided a link to do this.

Participants will then be asked to attend the inpatient unit where the stroke patient is admitted to engage in an initial session (~15 minutes) with an allied healthcare professional. During this initial contact healthcare professionals will provide carers with the core resource booklet resource including topics on stoke education (e.g., signs and symptoms, types of stroke, stroke rehabilitation), the role of healthcare professionals, strategies to promote carer health and wellbeing, carer stories, and support services. This core resource was developed specifically for this study using a co-design approach that involved stroke carers and healthcare professionals to ensure it met the needs of end users. Then, the healthcare professionals will go through a standardised checklist via Qualtrics with a list of additional topics (i.e., additional stroke resources, funding schemes, healthy habits, etc.) and participants will be asked to indicate which topics they would like more information on and whether they would like the information to be detailed or brief (this will determine the versions of the tailored support documents that will be provided). This list of topics will also be available within the core resource booklet for participants to review in their own time. If participants would like to request further information on any of the topics they can do so throughout the program.

Following this initial session, a member of the research team will contact the participant via the preferred method and provide them with a tailored resource package including the preferred topics that the informal carer selected during the initial session with the allied health professional.

Starting from week three of the program participants will be provided with a "check in" session every three weeks (~15-30 minutes) for the duration of the program. This contact will be made by a member of the research team who is a qualified healthcare professional with relevant experience. "Check in" sessions will be conducted with participants to provide an opportunity for participants to ask any questions, request additional information, and ensure they are aware of support services that are available for informal carers. Regular check ins may also help to support the general wellbeing of the participants as they navigate the carer role. During “check in” sessions, a member of the research team initiating the contact will use a standardised observation form through Qualtrics to record general notes around topics discussed and questions. This will also be used to track attendance and what information participants are requesting information on and at what time point.
Intervention code [1] 330936 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341789 0
Acceptability and Satisfaction
Timepoint [1] 341789 0
3 months post-discharge (end of program)
Primary outcome [2] 341271 0
Recruitment
Timepoint [2] 341271 0
Baseline (just prior to stroke patient discharge)
Primary outcome [3] 341790 0
Attendance
Timepoint [3] 341790 0
Tracked across program and assessed at 3 months post-discharge (end of program)
Secondary outcome [1] 446987 0
Depression
Timepoint [1] 446987 0
Baseline (just prior to stroke patient discharge) and 3 months post-discharge (end of program)
Secondary outcome [2] 446982 0
Carer Satisfaction
Timepoint [2] 446982 0
Baseline (just prior to stroke patient discharge) and 3 months post-discharge (end of program)
Secondary outcome [3] 449265 0
Support Needs
Timepoint [3] 449265 0
Baseline and throughout 12 week program.
Secondary outcome [4] 446981 0
Self-efficacy
Timepoint [4] 446981 0
Baseline (just prior to stroke patient discharge) and 3 months post-discharge (end of program)
Secondary outcome [5] 449267 0
Retention (additional primary outcome)
Timepoint [5] 449267 0
Baseline (just prior to stroke patient discharge) and 3 months post-discharge (end of program)
Secondary outcome [6] 448703 0
Anxiety
Timepoint [6] 448703 0
Baseline (just prior to stroke patient discharge) and 3 months post-discharge (end of program)

Eligibility
Key inclusion criteria
• Being a carer for someone with a current diagnosis of stroke (first or subsequent) or transient ischaemic attack;
• Stroke patient is not living in residential care prior to admission to hospital, or having residential care as the planned discharge destination;
• Adequate English to provide written consent and participate in sessions and complete the checklist.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Stroke patient for whom care is being provided is living in a residential care facility or supported independent living.
• Stroke patient for whom care is being provided has evidence of a co-existing malignant or other rapidly progressive medial disease (e.g., multiple sclerosis, Parkinson’s, cancer).

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
31/07/2025
Actual
Date of last participant enrolment
Anticipated
1/09/2025
Actual
Date of last data collection
Anticipated
15/12/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27856 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [2] 27858 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [3] 27857 0
Camden Hospital - Camden
Recruitment postcode(s) [1] 44053 0
2560 - Campbelltown
Recruitment postcode(s) [2] 44052 0
2570 - Camden
Recruitment postcode(s) [3] 44051 0
2200 - Bankstown

Funding & Sponsors
Funding source category [1] 318842 0
University
Name [1] 318842 0
Western Sydney University
Country [1] 318842 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Country
Australia
Secondary sponsor category [1] 321298 0
None
Name [1] 321298 0
Address [1] 321298 0
Country [1] 321298 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317459 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 317459 0
Ethics committee country [1] 317459 0
Australia
Date submitted for ethics approval [1] 317459 0
26/02/2025
Approval date [1] 317459 0
02/06/2025
Ethics approval number [1] 317459 0
2025/ETH00416

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

Contacts
Principal investigator
Name 141102 0
Ms Melissa Jammal
Address 141102 0
School of Health Sciences Western Sydney University PO Box 1797, Penrith NSW 2751
Country 141102 0
Australia
Phone 141102 0
+61 2 4620 3257
Fax 141102 0
Email 141102 0
[email protected]
Contact person for public queries
Name 141103 0
Melissa Jammal
Address 141103 0
School of Health Sciences Western Sydney University PO Box 1797, Penrith NSW 2751
Country 141103 0
Australia
Phone 141103 0
+61 2 4620 3257
Fax 141103 0
Email 141103 0
[email protected]
Contact person for scientific queries
Name 141104 0
Melissa Jammal
Address 141104 0
School of Health Sciences Western Sydney University PO Box 1797, Penrith NSW 2751
Country 141104 0
Australia
Phone 141104 0
+61 2 4620 3257
Fax 141104 0
Email 141104 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.